[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"lung-cancer-nsclc\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:lung-cancer-nsclc":32},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,76,0,25,[9,58,96,126,149,179,227,252,281,308,341,364,394,427,454,475,502,521,545,565,591,611,629,650,676],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":35,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":46,"lastUpdatePostDateStruct":47,"startDateStruct":50,"completionDateStruct":52,"leadSponsor":54,"locationsCount":57},"100652721","phase-3-study-of-pembrolizumab--pemetrexed--platinum-chemotherapy-with-or-without-zoldonrasib-as-first-line-treatment-in-metastatic-non-squamous-ras-g12d-mutated-nsclc-100652721",false,"NCT07777822","Study of Pembrolizumab + Pemetrexed + Platinum Chemotherapy With or Without Zoldonrasib as First Line Treatment in Metastatic Non-squamous RAS G12D-Mutated NSCLC","A Randomized, Double-blind, Phase 3 Study of Pembrolizumab + Pemetrexed + Platinum Chemotherapy With or Without Zoldonrasib (RMC-9805) as First Line Treatment in Patients With Metastatic Non-squamous RAS G12D-Mutated Non-small Cell Lung Cancer (RASolve 308)","RASolve 308","Inclusion Criteria:\n\n* At least 18 years old and has provided informed consent.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Histologically or cytologically confirmed, previously untreated metastatic non-squamous NSCLC.\n* Known PD-L1 status\n* Documented RAS G12D mutation status.\n* Measurable disease per RECIST v1.1.\n* Adequate organ function (bone marrow, liver, kidney, coagulation, thyroid).\n* Able to take oral medications.\n\nExclusion Criteria:\n\n* Prior treatment with systemic anticancer therapy in metastatic setting for NSCLC.\n* Prior systemic therapy with any RAS-directed therapy.\n* Untreated (symptomatic or asymptomatic) central nervous system metastatic disease.\n* Any conditions that may affect the ability to take or absorb study drug.\n* Major surgery on or within 28 days prior to randomization.\n* Patient is unable or unwilling to comply with protocol-required study visits or procedures.\n* Additional inclusion and exclusion criteria may apply","ALL","18 Years",{"count":21,"type":22},430,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","The purpose of this study is to evaluate the efficacy of an investigational RAS(ON) inhibitor administered in combination with pembrolizumab and platinum-based chemotherapy doublet compared to placebo in combination with pembrolizumab and platinum-based chemotherapy doublet.",[28,29,30,31,32,33,34],"NSCLC","Non-small Cell Lung Cancer","Non-Small Cell Lung Cancer NSCLC","Non-Squamous Non Small Cell Lung Cancer","Lung Cancer (NSCLC)","Metastatic NSCLC - Non-Small Cell Lung Cancer","Metastatic Non-Squamous Non-Small Cell Lung Cancer",[28,36,31,34,37,38,39,40,41,42,43,44],"Non-Small Cell Lung Cancer","RAS","KRAS","NRAS","HRAS","RAS Mutation","Lung Cancer","G12D","RAS G12D","RECRUITING","2026-08-17",{"date":48,"type":49},"2026-08-20","ACTUAL",{"date":51,"type":49},"2026-08-14",{"date":53,"type":22},"2031-02",{"name":55,"class":56},"Revolution Medicines, Inc.","INDUSTRY",1,{"id":59,"slug":60,"hasResults":12,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":4,"eligibilityCriteria":64,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":65,"targetDuration":4,"studyType":23,"phases":67,"briefSummary":69,"conditions":70,"keywords":78,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":51,"lastUpdatePostDateStruct":88,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":95},"100630545","phase-2-symbiotic-lung-10-a-study-to-learn-about-pf-08634404-alone-or-in-combination-in-early-stage-or-locally-advanced-nsclc-100630545","NCT07489066","Symbiotic-Lung-10: A Study to Learn About PF-08634404 Alone or in Combination in Early-stage or Locally Advanced NSCLC","AN INTERVENTIONAL, OPEN-LABEL, PHASE 2 STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF PF-08634404 MONOTHERAPY OR IN COMBINATION IN ADULT PARTICIPANTS WITH EARLY-STAGE RESECTABLE OR LOCALLY ADVANCED UNRESECTABLE NON-SMALL CELL LUNG CANCER","Inclusion Criteria:\n\n* 18 years of age or older at screening.\n* Have tumor tissue available, either paraffin block or slides from a core, excisional or fine needle biopsy\n* PD-L1 status available based on local testing results\n* Adequate organ function\n* Eastern Cooperative Oncology Group performance status (ECOG) score of 0 or 1\n* Part A only: Participants must have newly diagnosed, previously untreated, pathologically confirmed early-stage or LA (Stage II or IIIA\u002FB), squamous or non-squamous NSCLC (according to the 9th edition of the Union for International Cancer Control and American Joint Committee on Cancer lung cancer TNM staging system) with disease that is considered resectable, as assessed by a multidisciplinary evaluation, which must include a thoracic surgeon who performs lung cancer surgery as a prominent part of his\u002Fher practice. The participant must be a candidate for neoadjuvant therapy followed by complete surgical resection.\n* Part B only: Participants must have pathologically confirmed early-stage or LA (Stage II or IIIA\u002FB), squamous or non-squamous NSCLC (according to the 9th edition of the Union for International Cancer Control and American Joint Committee on Cancer lung cancer TNM staging system) and have undergone complete surgical resection. The participant must be considered a candidate for adjuvant therapy and must not have achieved pCR with SOC neoadjuvant chemo-immunotherapy.\n* Part C only: Participants must have pathologically confirmed LA, unresectable (Stage III) squamous or non-squamous NSCLC (according to the 9th edition of the Union for International Cancer Control and American Joint Committee on Cancer lung cancer TNM staging system) and have received ≥ 60 Gy of radiation and ≥ 2 cycles of definitive, platinum-based concurrent chemotherapy and achieved SD or better per RECIST 1.1.\n\nExclusion Criteria:\n\n* Participants with known EGFR and ALK AGAs; documented negative results for EGFR and ALK AGAs are required for participants with non-squamous histology.\n* Participants with CNS lesions, including leptomeningeal metastasis, brainstem, meningeal, or spinal cord metastases or compression.\n* Participants with clinically significant risk of hemorrhage or fistula are excluded.\n* Participants with any history of another malignancy within 3 years before the first dose of study intervention, or any evidence of residual disease from a previously diagnosed malignancy.\n* Unresolved toxicities from prior anti-tumor therapy, that did not recover to NCI CTCAE v5.0 Grade 0 or 1.\n* Known to have a history of a severe allergy to any component of the study intervention, or a history of severe allergic reaction to chimeric or humanized antibody.\n* History of allogeneic organ \u002F hematopoietic stem cell transplantation.\n* Participants with any of the following respiratory conditions:\n\n  * Evidence of noninfectious or drug-induced interstitial lung disease (ILD) or pneumonitis\n  * Grade ≥3 pulmonary disease unrelated to underlying malignancy\n* History of uncontrolled comorbidities within 6 months prior to the first dose including uncontrolled cardiac and cerebrovascular conditions, hypertension, diabetes, significant vascular disease or arterial\u002Fsevere venous thromboembolic events.\n* Major surgery \\\u003C 4 weeks or minor surgery \\\u003C 3 days prior to first dose of study intervention.\n* History of severe bleeding tendency or coagulation dysfunction\n* History of esophageal varices, severe ulcers, unhealed wounds, gastrointestinal perforation, abdominal fistula, gastrointestinal obstruction, intra-abdominal abscess, or acute gastrointestinal bleeding within 6 months prior to the first dose.\n* Participants with acute, chronic or symptomatic infections including participants positive for active HIV, hepatitis B virus (HBV), or Hepatitis C virus (HCV).\n* Participants with history of immunodeficiency\n* Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation\u002Fbehavior (in the past 5 years) or laboratory abnormality that may increase the risk of study participation or make the participant inappropriate for the study.\n* Breastfeeding participants, participants of childbearing potential, and male participants who are unwilling to follow contraceptive measures.",{"count":66,"type":22},120,[68],"PHASE2","This study is being done to learn more about a new medicine called PF-08634404. The study team wants to understand how well it works when given alone or with chemotherapy. The study is for adults with early stage or locally advanced non-small cell lung cancer (NSCLC) that may or may not be removable with surgery.\n\nThe study is seeking participants who:\n\n* Are aged 18 years or older\n* Have either:\n\n  * Early-stage or locally advanced (Stage II or IIIA\u002FB) NSCLC and are a candidate for neoadjuvant therapy, followed by surgical removal of the tumor. Neoadjuvant therapy is a treatment given as a first step to shrink the tumor before surgery.\n  * Early-stage or locally advanced (Stage II or IIIA\u002FB) NSCLC and are a candidate for adjuvant therapy and did not achieve a pathological complete response (pCR) from approved treatment that was administered before surgery. Adjuvant therapy is an additional cancer treatment given after the primary treatment to lower the risk that the cancer will come back. pCR is defined as absence of viable tumor in all surgically removed samples.\n  * Locally advanced (Stage III) NSCLC that may not be removable with surgery, was treated with concurrent chemoradiotherapy (cCRT), and is a candidate for additional treatment, otherwise known as consolidation therapy. cCRT is chemotherapy and radiation given simultaneously.\n* Be in good physical condition and have healthy organs based on medical tests.\n* Do not have known actionable changes in DNA\n\nThe study has 3 parts and each participant will be assigned to one part by their doctor based on their disease diagnosis:\n\n* Part A will test PF-08634404 given with chemotherapy in the neoadjuvant setting, followed by surgery.\n* Part B will test PF-08634404 alone in adults who already were treated with neoadjuvant chemo-immunotherapy, underwent surgery, and did not achieve pCR per tumor tissue pathology analysis. Neoadjuvant chemo-immunotherapy refers to the combination of chemotherapy with immunotherapy per local standard-of-care, given before surgical removal of the tumor.\n* Part C will test PF-08634404 alone in adults with unresectable disease who received cCRT and did not have progressive disease. Progressive disease refers to a condition that grows, spreads, or worsens.\n\nAll treatments will be done at clinical study sites, where a trained medical team will monitor adults during and after each visit.",[71,72,32,73,74,75,36,76,77],"Carcinoma","Non-Small-Cell Lung","Lung Neoplasms","Carcinoma, Non-Small-Cell Lung (NSCLC)","Lung Disease","Non-small Cell Lung Cancer, Non-squamous","Non-small Cell Lung Cancer, Squamous",[79,28,80,81,82,83,84,85,86,87],"early stage non small cell lung cancer","adjuvant NSCLC","locally advanced non small cell lung cancer","resectable NSCLC","unresectable NSCLC","neoadjuvant NSCLC","consolidation NSCLC","squamous NSCLC","non-squamous NSCLC",{"date":46,"type":49},{"date":90,"type":49},"2026-06-30",{"date":92,"type":22},"2031-07-30",{"name":94,"class":56},"Pfizer",17,{"id":97,"slug":98,"hasResults":12,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":4,"eligibilityCriteria":102,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":103,"enrollmentInfo":104,"targetDuration":4,"studyType":23,"phases":106,"briefSummary":107,"conditions":108,"keywords":111,"overallStatus":116,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":4},"100645831","phase-2-first-line-therapy-with-egfr-tki-combined-with-trastuzumab-rezetecan-for-advanced-nsclc-harboring-egfr-mutations-concomitant-with-her2-alterations-100645831","NCT07699952","First-line Therapy With Epidermal Growth Factor Receptor-Tyrosine Kinase Inhibitor(EGFR-TKI) Combined With Trastuzumab Rezetecan for Advanced Non-small Cell Lung Cancer(NSCLC) Harboring EGFR Mutations Concomitant With Human Epidermal Growth Factor Receptor 2(HER2) Alterations","First-line Therapy With EGFR-TKI Combined With Trastuzumab Rezetecan for Advanced NSCLC Harboring EGFR Mutations Concomitant With HER2 Alterations","Inclusion Criteria:\n\n1. Aged 18-75 years, male or female without restriction;\n2. Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1; Estimated survival time ≥ 3 months;\n3. Histologically or cytologically confirmed unresectable locally advanced or metastatic non-small cell lung cancer (NSCLC);\n4. At least one measurable lesion per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1);\n5. No prior systemic anti-tumor therapy before enrollment (oral EGFR-TKI administered within 2 weeks prior to screening is permitted);\n6. Confirmed EGFR mutations via genetic testing, including Exon 19 deletion or L858R point mutation;\n7. Presence of HER2 alterations, any of the following subtypes is acceptable: confirmed HER2 mutations or amplification by genetic testing; HER2 low expression or overexpression by immunohistochemistry (IHC 1+\u002F2+\u002F3+);\n8. Adequate laboratory parameters. No blood product transfusion or hematopoietic growth factor support administered within 14 days prior to the first study drug dose to correct lab abnormalities.\n9. Female subjects of childbearing potential must have a negative serum pregnancy test within 3 days before the initial study drug administration. 10. They must agree to use a medically approved highly effective contraceptive method (e.g., intrauterine device, oral contraceptives, condoms) throughout the study and for 180 days after the last dose of study drug. Male subjects with female partners of childbearing potential must be surgically sterilized or agree to effective contraception during the study and for 180 days after the last study drug administration.\n\n11\\. Voluntarily participate in this trial, sign written informed consent, demonstrate good treatment compliance, and agree to complete all scheduled visits and study-related procedures.\n\n12\\. Estimated survival time ≥ 3 months.\n\nExclusion Criteria:\n\n1. Histologically confirmed tumor containing small cell lung cancer components.\n2. Medical history of interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis requiring steroid intervention, or any clinical evidence of active ILD.\n3. Symptomatic or actively progressive central nervous system (CNS) metastases or leptomeningeal metastases confirmed by CT\u002FMRI during screening and prior to radiological assessment.\n\n   Asymptomatic patients with stable CNS lesions who have received local therapy may be enrolled only if all of the following criteria are simultaneously met:\n\n   Fewer than 5 brain metastatic lesions; At least one measurable lesion per RECIST v1.1 exists outside the CNS; No history of intracranial or spinal hemorrhage; No neurosurgical resection within 28 days prior to the first study treatment dose, no whole-brain radiotherapy within 14 days, and no stereotactic radiotherapy within 7 days; Imaging confirms lesion stability for at least 4 weeks before enrollment, and systemic steroid therapy has been discontinued for more than 2 weeks (equivalent to ≤10 mg prednisone per day or equivalent steroids); Metastases do not involve the midbrain, pons, medulla oblongata, or spinal cord.\n4. Subjects requiring systemic corticosteroids or other immunosuppressive agents within 14 days before the first study drug administration. 5. Nasal\u002Finhaled corticosteroids or physiological doses of systemic steroids (i.e., ≤10 mg prednisolone per day or equivalent physiological doses of other corticosteroids) are excluded from this restriction.\n\n6\\. Received systemic anti-tumor vaccines, anti-tumor traditional Chinese herbal medicines, or immunomodulatory drugs (including thymopeptides, interferons, interleukins, excluding local administration for pleural effusion control) within 4 weeks prior to the first dose.\n\n7\\. Prior anti-HER2 therapy or anticipated need for any other anti-tumor treatment during the study.\n\n8\\. History of other malignant tumors within 5 years before enrollment, except for in situ carcinomas that have achieved complete remission after treatment and require no additional therapy during the trial.\n\n9\\. Received live attenuated vaccines within 4 weeks before the first dose or planned to receive such vaccines during the study.\n\n10\\. Currently receiving treatment in another interventional clinical trial, or administered any other investigational product\u002Fdevice within 4 weeks before the first study dose.\n\n11\\. Complicated with severe infection, localized infection within 4 weeks prior to the first dose (including but not limited to infectious complications requiring hospitalization or ≥2 weeks of intravenous antibiotics, bacteremia, severe pneumonia, etc.), or any active infectious disease.\n\n12\\. History of active tuberculosis infection within 1 year before the first dose.\n\nDiagnosis of any active, known or suspected autoimmune disease, or past medical history of autoimmune disease. Subjects with stable disease not requiring systemic immunosuppressants are eligible for enrollment.\n\nHBsAg positive with HBV DNA above the upper limit of normal (1000 copies\u002FmL or 500 IU\u002FmL); HCV positivity indicating acute or chronic HCV infection via HCV RNA or HCV antibody testing; active hepatitis B or C; known HIV positivity or AIDS diagnosis.\n\n13\\. Received major surgery within 4 weeks before the first dose; invasive minor procedures (catheter placement, biopsy, bronchoscopy) within 7 days before the first dose; non-thoracic radiotherapy \\>30 Gy within 4 weeks before the first dose; thoracic radiotherapy \\>30 Gy within 24 weeks before the first dose; or palliative radiotherapy \\\u003C30 Gy within 2 weeks before the first dose.\n\n14\\. Have not fully recovered from toxicities and\u002For complications induced by any prior interventions before the first dose (i.e., residual toxicity \\> Grade 1 or not returned to baseline; fatigue and alopecia are exempted).\n\n15\\. Grade ≥2 myocardial ischemia or myocardial infarction; uncontrolled arrhythmia (QTc interval ≥450 ms for males, ≥470 ms for females); New York Heart Association (NYHA) Class III-IV cardiac insufficiency; or left ventricular ejection fraction (LVEF) \\\u003C50% on echocardiography.\n\n16\\. History of severe bleeding events, arterial\u002Fvenous thrombosis, or pulmonary embolism.\n\n17\\. Patients at risk of gastrointestinal perforation. 