[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"nsclc\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:nsclc":27},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,185,0,25,[9,41,63,85,121,154,184,211,236,256,286,359,383,409,432,480,503,539,559,582,615,641,665,686,709],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100572881","clinical-trial-to-evaluate-the-efficacy-and-safety-of-pulsed-electric-field-ablation-devices-in-the-treatment-of-lung-tumors-100572881",false,"NCT06739031","Clinical Trial to Evaluate the Efficacy and Safety of Pulsed Electric Field Ablation Devices in the Treatment of Lung Tumors","A Multi-center, Single-group Clinical Trial to Evaluate the Efficacy and Safety of Pulsed Electric Field (PEF) Ablation Devices in the Treatment of Lung Tumors","Inclusion criteria (all requirements must be met at the same time):\n\n1\\. Age ≥ 18 years old; 2. Pathological diagnosis of non-small cell lung cancer, with the maximum diameter of the tumor ≤ 3 cm and the number ≤ 3; 3. ECOG score ≤ 2 points; 5. According to the evaluation of the researcher, it is technically feasible to perform ablation treatment on the lesion; 6. The subject agrees to receive ablation treatment and signs the informed consent form.\n\nExclusion criteria (if any of the above conditions are met, the patient will be excluded):\n\n1. The subject cannot tolerate or refuses general anesthesia;\n2. Has a history of severe allergic reactions;\n3. Has contraindications to bronchoscopy or refuses bronchoscopy;\n\n5\\. Has active implants in the chest cavity or metal implants in the lung to be treated; 6. Uncorrectable coagulation abnormalities (INR\\>1.5 or APTT\\>1.5 ULN), with bleeding tendency; anticoagulant therapy and\u002For antiplatelet drugs are discontinued before ablation for no longer than the prescribed safety period; platelets \\\u003C50×10\\^9\u002FL; 7. Severe liver and kidney dysfunction, assessed by the researchers as unsuitable for inclusion; 8. Accompanied by infectious diseases that cannot be effectively controlled; 9. Subjects with other severe lung diseases (including severe interstitial pneumonia, pulmonary fibrosis, pulmonary fibrosis combined with emphysema, atelectasis, etc.), assessed by the researchers as unsuitable for inclusion 10. Acute cardiovascular and cerebrovascular accidents such as acute cerebral infarction, acute coronary syndrome, etc. within 3 months; 11. Subjects with severe cardiac dysfunction; history of severe arrhythmias in the past 2 years, including rapid atrial arrhythmias, any rapid ventricular arrhythmias; history of II degree type II or III degree atrioventricular block; and sinus bradycardia with a heart rate of less than 45 beats per minute, etc.; 12. Subjects have participated in or are participating in other clinical trials within three months; 13. Pregnant, lactating women, or women who plan to become pregnant during the study; 14. Subjects determined by the researchers to have other conditions that are unsuitable for inclusion.","ALL","18 Years",{"count":20,"type":21},126,"ESTIMATED","INTERVENTIONAL",[24],"NA","The goal of this clinical trial is to verify the efficacy and safety of pulsed electric field (PEF) treatment of early-stage unreseectable non-small cell lung cancer(NSCLC) patients.\n\nThe main questions it aims to answer are:\n\n* Safety of PEF treatment of early-stage unreseectable NSCLC patients.\n* Locoregional control of ablated lesions.\n* Survival and quality of life assessment of early-stage unreseectable NSCLC patients.",[27],"NSCLC","RECRUITING","2026-08-20",{"date":31,"type":32},"2026-08-21","ACTUAL",{"date":34,"type":32},"2024-12-25",{"date":36,"type":21},"2027-08-25",{"name":38,"class":39},"Energenx Medical LTD.","INDUSTRY",1,{"id":42,"slug":43,"hasResults":12,"nctId":44,"briefTitle":45,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":47,"enrollmentInfo":48,"targetDuration":4,"studyType":22,"phases":50,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":57,"completionDateStruct":58,"leadSponsor":60,"locationsCount":4},"100652885","phase-2-a-prospective-phase-ii-clinical-trial-evaluating-the-efficacy-and-safety-of-adebrelimab-in-combination-with-trastuzumab-rezetecan-for-patients-with-stage-iii-unresectable-her2-positive-nsclc-100652885","NCT07778745","A Prospective Phase II Clinical Trial Evaluating the Efficacy and Safety of Adebrelimab in Combination With Trastuzumab Rezetecan for Patients With Stage III Unresectable HER2-Positive NSCLC","Inclusion Criteria:\n\n* Aged 18-75 years, male or female.\n* Histologically or cytologically confirmed stage III unresectable NSCLC per AJCC 9th edition, judged unresectable by institutional MDT team.\n* Confirmed HER2 alteration: HER2 mutation\u002Famplification detected by tissue NGS, or HER2 protein overexpression (IHC 2+ or 3+).\n* No prior systemic anti-tumor therapy for NSCLC; prior anti-tumor Chinese herbal medicine allowed if ≥2 weeks washout before first dose.\n* At least 1 measurable target lesion per RECIST v1.1.\n* ECOG performance status 0 or 1.\n* Able to provide tumor tissue specimen (archival ≤6 months or newly biopsied non-irradiated lesion).\n* FEV1 \\>1.0 L and FEV1% predicted \\>40% within past 3 months.\n* Adequate organ function within 7 days before first dose (no blood product\u002FG-CSF support within 14 days):\n\n  * Hematology: WBC ≥3.0×10⁹\u002FL, ANC ≥1.5×10⁹\u002FL, PLT ≥100×10⁹\u002FL, Hb ≥90g\u002FL\n  * Liver: AST\u002FALT ≤2.5×ULN (≤5×ULN for liver metastasis), TBIL ≤1.5×ULN\n  * Renal: Serum Cr ≤1.5×ULN or CrCl ≥50 mL\u002Fmin\n  * Cardiac: LVEF ≥50% by echocardiogram\n* Fertile male\u002Ffemale participants must use effective contraception during treatment and 6 months after last dose; female participants non-lactating, negative serum HCG within 14 days pre-first dose.\n* Voluntarily sign written informed consent, good compliance for follow-up.\n\nExclusion Criteria:\n\n* Mixed small cell\u002Flarge cell neuroendocrine\u002Fsarcomatoid NSCLC histology.\n* Concurrent other actionable driver gene alterations (EGFR, ALK, MET, BRAF, RET etc.) besides HER2.\n* Past or concurrent other malignant tumor (except fully resected cancer ≥5 years without active treatment).\n* Prior thoracic radiotherapy.\n* Major surgery within 28 days or minor invasive surgery within 7 days before first dose.\n* HIV infection, active hepatitis B\u002FC, organ transplant history, congenital\u002Facquired immunodeficiency.\n* Systemic immune modulators (thymosin, interferon, IL-2) within 4 weeks pre-enrollment.\n* Uncontrolled severe cardiovascular disease, unstable angina or intervention-required ventricular arrhythmia within 1 month.\n* Confirmed or suspected interstitial lung disease, severe baseline pulmonary dysfunction interfering with lung toxicity monitoring.\n* Active uncontrolled ≥2 grade infection within 2 weeks before enrollment.\n* Active tuberculosis under treatment.\n* Known hypersensitivity to any component of study drugs or other monoclonal antibodies\u002Ffusion proteins.\n* Any condition judged by investigator to compromise participant safety or trial compliance.","75 Years",{"count":49,"type":21},37,[51],"PHASE2","This is a single-arm, open-label, multicenter phase II investigator-initiated trial. The study aims to explore the efficacy and safety of Adebrelimab plus Trastuzumab rezetecan induction therapy in patients with stage III unresectable HER2-altered non-small cell lung cancer (NSCLC). Eligible patients receive 3-4 cycles Q3W induction combination therapy. After induction, patients will receive radical surgery or concurrent chemoradiotherapy via MDT evaluation, followed by consolidation therapy and long-term survival follow-up. The primary endpoint is objective response rate (ORR) assessed per RECIST v1.1. Secondary endpoints include surgical conversion rate, major pathological response (MPR), event-free survival (EFS), overall survival (OS), and safety profiles.",[27],"NOT_YET_RECRUITING","2026-08-19",{"date":31,"type":32},{"date":29,"type":21},{"date":59,"type":21},"2029-08-30",{"name":61,"class":62},"Tianjin Medical University Cancer Institute and Hospital","OTHER",{"id":64,"slug":65,"hasResults":12,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":4,"eligibilityCriteria":69,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":70,"targetDuration":4,"studyType":22,"phases":72,"briefSummary":74,"conditions":75,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":77,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":84},"100548526","phase-3-pembrolizumab-with-or-without-maintenance-sacituzumab-tirumotecan-sac-tmt-mk-2870-in-metastatic-squamous-non-small-cell-lung-cancer-nsclc-mk-2870-023-100548526","NCT06422143","Pembrolizumab With or Without Maintenance Sacituzumab Tirumotecan (Sac-TMT; MK-2870) in Metastatic Squamous Non-small Cell Lung Cancer (NSCLC) [MK-2870-023]","Phase 3 Study of Pembrolizumab in Combination With Carboplatin\u002FTaxane (Paclitaxel or Nab-paclitaxel) Followed by Pembrolizumab With or Without Maintenance MK-2870 in the First-line Treatment of Metastatic Squamous Non-small Cell Lung Cancer","Inclusion Criteria:\n\n* Histologically or cytologically confirmed diagnosis of squamous non-small cell lung cancer (NSCLC) \\[Stage IV: M1a, M1b, M1c, American Joint Committee on Cancer Staging Manual, version 8\\]\n* Measurable disease per Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 as assessed by the local site investigator\u002Fradiology\n* Has life expectancy ≥3 months\n* Has Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1 assessed within 7 days prior to allocation\n* Archival tumor tissue sample or newly obtained core, incisional, or excisional biopsy of a tumor lesion not previously irradiated has been provided\n* Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)\n* Participants who are hepatitis B surface antigen (HBsAg)-positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load before allocation\n* Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening\n* Participants who have adverse events (AEs) due to previous anticancer therapies must have recovered to Grade ≤1 or baseline (participants with endocrine-related AEs who are adequately treated with hormone replacement are eligible)\n* Has adequate organ function\n* For Maintenance only (prior to randomization): is without disease progression of their NSCLC, as determined by BICR using RECIST 1.1 after completion of study-specified Induction with an evaluable scan at Week 12 or most recent scan before randomization\n* For Maintenance only (prior to randomization): has ECOG PS of 0 or 1 as assessed at the Prerandomization Visit\n* For Maintenance only (prior to randomization): all AEs (with the exception of alopecia, Grade ≤2 fatigue, Grade ≤2 peripheral neuropathy, and Grade ≤2 endocrine-related AEs requiring treatment or hormone replacement) have recovered\n* For Maintenance only (prior to randomization): has not experienced a pneumonitis\u002Finterstitial lung disease (ILD) event during the study-specified induction\n\nExclusion Criteria:\n\n* Diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements\n* History of documented severe dry eye syndrome, severe Meibomian