18. History of allogeneic solid organ transplantation or allogeneic hematopoietic stem cell transplantation.\n\n19\\. Uncontrolled pleural effusion, pericardial effusion or ascites requiring repeated drainage.\n\n20\\. Known allergy, hypersensitivity or intolerance to the study drug or its excipients.\n\n21\\. Diagnosed with psychiatric disorders or substance abuse; female patients who are pregnant, breastfeeding, or planning pregnancy during the trial.\n\n22\\. Any medical condition that, in the Investigator's judgment, may harm the subject or prevent the subject from complying with study requirements and procedures.","75 Years",{"count":105,"type":22},35,[68],"To explore the efficacy and safety of first-line EGFR-TKI combined with Trastuzumab Rezetecan in advanced NSCLC patients harboring EGFR mutations with concomitant HER2 genomic alterations or HER2 protein expression (1+\u002F2+\u002F3+)",[32,109,110],"EGFR Activating Mutation","HER2",[112,113,114,115],"EGFR","ERBB2","TKI","ADC","NOT_YET_RECRUITING","2026-08-13",{"date":46,"type":49},{"date":120,"type":22},"2026-09-09",{"date":122,"type":22},"2029-03",{"name":124,"class":125},"Yongsheng Wang","OTHER",{"id":127,"slug":128,"hasResults":12,"nctId":129,"briefTitle":130,"officialTitle":130,"acronym":4,"eligibilityCriteria":131,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":132,"targetDuration":4,"studyType":23,"phases":134,"briefSummary":136,"conditions":137,"keywords":4,"overallStatus":116,"whyStopped":4,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":57},"100626532","phase-1-whole-body-her2-quantification-with-89zr-trastuzumab-petct-to-asses-zr-trastuzumab-accumulation-in-her2-mutated-and-her2-overexpressing-metastatic-non-small-cell-lung-cancer-100626532","NCT07436858","Whole Body HER2 Quantification With 89Zr-Trastuzumab PET\u002FCT to Asses Zr-trastuzumab Accumulation in HER2-mutated and HER2-overexpressing Metastatic Non-small Cell Lung Cancer","Inclusion Criteria:\n\n* Signed written informed consent\n* Age≥ 18 years, willing and able to comply with the protocol as judged by the investigator\n* Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1 at screening.\n* Patients with histologically or cytologically confirmed diagnosis of advanced stage:\n* HER2 overexpression, defined as an immunohistochemistry score (IHC) of 2+ or 3+ in at least 10% of tumour cells without an activating HER2 mutation\n* HER2 activating (insertion) mutation diagnosed through RNA sequencing (RNAseq)\n* Disease progression after at least one line of platinum-based chemotherapy ± immunotherapy and starting (new) systemic treatment.\n* Be willing to provide a recent tumor tissue specimen after the last line of therapy. Samples must be of sufficient quantity and of adequate tumor tissue content.\n* Able to undergo PET imaging procedures.\n* Measurable disease according to RECIST 1.1.\n* At least two measurable lesions with a long axis diameter ≥2 cm.\n* Adequate organ and bone marrow function within 21 days prior to tracer injection, defines as:\n\nLaboratory Test Laboratory Value Platelet count ≥100 000\u002Fmm3 or ≥100 × 109\u002FL (platelet transfusions are not allowed up to 14 days prior to Cycle 1 Day 1 to meet eligibility) Hemoglobin ≥9.0 g\u002FdL or 5.6 mmol\u002FL (transfusion and\u002For growth factor support is allowed) Absolute neutrophil count (ANC) ≥1500\u002Fmm3 or ≥1.5 × 109\u002FL Aspartate aminotransferase \u002Falanine aminotransferase ≤3 × ULN (if liver metastases are present, ≤5 ×ULN) Total bilirubin ≤1.5 × ULN if no liver metastases (\\\u003C3 x ULN in the presence of documented Gilbert's Syndrome (unconjugated hyperbilirubinemia) or liver metastases Creatinine Creatinine clearance (CrCl) ≥30 mL\u002Fmin as calculated using the Cockcroft-Gault equation.\n\nInternational normalised ratio (INR)\u002FProthrombin time and activated partial thromboplastin time (aPTT) ≤1.5 × (ULN), except for subjects on coumarinderivative anticoagulants or other similar anticoagulant therapy, who must have PT-INR within therapeutic range as deemed appropriate by the Investigator\n\n* Women aged \\\u003C50 years will be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels in the post-menopausal range for the site.\n* Women aged ≥ 50 years will be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses \\>1 year ago, had chemotherapy-induced menopause with last menses \\>1 year ago.\n* Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the contraception methods outlined for women of childbearing potential if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to randomization\u002Fstudy enrolment. For most forms of HRT, at least 2-4 weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their post-menopausal status, they can resume use of HRT during the study without use of a contraceptive method.\n* Female patients of childbearing potential who are sexually active with a non-sterilized male partner must use at least one highly effective method of contraception, presented in Table 3. from the time of screening and must agree to continue using such precautions for 7 months after the last dose of IMP. Not all methods of contraception are highly effective. Female patients must refrain from breastfeeding while on study and for 7 months after the last dose of IMP. Complete heterosexual abstinence for the duration of the study and drug washout period is an acceptable contraceptive method if it is line with the patient's usual lifestyle (consideration must be made to the duration of the clinical trial); however, periodic or occasional abstinence, the rhythm method, and the withdrawal method are not acceptable.\n* Female subjects must not donate, or retrieve for their own use, ova from the time of screening and throughout the study treatment period, and for at least 7 months after the final study drug administration\n* Highly Effective Methods of Contraception (\\\u003C1% failure rate) include:\n\n  * Total heterosexual abstinence (evaluate in relation to the duration of the clinical study and the preferred and usual lifestyle choice of the participant)\n  * Vasectomised sexual partner (provided that partner is the sole sexual partner of the trial participant and that the vasectomised partner has received medical assessment of the surgical success)\n  * Bilateral tubal occlusion\n  * Intrauterine device (provided coils are copper banded)\n  * Combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation i. Oral ii. Intravaginal iii. transdermal\n  * Progestogen-only hormonal contraception associated with inhibition of ovulation (oral\u002Finjectable\u002Fimplantable)\n  * Intrauterine hormone-releasing system (IUS)\n  * All methods of contraception must be used in combination with the use of a condom by their male sexual partners for intercourse.\n\nExclusion Criteria:\n\n* Contraindications for systemic treatment (as will be assigned by the treating physician)\n* Pregnant or lactating women\n* Prior allergic reaction to immunoglobulins or immunoglobulin allergy\n* Inability to comply with study procedures\n* Has substance abuse or any other medical conditions such as clinically significant cardiac or psychological conditions, that may, in the opinion of the investigator, interfere with the subject's participation in the clinical study or evaluation of the study results\n* Prior treatment with HER2-targeted therapies (except pan HER TKIs).",{"count":133,"type":22},20,[135],"PHASE1","The investigators investigate whether PET imaging with ⁸⁹Zr-trastuzumab can reliably demonstrate the extent of tracer accumulation in tumors of patients with HER2-mutated or HER2-overexpressing non-small cell lung cancer (NSCLC). The aim is to determine whether differences in tracer uptake can be detected between these groups, as translational studies indicate that HER2-mutated tumors may internalize trastuzumab-based agents more efficiently than tumors that solely overexpressed HER2.",[32,138,139],"HER2 Expression","HER2 Gene Mutation","2026-08-07",{"date":142,"type":49},"2026-08-11",{"date":144,"type":22},"2026-09-07",{"date":146,"type":22},"2030-07-07",{"name":148,"class":125},"The Netherlands Cancer Institute",{"id":150,"slug":151,"hasResults":12,"nctId":152,"briefTitle":153,"officialTitle":154,"acronym":4,"eligibilityCriteria":155,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":156,"targetDuration":4,"studyType":23,"phases":158,"briefSummary":159,"conditions":160,"keywords":165,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":169,"lastUpdatePostDateStruct":170,"startDateStruct":172,"completionDateStruct":174,"leadSponsor":176,"locationsCount":178},"100602773","phase-1-a-study-of-phn-012-in-patients-with-advanced-solid-tumors-100602773","NCT07127874","A Study of PHN-012 in Patients With Advanced Solid Tumors","First-in-Human, Phase 1 Study of PHN-012, an Antibody Drug Conjugate, in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n* Has histologically confirmed, advanced\u002Fmetastatic:\n\n  1. Colorectal adenocarcinoma (CRC), or\n  2. Non-small cell lung cancer (NSCLC), or\n  3. Pancreatic ductal adenocarcinoma (PDAC).\n* Has received at least one prior systemic therapy and radiologically or clinically determined progressive disease during or after the most recent line of therapy, and for whom no further standard therapy is available or who is intolerant to standard therapy.\n* Has measurable disease.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Has adequate organ function.\n* Has available tumor tissue sample at screening (either an archival specimen or fresh biopsy material).\n\nExclusion Criteria:\n\n* Had prior treatment with any ADC containing topoisomerase-1 inhibiting payload.\n* Has unstable central nervous system metastasis.\n* Has persistent toxicities from previous systemic anti-cancer treatments of Grade \\>1.\n* Has received systemic anti-neoplastic therapy within five half-lives or 21 days, whichever is shorter, prior to first dose of the study drug.\n* Has received wide-field radiotherapy (\\> 30% of marrow-bearing bones) within 28 days, or focal radiation for analgesic purpose or for lytic lesions at risk of fracture within 14 days prior to first dose of the study drug, or no recovery from side effects of such intervention.\n* Had major surgery (not including placement of vascular access device or tumor biopsies) within 28 days prior to first dose of the study drug, or no recovery from side effects of such intervention.\n* Has a history of non-infectious pneumonitis (NIP) \u002F interstitial lung disease (ILD) requiring systemic steroids within 6 months prior to first dose of the study drug, active NIP \u002F ILD or suspected NIP \u002F ILD which cannot be ruled out by imaging for Screening.",{"count":157,"type":22},165,[135],"This first-in-human study will evaluate safety, tolerability, anti-tumor activity, immunogenicity, pharmacokinetics and pharmacodynamics of PHN-012, a novel antibody-drug conjugate (ADC), in patients with advanced solid tumors.",[161,162,32,163,164],"Colon Cancer","Pancreatic Cancer","Advanced Cancer","Advanced Solid Tumors",[166,71,167,168],"Antibody Drug Conjugate","Cancer","Solid Tumor","2026-08-05",{"date":171,"type":49},"2026-08-06",{"date":173,"type":49},"2025-09-23",{"date":175,"type":22},"2028-05",{"name":177,"class":56},"Pheon Therapeutics",26,{"id":180,"slug":181,"hasResults":12,"nctId":182,"briefTitle":183,"officialTitle":184,"acronym":185,"eligibilityCriteria":186,"healthyVolunteers":187,"sex":18,"minAge":188,"maxAge":4,"enrollmentInfo":189,"targetDuration":4,"studyType":191,"phases":4,"briefSummary":192,"conditions":193,"keywords":206,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":217,"lastUpdatePostDateStruct":218,"startDateStruct":220,"completionDateStruct":222,"leadSponsor":224,"locationsCount":226},"100650085","health-for-hungary-h4h---longitudinal-collection-of-blood-samples-and-corresponding-data-100650085","NCT07743021","Health for Hungary (H4H) - Longitudinal Collection of Blood Samples and Corresponding Data","Health for Hungary - Longitudinal Collection of Blood Samples and Corresponding Data for Longterm Evaluation of Innovative Diagnostic Techniques in Subjects Without Clinically Relevant Disorders at Baseline to Institute Molecular Fingerprinting Reference Norms","H4H","Low- and Moderate-risk Cohort:\n\nInclusion Criteria:\n\n1. Signed informed consent form (ICF) of the study.\n2. Age \\> 40 years.\n3. Willingness to fill in the study questionnaire.\n4. No clinically relevant symptoms as assessed by the investigator, subjects with existing medical conditions may be eligible given that they are symptom free and that full treatment of the condition is medically confirmed.\n5. Willingness to participate in future visits.\n\nExclusion Criteria:\n\n1. Self-reported pregnancy (no test).\n2. Indications of clinically relevant medical conditions in self-reported healthy subjects.\n3. Self-reported symptom-free HIV, HCV and HBV infections. If HIV, HBV or HCV serology test is done and any of them are positive, the subject will be considered a screen failure.\n4. Any conditions preventing blood-draw.\n5. Vulnerable subjects.\n6. Foreseeable lack of compliance.\n7. Participation in another sample collection project of the same sponsor, in order to avoid double evaluation of the same subject.\n8. Participation (currently or in the past month) in an early phase clinical trial (phases I and II) involving testing of pharmaceutical products, if the last dose of pharmaceutical product administration was within 30 days of the first sample collection, and \u002F or further pharmaceutical product administration is planned.\n9. Vaccination within the last 14 days.\n\nHigh-risk Cohort:\n\nInclusion Criteria:\n\n1. Signed informed consent form (ICF) of the study.\n2. Age \\> 50 years.\n3. Willingness to fill in the study questionnaire.\n4. Willingness to participate in future visits and medical investigations, the presence of at least 2 of the following 3 risk factors (inclusion criteria #5-7):\n5. Hypertension, receiving antihypertensive treatment.\n6. Dyslipidemia\u002F Hypercholesterolemia (\\>5.2mmol\u002FL total cholesterol level), on or not on statin-treatment.\n7. Active or former smoker, with smoking history of at least 20 pack-years, and\u002For the presence of intermediate lung nodule on prior LDCT testing.\n8. No clinically relevant symptoms as assessed by the investigator; subjects with existing medical conditions may be eligible given that they are symptom free and that treatment of the condition is well documented.\n\nExclusion Criteria:\n\n1. Self-reported pregnancy (no test).\n2. Cardiovascular disease (including obstructive coronary artery disease, peripheral artery disease, aortic aneurysm) or other clinically significant heart disease (congenital, valvular heart disease, cardiomyopathy, heart failure and heart disease requiring ICD \\[implantable cardioverter defibrillator\\] or pacemaker therapy).\n3. Interstitial lung disease or severe COPD (chronic obstructive pulmonary disease) in GOLD stages 3 or 4.\n4. Active cancer or malignant disease with less than 5 years history of remission.\n5. Indications of clinically relevant medical conditions in self-reported healthy subjects, especially if (a) the condition requires regular or constant specialist checkups, or (b) pharmacological therapy indicates the presence of significant NCDs or multimorbidity, i.e., chronic polypharmacy (use of 5 or more medications at enrollment or over the last 6 months), or drug therapy necessitating a specialist input for initiation or management (e.g., combined anti-diabetic treatment with two or more medications).\n6. Self-reported symptom-free HIV, HCV and HBV infections. If HIV, HBV or HCV serology test is done and any of them are positive, the subject will be considered a screen failure.\n7. Any conditions preventing blood-draw or CT scans.\n8. Vulnerable subjects.\n9. Foreseeable lack of compliance.\n10. Participation in another sample collection project of the same sponsor, in order to avoid double evaluation of the same subject. 'High-risk' subjects enrolled in the low- and moderate-risk arm of the H4H study might be reallocated to the high-risk study arm after the first 4-5 visits.\n11. Participation (currently or in the past month) in an early phase clinical trial (phases I and II) involving testing of pharmaceutical products, if the last dose of pharmaceutical product administration was within 30 days of the first sample collection, and\u002For further pharmaceutical product administration is planned.\n12. Vaccination within the last 14 days of sample collection.",true,"40 Years",{"count":190,"type":22},15000,"OBSERVATIONAL","The Health for Hungary (H4H) study collects blood samples and corresponding health data to investigate healthy aging and health-to-disease transitions in middle-aged and elderly participants.\n\nIndications Studied:\n\nApparently healthy, symptom-free participants are enrolled and followed up to study the onset of new-onset diseases with special emphasis on non-communicable diseases (NCDs).\n\nStudy Design:\n\nSingle-country, multicenter, prospective, longitudinal survey.\n\nObjectives:\n\nThe study aims to establish reference ranges of blood parameters using routine clinical blood tests and high-information-content methods, including proteomics, metabolomics and the so-called infrared molecular fingerprinting.\n\nThe study also aims to identify novel biomarkers of major non-communicable diseases, including atherosclerotic cardiovascular disease, cancer, diabetes and chronic respiratory disease.",[194,195,167,32,196,197,198,199,200,201,202,203,204,205],"Non-communicable Diseases (NCD)","Neoplams","Cardiovascular Diseases (CVD)","Atherosclerotic Cardiovascular Disease (ASCVD)","Peripheral Artery Disease (PAD)","Coronary Artery Disease (CAD)","Stroke (CVA) or TIA","Diabetes Mellitus (DM)","Type 2 Diabetes (T2DM)","Prediabetes","Chronic Respiratory Diseases","Chronic Obstructive Pulmonary Disease (COPD)",[207,208,209,210,211,212,213,214,215,216],"Personalized health","Molecular fingerprints","Longitudinal health monitoring","Early-stage disease detection","Innovative research platforms","Precision care","Proteomics","Metabolomics","in vitro diagnostics","Prevention medicine","2026-07-29",{"date":219,"type":49},"2026-08-03",{"date":221,"type":49},"2021-07-27",{"date":223,"type":22},"2030-12-31",{"name":225,"class":125},"Center for Molecular Fingerprinting Research Nonprofit LLC",33,{"id":228,"slug":229,"hasResults":12,"nctId":230,"briefTitle":231,"officialTitle":232,"acronym":4,"eligibilityCriteria":233,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":234,"targetDuration":236,"studyType":191,"phases":4,"briefSummary":237,"conditions":238,"keywords":240,"overallStatus":116,"whyStopped":4,"lastUpdateSubmitDate":217,"lastUpdatePostDateStruct":245,"startDateStruct":246,"completionDateStruct":248,"leadSponsor":250,"locationsCount":57},"100649984","multi-omics-prediction-of-radiation-lung-injury-in-immunotherapy-treated-lung-cancer-patients-100649984","NCT07742800","Multi-Omics Prediction of Radiation Lung Injury in Immunotherapy-Treated Lung Cancer Patients","Multi-Omics Prediction of Radiation Pneumonitis Risk in Lung Cancer Patients After Immunotherapy and Thoracic Radiotherapy","Inclusion Criteria:\n\nPatients aged 18 or older years with a life expectancy of at least 6 months. Additional inclusion criteria were a Zubrod performance status of 0-1, documentation of baseline chest computed tomography (CT) scans prior to the initiation of immunotherapy, receipt of at least 2 cycles of systemic therapy (PD-1) as either monotherapy or combination therapy within the past six months, voluntary participation with written informed consent, and appropriate baseline biochemical tests. The radiation dose for thoracic radiotherapy was ≥30Gy for all eligible patients in this study. No use of antibiotics within 1 week prior to the initiation of thoracic radiotherapy.