gland disease and\u002For blepharitis, or severe corneal disease that prevents\u002Fdelays corneal healing\n* Active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, or chronic diarrhea)\n* Has uncontrolled, significant cardiovascular disease or cerebrovascular disease including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, uncontrolled symptomatic arrhythmia, prolongation of QTcF interval to \\>480 ms, and other serious cardiovascular and cerebrovascular diseases within 6 months before study intervention\n* HIV-infected participants who have been newly diagnosed or with a history of Kaposi's sarcoma and\u002For Multicentric Castleman's Disease\n* Received prior systemic chemotherapy or other targeted or biological antineoplastic therapy for their metastatic NSCLC. Note: Prior treatment with chemotherapy and\u002For radiation as a part of neoadjuvant or adjuvant therapy or chemoradiation therapy for nonmetastatic NSCLC is allowed as long as therapy was completed at least 12 months before diagnosis of metastatic NSCLC\n* Received prior therapy with an anti-programmed cell death 1 protein (PD-1), anti-programmed cell death ligand 1 (PD-L1), or anti programmed cell death ligand 2 (PD-L2) agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor (eg, cytotoxic T lymphocyte-associated protein 4, OX-40, CD137). Note: Prior treatment with an anti-PD-1 or anti-PD-L1 agent for nonmetastatic NSCLC is allowed as long as therapy was completed at least 12 months before diagnosis of metastatic NSCLC\n* Received prior treatment with a trophoblast cell-surface antigen 2 (TROP2)-targeted antidrug conjugate (ADC)\n* Received radiation therapy to the lung that is \\>30 Gray within 6 months of start of study intervention\n* Received prior radiotherapy within 2 weeks of start of study intervention, or radiation-related toxicities, requiring corticosteroids\n* Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention\n* Participants who have not adequately recovered from major surgery or have ongoing surgical complications\n* Received prior treatment with a topoisomerase I inhibitor-containing ADC\n* Is currently receiving a strong inducer\u002Finhibitor of CYP3A4 that cannot be discontinued for the duration of the study (the required washout period before starting sac-TMT is 2 weeks)\n* Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.\n* Has known central nervous system (CNS) metastases\u002Fcarcinomatous meningitis\n* Severe hypersensitivity (≥Grade 3) to study intervention and\u002For any of its excipients or to another biologic therapy\n* Active autoimmune disease that has required systemic treatment in the past 2 years (replacement therapy \\[eg, thyroxine, insulin, or physiologic corticosteroid\\] is allowed)\n* Has a history of (noninfectious)pneumonitis\u002FILD that required steroids, has current pneumonitis\u002FILD, or has suspected ILD or pneumonitis that cannot be ruled out by standard diagnostic assessments at Screening\n* Active infection requiring systemic therapy\n* History of allogeneic tissue\u002Fsolid organ transplant",{"count":71,"type":21},851,[73],"PHASE3","This is a phase 3 study of pembrolizumab in combination with carboplatin\u002Ftaxane (paclitaxel or nab-paclitaxel) followed by pembrolizumab with or without maintenance sacituzumab tirumotecan (sac-TMT; MK-2870) in first-line treatment of metastatic squamous non-small cell lung cancer. It is hypothesized that pembrolizumab with maintenance sacituzumab tirumotecan is superior to pembrolizumab without sacituzumab tirumotecan maintenance with respect to overall survival (OS).",[76,27],"Non-small Cell Lung Cancer",{"date":29,"type":32},{"date":79,"type":32},"2024-06-10",{"date":81,"type":21},"2031-08-15",{"name":83,"class":39},"Merck Sharp & Dohme LLC",215,{"id":86,"slug":87,"hasResults":12,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":91,"eligibilityCriteria":92,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":93,"targetDuration":4,"studyType":22,"phases":95,"briefSummary":96,"conditions":97,"keywords":103,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":40},"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","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",{"count":94,"type":21},430,[73],"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.",[27,76,98,99,100,101,102],"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",[27,104,99,102,105,106,107,108,109,110,111,112],"Non-Small Cell Lung Cancer","RAS","KRAS","NRAS","HRAS","RAS Mutation","Lung Cancer","G12D","RAS G12D","2026-08-17",{"date":29,"type":32},{"date":116,"type":32},"2026-08-14",{"date":118,"type":21},"2031-02",{"name":120,"class":39},"Revolution Medicines, Inc.",{"id":122,"slug":123,"hasResults":12,"nctId":124,"briefTitle":125,"officialTitle":126,"acronym":4,"eligibilityCriteria":127,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":128,"targetDuration":4,"studyType":22,"phases":130,"briefSummary":132,"conditions":133,"keywords":143,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":145,"startDateStruct":147,"completionDateStruct":149,"leadSponsor":151,"locationsCount":153},"100606945","phase-1-a-phase-1-study-of-nrm-823-in-participants-with-locally-advanced-or-metastatic-refractory-solid-tumors-100606945","NCT07182149","A Phase 1 Study of NRM-823 in Participants With Locally Advanced or Metastatic Refractory Solid Tumors","A Phase 1a\u002F1b Study of NRM-823 as Monotherapy and in Combination With Immune Checkpoint Inhibition in Participants With Locally Advanced or Metastatic Refractory Solid Tumors","Inclusion Criteria:\n\n* Have histologically- or cytologically-diagnosed NSCLC (squamous or adenocarcinoma), TNBC, HNSCC, ESCC, esophageal adenocarcinoma, gastric\u002FGEJ adenocarcinoma, cervical, endometrial, or ovarian cancer which is advanced or metastatic.