\n\nExclusion Criteria:Participation in other interventional clinical studies or treatments, having received investigational drugs or treatments within 4 weeks prior to the first dose, or prior receipt of a solid organ or hematopoietic stem cell transplant, having an active infection, or pre-existing\u002Factive ICI-induced pneumonitis.\n\n\\-",{"count":235,"type":22},160,"6 Months","This prospective study aims to develop a multi-omics-based predictive model for radiation pneumonitis in lung cancer patients receiving sequential immunotherapy and thoracic radiotherapy.",[32,239],"Lung Cancer (SCLC)",[241,242,243,244],"Radiation Pneumonitis","Multi-Omics","Immunotherapy","Predictive Biomarkers",{"date":219,"type":49},{"date":247,"type":22},"2026-08-15",{"date":249,"type":22},"2028-08-15",{"name":251,"class":125},"HAN GUANG",{"id":253,"slug":254,"hasResults":12,"nctId":255,"briefTitle":256,"officialTitle":257,"acronym":4,"eligibilityCriteria":258,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":259,"targetDuration":4,"studyType":23,"phases":261,"briefSummary":262,"conditions":263,"keywords":264,"overallStatus":116,"whyStopped":4,"lastUpdateSubmitDate":272,"lastUpdatePostDateStruct":273,"startDateStruct":275,"completionDateStruct":277,"leadSponsor":279,"locationsCount":57},"100648542","phase-2-navigation-bronchoscopy-guided-microwave-ablation-versus-sbrt-in-early-nsclc-100648542","NCT07722182","Navigation Bronchoscopy Guided Microwave Ablation Versus SBRT in Early NSCLC","A Pragmatic Randomised Trial Comparing Navigation Bronchoscopy-guided Microwave Ablation Versus Stereotactic Body Radiotherapy for Medically Inoperable or Surgery-declining Early-stage Non-small Cell Lung Cancer","Inclusion Criteria:\n\n* 1\\. Adults aged 18 years or above. 2. Clinically stage IA NSCLC suitable for definitive local therapy, defined as T1N0M0 with maximum tumour diameter 3 cm or less, based on routine staging work up and multidisciplinary team review.\n\n  3\\. Pathological confirmation of NSCLC by histology or cytology whenever feasible. If tissue confirmation is not feasible or poses unacceptable risk, eligibility may be allowed after multidisciplinary consensus that imaging and clinical features are highly consistent with primary lung cancer, consistent with SBRT guidance for selected unbiopsied cases.\n\n  4\\. Medically inoperable status, or patient declines surgery after multidisciplinary discussion, and both navigation bronchoscopy-guided microwave ablation and SBRT are considered acceptable treatment options by the treating teams (clinical equipoise).\n\n  5\\. Target lesion technically suitable for both modalities, including feasibility and safety for bronchoscopy-based ablation and suitability for SBRT planning and delivery.\n\n  6\\. Willing and able to provide informed consent and accept random assignment to either navigation bronchoscopy guided microwave ablation or SBRT, and able to comply with the follow up schedule.\n\nExclusion Criteria:\n\n* 1\\. Evidence of lymph node involvement (N1 or higher) or distant metastases (M1) on routine staging.\n\n  2\\. Multiple synchronous primary lung cancers requiring different local strategies, or inability to define a single index lesion for primary endpoint assessment.\n\n  3\\. Prior thoracic radiotherapy that would overlap the planned SBRT field, or prior local therapy to the index lesion.\n\n  4\\. Another active malignancy that is likely to confound outcome assessment (for example, malignancy requiring systemic therapy or expected to limit 2-year survival), except adequately treated non melanoma skin cancer or in situ carcinoma with negligible recurrence risk. 5. Contraindications to bronchoscopy sedation or anaesthesia that preclude RAB or ENB guided ablation, or medical conditions that preclude SBRT positioning or safe delivery.\n\n  6\\. Lesions judged unsafe or technically infeasible for either modality (for example, proximity to critical structures beyond predefined safety limits), as determined by the procedural and radiation oncology teams.\n\n  7\\. Pregnant or breastfeeding women. 8. Inability or unwillingness to comply with study procedures or follow up.",{"count":260,"type":22},100,[68],"Background: Stereotactic body radiotherapy (SBRT) is a standard definitive local therapy for medically inoperable early stage non-small cell lung cancer (NSCLC). Navigation bronchoscopy guided microwave ablation is an emerging alternative that may reduce treatment burden and avoid ionising radiation. However, comparative evidence against SBRT remains limited.\n\nObjective: To generate relevant comparative evidence to inform treatment selection for medically inoperable patients or patients who decline surgery with early-stage NSCLC.\n\nMethods: This is a Hong Kong led, pragmatic, multicentre, parallel group randomised controlled clinical trial with open label treatment delivery and blinded end point assessment. Eligible participants will be randomised one to one to navigation bronchoscopy guided microwave ablation or SBRT.\n\nSurveillance includes scheduled chest computed tomography at 1, 3, 6, 12, 18, and 24 months, with independent blinded imaging adjudication using a prespecified review charter. The primary end point is 24-month local tumour control, defined as absence of local progression of the treated lesion. The primary analysis will follow intention to treat and will test noninferiority using an absolute risk difference margin of 0.15. Secondary outcomes include time to local progression, progression free survival, overall survival, treatment related toxicity and serious adverse events, patient reported outcomes including quality of life trajectories, and healthcare utilisation such as hospital visits, unplanned admissions, and retreatment. The target sample size is 100 participants, providing adequate power for the prespecified noninferiority margin and supporting secondary outcome estimation.\n\nImpact: Findings will directly inform multidisciplinary decision making, local pathway design, and service planning in Hong Kong and collaborating centres.",[32],[265,266,267,268,269,270,271],"Non-small cell lung cancer","navigation bronchoscopy","robotic assisted bronchoscopy","microwave ablation","stereotactic body radiotherapy","pragmatic randomised trial","local tumour control","2026-07-23",{"date":274,"type":49},"2026-07-24",{"date":276,"type":22},"2026-08-10",{"date":278,"type":22},"2029-12-31",{"name":280,"class":125},"Chinese University of Hong Kong",{"id":282,"slug":283,"hasResults":12,"nctId":284,"briefTitle":285,"officialTitle":286,"acronym":4,"eligibilityCriteria":287,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":288,"targetDuration":4,"studyType":23,"phases":290,"briefSummary":291,"conditions":292,"keywords":294,"overallStatus":116,"whyStopped":4,"lastUpdateSubmitDate":299,"lastUpdatePostDateStruct":300,"startDateStruct":302,"completionDateStruct":304,"leadSponsor":306,"locationsCount":4},"100630048","phase-2-furmonertinib-plus-radiotherapy-for-egfr-nsclc-with-pleural-effusion-100630048","NCT07482605","Furmonertinib Plus Radiotherapy for EGFR+ NSCLC With Pleural Effusion","A Prospective, Multicenter Study on the Safety and Efficacy of Furmonertinib Combined With Local Chest Radiotherapy in EGFR+ Non-small Cell Lung Adenocarcinoma Patients With Malignant Pleural Effusion","Inclusion Criteria:\n\n1. Age ≥ 18 years.\n2. Histologically or cytologically confirmed advanced lung adenocarcinoma.\n3. Unlimited number of metastatic lesions, but with involvement of no more than 3 organs.\n4. Previously untreated, clinical stage IV disease per AJCC\u002FUICC 9th edition.\n5. Presence of pleural effusion as indicated by chest CT or ultrasound; cytological confirmation of malignant cells in the pleural effusion is preferred. If malignant cells are not detected in the pleural effusion, chest CT with contrast or whole-body PET\u002FCT must demonstrate unequivocal pleural nodular metastases.\n6. After 8-10 weeks of furmonertinib therapy with or without therapeutic thoracentesis, the overall radiographic response is assessed as effective (CR + PR + SD), and malignant pleural effusion is adequately controlled (defined as no pleural effusion or only minimal pleural effusion on ultrasound or chest CT: maximum depth \\\u003C 3 cm, estimated volume \\\u003C 500 mL). Concurrent minimal pericardial effusion is permissible (defined as maximum diastolic width \\\u003C 1 cm on echocardiography, estimated volume \\\u003C 100 mL).\n7. No prior thoracic radiotherapy.\n8. Positive for EGFR-sensitive mutations (exon 19 deletion or exon 21 L858R).\n9. No prior systemic anticancer therapy.\n10. ECOG performance status 0-2, with a life expectancy of ≥ 12 weeks.\n11. At least one measurable lesion per RECIST 1.1.\n12. Adequate bone marrow function to tolerate anticancer treatment: WBC ≥ 3 × 10⁹\u002FL, Hb ≥ 80 g\u002FL, PLT ≥ 75 × 10⁹\u002FL, and absolute neutrophil count (NEUT) ≥ 1.5 × 10⁹\u002FL.\n13. Essentially normal hepatic and renal function:\n\n    1. Serum creatinine ≤ 1.5 × upper limit of normal (ULN) or creatinine clearance (CrCl) ≥ 50 mL\u002Fmin;\n    2. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN (≤ 5 × ULN is acceptable in patients with liver metastases);\n    3. Total bilirubin (TBIL) ≤ 1.5 × ULN;\n    4. Albumin ≥ 30 g\u002FL and prealbumin ≥ 150 g\u002FL.\n14. Asymptomatic brain metastases.\n15. Written informed consent obtained from all subjects.\n\nExclusion Criteria:\n\n1. Pre-existing interstitial lung disease (ILD) or infectious fever prior to treatment.\n2. Radiographic progression (PD) after 8-10 weeks of TKI therapy, or development of grade ≥ 2 ILD.\n3. Concurrent autoimmune disease requiring long-term oral corticosteroid therapy.\n4. Severe anemia.\n5. Known hypersensitivity to furmonertinib.\n6. Significant respiratory symptoms (e.g., chest tightness, cough) that preclude tolerance to radiotherapy.\n7. Active hepatitis B or C virus infection with concomitant grade \\> 2 hepatic impairment. Patients may be considered eligible if liver function recovers to grade 1 after active hepatoprotective therapy and antiviral treatment.\n8. Poorly controlled or continuously progressive pleural effusion after 8-10 weeks of furmonertinib therapy.\n9. Symptomatic brain metastases.",{"count":289,"type":22},63,[68],"This study is designed as a prospective, multi-center investigation to explore the efficacy and safety of furmonertinib combined with upfront thoracic radiotherapy with or without metastatic lesion radiotherapy in subjects with EGFR-mutant NSCLC and malignant pleural effusion (MPE), aiming to provide additional evidence-based medical support for optimizing the management of NSCLC-MPE subjects. In addition, peripheral blood ctDNA next-generation sequencing (NGS) will be performed at two time points-before the first furmonertinib treatment and one month after the completion of thoracic radiotherapy-to identify subpopulations most likely to benefit from this therapeutic approach and to elucidate resistance mechanisms specific to the radiotherapy-plus-furmonertinib combination, ultimately facilitating more personalized care for these subjects.",[32,293],"Malignant Pleural Effusions (Mpe)- Pleurodesis",[295,296,297,298],"Furmonertinib","Radiotherapy","EGFR mutation","Lung adenocarcinoma","2026-07-16",{"date":301,"type":49},"2026-07-17",{"date":303,"type":22},"2026-07-01",{"date":305,"type":22},"2028-01-01",{"name":307,"class":125},"Jiangmen Central Hospital",{"id":309,"slug":310,"hasResults":12,"nctId":311,"briefTitle":312,"officialTitle":313,"acronym":4,"eligibilityCriteria":314,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":315,"targetDuration":4,"studyType":23,"phases":317,"briefSummary":318,"conditions":319,"keywords":325,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":331,"lastUpdatePostDateStruct":332,"startDateStruct":334,"completionDateStruct":336,"leadSponsor":338,"locationsCount":340},"100624096","phase-2-ivonescimab-alone-and-with-carboplatinpemetrexed-for-nsclc-100624096","NCT07405190","Ivonescimab Alone And With Carboplatin\u002FPemetrexed For NSCLC","A Phase II Study of Ivonescimab as Monotherapy or in Combination With Platinum\u002FPemetrexed Chemotherapy in Patients With Advanced Non-small Cell Lung Cancer (NSCLC) Harboring Actionable Genomic Alterations (AGAs)","Inclusion Criteria:\n\n* Histologically or cytologically confirmed advanced or metastatic non-squamous NSCLC not amenable to curative resection or radiation.\n* AGA requirements as follows:\n\nIvonescimab monotherapy: Tumor harboring classical EGFR sensitizing mutation (i.e., L858R, exon 19 deletion), or ALK, ROS1, RET, or NTRK1-3 fusion, per local testing. Note: The number of patients with EGFR mutation-positive NSCLC enrolled will be capped at maximum of 10 (in order to ensure the assessment of non-EGFR disease subsets). Ivonescimab plus carboplatin\u002Fpemetrexed: Tumor harboring ALK, ROS1, RET, or NTRK1-3 fusion, per local testing.\n\n* Prior therapy requirements as follows:\n\n  a. Prior genotype-specific standard-of-care targeted therapy must have included at least one genotype-appropriate TKI(s) specified below: i. EGFR sensitizing mutation: a third-generation EGFR TKI such as osimertinib or lazertinib ii. ALK fusion: a third- or fourth-generation ALK TKI such as lorlatinib or neladalkib (NVL-655) iii. ROS1 fusion: crizotinib, entrectinib, repotrectinib, or taletrectinib iv. RET fusion: selpercatinib or pralsetinib v. NTRK1-3 fusion: entrectinib, larotrectinib, or repotrectinib Ivonescimab monotherapy: Must have received platinum\u002Fpemetrexed chemotherapy. No limitations on the number of prior lines of systemic therapy including the number of lines of chemotherapy or TKI(s). Ivonescimab plus carboplatin\u002Fpemetrexed: May not have received any prior chemotherapy. No limitations on the number of prior TKI(s).\n* At least 1 measurable lesion as assessed by investigator per the RECIST v1.1 criteria for both cohorts.\n* Participants must be willing to undergo the mandatory pre-treatment and post-progression tissue biopsies. If archival pre-treatment tissue is available from within 6 months of study enrollment, with no new intervening systemic therapy since the biopsy, a repeat pre-treatment biopsy may be omitted upon discussion with the principal investigator. On-treatment tissue biopsy (obtained within 7 days prior to Cycle 2 Day 1) will be mandatory for patients in Cohort 1 and optional for patients in Cohort 2. In select cases, if medically deemed unsafe\u002Fnot feasible, exception may be granted upon discussion with the principal investigator.\n* Clinically asymptomatic treated or untreated brain metastases are allowed if they have not required increasing doses of steroids within 2 weeks prior to study entry for CNS symptoms.\n* Age ≥18 years old.\n* ECOG performance status of 0 or 1.\n* Adequate Organ Function:\n\n  a. Hematology (no blood transfusions or growth factor therapy used within 7 days of the screening CBC): i. Absolute neutrophil count (ANC) ≥ 1.5 × 109\u002FL ii. Platelet count ≥ 100 × 109\u002FL iii. Hemoglobin ≥ 9.0 g\u002FdL b. Kidneys: i. Creatinine clearance (CrCl) ≥ 50 mL\u002Fmin using the Cockcroft-Gault formula (Cohorts 1 and 2) or estimated glomerular filtration rate (eGFR) value ≥ 60 mL\u002Fmin (for Cohort 1) or ≥30 mL\u002Fmin (for Cohort 2) using the Cockcroft-Gault formula or estimated glomerular filtration rate (eGFR) ii. Urine protein \\\u003C 2+ or 24 hour urine protein quantification \\\u003C 1.0 g c. Liver: i. Serum total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN); for patients with liver metastases or confirmed\u002Fsuspected Gilbert syndrome, TBIL ≤3 × ULN ii. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT)\n  * 2.5 × ULN; for patients with liver metastases, AST and ALT ≤ 5 × ULN d. Coagulation: prothrombin time (PT) or international normalized ratio (INR)\n  * 1.5 x ULN, and partial prothrombin time (PTT) or activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN (unless abnormalities are unrelated to coagulopathy). This applies only to patients who are not on therapeutic anti-coagulation. Patients receiving therapeutic anti-coagulation should be on a stable dose for at least one month prior to study enrollment.\n* Female patients of childbearing age must have negative serum pregnancy test results before first ivonescimab drug dose or per region-specific guidance documented in the informed consent and a negative urine pregnancy test on the day of first dose prior to dosing.\n* Female patient of childbearing potential having sex with an unsterilized male partner must agree to use a highly effective method of contraception from the beginning of screening until 90 days after the last dose of the ivonescimab and until 6 months after the last doses of carboplatin and pemetrexed.\n* Unsterilized male patients having sex with a female partner of childbearing potential, or a pregnant or breastfeeding partner must agree to use barrier contraception (male condom) for the duration of the treatment period until 90 days after the last dose of ivonescimab and until 90 days after the last doses of carboplatin and pemetrexed. Male patients with female partners of childbearing potential must have the female partner agree to use at least 1 form of highly effective contraception for the duration of the treatment period until 90 days after the last dose of ivonescimab and until 90 days after the last doses of carboplatin and pemetrexed.