\n* Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.\n* Adequate liver, renal, pulmonary, and cardiac function.\n* Adequate hematologic function.\n\nExclusion Criteria:\n\n* Has received cytotoxic chemotherapy, biologic anticancer agents, checkpoint inhibitors, or radiation therapy (excluding bone-only radiation therapy) ≤3 weeks or 5 half-lives (whichever is shorter) prior to the first dose of NRM-823\n* History of Grade 2 pneumonitis requiring steroids or any Grade 3 or 4 pneumonitis from any prior therapy.\n* Has received an investigational therapy \\\u003C4 weeks or 5 half-lives prior to the first dose of NRM823, whichever is shorter prior to the first dose of NRM-823.\n* With the exception of alopecia and Grade ≤2 neuropathy, any unresolved toxicities from prior therapy greater than CTCAE Grade 1 at the time of starting study drug.",{"count":129,"type":21},150,[131],"PHASE1","This study is being done to find out of NRM-823 is safe and can treat participants with locally advanced or metastatic solid tumors.",[134,135,136,137,138,139,27,140,141,142],"HNSCC","ESCC","Esophageal Adenocarcinoma","Gastric Adenocarcinoma","GEJ Adenocarcinoma","Ovarian Cancer","Cervical Cancer","Endometrial Cancer","Triple Negative Breast Cancer (TNBC)",[144],"NRM-823",{"date":146,"type":32},"2026-08-18",{"date":148,"type":32},"2025-10-30",{"date":150,"type":21},"2028-10-31",{"name":152,"class":39},"Normunity AccelCo, Inc.",18,{"id":155,"slug":156,"hasResults":12,"nctId":157,"briefTitle":158,"officialTitle":158,"acronym":159,"eligibilityCriteria":160,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":161,"targetDuration":4,"studyType":22,"phases":163,"briefSummary":164,"conditions":165,"keywords":166,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":177,"startDateStruct":178,"completionDateStruct":180,"leadSponsor":182,"locationsCount":40},"100551261","assessment-of-pet-tracers-to-evaluate-t-cell-change-and-activation-in-relation-to-immunotherapy-treatment-response-in-non-small-cell-lung-cancer-100551261","NCT06457789","Assessment of PET Tracers to Evaluate T Cell Change and Activation in Relation to Immunotherapy Treatment Response in Non-Small Cell Lung Cancer","iRelate","Inclusion Criteria:\n\n* Histologically confirmed NSCLC\n* T1-4N0-2, lesion size of ≥2cm, at time of the restaging FDG PET\u002FCT\n* Planned to undergo resection after chemo-IO according to routine treatment guidelines\n* Willing and able to provide written informed consent for the trial\n* Above 18 years of age on day of signing informed consent\n* Have measurable disease based on RECIST 1.1\n* Have a ECOG performance status of 0-1, and are considered operable based on pulmonary function test and\u002For exercise testing\n\nExclusion Criteria:\n\n* Patients deemed inoperable\n* Patients who have received a splenectomy\n* Patients who have received any vaccination within 14 days of enrollment\n* Patients with a condition requiring systemic treatment with either corticosteroids (\\> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of day 0. Inhaled or topical steroids, and adrenal replacement steroid \\>10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.\n* Psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n* Patient is pregnant or breastfeeding or expecting to conceive within the projected duration of the trial.",{"count":162,"type":21},34,[24],"The iRelate is a PET imaging trial to compare two upcoming and promising T cell PET tracers. Following chemo-immuno therapy, as part of standard care, NSCLC patients will be recruited to receive two PET scans, shortly before their surgery. Both PET scans will be compared to each other, as well as compared to the pathological analysis of the resected tumor.\n\nThis study will provide detailed information on the unique as well as additive capacities of imaging biomarkers derived from the immune cell targeting PET tracers.",[27],[27,167,168,169,170,171,172,173,174,175,176],"immunoPET","18F-AraG","AraG","89Zr-crefmirlimab","Crefmirlimab","tracers","PET tracers","[18F]F-AraG","[89Zr]Zr-Df-Crefmirlimab","IAB22M2C",{"date":146,"type":32},{"date":179,"type":32},"2024-12-01",{"date":181,"type":21},"2028-07",{"name":183,"class":62},"Amsterdam UMC, location VUmc",{"id":185,"slug":186,"hasResults":12,"nctId":187,"briefTitle":188,"officialTitle":189,"acronym":190,"eligibilityCriteria":191,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":192,"targetDuration":4,"studyType":22,"phases":194,"briefSummary":195,"conditions":196,"keywords":198,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":201,"lastUpdatePostDateStruct":202,"startDateStruct":204,"completionDateStruct":206,"leadSponsor":208,"locationsCount":210},"100593744","phase-3-a-study-to-assess-the-efficacy-and-safety-of-firmonertinib-versus-placebo-for-adjuvant-treatment-in-participants-with-stage-ib---iiib-nsclc-with-uncommon-epidermal-growth-factor-receptor-egfr-mutations-following-complete-surgical-resection-with-or-without-adjuvant-chemotherapyfirmost-100593744","NCT07010419","A Study to Assess the Efficacy and Safety of Firmonertinib Versus Placebo for Adjuvant Treatment in Participants With Stage IB - IIIB NSCLC With Uncommon Epidermal Growth Factor Receptor (EGFR) Mutations, Following Complete Surgical Resection With or Without Adjuvant Chemotherapy（FIRMOST）","A Global Phase 3, Double-Blind, Randomized, Controlled Multicenter Study to Assess the Efficacy and Safety of Firmonertinib Versus Placebo for Adjuvant Treatment in Participants With Stage IB - IIIB NSCLC With Uncommon Epidermal Growth Factor Receptor (EGFR) Mutations, Following Complete Surgical Resection With or Without Adjuvant Chemotherapy (FIRMOST)","FIRMOST","Inclusion Criteria:\n\n1. Sign the Informed Consent Form (ICF).