\n\nExclusion Criteria:\n\n* Participants previously treated with immune checkpoint inhibitors or other T cell immune-modulating antibodies, including anti-CTLA-4, anti-PD-1 and\u002For anti-PD-L1 agents.\n* Major surgical procedures or serious trauma within 4 weeks prior to first ivonescimab dose or plans for major surgical procedures within 4 weeks after the first ivonescimab dose (as determined by the investigator). Minor local procedures (excluding central venous catheterization and port implantation) within 3 days prior to first ivonescimab dose.\n* History of bleeding tendencies or coagulopathy and\u002For clinically significant bleeding symptoms or risk within 4 weeks prior to first ivonescimab dose, including but not limited to:\n\n  1. Hemoptysis (defined as coughing up ≥ 0.5 teaspoon of fresh blood or small blood clots). Note: transient hemoptysis associated with diagnostic bronchoscopy is allowed.\n  2. Nasal bleeding\u002Fepistaxis (bloody nasal discharge is allowed)\n  3. Current use of prophylactic or full-dose anticoagulants or anti-platelet agents for therapeutic purposes that is not stable prior to first ivonescimab dose is not allowed; stability of anti-coagulation dosing will be defined by remaining on the same dose for at least one month prior to study enrollment.\n  4. The use of full-dose anticoagulants is permitted as long as the international normalized ratio (INR) or activated partial thromboplastin time (aPTT) is within therapeutic limits according to the medical standard of the enrolling institution.\n* Poorly controlled hypertension with repeated systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg after oral antihypertensive therapy.\n* Active autoimmune or lung disease requiring systemic therapy (eg, with disease modifying drugs, prednisone \\>10 mg daily or equivalent, immunosuppressant therapy) within 2 years prior to first ivonescimab dose; however, the following will be allowed:\n\n  1. Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is permitted.\n  2. Intermittent use of bronchodilators, inhaled corticosteroids, or local corticosteroid injections is permitted.\n* History of major diseases before first ivonescimab dose, specifically:\n\n  1. Unstable angina, myocardial infarction, congestive heart failure (New York Heart Association \\[NYHA\\] classification ≥ grade 2) or unstable vascular disease (eg, aortic aneurysm at risk of rupture, Moyamoya disease) that required hospitalization within 6 months prior to first ivonescimab dose, or other cardiac impairment that may affect the safety evaluation of the study drug (eg, poorly controlled arrhythmias, myocardial ischemia)\n  2. History of esophageal gastric varices, severe ulcers, wounds that do not heal, abdominal fistula, intra-abdominal abscesses, or acute gastrointestinal bleeding within 6 months before first ivonescimab dose\n  3. History of any grade arterial thromboembolic event, Grade 3 and above venous thromboembolic event, as specified in National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) 6.0, transient ischemic attack, cerebrovascular accident, hypertensive crisis, or hypertensive encephalopathy within 6 months prior to first ivonescimab dose\n  4. Acute exacerbation of chronic obstructive pulmonary disease within 4 weeks before first ivonescimab dose\n  5. History of perforation of the gastrointestinal tract and\u002For fistula, history of gastrointestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), extensive bowel resection (partial colectomy or extensive small bowel resection) within 6 months prior to first ivonescimab dose\n* Imaging during the screening period shows that the patient has:\n\n  1. Radiologically documented evidence of major blood vessel invasion (central pulmonary artery, central pulmonary veins, aorta, brachiocephalic artery, common carotid artery, subclavian artery, superior vena cava) or tumor invading organs (heart, trachea, esophagus, central bronchi \\[not including segmental bronchi\\]) or if there is a risk of esophagotracheal or esophagopleural fistula in the opinion of the investigator.\n  2. Radiographic evidence of major blood vessel encasement with narrowing of the vessel or intratumor lung cavitation or necrosis that the investigator determines will pose a significantly increased risk of bleeding.\n* Symptomatic CNS metastases, CNS metastases with hemorrhagic features, CNS metastasis ≥ 1.5 cm, CNS radiation within 7 days prior to first ivonescimab dose, potential need for CNS radiation within the first cycle, or leptomeningeal disease.\n\nNote: Patients must have stopped corticosteroids or be on physiologic corticosteroid replacement therapy (prednisone ≤ 10 mg daily or equivalent).\n\n* Live vaccine or live attenuated vaccine within 4 weeks prior to planned first ivonescimab dose, or if scheduled to receive a live vaccine or live attenuated vaccine during the study period. Inactivated vaccines are permitted.\n* Severe infection within 4 weeks prior to first ivonescimab dose, including but not limited to comorbidities requiring hospitalization, sepsis, or severe pneumonia; active infection (as determined by the investigator) requiring systemic anti-infective therapy within 2 weeks prior to first ivonescimab dose (excluding antiviral therapy for hepatitis B or C)\n* Has pre-existing peripheral neuropathy that is ≥ Grade 2 by CTCAE version 6\n* Uncontrolled pleural effusions, pericardial effusions, or ascites that is clinically symptomatic Note: Patients managed with indwelling catheters (eg, PleurX) are allowed.\n* Any evidence of current ILD or pneumonitis or a prior history of ILD or non-infectious pneumonitis requiring systemic corticosteroids\n* Active or prior history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, or chronic diarrhea)\n* Known history of human immunodeficiency virus (HIV) whose viral load is not controlled.\n* Current use of systemic corticosteroids (\\>10 mg daily prednisone or equivalent)\n* Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation\n* Patients with active hepatitis B are required to have stable or declining levels of hepatitis B DNA by polymerase chain reaction (PCR) on appropriate anti-viral therapy with acceptable tolerability for one month prior to first ivonescimab dose. All patients with active hepatitis C (hepatitis C virus \\[HCV\\] antibody positive with HCV RNA levels above the lower limit of detection) are excluded.\n* Known allergy to any component of any study drug; known history of severe hypersensitivity to other monoclonal antibodies\n* History or current evidence of any condition (medical \\[including adverse events from prior anticancer therapy, disorders secondary to tumor\\], surgical or psychiatric \\[including substance abuse\\]), or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, might lead to higher medical risk and\u002For is not in the best interest of the patient to participate, in the opinion of the treating investigator\n* Patient is breastfeeding or plans to breastfeed during the study",{"count":316,"type":22},46,[68],"The goal of this clinical trial is to assess the efficacy of ivonescimab monotherapy in patients with advanced non-small cell lung cancer harboring actionable genomic alterations who have received prior targeted therapies and chemotherapy. This clinical trial also aims to assess the efficacy of ivonescimab plus carboplatin\u002Fpemetrexed chemotherapy in patients with advanced non-small cell lung cancer harboring actionable genomic alterations other than epidermal growth factor receptor mutations who have received prior targeted therapies but no chemotherapy. The main questions it aims to answer are:\n\n* Will ivonescimab alone or together with carboplatin\u002Fpemetrexed chemotherapy shrink tumors in the clinical trial's patients?\n* Will ivonescimab alone or together with carboplatin\u002Fpemetrexed chemotherapy effectively influence if the patients' cancer grows, how long the treatment takes to start working, how long the treatment keeps working after it first starts to help, how long the treatment keeps the cancer from getting worse, and overall survival of patients?\n* How many patients receiving ivonescimab alone or together with carboplatin\u002Fpemetrexed chemotherapy will experience treatment-emergent, treatment-related, immune-related, and especially interesting side effects? Patients receiving ivonescimab alone will receive an intravenous infusion of ivonescimab every 3 weeks for up to 24 months. Patients receiving ivonescimab together with carboplatin\u002Fpemetrexed chemotherapy will receive separate intravenous infusions of ivonescimab, pemetrexed, and carboplatin every 3 weeks for 4 cycles (each cycle is 21 days). These patients will continue to receive infusions of ivonescimab and pemetrexed every 3 weeks for up to 24 total months.",[32,320,321,322,323,324],"Lung Cancer Non-Small Cell Cancer (NSCLC)","Lung Cancer (Non-Small Cell)","Lung Cancer - Non Small Cell","Lung Cancer Non Small Cell","Genomic Alterations",[28,326,327,328,329,330],"AGAs","lung cancer","non-small cell","chemotherapy","ivonescimab","2026-07-14",{"date":333,"type":49},"2026-07-15",{"date":335,"type":49},"2026-05-01",{"date":337,"type":22},"2029-03-01",{"name":339,"class":125},"Massachusetts General Hospital",3,{"id":342,"slug":343,"hasResults":12,"nctId":344,"briefTitle":345,"officialTitle":346,"acronym":4,"eligibilityCriteria":347,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":348,"targetDuration":4,"studyType":23,"phases":349,"briefSummary":350,"conditions":351,"keywords":352,"overallStatus":116,"whyStopped":4,"lastUpdateSubmitDate":356,"lastUpdatePostDateStruct":357,"startDateStruct":358,"completionDateStruct":360,"leadSponsor":362,"locationsCount":57},"100627557","phase-2-perioperative-cemiplimab-for-resectable-non-small-cell-lung-cancer-with-high-pd-l1-100627557","NCT07450183","Perioperative Cemiplimab for Resectable Non-Small Cell Lung Cancer With High PD-L1","Phase II Trial of Perioperative Cemiplimab in Patients With Resectable Non-small Cell Lung Cancer and PD-L1 ≥50%","Inclusion Criteria:\n\n* Participant is willing and able to give informed consent for participation in the trial\n* Male or Female, aged 18 years or above\n* ECOG 0-1\n* Patient diagnosed with early-stage resectable stage II to IIIA squamous or non-squamous, operable treatment naïve NSCLC with PD-L1 TPS ≥50%. Patients who are eligible for standard of care treatment are allowed as well as those who are ineligible for chemo, if they fit the rest of the criteria\n* PD-L1 TPS ≥50% as assessed by DAKO 22C3 assay\n* Adequate bone marrow function, as determined by hematological parameters:\n\n  1. ANC ≥1.5 x 10\\^9\u002FL (1500\u002Fmm3)\n  2. Hemoglobin ≥9.0 g\u002FdL (5.59 mmol\u002FL).\n  3. Platelet count ≥75,000\u002Fmm³\n* Adequate hepatic function, as determined by:\n\n  1. AST\u002FALT for adults: AST ≤3x ULN, ALT ≤3x ULN\n  2. Serum bilirubin ≤1.5x ULN, except in patients with clinically documented Gilbert's Syndrome where ≤3x the ULN is permitted\n* Adequate kidney function as determined by serum creatinine ≤1.5x ULN OR calculated CrCl ≥50 ml\u002Fmin (using the Cockcroft-Gault formula)\n* Female participants of childbearing potential and male participants whose partner is of childbearing potential must be willing to ensure that they or their partner use highly effective contraception during the trial and for 4 months thereafter\\*.\n* Participant has clinically acceptable laboratory and ECG results (specify any other additional assessments) during screening.\n* In the Investigator's opinion, is able and willing to comply with all trial requirements\n\n  * NOTE where the use of effective contraception is a protocol requirement a section on Contraception and Pregnancy should be added to the safety reporting section with corresponding information in the Participant Information Sheet.\n\nExclusion Criteria:\n\n* Patients showing evidence of any distant metastases during screening.\n* Patients with tumors with known actionable EGFR gene mutations, ALK, RET or ROS1 gene translocations\n* Any condition that requires ongoing\u002Fcontinuous corticosteroid therapy (\\>10 mg prednisone\u002Fday or anti-inflammatory equivalent) within 1 week prior to the first dose of study medication. Participants who require a brief course of steroids (up to 2 days in the week before enrollment) or physiologic replacement are not excluded.\n* Significant renal or hepatic impairment.\n* Presence of cardiovascular disease, as defined by:\n\n  a. New York Heart Association heart failure classifications of Class II, III, or IV; or myocardial infarction, or acute coronary syndrome within 12 months of first dose of study medication; or b. Transient ischemic attack or stroke within 1 year\n* Scheduled elective surgery or other procedures requiring general anaesthesia during the trial.\n* Participant with life expectancy of less than 6 months or is inappropriate for placebo medication.\n* Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial.\n* Ongoing or recent evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments within the last 2 years.\n\nNote: The following are not exclusionary: vitiligo, childhood asthma that has resolved, endocrinopathies (such as hypothyroidism or type 1 diabetes) that require only hormone replacement, or psoriasis that does not require systemic treatment.\n\n* Any infection requiring hospitalization or treatment with IV anti-infectives within 2 weeks of first dose of study medication\n* Uncontrolled infection with HIV, hepatitis B or hepatitis C infection, diagnosis of immunodeficiency, and\u002For tuberculosis (active or latent).\n* Participants with known controlled HIV infection (undetectable viral load on HIV RNA PCR) and CD4 count above 350 either spontaneously or on a stable antiviral regimen are eligible. For these participants monitoring will be performed per local standards.\n* Participants with HBsAg positive who have controlled infection (serum HBV DNA PCR that is below the limit of detection and receiving anti-viral therapy for hepatitis B) are eligible. Participants with controlled infections must undergo periodic monitoring of HBV DNA. Participants must remain on anti-viral therapy for at least 6 months beyond the last dose of investigational study medication.\n* Participants with HBsAg negative but total HBcAb positive are permitted with the following requirements: If serum HBV DNA PCR is above the limit of detection at screening, initiate HBV antiviral therapy before study entry. If serum HBV DNA PCR is below the limit of detection, periodic monitoring of HBsAg must be performed.\n* Participants who are HCV Ab+ who have controlled infection (undetectable HCV RNA by PCR either spontaneously or in response to a successful prior course of anti-HCV therapy) are eligible\n* Receipt of a live vaccine within 4 weeks of start of study medication\n* Receipt of COVID-19 vaccination within 1 week of planned start of study medication or for which the planned COVID-19 vaccinations would not be completed 1 week prior to start of study medication.\n* Known hypersensitivity to the active substances or to any of the excipients.\n* WOCBP\\* and men\\*\\* who are unwilling to practice highly effective contraception prior to the initial dose\u002Fstart of the first treatment, during the study, and for at least 6 months after the last dose. Highly effective contraceptive measures include:\n\n  1. Stable use of combined (estrogen and progestogen containing) hormonal contraception (oral, intravaginal, transdermal) or progestogen-only hormonal contraception (oral, injectable, implantable) associated with inhibition of ovulation initiated 2 or more menstrual cycles prior to screening;\n  2. Intrauterine device; intrauterine hormone-releasing system;\n  3. Bilateral tubal occlusion\u002Fligation;\n  4. Vasectomized partner (provided that the male vasectomized partner is the sole sexual partner of the WOCBP study participant and that the vasectomized partner has obtained medical assessment of surgical success for the procedure); and\u002For\n  5. Sexual abstinence†,‡. Pregnancy testing and contraception are required for WOCBP. Pregnancy testing and contraception are not required for women who are postmenopausal or permanently sterile.\n\n     * WOCBP are defined as women who are fertile following menarche until becoming postmenopausal, unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high FSH level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient to determine the occurrence of a postmenopausal state. The above definitions are according to the CTFG guidance. Pregnancy testing and contraception are not required for women with documents hysterectomy or tubal ligation.\n\n       * Male participants: A male participant will be excluded from the study if that participant does not agree to use condoms or practice sexual abstinence†‡, unless vasectomized, prior to the initial dose\u002Fstart of study medication, during the study, and for at least 6 months after the last dose. Sperm donation is also prohibited during the same period. Vasectomy success must be confirmed by semen analysis.\n\n         * Sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study drugs. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the participant.\n\n           * Periodic abstinence (calendar, symptothermal, post-ovulation methods), withdrawal (coitus interruptus), spermicides only, and lactational amenorrhea method are not acceptable methods of contraception. Female condom and male condom should not be used together.\n* Participants who have participated in another research trial involving an investigational product in the past 12 weeks.",{"count":226,"type":22},[68],"This is a single arm phase II trial enrolling patients with stage II-IIIA non-small cell lung cancer whose disease is deemed amenable for surgical resection and has a PD-L1 level of ≥50%. Patients will receive cemiplimab for 3 cycles followed by surgical resection. The primary endpoint evaluated by the study is the amount of residual tumor in the resected tissue after 3 cycles of cemiplimab. After surgery, all patients will receive additional 10 cycles of cemiplimab and the treating oncologist will decide on the need of administering chemotherapy prior to that.",[32],[353,354,355],"Cemiplimab","Stage II lung cancer","Stage IIIA lung cancer","2026-07-13",{"date":333,"type":49},{"date":359,"type":22},"2027-01-01",{"date":361,"type":22},"2027-12-01",{"name":363,"class":125},"Henry Ford Health System",{"id":365,"slug":366,"hasResults":12,"nctId":367,"briefTitle":368,"officialTitle":369,"acronym":4,"eligibilityCriteria":370,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":371,"targetDuration":4,"studyType":23,"phases":373,"briefSummary":374,"conditions":375,"keywords":382,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":385,"lastUpdatePostDateStruct":386,"startDateStruct":388,"completionDateStruct":390,"leadSponsor":392,"locationsCount":393},"100619816","phase-1-study-of-rmc-5127-in-patients-with-advanced-kras-g12v-mutant-solid-tumors-100619816","NCT07349537","Study of RMC-5127 in Patients With Advanced KRAS G12V-Mutant Solid Tumors","Phase 1\u002F1b, Multicenter, Open-Label, Study of RMC-5127 in Patients With Advanced KRAS G12V-Mutant Solid Tumors","Inclusion Criteria:\n\n* At least 18 years old and has provided informed consent.