\n2. Aged ≥ 18 years old. Participants from Japan\u002FTaiwan aged ≥ 20 years old.\n3. Histologically confirmed diagnosis of primary non-small cell lung cancer (NSCLC) of predominantly non-squamous histology.\n4. Underwent complete surgical resection of primary lung cancer and systematic lymph node dissection (R0 resection).\n5. Classified post-operatively as Stage IB, II, IIIA, or IIIB (T3N2M0 only) on the basis of pathologic criteria, with the disease staging following the 9th Edition TNM Staging Classification: Lung Cancer issued by Union for International Cancer Control (UICC) and American Joint Committee on Cancer (AJCC).\n6. Documented results of the presence of uncommon EGFR mutations (exon 20 insertion mutations, PACC mutations, and\u002For classical-like mutations, either as single mutations or as co-mutations), in tumor tissue or blood via a validated NGS or validated PCR assay.\n\nExclusion Criteria:\n\nA participant would be excluded from the study if he\u002Fshe meets any of the following:\n\n1. NSCLC with EGFR Exon 19 deletion or L858R or C797S mutation.\n2. Incomplete resection (R1\u002FR2) or segmentectomy or wedge resection only.\n3. Prior treatment with any of the following:\n\n   1. Prior treatment with any antineoplastic therapy other than standard platinum-based doublet adjuvant chemotherapy.\n   2. prior treatment with neoadjuvant therapy.\n4. Concurrent malignant tumors other than the primary tumor; participants with cancers that can be treated locally and cured may be eligible.\n5. Previous ILD (including drug-induced ILD) or active ILD\u002Factive radiation pneumonitis.",{"count":193,"type":21},338,[73],"This is a Phase 3, global, double-blind, randomized, controlled multicenter clinical study to assess the efficacy and safety of adjuvant treatment with firmonertinib versus placebo in participants with Stage IB-IIIB NSCLC with uncommon EGFR mutations (exon 20 insertions, PACC and classical-like mutations) after complete surgical resection with or without adjuvant chemotherapy.\n\nAbout 338 eligible participants will be enrolled and randomized in a 1:1 ratio to receive either firmonertinib 240 mg QD or placebo QD in 21-day treatment cycles. Before randomization, the participant must have undergone complete surgical resection (R0 resection), must have sufficiently recovered from surgery, and must have completed adjuvant chemotherapy (if applicable). The participants will receive firmonertinib or placebo as adjuvant treatment until unacceptable toxicity, withdrawal of informed consent, disease recurrence, initiation of new antitumor treatment, completion of treatment, or other end of treatment reason is met.",[27,197],"Adjuvant Treatment",[199,27,200],"EGFR","Firmonertinib","2026-08-12",{"date":203,"type":32},"2026-08-13",{"date":205,"type":32},"2025-05-28",{"date":207,"type":21},"2032-04-30",{"name":209,"class":39},"Allist Pharmaceuticals, Inc.",2,{"id":212,"slug":213,"hasResults":12,"nctId":214,"briefTitle":215,"officialTitle":216,"acronym":4,"eligibilityCriteria":217,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":218,"targetDuration":4,"studyType":22,"phases":220,"briefSummary":221,"conditions":222,"keywords":227,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":201,"lastUpdatePostDateStruct":229,"startDateStruct":230,"completionDateStruct":232,"leadSponsor":234,"locationsCount":153},"100566595","phase-1-first-in-human-study-of-tub-030-in-patients-with-advanced-solid-tumors-100566595","NCT06657222","First in Human Study of TUB-030 in Patients With Advanced Solid Tumors","A Multicenter FIH Dose Escalation and Optimization Phase I\u002FIIa Trial to Investigate Safety, Tolerability, PK, and Efficacy of the 5T4 ADC TUB-030 in Patients With Advanced Solid Tumors (5-STAR 1-01)","Inclusion Criteria:\n\n1. Male or non-pregnant, non-breastfeeding female aged 18 years or older\n2. Adequate organ function\n3. Patients who received anti-cancer treatment including chemotherapy, biological therapy, endocrine therapy, PARP inhibitor, or other oral or investigational drugs must have had their last dose at least 4 weeks (6 weeks for nitrosourea, mitomycin-C) or 5 half-lives, whichever is shorter, before C1D1\n4. AEs related to prior therapy, radiotherapy or surgical procedures must resolve to ≤grade 1.\n5. For patients with known brain metastases, evidence of clinically stable disease post radiation therapy is required prior to enrollment.\n6. For patients who underwent radiotherapy (≥ 30% of the bone marrow or wide field) to sites outside the brain, the final dose of radiation must have been administered ≥ 28 days prior to C1D1. For patients who underwent palliative radiotherapy (≤ 30% of the bone marrow or wide field) the final dose of radiation must have been administered ≥14 days prior to C1D1.\n7. Radiologically measurable disease by RECIST v1.1, 4 weeks before C1D1, that can include a lesion in an irradiated field that shows progression according to RECIST v1.1 after irradiation.\n8. Eastern Cooperative Oncology Group (ECOG) 0-1.\n9. Have a life expectancy of \\>12 weeks for disease-related mortality, as evaluated by the INV.\n10. In the opinion of the INV, the patient must be able and willing to understand and give signed informed consent\n11. Women of childbearing potential (WOCBP) who are sexually active with a non-sterilized partner must use at least 1 highly effective method of contraception (with a failure rate of 1% per year) from the time of screening and must agree to continue using such precautions until the end of exposure, plus 5 half-lives and 6 months add-on in the case of patients of childbearing potential Patients must agree to continue a highly effective contraceptive method, refrain from egg cell donation and breastfeeding while on study treatment and for 5 half-lives plus 6 months after the last dose of study treatment.\n12. Males must use an effective barrier method of contraception without interruption if the patient is sexually active with an WOCBP until the end of exposure, 5 half-lives plus 6 months add-on after the end of treatment. In addition, their female partners who are WOCBP should agree to use 1 highly effective barrier method of contraception at the same time. Male patients should refrain from donating sperm during study participation and for 6 months after the last dose of the study drug.\n\nExclusion Criteria:\n\n\\-",{"count":219,"type":21},250,[131,51],"The goal of this clinical trial is to learn if the drug TUB-030 works to treat solid cancer in adults. The study will also explore the safety of TUB-030. The main questions it aims to answer are:\n\nTo determine the safety and tolerability of TUB-030 To determine the maximum tolerated dose of TUB-030 as a single drug given to patients with solid cancer Researchers will also compare doses of TUB-030 in two specific cancer types, in patients with head and neck cancer and patients with non-small cell lung cancer, to see if TUB-030 works to treat these two solid cancer types and to determine the best dose.\n\nParticipants will:\n\nReceive drug TUB-030 every 3 weeks Visit the clinic once every 3 weeks for checkups and tests Answer patient reported outcome questionnaires about their symptoms",[223,134,224,27,225,226],"Advanced Solid Tumors","SCLC","TNBC - Triple-Negative Breast Cancer","CRC",[223,27,228],"Head and Neck Cancer",{"date":116,"type":32},{"date":231,"type":32},"2024-12-13",{"date":233,"type":21},"2028-12",{"name":235,"class":39},"Tubulis GmbH",{"id":237,"slug":238,"hasResults":12,"nctId":239,"briefTitle":240,"officialTitle":241,"acronym":4,"eligibilityCriteria":242,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":47,"enrollmentInfo":243,"targetDuration":4,"studyType":22,"phases":245,"briefSummary":246,"conditions":247,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":248,"lastUpdatePostDateStruct":249,"startDateStruct":250,"completionDateStruct":252,"leadSponsor":254,"locationsCount":210},"100645919","phase-2-skb264-in-combination-with-skb118-for-non-small-cell-lung-cancer-100645919","NCT07697586","SKB264 in Combination With SKB118 for Non-Small Cell Lung Cancer","A Phase II Clinical Study to Evaluate Sacituzumab Tirumotecan (SKB264) in Combination With SKB118 for the Treatment of Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer","Inclusion Criteria:\n\n* Histologically or cytologically confirmed locally advanced or metastatic NSCLC\n* Without epidermal growth factor receptor (EGFR) sensitizing mutation, and anaplastic lymphoma kinase (ALK) fusion gene.\n* Provide a tumor tissue sample.\n* At least one measurable lesion as assessed by the investigator according to RECIST v1.1.\n* ECOG performance status of 0 or 1.\n* Life expectancy ≥ 12 weeks.\n* Adequate bone marrow, liver, kidney, and coagulation function.\n* Male and female participants must agree to use highly effective methods of contraception during the specified period of the study.\n\nExclusion Criteria:\n\n* Histologically or cytologically confirmed co-existing small cell lung cancer, neuroendocrine carcinoma, or carcinosarcoma components.\n* Participants with known metastases to meninges, brainstem metastases, metastases to spinal cord and\u002For compression, or active metastases to central nervous system (CNS).\n* Uncontrolled systemic disease as judged by the investigator.\n* Presence of uncontrolled, clinically symptomatic, or requiring repeated drainage pleural effusion, pericardial effusion, or ascites.\n* Presence of other moderate to severe lung disorders.\n* History of haemorrhagic diathesis or coagulopathy and\u002For clinically significant bleeding symptoms or risks.\n* Previous or co-existing gastrointestinal diseases, surgery, and wound healing complications.\n* Active hepatitis b or hepatitis c or co-infection with HBV and HCV.\n* Known history of allogeneic organ transplantation or hematopoietic stem cell transplantation.\n* Known hypersensitivity to the study drug or any of its components.\n* Pregnant or lactating women.",{"count":244,"type":21},206,[51],"This is an open-label, multi-center, Phase II clinical study to evaluate the safety, tolerability, and efficacy of SKB264 in combination with SKB118 in participants with NSCLC. The study includes a dose escalation phase and an expansion phase.",[27],"2026-08-10",{"date":201,"type":32},{"date":251,"type":32},"2026-08-07",{"date":253,"type":21},"2029-08",{"name":255,"class":39},"Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.",{"id":257,"slug":258,"hasResults":12,"nctId":259,"briefTitle":260,"officialTitle":261,"acronym":262,"eligibilityCriteria":263,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":264,"targetDuration":4,"studyType":22,"phases":266,"briefSummary":267,"conditions":268,"keywords":270,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":251,"lastUpdatePostDateStruct":277,"startDateStruct":279,"completionDateStruct":281,"leadSponsor":283,"locationsCount":285},"100605128","phase-2-overcoming-resistance-to-immunotherapy-combining-gemcitabine-with-ivonescimab-in-advanced-nsclc-100605128","NCT07158489","Overcoming