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Pathologically documented, locally advanced or metastatic KRAS G12V-mutated solid tumor malignancy.\n* Received and progressed or been intolerant to prior standard therapy (including targeted therapy) appropriate for tumor type and stage.\n* Measurable per RECIST v1.1\n* Adequate organ function (bone marrow, liver, kidney, coagulation).\n* Able to take oral medications.\n\nExclusion Criteria:\n\n* Primary central nervous system (CNS) tumors\n* Prior therapy with KRAS G12V inhibitor or direct RAS-targeted therapy (eg. degraders and\u002For inhibitors).\n* Any conditions that may affect the ability to take or absorb study drug.\n* Major surgery within 28 days prior to receiving study drug(s).\n* Patient is unable or unwilling to comply with protocol-required study visits or procedures.",{"count":372,"type":22},574,[135],"The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of RMC-5127 as a monotherapy and in combination with either daraxonrasib or cetuximab in adults with KRAS G12V-mutant solid tumors.",[376,377,378,379,380,381,28,162,32,164],"Non-small Cell Lung Cancer (NSCLC)","Colorectal Cancer (CRC)","Pancreatic Adenocarcinoma","Pancreatic Ductal Adenocarcinoma (PDAC)","PDAC","CRC",[164,162,383,380,384,381,42,29,28,37,38,41],"Pancreatic Ductal Adenocarcinoma","Colorectal Cancer","2026-07-08",{"date":387,"type":49},"2026-07-10",{"date":389,"type":49},"2026-01-08",{"date":391,"type":22},"2028-10",{"name":55,"class":56},9,{"id":395,"slug":396,"hasResults":12,"nctId":397,"briefTitle":398,"officialTitle":399,"acronym":4,"eligibilityCriteria":400,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":401,"targetDuration":4,"studyType":23,"phases":403,"briefSummary":404,"conditions":405,"keywords":4,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":385,"lastUpdatePostDateStruct":421,"startDateStruct":422,"completionDateStruct":423,"leadSponsor":425,"locationsCount":57},"100619216","phase-1-sl-28-for-advanced-solid-tumours-100619216","NCT07341737","SL-28 for Advanced Solid Tumours","A Phase 1\u002F2, Multicentre, Open-Label, Dose Escalation and Expansion Study to Assess the Safety, Pharmacokinetics, and Preliminary Efficacy of SL-28 in Patients With Advanced Solid Tumours","Inclusion Criteria:\n\n* Ability to provide written informed consent prior to any study-related procedures and to understand the nature, purpose, and potential risks of the study\n* Adult males and females ≥18 years of age at screening\n* Life expectancy of at least 3 months\n* Histologically or cytologically confirmed unresectable advanced solid tumor (recurrent, metastatic, or locally advanced)\n* Disease refractory to, intolerant of, or refusal of standard therapies, including immunotherapy and molecular\u002Fbiomarker-directed treatments, as determined by the Principal Investigator (PI) or delegate\n* Eligible tumor types include:\n* Head and neck squamous cell carcinoma\n* Thoracic malignancies (small-cell lung cancer, non-small cell lung cancer, esophageal cancer)\n* Gastrointestinal malignancies (gastric, liver, colorectal, pancreatic adenocarcinoma)\n* Genitourinary malignancies (bladder, renal cell, prostate cancer)\n* Gynecologic malignancies (ovarian, endometrial cancer)\n* Breast cancer and melanoma\n* Evaluable disease per RECIST v1.1\n* ECOG performance status 0-1 (or up to 2 at PI discretion)\n* Adequate organ function, defined as:\n* Total bilirubin ≤1.5 × ULN (≤2.0 × ULN for liver metastases or Gilbert's syndrome)\n* AST, ALT, alkaline phosphatase ≤2.5 × ULN (≤5 × ULN if liver metastases, at PI discretion)\n* Creatinine clearance ≥50 mL\u002Fmin (Cockcroft-Gault) or eGFR ≥50 mL\u002Fmin (CKD-EPI)\n* Absolute neutrophil count ≥1,000\u002Fmm³\n* Platelet count ≥100,000\u002Fmm³\n* Hemoglobin ≥90 g\u002FL without transfusion within 2 weeks\n* Prothrombin time and aPTT ≤1.5 × ULN (or stable INR if on anticoagulation)\n\nFemale patients:\n\n-Non-childbearing potential (surgically sterile or postmenopausal), or of childbearing potential with negative pregnancy tests and agreement to effective contraception through 90 days post-dose\n\nMale patients:\n\n* Agreement not to donate sperm for 90 days post-dose\n* Agreement to use adequate contraception as applicable\n* Suitable venous access for blood sampling\n* Willingness and ability to comply with study procedures and protocol requirements\n\nExclusion Criteria:\n\n* Ongoing toxicities ≥ Grade 2 per NCI CTCAE v5.0 (except alopecia, fatigue, sensory neuropathy, or adequately treated endocrine deficiencies)\n* NYHA Class III or IV heart disease, myocardial infarction within 6 months, unstable arrhythmia, or ischemia on ECG\n* QTcF \\>470 ms (females) or \\>450 ms (males)\n* Active, uncontrolled bacterial, viral, or fungal infection requiring systemic therapy\n* Requirement for systemic corticosteroids or other immunosuppressive therapy that cannot be discontinued ≥14 days prior to dosing\n* Prior therapies within restricted timeframes:\n* Immune checkpoint inhibitors or biologics within 28 days\n* Antineoplastic therapies, surgery, radiotherapy, or radiopharmaceuticals within 21 days\n* Unapproved investigational drugs within 5 half-lives\n* Nitrosoureas or mitomycin C within 6 weeks\n* Concurrent malignancy within 5 years, except specified low-risk cancers\n* Pregnancy or breastfeeding\n* Known HIV, hepatitis B (HBsAg positive), or hepatitis C infection\n* Inability or unwillingness to comply with protocol procedures\n* History of anaphylaxis or significant allergy interfering with participation\n* Clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, neurologic, psychiatric, or immunologic disease within 6 months\n* Conditions affecting drug absorption, distribution, metabolism, or excretion\n* Receipt of live vaccines within 28 days prior to screening\n* Participation in another investigational study within 30 days prior to screening",{"count":402,"type":22},60,[135,68],"Second Life Therapeutics is developing SL-28, an allogeneic, non-genetically modified cell-based therapy for the treatment of advanced solid tumours. The company has recently demonstrated a novel, non-genetic approach to modulate immune cell activity through targeted manipulation of the Universal Receptive System. The purpose of this open label, multi-center clinical trial is to evaluate the anti-tumor activity, safety, and pharmacokinetics, single-agent SL-28 in patients with a diverse array of solid tumors. The study includes an initial Phase 1 dose escalation to determine recommended dose(s) for expansion of SL-28 as a monotherapy and Phase 2 expansion cohorts. The study will enroll patients with advanced solid tumours, including those who failed previous lines of chemo- and immunotherapies.",[406,407,408,409,32,321,410,411,412,413,414,415,416,417,418,419,420,384],"Head & Neck Cancer","Pancreas Carcinoma","Pancreas Cancer, Metastatic","Lung Adenocarcinoma","Esophageal Cancer","Stomach (Gastric) Cancer","Liver Cancer","Intestinal Cancer","Bladder Cancer","Renal Cancer","Prostate Cancer","Melanoma (Skin Cancer)","Breast Cancer","Ovarian Cancer","Endometrial Cancer",{"date":387,"type":49},{"date":356,"type":22},{"date":424,"type":22},"2027-03-01",{"name":426,"class":56},"Second Life Therapeutics",{"id":428,"slug":429,"hasResults":12,"nctId":430,"briefTitle":431,"officialTitle":432,"acronym":4,"eligibilityCriteria":433,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":434,"targetDuration":4,"studyType":23,"phases":435,"briefSummary":436,"conditions":437,"keywords":439,"overallStatus":116,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":446,"startDateStruct":448,"completionDateStruct":450,"leadSponsor":452,"locationsCount":57},"100643366","phase-2-olomorasib--pembrolizumab-kras-g12c-mutant-pd-l1-tps-1-49-locally-advanced-or-metastatic-nsclc-100643366","NCT07639242","Olomorasib + Pembrolizumab KRAS G12C Mutant, PD-L1 TPS 1-49% Locally Advanced or Metastatic NSCLC","Olomorasib Plus Pembrolizumab as First-Line Treatment for KRAS G12C Mutant, PD-L1 TPS 1-49% Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)","In order to participate in this study a subject must meet all of the eligibility criteria outlined below. Eligibility must be maintained up until the point at which the subject receives treatment for the subject to be considered eligible for treatment.\n\nInclusion Criteria:\n\nIn order to participate in this study a subject must meet ALL of the eligibility criteria outlined below.\n\nWritten informed consent obtained to participate in the study and HIPAA authorization for release of personal health information. Subject is willing and able to comply with study procedures based on the judgement of the investigator.\n\n* Age ≥ 18 years at the time of consent.\n* Eastern Cooperative Oncology Group performance status (ECOG) of 0-2\n* Subjects must have previously untreated, Stage IIIB-IIIC or Stage IV Non-Small Cell Lung Cancer (NSCLC) not amenable to curative intent treatment.\n* Measurable disease according to Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1 within 28 days prior to treatment\n* Known KRAS G12C mutation identified on tumor tissue or circulating tumor DNA (ctDNA) as determined by molecular testing performed in a CLIA, CAP or other similarly certified laboratory per local guidelines.\n* Subjects must have a known PD-L1 tumor proportion score (TPS) of 1-49% as determined by an IHC assay in a CLIA, CAP, or other similarly certified laboratory as per local guidelines\n\nExclusion Criteria:\n\n• Subject has a serious pre-existing medical condition(s) that, in the judgment of the Investigator, would preclude participation in this study, including interstitial lung disease (ILD) or severe dyspnea at rest and uncontrolled disease-related pericardial effusion or pleural effusion.",{"count":402,"type":22},[68],"This clinical trial evaluates the combination of olomorasib and pembrolizumab as a first-line treatment for patients with advanced or metastatic non-small cell lung cancer (NSCLC) that has a Kirsten Rat Sarcoma Virus (KRAS) G12C mutation and a programmed death-ligand (PD-L1) score between 1% and 49%. The main goal of the study is to determine how long patients live without their cancer worsening after starting treatment, also known as progression-free survival (PFS). Additional goals include evaluating how many patients experience tumor shrinkage or disappearance, how long responses to treatment last, overall survival, and the safety and side effects of the treatment combination. Furthermore, how well the treatment works in patients whose cancer has spread to the brain, outcomes in patients with a lower Eastern Cooperative Oncology Group performance status (ECOG), and whether certain tumor or blood-based biomarkers are associated with treatment response or side effects, if enough patient data is available for analysis.",[42,32,438,33],"Locally Advanced NSCLC",[440,441,442,443,444,445],"olomorasib","pembrolizumab","KRAS G12C+mutant","Kirsten Rat Sarcoma Virus G12C+ mutant","programmed death-ligand","PD-L1",{"date":447,"type":49},"2026-07-02",{"date":449,"type":22},"2026-06",{"date":451,"type":22},"2030-06-21",{"name":453,"class":125},"UNC Lineberger Comprehensive Cancer Center",{"id":455,"slug":456,"hasResults":12,"nctId":457,"briefTitle":458,"officialTitle":458,"acronym":459,"eligibilityCriteria":460,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":461,"targetDuration":4,"studyType":23,"phases":463,"briefSummary":464,"conditions":465,"keywords":4,"overallStatus":116,"whyStopped":4,"lastUpdateSubmitDate":467,"lastUpdatePostDateStruct":468,"startDateStruct":469,"completionDateStruct":471,"leadSponsor":473,"locationsCount":57},"100645091","phase-2-gcc-2545--improving-post-radiotherapy-respiratory-function-through-sparing-serial-and-parallel-components-in-the-lung-100645091","NCT07679607","GCC 2545- Improving Post-Radiotherapy Respiratory Function Through Sparing Serial and Parallel Components in the Lung","INSPIRE","Inclusion Criteria:\n\n* Step 1- Inclusion Criteria\n\n  1. Adult (≥18 years) patients (both sexes) with histologically diagnosed Stage III NSCLC per AJCC ver 9\n  2. Patients to be treated with definitive external beam photon radiotherapy with or without systemic therapy (e.g., chemothrapy, immunotherapy).\n  3. No restrictions on number radiotherapy fractions, or location\u002Fnumber of lesions\n  4. ECOG performance status ≤ 3\n  5. Ability to hold breath for ≥ 15 seconds\n  6. Patient has signed informed consent document and agreed to study procedures\n\nStep 2- Inclusion Criteria 1. Patient has completed 4DCT and BHCT with subsequent plans created and Radiation Oncologist has determined that patient would benefit from INSPIRE RT.\n\nExclusion Criteria:\n\n* Step 1- Exclusion Criteria\n\n  1. Prior lung cancer-directed radiotherapy\n  2. Recent (\\\u003C 12 mo) or planned lung surgery (which would confound pre- and post-RT lung function measures)\n  3. Patients with metal implants or metal stents in the thoracic region\n  4. Known severe chronic obstructive pulmonary disease or interstitial lung disease\n  5. Women who are pregnant or trying to get pregnant\n\nStep 2- Exclusion Criteria\n\n1\\. Patient found to not benefit from INSPIRE RT after comparison of treatment plans.",{"count":462,"type":22},70,[68],"Decreased respiratory function is a common side effect experienced by non-small cell lung cancer (NSCLC) patients who receive radiation therapy. In current clinical practice when treating cancerous lesions in the lung, it is not standard to explicitly try and avoid excessive radiation dose and therefore radiation injury to smaller airways. However, because of this patients may obtain damage to an airway segment can cause downstream regions in the lung to lose their \"supply line\" and, therefore, cause patients to lose the ability to exchange oxygen with the blood. The purpose of this clinical trial is to systematically compare post-treatment lung function of those who receive regular clinical radiation therapy (standard of care \\[SoC\\]) versus those who receive the airway-sparing radiation therapy regimen. The investigators hope to show that, by preserving airways and connected lung regions, participants will be able to retain a larger amount of their lung function, which will have a direct, positive impact on their post-treatment quality of life.",[32,466],"Radiation","2026-06-29",{"date":303,"type":49},{"date":470,"type":22},"2026-08",{"date":472,"type":22},"2030-08",{"name":474,"class":125},"University of Maryland, Baltimore",{"id":476,"slug":477,"hasResults":12,"nctId":478,"briefTitle":479,"officialTitle":479,"acronym":480,"eligibilityCriteria":481,"healthyVolunteers":12,"sex":18,"minAge":482,"maxAge":4,"enrollmentInfo":483,"targetDuration":4,"studyType":23,"phases":485,"briefSummary":487,"conditions":488,"keywords":491,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":493,"lastUpdatePostDateStruct":494,"startDateStruct":496,"completionDateStruct":498,"leadSponsor":500,"locationsCount":57},"100592012","practical-geriatric-assessment-in-older-adults-with-non-small-cell-lung-cancer-undergoing-stereotactic-body-radiation-therapy-100592012","NCT06987890","Practical Geriatric Assessment in Older Adults With Non-Small Cell Lung Cancer Undergoing Stereotactic Body Radiation Therapy","Lung-GAP","Inclusion Criteria:\n\n* Age ≥ 65 years old at time of study enrollment.\n* Radiographically or pathologically confirmed stage I-II non-small cell lung cancer.\n* All patients must have undergone appropriate complete imaging of their cancer consistent with the standard of care.\n* Patient is expected to undergo stereotactic body radiation therapy (SBRT)\n* Able to read questions in English or willing to complete survey questionnaires with the assistance of an interpreter.\n\nExclusion Criteria:\n\n* There are no exclusion criteria.","65 Years",{"count":484,"type":22},64,[486],"NA","National guidelines recommend that older adults with cancer undergo a special health assessment before starting cancer treatment. This type of assessment evaluates physical function, nutrition, social support, psychological well-being, medical conditions (both cancer-related and non-cancer-related), and cognitive function. The results can help doctors make better treatment decisions and determine whether additional support services-such as nutrition counseling, physical therapy, or social work-would be beneficial. Even though these assessments are recommended, they are not typically used because they need to be performed by a specialist and can take over an hour to complete. Given these challenges, a 10-15-minute assessment called the Practical Geriatric Assessment (PGA) was recently developed. The PGA can be completed by any healthcare provider and helps identify older adults who may need extra support alongside their cancer treatment. While the PGA has the potential to make geriatric assessments more accessible, the investigators do not yet know whether patients will find it useful or easy to complete.