Resistance to Immunotherapy Combining Gemcitabine With Ivonescimab in Advanced NSCLC","Protocol SAKK 18\u002F 25 Overcoming Resistance to Immunotherapy Combining Gemcitabine With Ivonescimab in Advanced NSCLC Progressing on Immune Checkpoint Inhibitors: A Multicenter, Single-arm, Open-label Phase II Trial (ORIGIN2)","ORIGIN2","Inclusion Criteria:\n\n* Patients fulfilling all of the following inclusion criteria are eligible for the trial:\n* Written informed consent according to Swiss law and ICH GCP E6 regulations before registration and prior to any trial specific procedures including patient screening.\n* Confirmed squamous or non-squamous mNSCLC stage IIIB-IV (based on 9th edition Tumor-Node-Metastasis (TNM) classification of lung cancers with disease recurrence or progression during or after one or more prior immunotherapy or CIT regimens for metastatic disease.\n* Patients with treated and stable central nervous system (CNS) metastases are eligible, if:\n\n  * Previous CNS-directed therapy has been completed at least 4 weeks prior to treatment start.\n  * No evidence of progression after completion of CNS-directed therapy as ascertained by clinical examination and brain imaging with Magnetic Resonance Imaging (MRI) or CT.25\n* Patients with known HIV-infection are eligible, if:\n\n  * CD4+ T-cell counts are ≥ 350 cells\u002Fµl\n  * No history of AIDS-defining opportunistic infection within past 12 months\n  * Patient agrees to concomitant antiretroviral therapy (ART) if not currently on ART, or is on ART for ˃ 4 weeks and has a HIV viral load ˂ 400 copies\u002Fml.26\n* Patients with a previously treated malignancy are eligible if this is clinically stable and does not require concurrent tumor-directed treatment.\n\nException: patients suffering from prostate cancer under hormonal ablation therapy (hormone sensitive disease).\n\n* Patients with measurable disease according to RECIST v1.1.\n* Availability of newly collected or archival (maximum 3 months) samples for TR prior to treatment initiation.\n* Age ≥ 18 years\n* ECOG performance status 0-2.\n* Adequate bone marrow function: absolute neutrophil count ≥ 1.5 x 109\u002Fl, platelet count ≥ 100 x 109\u002Fl, hemoglobin ≥ 90 g\u002Fl.\n\n6.1.11 Adequate hepatic function: total bilirubin ≤ 1.5 x upper limit of normal (\\[ULN\\]; except for patients with Gilbert's disease ≤ 3.0 x ULN), aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 x ULN, or ≤ 5 x ULN for patients with hepatic metastasis.\n\n* Adequate renal function: estimated glomerular filtration rate (eGFR) ≥ 40 ml\u002Fmin\u002F1.73 m2 (according to the Chronic Kidney Disease Epidemiology Collaboration) abbreviated formula CKD-EPI formula.\n* Women of childbearing potential, including women who had their last menstrual period in the last 2 years, must use highly effective contraception, are not pregnant or lactating and agree not to become pregnant during trial treatment and until 6 months after the last dose of investigational drug . A negative serum or urine pregnancy test before starting trial treatment is required for all women of childbearing potential.\n* Men agree not to donate sperm or father a child during trial treatment and until 6 months after the last administration of investigational drug.\n* Patients give their consent to participate in TR projects and providing the mandatory samples.\n\nExclusion Criteria:\n\n* Symptomatic brain metastases.\n* Prior treatment with gemcitabine in combination with immunotherapies.\n* Tumor progression within the first 8 weeks from start of first-line treatment.\n* Activating EGFR or ALK mutations.\n* Concomitant use of other anti-cancer drugs or radiotherapy.\n* Major surgery within 1 month prior to treatment start.\n* Known history of any uncontrolled active systemic infection requiring intravenous antimicrobial treatment.\n* Known history of tuberculosis, primary immunodeficiency, allogeneic tissue\u002Fsolid organ transplant, or receipt of live attenuated vaccine.\n* History of interstitial lung disease or severe pneumonitis.\n* Concomitant use of corticosteroids as premedication for gemcitabine therapy.\n* Concomitant or prior use of immunosuppressive medication such as interferon or methotrexate within 28 days prior to trial treatment start, with the exceptions of local (i.e., intranasal, inhaled and topical) corticosteroids.\n* Major blood vessel tumor invasion.\n* Minor local procedures (excluding central venous catheterization and port implantation) within 3 days prior to study treatment initiation.\n* Unstable angina, myocardial infarction, congestive heart failure (NYHA classification Grade ≥2;27) or vascular disease (e.g., aortic aneurysm at risk of rupture) that required hospitalization within 12 months prior to study treatment initiation, or other cardiac impairment that may affect the safety evaluation of the study drug (e.g., poorly controlled arrhythmias, myocardial ischemia).\n* History of esophageal gastric varices, severe ulcers, wounds that do not heal, abdominal fistula, intra-abdominal abscesses, or acute gastrointestinal bleeding within 6 months prior to study treatment initiation.\n* History of arterial thromboembolic event, venous thromboembolic event of Grade ≥3 as specified in NCI CTCAE v5.0, transient ischemic attack, cerebrovascular accident, hypertensive crisis, or hypertensive encephalopathy within 6 months prior to study treatment initiation.