\n\nAdditionally, it is unclear whether using the PGA will lead to more referrals for recommended supportive care services. This study aims to address these questions. The investigators will evaluate whether using the PGA impacts the number of patients referred to recommended supportive care services. Investigators will also evaluate how participants feel about completing the PGA, including how easy or difficult it is, and to assess the feasibility of implementing this survey on a larger scale. Finally, the investigators will use facial photographs and audio-visual data from the PGA to develop and evaluate artificial intelligence algorithm(s) to identify vulnerable patients who might benefit from additional supportive care services; namely, FaceAge, a validated deep learning model capable of estimating biological age from still facial images.",[32,489,490],"Geriatric Assessment","Stereotactic Body Radiation Therapy (SBRT)",[42,492],"Geriatric","2026-06-24",{"date":495,"type":49},"2026-06-25",{"date":497,"type":49},"2025-05-26",{"date":499,"type":22},"2026-06-26",{"name":501,"class":125},"Brigham and Women's Hospital",{"id":503,"slug":504,"hasResults":12,"nctId":505,"briefTitle":506,"officialTitle":507,"acronym":4,"eligibilityCriteria":508,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":509,"targetDuration":4,"studyType":23,"phases":511,"briefSummary":512,"conditions":513,"keywords":4,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":514,"lastUpdatePostDateStruct":515,"startDateStruct":516,"completionDateStruct":518,"leadSponsor":520,"locationsCount":57},"100623559","gcc-2546--motion-management-100623559","NCT07398209","GCC 2546- Motion Management","Combining 4D MRI and 4DCT for Personalized Volumetric Motion Monitoring in Lung Radiation Therapy","Inclusion Criteria:\n\n1. Adult (≥18 years) patients (both sexes) with histologically diagnosed Stage II-IIIb NSCLC\n2. Patients to be treated with definitive external beam photon radiotherapy with or without systemic therapy (e.g., chemotherapy, immunotherapy).\n3. No restrictions on number radiotherapy fractions, or location\u002Fnumber of lesions\n4. ECOG performance status ≤ 3\n5. Ability to undergo MRI scans\n6. Patient has signed informed consent document and agreed to study procedures\n\nExclusion Criteria:\n\n1. Pre-existing contraindications for MRI, such as any MRI-conditional or MRI-unsafe foreign objects within the body, non-removable ear cochlear or eye implant, aneurysm clip, cardiac pacemaker\u002Fwires, internal defibrillator, tissue expander, recent stent placement, penile prosthesis, medication patch, artificial limb, pregnancy, and claustrophobia\n2. Women who are pregnant or trying to get pregnant (self-reported)\n3. Pain in supine position or inability to raise arm above head in supine position",{"count":510,"type":22},44,[486],"The purpose of this study is to assess a real time motion tracking of lung tumors and important organs next to the tumor while breathing during a participant's radiation treatment. This will be assessed through a four-dimensional magnetic resonance imaging (MRI) scan before starting your radiation treatment and x-ray fluoroscopy images that are taken during radiation",[32,466],"2026-06-23",{"date":499,"type":49},{"date":517,"type":49},"2026-04-14",{"date":519,"type":22},"2029-04",{"name":474,"class":125},{"id":522,"slug":523,"hasResults":12,"nctId":524,"briefTitle":525,"officialTitle":526,"acronym":4,"eligibilityCriteria":527,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":103,"enrollmentInfo":528,"targetDuration":4,"studyType":23,"phases":530,"briefSummary":531,"conditions":532,"keywords":4,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":537,"lastUpdatePostDateStruct":538,"startDateStruct":540,"completionDateStruct":542,"leadSponsor":543,"locationsCount":57},"100642769","acute-effects-of-visual-feedback-assisted-inspiratory-muscle-training-after-lobectomy-100642769","NCT07646288","Acute Effects of Visual Feedback-Assisted Inspiratory Muscle Training After Lobectomy","Evaluation of the Acute Effects of Respiratory Muscle Strength Training With Visual Feedback in Lung Cancer Patients Undergoing Lobectomy","Inclusion Criteria:\n\n* Volunteering to participate in the study,\n* Being clinically stable,\n* Being a lung cancer patient scheduled for lobectomy,\n* Being between 18 and 75 years of age,\n* Being able to cooperate with the tests to be performed.\n\nExclusion Criteria:\n\n* Presence of any orthopedic or neurological problem that prevents walking,\n* History of any surgery involving the thoracic wall,\n* Having diseases that may affect respiratory parameters, such as severe heart failure or severe chronic obstructive pulmonary disease (COPD).",{"count":529,"type":22},40,[486],"This study aims to evaluate the acute effects of inspiratory muscle training performed with and without a mobile application providing visual feedback on exercise motivation, patient adherence, dyspnea perception, usability, and patient satisfaction in lung cancer patients undergoing lobectomy via video-assisted thoracic surgery. Participants will perform conventional inspiratory muscle training without visual feedback in the morning on postoperative day 1 after transfer to the ward. After at least two hours of rest, the same exercise protocol will be repeated with a smart adaptor connected to a mobile application to provide visual feedback. Inspiratory muscle training will be performed using a threshold-loading device at 40% of maximal inspiratory pressure, with three sets of ten breaths. Outcomes will be assessed before and\u002For after each session as appropriate.",[533,534,535,32,536],"VATS","Respiratory Muscles","Exercise Training","Lobectomy","2026-06-11",{"date":539,"type":49},"2026-06-15",{"date":541,"type":49},"2025-12-01",{"date":424,"type":22},{"name":544,"class":125},"Hacettepe University",{"id":546,"slug":547,"hasResults":12,"nctId":548,"briefTitle":549,"officialTitle":550,"acronym":4,"eligibilityCriteria":551,"healthyVolunteers":12,"sex":18,"minAge":552,"maxAge":4,"enrollmentInfo":553,"targetDuration":4,"studyType":191,"phases":4,"briefSummary":555,"conditions":556,"keywords":4,"overallStatus":116,"whyStopped":4,"lastUpdateSubmitDate":557,"lastUpdatePostDateStruct":558,"startDateStruct":560,"completionDateStruct":561,"leadSponsor":563,"locationsCount":340},"100638033","analysis-of-different-second-line-treatment-in-advanced-nsclc-patients-progressing-after-1st-line-immune-checkpoint-inhibitor-therapy-100638033","NCT07596524","Analysis of Different Second Line Treatment in Advanced NSCLC Patients Progressing After 1st Line Immune Checkpoint Inhibitor Therapy","Analysis of Different Treatment Modalities and Clinical Outcomes in Advanced NSCLC Patients Progressing After First-Line Immune Checkpoint Inhibitor Therapy: An Observational Study Based on Real-World Data","Inclusion Criteria:\n\n* Locally advanced or metastatic NSCLC that is not curable and confirmed by histological or cytological examination based on the 8th edition of AJCC staging.\n* Previously received advanced first-line treatment based on immune checkpoint inhibitor drugs.\n* Has a medical record of disease progression during the first-line treatment.\n* Complete clinical and pathological data, such as age, gender, smoking history, primary tumor location, differentiation, metastatic site, and imaging and serological review as required.\n\nExclusion Criteria:\n\n* First-line treatment with immune checkpoint inhibitor drugs was ≤ 2 cycles.\n* Excluding patients with incomplete key baseline and treatment information.\n* Have other potential factors that may affect the study results or result in the premature discontinuation, as determined by the investigator","1 Year",{"count":554,"type":22},300,"The second-line treatment options in clinical practice for immunotherapy progress are complex. Treatment strategies need to be selected based on different progression patterns. It is difficult to simultaneously explore multiple treatment modalities through previous clinical studies. Observational studies through real-world research can efficiently convert clinical practice data into clinical treatment evidence. This study aims to observe the treatment patterns and clinical outcomes of advanced NSCLC patients who received first-line immunotherapy checkpoint inhibitor treatment after progression, in order to provide guidance for the second-line treatment options for patients with first-line immunotherapy progress.",[32],"2026-05-18",{"date":559,"type":49},"2026-05-19",{"date":303,"type":22},{"date":562,"type":22},"2027-06-30",{"name":564,"class":125},"Cancer Institute and Hospital, Chinese Academy of Medical Sciences",{"id":566,"slug":567,"hasResults":12,"nctId":568,"briefTitle":569,"officialTitle":570,"acronym":571,"eligibilityCriteria":572,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":573,"targetDuration":4,"studyType":23,"phases":575,"briefSummary":576,"conditions":577,"keywords":579,"overallStatus":116,"whyStopped":4,"lastUpdateSubmitDate":581,"lastUpdatePostDateStruct":582,"startDateStruct":584,"completionDateStruct":586,"leadSponsor":588,"locationsCount":590},"100630359","phase-1-osimertinib-plus-capivasertib-in-nsclc-with-pik3caakt1pten-alterations-following-prior-1l-osimertinib-100630359","NCT07486648","Osimertinib Plus Capivasertib in NSCLC With PIK3CA\u002FAKT1\u002FPTEN Alterations Following Prior 1L Osimertinib","The Safety and Efficacy of Osimertinib Plus Capivasertib in EGFRm Advanced Non-small Cell Lung Cancer (NSCLC) Participants With PIK3CA\u002FAKT1\u002FPTEN Alterations Who Had Progressed on First-line Osimertinib Monotherapy or Plus Chemotherapy: a First-in-human, Phase Ib\u002FⅡa Study (PRECISION)","Precision","Inclusion criteria\n\nInformed consent\n\n1. Provision of signed and dated, written informed consent form (ICF) prior to any mandatory and non-mandatory study-specific procedures, sampling and analyses\n\n   Age\n2. Male or female age ≥18 years at the time of signing the ICF.\n\n   Type of participant and disease characteristics\n3. Histologically or cytologically confirmed non-squamous locally advanced or metastatic NSCLC which is not amenable to curative therapy.\n4. Documented EGFR sensitive mutations (exon19 deletion, L858R mutation) prior to the first-line EGFR-TKI therapy.\n5. Documented radiologic progression on first-line treatment with Osimertinib monotherapy or Osimertinib plus chemotherapy:\n\n   * Participants treated with Osimertinib in the adjuvant setting can be included if progression occurred \\\u003C 6 months after last dose.\n   * Participants must be immunotherapy (i.e., programmed cell death protein 1 \\[PD-1\\] inhibitor, programmed cell death protein 1 ligand 1 \\[PD-L1\\] inhibitor, Cytotoxic T-lymphocyte associated protein 4 inhibitor) naïve in the metastatic setting.\n   * Prior immunotherapy in the neoadjuvant or adjuvant setting is acceptable providing treatment was completed more than 6 months before metastatic\u002Frecurrent disease was diagnosed.\n6. Mandatory provision of the required number of FFPE tumour tissue samples for PIK3CA mutations and\u002For AKT1 mutations and\u002For PTEN loss-of-function (LOF) mutations testing, which fulfils the following requirements:\n\n   * Obtained following progression on previous Osimertinib monotherapy or Osimertinib plus chemotherapy as first-line treatment.\n   * Specimen to meet the requirements defined in the Central Laboratory Manual and Diagnostic Testing Manual.\n   * Have PIK3CA and\u002For AKT1 and\u002For PTEN alterations as determined by NGS testing by a sponsor designated central laboratory on tumour specimen collected following progression on prior Osimertinib treatment.\n7. At least one lesion, not previously irradiated, not biopsied during the screening period, that can be accurately measured at baseline as ≥ 10 mm in the longest diameter (except lymph nodes which must have short axis ≥ 15 mm) with CT or MRI, which is suitable for accurate repeated measurements. If only one measurable lesion exists, it is acceptable to be used if baseline tumour assessment scans are done at least 14 days after the screening tumour specimen collection is performed.\n8. Adequate bone marrow reserve and organ function as follows:\n\n   * Absolute neutrophils count (ANC) ≥1.5x109\u002FL.\n   * Platelets count ≥100x109\u002FL.\n   * Haemoglobin (Hb) ≥90g\u002FL.\n   * Total bilirubin ≤1.5 times upper limit of normal (ULN) or ≤3 times ULN in the presence of documented Gilbert's Syndrome (unconjugated hyperbilirubinaemia) or liver metastases.\n   * Alanine transaminase (ALT) and aspartate transaminase (AST) ≤2.5ULN (or ≤5 ULN in the presence of liver metastases).\n   * Serum Creatinine ≤1.5 ULN or creatinine clearance (CCr) ≥50mL\u002Fmin (measured or calculated by Cockcroft and Gault equation); confirmation of creatinine clearance is only required when creatinine is \\>1.5 times ULN.\n9. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n10. Patients with hepatitis B virus (HBV) are only eligible for inclusion if they meet all the following criteria:\n\n    * Demonstrated absence of hepatitis C virus (HCV) co-infection or history of HCV co-infection\n    * Demonstrated absence of human immunodeficiency virus (HIV) infection\n    * Participants with active HBV infection are eligible if they are:\n    * Receiving anti-viral treatment for at least 6 weeks prior to study treatment, HBV DNA is suppressed to \\\u003C100 IU\u002FmL and transaminase levels are below ULN.\n    * Participants with a resolved or chronic HBV infection are eligible if they are:\n    * Negative for HBsAg and positive for hepatitis B core antibody \\[anti-HBc IgG or total anti-HBc Ab\\]. In addition, patients should be referred to a local hepatologist and treated as per local guidelines.\n\n    or\n\n    • Positive for HBsAg, but for \\> 6 months have had transaminases levels below ULN and HBV DNA levels below \\\u003C100 IU\u002FmL or below the detectable limit of locally available test kit (i.e., are in an inactive carrier state). In addition, patients must be receiving anti-viral prophylaxis for 2-4 weeks prior to study treatment.\n\n    Patients with HIV are only eligible for inclusion if they meet all the following criteria:\n    * Demonstrated absence of HBV\u002F HCV co-infection\n    * Undetectable viral RNA load for 6 months\n    * CD4+ count of \\>350 cells\u002FµL\n    * No history of AIDS-defining opportunistic infection within the past 12 months\n\n    Stable for at least 4 weeks on the same anti-HIV medications.\n11. Ability to swallow and retain oral medications.\n12. Willingness and ability to comply with study and follow-up procedures. Reproduction\n13. Females must be using highly effective contraceptive measures, and must have a negative pregnancy test prior to start of dosing if of child-bearing potential, or must have evidence of non-child-bearing potential by fulfilling one of the following criteria at screening:\n\n    * Post-menopausal defined as aged 50 years or more and amenorrhoeic for at least 12 months following cessation of all exogenous hormonal treatments.\n    * Women under 50 years old would be considered postmenopausal if they have been amenorrhoeic for 12 months or more following cessation of exogenous hormonal treatments and with LH and FSH levels in the post-menopausal range for the institution.\n    * Documentation of irreversible surgical sterilisation by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation.\n\n    Further information in Appendix C (Definition of Women of Childbearing Potential and Acceptable Contraceptive Methods).\n14. Male participants must be willing to use barrier contraception. Exclusion criteria\n\nMedical conditions\n\n1. Patients harbouring concurrent actionable driver mutations with locally approved targeted therapies (e.g., MET amplification) will be excluded.\n2. Past medical history of interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD.\n3. Clinically significant abnormalities of glucose metabolism as defined by any of the following:\n\n   * Fasting glucose ≥7.0 mmol\u002FL (126 mg\u002FdL) or 2 hours after glucose solution intake, blood glucose ≥11.1 mmol\u002FL (200 mg\u002FdL).\n   * HbA1c ≥8.0% (63.9 mmol\u002Fmol) at screening. Note: for any patient with evidence of impaired glucose control or insulin resistance refer to the Capivasertib Toxicity Management Guidelines.\n4. Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses, which in the investigator's opinion makes it undesirable for the patient to participate in the trial or which would jeopardize compliance with the protocol, or active infection (e.g. patients receiving treatment for infection) including hepatitis C and human immunodeficiency virus (HIV), or active uncontrolled hepatitis B virus (HBV) infection, or active tuberculosis infection (clinical evaluation that may include clinical history, physical examination and radiographic findings, or tuberculosis testing in line with local practice) .\n\n   • Screening for chronic conditions is not required.\n5. Spinal cord compression, leptomeningeal metastasis, or brain metastases unless asymptomatic, stable, and not requiring steroids for at least 4 weeks prior to start of study intervention.\n6. Any of the following cardiac criteria:\n\n   * Mean resting corrected QTc \\>470 msec, obtained from triplicate electrocardiograms (ECGs), using the screening clinic ECG machine derived QTc value.\n   * History of QT prolongation associated with other medications that required discontinuation of that medication.\n   * Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG e.g., complete left bundle branch block, third degree heart block and second-degree heart block.\n   * Medical history significant for arrhythmia (e.g., multifocal premature ventricular contractions, bigeminy, trigeminy, ventricular tachycardia), which is symptomatic or requires treatment (Common Terminology Criteria for Adverse Events \\[CTCAE\\] Grade 3), symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia. Participants with atrial fibrillation controlled by medication or arrhythmias controlled by pacemakers may be permitted to enter the study based on the Investigator judgement with cardiologist consultation recommended.\n   * Patient with any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as electrolyte abnormalities including:\n\n     * Hypokalaemia\\|\\* ≥ CTCAE Grade 2.\n     * Heart failure, congenital long QT syndrome, family history of long QT syndrome, or unexplained sudden death under 40 years of age in first-degree relatives or any concomitant medication known to prolong the QT interval and cause Torsade de Pointes.\n     * Correction of electrolyte abnormalities should be documented prior to first dose.\n   * Experience of any of the following procedures or conditions in the preceding 6 months: coronary artery bypass graft, angioplasty, vascular stent, myocardial infarction, angina pectoris, congestive heart failure New York Heart Association (NYHA) Grade 2.\n7. History of another primary malignancy except for malignancy treated with curative intent with no known active disease ≥2 years before the first dose of investigational product (IP) and of low potential risk for recurrence. Exceptions include adequately resected non-melanoma skin cancer and curatively treated in situ disease.\n8. Any unresolved toxicities from prior therapy greater than CTCAE grade 1 at the time of starting study treatment except for alopecia and grade 2 prior platinum-therapy related neuropathy. Participants with irreversible toxicity that is not reasonably expected to be exacerbated by study intervention in the opinion of the Investigator may be included (e.g., hearing loss).\n9. Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption, distribution, metabolism, or excretion of IP.\n10. Any other disease, physical examination finding, or clinical laboratory finding that, in the investigator's opinion, gives reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug, may affect the interpretation of the results, render the patient at high risk from treatment complications or interferes with obtaining informed consent.\n\n    Prior\u002Fconcomitant therapy\n11. Prior or current treatment with a third-generation EGFR-TKI other than Osimertinib.\n12. Prior or current treatment with any PI3K\u002FAKT pathway inhibitors, including but not limited to: Capivasertib or other AKT inhibitors, PI3K inhibitors, or agents targeting key nodes in this pathway (e.g., PTEN-modulating therapies).\n13. Concurrent use of herbal or natural products intended as treatment or prophylaxis for any type of cancer.\n14. Wide field radiotherapy (including therapeutic radioisotopes such as strontium 89) administered ≤ 28 days or limited field radiation for palliation ≤ 14 days prior to starting study intervention or has not recovered from side effects of such therapy.\n15. Major surgery or significant traumatic injury within 4 weeks of the first dose of study intervention or an anticipated need for major surgery during the study. Procedures such as placement of vascular access, biopsy via mediastinoscopy or biopsy via video assisted thoracoscopic surgery (VATS) are permitted.\n16. Systemic therapy: Prior exposure to any anti-cancer agents other than those specified in the protocol (e.g. hormonal therapy such as luteinizing hormone releasing hormone \\[LHRH\\] agonists) without appropriate washout period before enrolment, for example, enrolment within 3 half-lives of a small molecule anti-cancer agent, or within 4 weeks for any antibody-based anticancer agents.\n17. Participants currently receiving (or unable to stop use prior to receiving the first dose of study treatment) medications or herbal supplements known to be strong inducers (at least 3-week prior), moderate inducers (at least 2-week prior) or strong inhibitors of CYP3A4 (at least 2-week prior). All participants must try to avoid concomitant use of any medications, herbal supplements and\u002For ingestion of foods with known inducer or inhibitor effects on CYP3A4. Any concomitant medication that may interfere with Osimertinib safety and efficacy based on the prescribing information of Osimertinib and local clinical guidelines.\n\n    Prior\u002Fconcurrent clinical study experience\n18. Participation in another clinical study with a study intervention or investigational medicinal device administered in the 4 weeks prior to first dose of study intervention or concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study.\n\n    Other exclusions\n19. History of hypersensitivity to active or inactive excipients of Capivasertib or Osimertinib or drugs with a similar chemical structure or class.\n20. Women who are currently pregnant (confirmed with positive pregnancy test) or breast-feeding or planning to become pregnant.\n21. Involvement in the planning and\u002For conduct of the study (applies to both Investigator staff and\u002For staff at the study site).",{"count":574,"type":22},53,[135,68],"The goal of this clinical trial is to learn if Osimertinib plus Capivasertib works to treat EGFRm advanced non-small cell lung cancer (NSCLC) in participants with PIK3CA\u002FAKT1\u002FPTEN alterations after progression on first-line Osimertinib (monotherapy or plus chemotherapy).\n\nThe main questions it aims to answer are:\n\nPart A:\n\n* Number of Dose-limiting toxicities (DLTs)\n* Adverse events (AEs)\u002Fserious adverse events (SAEs) (graded by CTCAE Version 5.0)\n* Recommended combined dose (RCD)\n\nPart B:Confirmed ORR assessed by the Investigator per RECIST 1.1 criteria.\n\nParticipants will:\n\nPart A:Take Capivasertib twice daily from day 1 to 4 of a 7-day cycle, Osimertinib will be given orally QD(once daily) at 80 mg throughout the study treatment period.\n\nPart B: Take Osimertinib (80mg QD, continuously) and Capivasertib(RCD,orally BID from day1-day 4 in 7-day cycle , 4 days on \u002F3 days off) till disease progression (PD) or unacceptable toxicity.",[32,321,578],"Advanced Non-small-cell Lung Cancer",[28,580],"Osimertinib plus Capivasertib","2026-03-23",{"date":583,"type":49},"2026-03-24",{"date":585,"type":22},"2026-05-15",{"date":587,"type":22},"2028-12-31",{"name":589,"class":125},"Shanxi Province Cancer Hospital",2,{"id":592,"slug":593,"hasResults":12,"nctId":594,"briefTitle":595,"officialTitle":595,"acronym":4,"eligibilityCriteria":596,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":597,"targetDuration":4,"studyType":23,"phases":599,"briefSummary":600,"conditions":601,"keywords":4,"overallStatus":116,"whyStopped":4,"lastUpdateSubmitDate":603,"lastUpdatePostDateStruct":604,"startDateStruct":606,"completionDateStruct":607,"leadSponsor":609,"locationsCount":4},"100631009","phase-1-phase-1b-trial-of-intratumoral-cisplatin-for-stage-iv-lung-cancer-100631009","NCT07495098","Phase 1B Trial of Intratumoral Cisplatin for Stage IV Lung Cancer","2.5.1 Inclusion criteria\n\n* Age 18 years or above\n* Eastern Cooperative Oncology Group (ECOG) performance score 0-2\n* Have known or suspected metastatic NSCLC at time of enrollment (including patients who progress on initial therapy or are found to have metastatic disease during therapy and are not excluded\n* Patient is able and willing to provide informed consent.\n* Rapid on-site cytopathologic examination (ROSE) performed during the procedure (if not previously diagnosed) and returns likely NSCLC. No injection will be performed if ROSE is non-diagnostic.\n* A CT scan of the chest (with or without contrast) within the prior 3 months.\n* The presence of an EBUS accessible target site determined by a treating investigator. These may be primary lung cancers or metastatic sites (including when a lymph node station has been replaced by metastatic tumor), that are accessible by EBUS.\n* MDC agreement of likely Stage IV NSCLC (confirmation from at minimum a Medical Oncologist and Radiation Oncologist on clinical stage).\n* Patients must have adequate organ and marrow function as defined below:\n\n  * Leukocytes ≥3,000\u002FmcL\n  * Platelets ≥100,000\u002FmcL\n  * Total bilirubin ≤ institutional upper limit of normal (ULN)\n  * AST(SGOT)\u002FALT(SGPT) ≤ institutional ULN\n  * Creatinine ≤ institutional ULN\n\n2.5.2 Exclusion criteria\n\n* Use of an investigational agent in prior 30 days\n* Pregnancy\u002Flactation (pregnancy test to be performed by pre-op as part of standard of care for women of child-bearing age as defined by UVMMC Policy NPREP16)\n* Treatment with intravenous cytotoxic chemotherapy within the past 14 days\n* Allergy to cisplatin or its derivatives\n* Allergy to iodinated contrast\n* Patient not appropriate for the research study based on physician discretion",{"count":598,"type":22},12,[135],"The addition of intravenous (given through a vein) cisplatin to immunotherapy improves treatment outcomes for lung cancer, but unfortunately results in significantly more side effects since the rest of the body is exposed to significant amounts of the drug. Our clinical trial data indicate that injecting cisplatin directly into the tumor using a bronchoscope (a small flexible tube with a camera in it) has very few side effects, and results in significant cell death and potentially improvement in the immune response. The goal of this proposal is to evaluate a computational approach, that incorporates data from a CT scan, to determine the optimal dose and delivery location within a tumor to maximize tumor cell killing and the immune response.",[602,32],"Lung Cancer Metastatic","2026-03-20",{"date":605,"type":49},"2026-03-27",{"date":303,"type":22},{"date":608,"type":22},"2031-06-30",{"name":610,"class":125},"University of Vermont",{"id":612,"slug":613,"hasResults":12,"nctId":614,"briefTitle":615,"officialTitle":615,"acronym":4,"eligibilityCriteria":616,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":617,"targetDuration":4,"studyType":191,"phases":4,"briefSummary":619,"conditions":620,"keywords":4,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":621,"lastUpdatePostDateStruct":622,"startDateStruct":623,"completionDateStruct":625,"leadSponsor":627,"locationsCount":57},"100630326","magnetic-resonance-imaging-of-the-lung-oncological-applications-100630326","NCT07486219","Magnetic Resonance Imaging of the Lung: Oncological Applications","Inclusion Criteria:\n\n* Primary NSCLC of the lung (TNM 8th edition T parameter ≥T1c)\n* Biopsy examination of the primary tumor adequate at least for PDL-1 quantification\n* Staging CT scan with uncertain N parameter and definite M parameter.\n\nExclusion Criteria:\n\n* Absolute contraindications to magnetic resonance imaging or the administration of gadolinium-based contrast agents",{"count":618,"type":22},50,"Lung neoplasms are characterized by a complex interaction between tumor cells and a variety of resident and infiltrating host elements, secreted factors, and extracellular matrix proteins, collectively referred to as the microenvironment. Nowadays, in the setting of lung cancer, and in particular non-small cell lung cancer (NSCLC), the evaluation of microenvironment characteristics can only be performed by a pathologist and only on histological material. By combining different MRI parameters, it may be possible to create a specific imaging \"signature\" for the three different immune phenotypes and thus be able to make a distinction based on MRI examination.",[32],"2026-03-18",{"date":603,"type":49},{"date":624,"type":49},"2020-01-15",{"date":626,"type":22},"2026-04",{"name":628,"class":125},"Fondazione IRCCS Policlinico San Matteo di Pavia",{"id":630,"slug":631,"hasResults":12,"nctId":632,"briefTitle":633,"officialTitle":633,"acronym":634,"eligibilityCriteria":635,"healthyVolunteers":187,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":636,"targetDuration":4,"studyType":23,"phases":637,"briefSummary":638,"conditions":639,"keywords":640,"overallStatus":116,"whyStopped":4,"lastUpdateSubmitDate":644,"lastUpdatePostDateStruct":645,"startDateStruct":646,"completionDateStruct":647,"leadSponsor":648,"locationsCount":57},"100605514","immune-response-to-immunotherapy-in-lung-cancer-study-of-sputum-and-blood-samples-100605514","NCT07163507","Immune Response to Immunotherapy in Lung Cancer: Study of Sputum and Blood Samples","RICEPS-2","Inclusion Criteria:\n\n. Age 18 years or older\n\n* Diagnosis of locally advanced or metastatic non-small cell lung cancer (NSCLC)\n* Requiring initiation of treatment with anti-PD1 or anti-PDL1 ICI (nivolumab, pembrolizumab, atezolizumab, durvalumab, cemiplimab), with or without chemotherapy\n* Never having received ICI treatment\n* Affiliated with a social security system\n* Having signed a written, free, and informed consent form\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding women\n* Individuals under guardianship, conservatorship, or judicial protection, or in a situation of deprivation of liberty",{"count":618,"type":22},[486],"Lung cancer is the leading cause of cancer-related death worldwide, with nearly 2.48 million cases and 1.8 million deaths in 2022. Despite therapeutic progress, late diagnosis and high mortality make it a major public health issue. Immune checkpoint inhibitors (ICI) such as nivolumab, pembrolizumab, and atezolizumab have improved outcomes for some patients, but only a small proportion benefit, and side effects can be severe. Research is focusing on combining ICIs with chemotherapy, radiotherapy, or other immunotherapies, but reliable biomarkers to predict responders are still lacking. The tumor microenvironment, which promotes resistance, is a promising therapeutic target. The RICEPS study (2021-2023) found specific immune cells and cytokines linked to treatment response, and the ongoing RICEPS-2 trial aims to confirm these findings in a larger group to better understand immune dynamics in lung cancer under ICI therapy.",[32,321],[641,642,643],"immunotherapy","sputum samples","blood samples","2026-03-17",{"date":621,"type":49},{"date":626,"type":22},{"date":391,"type":22},{"name":649,"class":125},"University Hospital, Tours",{"id":651,"slug":652,"hasResults":12,"nctId":653,"briefTitle":654,"officialTitle":655,"acronym":656,"eligibilityCriteria":657,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":658,"enrollmentInfo":659,"targetDuration":4,"studyType":23,"phases":661,"briefSummary":662,"conditions":663,"keywords":665,"overallStatus":116,"whyStopped":4,"lastUpdateSubmitDate":667,"lastUpdatePostDateStruct":668,"startDateStruct":670,"completionDateStruct":672,"leadSponsor":674,"locationsCount":4},"100629269","phase-2-phase-ii-neoadjuvant-study-of-garsorasib-followed-by-ivonescimab-plus-chemotherapy-in-resectable-stage-iia-iiib-kras-g12c-mutant-nsclc-given-study-100629269","NCT07472478","Phase II Neoadjuvant Study of Garsorasib Followed by Ivonescimab Plus Chemotherapy in Resectable Stage IIA-IIIB KRAS G12C-Mutant NSCLC (GIVEN Study)","An Exploratory Phase II Clinical Study Protocol of Perioperative Treatment With Glesorasib Sequentially Combined With Ivonescimab and Chemotherapy for Resectable, Stage IB-IIIB, KRAS G12C-Mutant NSCLC","GIVEN","Inclusion Criteria:\n\n1. Age Range: Males or females aged 18 years or older.\n2. Diagnosis and Stage: Patients with histologically or cytologically confirmed resectable IB-IIIB NSCLC, staged according to the International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology, 9th Edition.\n3. Informed Consent: Patients must voluntarily participate in the study, provide written informed consent, and be willing to comply with follow-up procedures.\n4. Prior Therapy: No prior systemic therapy for locally advanced or metastatic NSCLC (including adjuvant chemo\u002Fradiotherapy, neoadjuvant chemo\u002Fradiotherapy, definitive chemoradiotherapy, chemotherapy, radiotherapy, immune checkpoint inhibitors, targeted therapy, or anti-angiogenic therapy for locally advanced disease).\n5. Mutation Status: KRAS G12C mutation positivity must be confirmed by next-generation sequencing (NGS) or polymerase chain reaction (PCR) testing.\n6. Measurable Disease: At least one measurable target lesion as per RECIST v1.1. Lesions previously treated with radiotherapy or other local-regional therapies cannot be considered target lesions unless clear progression has been documented post-radiotherapy. At baseline, the lesion must be ≥10mm in the longest diameter (≥15mm in short axis for lymph nodes) on CT or MRI and be suitable for accurate repeated measurement per RECIST v1.1.\n7. Performance Status: Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.\n8. Adequate Organ Function: Must meet the following criteria within 14 days prior to relevant tests, without transfusion or use of hematopoietic growth factors:\n\n   1. Platelets (PLT) ≥90 × 10\\^9\u002FL\n   2. Hemoglobin (HGB) ≥90 g\u002FL\n   3. Absolute Neutrophil Count (ANC) ≥1.5 × 10\\^9\u002FL\n   4. Serum creatinine ≤1.5 × ULN or Creatinine Clearance (CrCl) ≥50 mL\u002Fmin (calculated using the Cockcroft-Gault formula)\n   5. Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) ≤2.5 × ULN (≤5 × ULN if liver metastases are present)\n   6. Total Bilirubin (TBIL) ≤1.5 × ULN (≤3 × ULN for patients with Gilbert's syndrome)\n   7. International Normalized Ratio (INR) or Prothrombin Time (PT) ≤1.5 × ULN, and Activated Partial Thromboplastin Time (APTT) ≤1.5 × ULN, or patients assessed by the investigator as having controlled bleeding tendency.\n   8. Urinalysis showing urine protein \\\u003C2+ or 24-hour urinary protein quantification \\\u003C1g.\n9. Life Expectancy: Expected survival time ≥3 months.\n10. Contraception: Fertile female subjects must agree to use effective contraception (e.g., IUD, oral contraceptives, condoms) during the study and for 6 months after study completion; have a negative serum pregnancy test within 7 days before enrollment; and must not be breastfeeding. Male subjects must agree to use effective contraception during the study and for 6 months after study completion.\n\nExclusion Criteria:\n\n1. Prior Anti-Tumor Therapy:\n\n   1. Previous receipt of any anti-tumor therapy for lung cancer (including adjuvant chemoradiotherapy, neoadjuvant chemoradiotherapy, chemotherapy, radiotherapy, immune checkpoint inhibitors, targeted therapy, anti-angiogenic therapy, etc.).\n   2. Treatment with any other investigational drug within 28 days prior to the first dose in this study.\n   3. Treatment within 2 weeks prior to the first dose with NMPA-approved Chinese patent medicines explicitly indicated for anti-tumor purposes in their drug说明书 (e.g., Compound Banmao Capsules, Kang'ai Injection, Kanglaite Capsules\u002FInjection, Aidi Injection, Yadanzi Oil Injection\u002FCapsules, Xiaoaiping Tablets\u002FInjection, Huachansu Capsules, etc.).\n2. Recent Surgery: Any surgery within 4 weeks prior to screening examinations.\n3. Concurrent Primary Malignancy: Patients with a concurrent primary malignancy (except for adequately treated basal cell carcinoma of the skin, carcinoma in situ of the cervix, etc.).\n4. Abnormal Organ Function: Meeting any of the following at screening:\n\n   1. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 1.5 times the upper limit of normal (ULN).\n   2. Creatinine clearance rate (CrCl) \\> ULN.\n5. Hematological Abnormalities: Total white blood cell (WBC) count \\> 10.0 × 10\\^9\u002FL or \\\u003C 1.0 × 10\\^9\u002FL at screening.\n6. Significant Comorbidities: History of immunodeficiency diseases (e.g., HIV), other active cancers or malignancy history, autoimmune diseases, severe cardiovascular or cerebrovascular diseases, or any other diseases that may significantly reduce life expectancy.\n7. Conditions Affecting Compliance: Any history of conditions that may affect protocol compliance (e.g., severe psychiatric disorders, cognitive dysfunction, drug abuse or addiction).\n8. Pregnancy, Lactation, and Contraception: Pregnant or lactating women, or subjects of childbearing potential unwilling or unable to use effective contraception.\n9. Allergy: Known allergy to any component of the study drug(s).\n10. Recent Trial Participation: Participation in any drug clinical trial within 6 months prior to screening.\n11. Investigator's Discretion: Any condition considered by the investigator as unsuitable for study participation.\n12. Other Driver Mutations: Non-small cell lung cancer with other standard-therapy-eligible driver gene mutations (e.g., EGFR, ALK, BRAF V600E, HER-2, MET Exon 14, ROS1, RET, or NTRK1\u002F2\u002F3).\n13. Central Nervous System (CNS) Metastases:\n\n    1. Symptomatic or progressive CNS metastases or carcinomatous meningitis.\n    2. Subjects with a history of brain metastases may be considered if they are clinically stable: no neurological symptoms, no corticosteroid treatment required, no indication for radiotherapy, and the largest diameter of the largest metastatic lesion on recent imaging is ≤ 1.5 cm.\n    3. Asymptomatic CNS metastases newly discovered during screening are allowed.\n    4. Subjects with a history of asymptomatic CNS metastases require confirmation of no progression via imaging scans performed at least 2 weeks apart.\n    5. Subjects with symptomatic CNS metastases may be considered if clinically stable after radiotherapy and\u002For surgery.\n    6. Subjects who underwent surgery for CNS metastases must have an interval of at least 4 weeks before the first study dose.\n    7. Asymptomatic subjects after CNS radiotherapy must have discontinued corticosteroids for at least 2 weeks prior to the first dose.\n14. Cardiovascular Disease: Any of the following:\n\n    1. Congestive heart failure of New York Heart Association Class II or above.\n    2. Severe arrhythmia requiring medication.\n    3. Acute myocardial infarction, severe or unstable angina, coronary or peripheral artery bypass graft within 6 months prior to enrollment.\n    4. Left ventricular ejection fraction (LVEF) \\\u003C 50%.\n    5. Prolonged QTcF interval ( \\> 470 ms for females, \\> 450 ms for males) or risk factors for Torsades de Pointes.\n    6. Uncontrolled hypertension (systolic BP ≥ 150 mmHg and\u002For diastolic BP ≥ 100 mmHg after antihypertensive therapy).\n15. Thromboembolic Events: Arterial\u002Fvenous thrombotic events within 6 months, hypertensive crisis, or hypertensive encephalopathy.\n16. History of Epilepsy: Previous history of epilepsy.\n17. Superior Vena Cava Syndrome: Presence of superior vena cava syndrome.\n18. Pulmonary Disease: Active non-infectious interstitial lung disease, radiation pneumonitis, etc., active tuberculosis, pneumoconiosis, ≥ Grade 2 other pneumonias, or severely impaired pulmonary function at screening.\n19. Severe Bone Lesions: Existing or potential severe bone damage from metastases, or uncontrolled bone pain.\n20. Active Infection: Active or uncontrolled severe infection, or unexplained fever \\> 38.5°C.\n21. Third-Space Fluid: Poorly controlled or drainage-requiring pleural effusion, ascites, or pericardial effusion. Subjects stabilized after treatment may be enrolled.\n22. Tumor Invading Major Vessels: Imaging shows tumor invading or with unclear boundaries to major blood vessels.\n23. Bleeding Risk: Evidence or history of bleeding tendency within 2 months before the first dose; history of hemoptysis, or unhealed wounds\u002Fulcers\u002Ffractures within 2 weeks before the first dose.\n24. Gastrointestinal Diseases: Known GI impairment or diseases significantly affecting drug absorption\u002Fmetabolism, or major GI surgery affecting absorption.\n25. Recent Live Vaccination: Administration of a live attenuated vaccine within 4 weeks before the first dose.\n26. Severe Hypersensitivity to mAbs: History of severe hypersensitivity reaction to other monoclonal antibodies.\n27. Autoimmune Disease: Active autoimmune disease requiring systemic treatment within 2 years before the first dose.\n28. Immunosuppressive Therapy: Receiving systemic corticosteroids or other immunosuppressive therapy.\n29. Viral Infections: Positive HIV antibody, or active viral hepatitis.\n\n    1. Active Hepatitis B or active Hepatitis C.\n    2. Carriers require antiviral therapy and monitoring during the study.\n30. Active Syphilis.\n31. Renal Failure: Requiring hemodialysis or peritoneal dialysis.\n32. Poorly Controlled Diabetes: Fasting blood glucose \\> 10 mmol\u002FL.\n33. Organ Transplant: History of or planned organ transplantation.\n34. Recent Major Surgery\u002FTrauma: Major surgery or significant trauma within 4 weeks before the first dose.\n35. Recent Radiotherapy: Palliative radiotherapy within 2 weeks before the first dose.\n36. Residual Toxicity from Prior Therapy: Toxicities from previous anti-cancer therapy not recovered to Grade ≤1.\n37. Other: Any other clinically significant abnormality or disease deemed by the investigator to pose risk or interfere with the study.","80 Years",{"count":660,"type":22},32,[68],"This study is a multicenter, prospective, open-label clinical trial. It enrolls previously untreated patients with resectable stage IB-IIIB KRAS G12C mutation-positive NSCLC to evaluate the efficacy and safety of glesorasib sequentially combined with ivonescimab and chemotherapy as perioperative treatment for this patient population.",[32,664],"KRAS G12C Lung Cancer",[327,38,666],"KRAS G12C","2026-03-13",{"date":669,"type":49},"2026-03-16",{"date":671,"type":22},"2026-03-15",{"date":673,"type":22},"2028-03-31",{"name":675,"class":125},"Guangdong Provincial People's Hospital",{"id":677,"slug":678,"hasResults":12,"nctId":679,"briefTitle":680,"officialTitle":681,"acronym":4,"eligibilityCriteria":682,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":683,"targetDuration":4,"studyType":23,"phases":685,"briefSummary":686,"conditions":687,"keywords":688,"overallStatus":116,"whyStopped":4,"lastUpdateSubmitDate":691,"lastUpdatePostDateStruct":692,"startDateStruct":694,"completionDateStruct":695,"leadSponsor":697,"locationsCount":4},"100628595","phase-2-tunlametinib-combination-therapy-in-kras-mutated-unresectable-locally-advanced-or-metastatic-non-small-cell-lung-cancer-100628595","NCT07463677","Tunlametinib Combination Therapy in KRAS-Mutated Unresectable Locally Advanced or Metastatic Non-Small Cell Lung Cancer","A Study Protocol for Evaluating the Efficacy and Safety of Tunlametinib Combination Therapy in KRAS-Mutated Unresectable Locally Advanced or Metastatic Non-Small Cell Lung Cancer","Inclusion Criteria:\n\n1. Informed consent, all participants will provide written informed consent.\n2. Participants older than 18 years of age signed their own informed consent form.\n3. The TNM staging was classified according to the 8th edition of the AJCC Cancer Staging Manual of the American Joint Committee on Cancer (AJCC). Eligible patients had histologically or cytologically confirmed unresectable, locally advanced, or metastatic NSCLC9(IIIB、IIIC、IV).\n4. Eligible patients had failed, were intolerant to first-line standard treatment after diagnosis.\n5. Positive for KRAS driver gene mutations (including: KRAS G12C and KRAS non-G12C).\n6. Patients were required to have at least 1 site of disease that qualified as a measurable (target) lesion by RECIST v1.1 (If the lesion at the previous radiotherapy site is selected as the target lesion, there is a clear evidence of progression of this lesion).\n7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n8. The functions of the major organs meet the following requirements, and no blood transfusion or use of hematopoietic stimulating factor drugs has been conducted within 14 days prior to the relevant examination: 1) Thrombocytopenia（PLT）≥100×109\u002FL； 2) Blood hemoglobin（HGB）≥90g\u002FL； 3) neutrophil count（NEUT）≥1.5×109\u002FL； 4) creatinine ≤1.5×ULN or Creatinine clearance（CrCl）≥50 mL\u002Fmin（was calculated using the Modification of CockroftGaul）； 5) alanine aminotransferase (ALT) and aspartate transaminase (AST) ≤2.5×ULN（If the patient has liver metastasis ≤5×ULN）； 6) total bilirubin level（TBIL）≤1.5×ULN（Patients with Gilbert's syndrome may receive ≤3×ULN.）；If direct bilirubin (DBIL) indicates extrahepatic obstruction, then TBIL \\\u003C 3.0 × ULN is permissible； 7) International normalized ratio（INR）or prothrombin time（PT）≤1.5×ULN，activated partial thromboplastin time（APTT）≤1.5×ULN，Patients whose bleeding tendency is assessed by the researchers as controllable 8) The urine protein creatinine ratio had to be 2+ or less, or the 24-hour urine protein had to be less than 1,000 mg, for patient enrollment.\n9. The life expectance should be at least 3 months.\n10. Eligible patients of child-bearing age (men and women) agreed to take effective contraceptive measures (including hormonal contraception, barrier methods, or abstinence) during the study period and for at least 6 months after the last study drug administration.\n\nExclusion Criteria:\n\n1. Subjects had received anticancer drugs or investigational drugs within the following time window: 1) Any KRAS G12C mutation inhibitor within 3 years prior to the first dose in this study, including but not limited to Sotorasib (AMG510), Adagrasib (MRTX849), IBI351 (GFH925), Glecirasib (JAB-21822), JDQ443, LY3537982, and GDC-6036; 2) Cituximab or its analogues within 3 years prior to the first dose of this study; 3) Prior MEK inhibitor therapy; 4) Any anticancer therapy (including chemotherapy, targeted therapy, immunotherapy, etc.) or any other investigational drug within 28 days prior to the first dose of this study; 5) Received traditional Chinese patent medicines with explicit antitumor indications in NMPA-approved drug labels within 2 weeks prior to the first dose of this study (including Compound Mylabris Capsules, Kang'ai Injection, Kanglaite Capsules\u002FInjection, Aidi Injection, Yadanzi Oil Injection\u002F capsules, Xiaoaiping tablets\u002Finjection, Huachansu capsules, etc.) within 28 days prior to receiving any anticancer therapy (including chemotherapy, targeted therapy, immunotherapy, etc.) or any other investigational drug therapy in this study; and 6) Received known CYP2D6, CYP3A4, P-gp, and BCRP sensitive substrates with narrow therapeutic windows within 14 days prior to study dosing or within 5 drug half-lives (whichever is longer), unless the participants are approved for inclusion by the researchers and all parties involved..\n2. NSCLC with other driver gene mutations that have standard treatment drugs (such as EGFR, ALK, BRAF(V600E), HER-2, MET(exon14), ROS1, RET or NTRK1\u002F2\u002F3, etc.) in the past.\n3. Concurrent primary malignancies are permitted, except in the following circumstances: Other malignancies treated with a single surgical procedure, with complete remission for at least 3 years prior to enrollment; or Untreated basal cell carcinoma or carcinoma in situ (e.g., carcinoma in situ of the skin, breast carcinoma in situ, cervical carcinoma in situ); Prostate cancer requiring only clinical monitoring without treatment.\n4. Symptomatic or progressively worsening CNS metastases or carcinomatous meningitis. Subjects with a history of brain metastases may be considered for inclusion if clinically stable, provided they meet all of the following criteria: 1) Absence of neurological symptoms, no requirement for corticosteroid therapy, and no indication for radiotherapy; the largest lesion on the most recent pre-enrollment imaging study must have a maximum diameter ≤1.5 cm. 2) Active CNS metastases (e.g., brain or meningeal metastases) are not eligible for enrollment. For subjects with brain metastases who have undergone radiotherapy or local treatment: - If no corticosteroids or antiepileptic drugs were used, asymptomatic status must be maintained for at least 7 days after radiotherapy completion. - If corticosteroids or antiepileptic drugs were used, symptomatic status must be maintained for at least 7 days after discontinuation, and the investigator must assess brain metastases as stable and controlled. 3) For subjects asymptomatic after CNS radiotherapy, corticosteroids must have been discontinued for at least 2 weeks prior to the first study dose.\n5. Cardiovascular system meeting any of the following criteria: 1) Congestive heart failure at New York Heart Association (NYHA) functional class II or higher; 2) Severe arrhythmia requiring medication; 3) Acute myocardial infarction, severe or unstable angina, coronary artery bypass grafting (CABG), or peripheral artery bypass grafting within 6 months prior to enrollment; 4) Left ventricular ejection fraction (LVEF) \\\u003C50%; 5) Resting QT interval prolongation (QTcF) as measured by the Fridericia formula, ECG-measured QTcF \\> 470 ms in females or \\> 450 ms in males, or presence of risk factors for torsades de pointes, such as investigator-assessed clinically significant hypokalemia, family history of long QT syndrome, or familial arrhythmia history (e.g., Wolff-Parkinson-White syndrome); 6) Uncontrolled hypertension (defined as systolic blood pressure ≥150 mmHg and\u002For diastolic blood pressure ≥100 mmHg despite standardized antihypertensive therapy);\n6. Patients who have experienced arterial or venous thrombotic events within the past 6 months, such as cerebrovascular accidents (including transient ischemic attacks), deep vein thrombosis, pulmonary embolism, hypertensive crisis, or hypertensive encephalopathy;\n7. Patients with a history of seizures were excluded.\n8. The superior vena cava.\n9. Active non-infectious pneumonia with interstitial changes such as interstitial lung disease, radiation pneumonitis, or immune-related pneumonia during the screening period; active pulmonary tuberculosis; pneumoconiosis; or other types of pneumonia classified as Grade ≥2; or severe impairment of pulmonary function confirmed by pulmonary function tests (FEV1 or DLCO or DLCO\u002FVA \\\u003C40% of predicted value).\n10. Severe bone damage caused by tumor bone metastases present at baseline or likely to occur after enrollment, such as weight-bearing pathological fractures, extensive bone metastases, or spinal cord compression occurring within 6 months prior to enrollment or likely to occur after enrollment; or uncontrollable pain related to tumor bone metastases;\n11. Active or uncontrolled severe infection (≥ CTCAE Grade 2 infection) or unexplained fever \\>38.5°C.\n12. Third-space effusions (including pleural effusion, ascites, or pericardial effusion) that are poorly controlled clinically or require local symptomatic management such as paracentesis. Subjects may be enrolled if clinically stable after symptomatic treatment (e.g., paracentesis and pleurodesis) with no significant increase in effusion volume for at least 3 days after cessation of drainage.\n13. Within 2 months prior to the first dose, subjects with evidence or history of bleeding tendency, regardless of severity; within 2 weeks prior to the first dose, subjects with a history of hemoptysis (\\>2.5 ml\u002Fday) or presence of unhealed wounds, ulcers, or fractures;\n14. Known impaired gastrointestinal (GI) function or GI diseases that may significantly affect the absorption or metabolism of oral medications, such as: nausea, vomiting, severe peptic ulcer disease, liver cirrhosis, active gastrointestinal bleeding, intestinal obstruction, intestinal perforation, inflammatory bowel disease causing chronic diarrhea (e.g., colitis or Crohn's disease), or other conditions affecting tablet swallowing or significantly impairing oral drug absorption. History of major gastrointestinal (esophageal, gastrointestinal) surgery that may alter absorption of the study treatment or prevent swallowing of tablets;\n15. Received a live attenuated vaccine within 4 weeks prior to the first dose;\n16. Active autoimmune diseases requiring systemic treatment (e.g., disease-modifying antirheumatic drugs, corticosteroids, or immunosuppressants) within 2 years prior to first dosing, including but not limited to: autoimmune hepatitis, interstitial pneumonia, enteritis, vasculitis, nephritis; subjects with asthma requiring medical intervention with bronchodilators are ineligible. . Replacement therapy (e.g., thyroxine, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency) is not considered systemic treatment.\n17. Diagnosed with immunodeficiency or currently receiving systemic glucocorticoid therapy or any other form of immunosuppressive therapy (dose \\>10 mg\u002Fday of prednisone or other equivalent corticosteroids), and continuing such therapy within 2 weeks prior to the first dose;\n18. Human Immunodeficiency Virus (HIV) antibody positive, cirrhosis, or active viral hepatitis: 1) Definition of active viral hepatitis: Hepatitis B surface antigen (HBsAg) positive with hepatitis B virus deoxyribonucleic acid (HBV DNA) copy number \\>2500 copies \\[cps\\]\u002FmL or 500 IU\u002FmL; or hepatitis C virus (HCV) antibody positive with hepatitis C virus ribonucleic acid (HCV RNA) copy number \\>the lower limit of detection at the study site; 2) Regular assessment and receipt of anti-HBV therapy throughout the study treatment period.\n19. active syphilis\n20. Renal failure requiring haemodialysis or peritoneal dialysis.\n21. Poorly controlled diabetes \\[fasting blood glucose (FBG) \\> 10 mmol\u002FL\\];\n22. History of organ transplantation or preparation for organ transplantation;\n23. This study excluded participants who, within 4 weeks prior to the first dose, had experienced significant uncontrolled diabetes \\[fasting blood glucose (FBG) \\>10 mmol\u002FL\\]; surgical intervention; or major traumatic injury.\n24. Palliative radiation therapy to 1-2 sites of disease is initiated within2 weeks of the first dose\n25. Toxicities resulting from prior antitumour therapy (excluding alopecia, hyperpigmentation, and Laboratory test abnormalities without clinical significance are excluded) have not resolved to ≤ Grade 1. Peripheral neurotoxicity has not resolved to ≤ Grade 2 (NCI CTCAE v5.0).\n\n26: 26. History or current presence of retinal diseases, such as: retinal vein occlusion (RVO), retinal artery occlusion (RAO), retinal vasculitis, diabetic retinopathy, hypertensive retinopathy, retinal capillaropathy (Costs disease), pigment epithelial detachment (RPED), etc.\n\n27\\. History or current presence of neuromuscular diseases associated with elevated CPK (e.g., inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis, spinal muscular atrophy, rhabdomyolysis).\n\n28\\. Subjects who are pregnant or breastfeeding; 29. Severe psychiatric\u002Fpsychological disorders or history of drug abuse. 30. Subjects with known allergy or sensitivity to any component of the investigational product were excluded from the study.\n\n31\\. Any other condition or circumstance that, in the investigator's judgment, would preclude safe participation in or compromise the objectives of the study.",{"count":684,"type":22},55,[68],"This study investigated the efficacy and safety of Tunlametinib Combination Therapy in KRAS-Mutated Unresectable Locally Advanced or Metastatic Non-Small Cell Lung Cancer.",[32],[38,689,690],"Unresectable Locally Advanced or Metastatic Non-Small Cell Lung Cancer","MEK","2026-03-05",{"date":693,"type":49},"2026-03-11",{"date":671,"type":22},{"date":696,"type":22},"2029-03-31",{"name":698,"class":125},"Sun Yat-sen University"]