\n* Acute exacerbation of chronic obstructive pulmonary disease within 4 weeks prior to study treatment initiation.\n* 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 study treatment initiation.\n* Any concomitant drugs contraindicated for use with the trial drugs according to the approved product information or to the Investigator's Brochure (IB).\n* Known or suspected hypersensitivity to gemcitabine or ivonescimab or to any component of the trial drugs.\n* History of bleeding tendencies or coagulopathy and\u002For clinically significant bleeding symptoms or risk within 4 weeks prior to registration, including but not limited to:\n\n  * Hemoptysis (defined as coughing up ≥ 0.5 teaspoon of fresh blood or small blood clots).\n\nNote: transient hemoptysis associated with diagnostic bronchoscopy is allowed.\n\n* Nasal bleeding \u002Fepistaxis (bloody nasal discharge is allowed).\n* Current use of prophylactic or full-dose anticoagulants or anti-platelet agents for therapeutic purposes that is not stable prior to registration is not allowed. The use of full-dose anticoagulants is permitted as long as the international normalized ratio (INR) or activated partial thromboplastin time is within therapeutic limits according to the medical standard of the enrolling institution.\n\n  * Poorly controlled hypertension with repeated systolic blood pressure ≥ 150 mmHg or diastolic pressure ≥ 100 mmHg after oral antihypertensive therapy.\n  * Active autoimmune or lung disease requiring systemic therapy (e.g., with disease modifying drugs, prednisone \\>10 mg daily or equivalent, immunosuppressant therapy) within 2 years prior to registration, however the following will be allowed:\n* Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is permitted.\n* Intermittent use of bronchodilators, inhaled corticosteroids, or local corticosteroid injections is permitted.\n\n  * Has pre-existing peripheral neuropathy that is ≥ Grade 2 by NCI CTCAE v5.0.\n  * Uncontrolled pleural effusions, pericardial effusions, or ascites that is clinically symptomatic.\n\nNote: Patients managed with indwelling catheters (e.g., PleurX) are allowed.\n\n* History of non-infectious pneumonia requiring systemic corticosteroids, or current interstitial lung disease.\n* Active or prior history of inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis, or chronic diarrhea).\n* Any other serious underlying medical, psychiatric, psychological, familial or geographical condition, which in the judgment of the investigator may interfere with the planned staging, treatment and follow-up, affect patient compliance or place the patient at high risk from treatment-related complications.",{"count":265,"type":21},47,[51],"This Phase II clinical trial (investigates the efficacy of combining gemcitabine, a chemotherapy agent, with ivonescimab, a bispecific PD-1\u002FVEGF antibody, in patients with advanced non-small cell lung cancer (NSCLC) who have experienced disease progression following chemoimmunotherapy (CIT). Lung cancer remains the leading cause of cancer-related death globally, and treatment options after CIT failure are limited. Gemcitabine has demonstrated immunostimulatory properties, including enhanced T-cell infiltration and reduced immunosuppressive cell populations, which may synergize with immune checkpoint inhibitors. Ivonescimab targets both PD-1 and VEGF pathways, potentially enhancing antitumor immune responses and inhibiting tumor angiogenesis. The trial aims to evaluate the objective response rate (ORR) according to RECIST v1.1 criteria. The combination therapy is expected to offer a novel and effective treatment strategy for patients with relapsed NSCLC, addressing a significant unmet medical need.",[27,269],"NSCLC (Advanced Non-small Cell Lung Cancer)",[271,272,273,274,275,276],"advanced NSCLC","immune checkpoint inhibitors","Resistance to immunotherapy","Gemcitabine and Ivonescimab","Gemcitabine","Ivonescimab",{"date":278,"type":32},"2026-08-11",{"date":280,"type":21},"2026-09",{"date":282,"type":21},"2029-07-31",{"name":284,"class":62},"Swiss Cancer Institute",7,{"id":287,"slug":288,"hasResults":12,"nctId":289,"briefTitle":290,"officialTitle":291,"acronym":4,"eligibilityCriteria":292,"healthyVolunteers":12,"sex":17,"minAge":293,"maxAge":4,"enrollmentInfo":294,"targetDuration":4,"studyType":22,"phases":296,"briefSummary":297,"conditions":298,"keywords":322,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":251,"lastUpdatePostDateStruct":351,"startDateStruct":352,"completionDateStruct":354,"leadSponsor":356,"locationsCount":358},"100407463","the-evaluation-of-pc14586-in-patients-with-advanced-solid-tumors-harboring-a-tp53-y220c-mutation-pynnacle-100407463","NCT04585750","The Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)","A Phase 1\u002F2 Open-label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of PC14586 in Patients With Locally Advanced or Metastatic Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)","Inclusion Criteria:\n\n* At least 18 years of age or 12 to 17 years of age after Safety Review Committee approval.\n* Locally advanced or metastatic solid malignancy with a TP53 Y220C mutation\n* Eastern Cooperative Oncology Group (ECOG) status of 0 or 1\n* Previously treated with one or more lines of anticancer therapy and progressive disease\n* Adequate organ function\n* Measurable disease per RECIST v1.1 (Phase 2)\n\nAdditional Criteria for Inclusion in Phase 1b (rezatapopt) + pembrolizumab combination)\n\n* Anti-PD-1\u002FPD-L1 naive or must have progressed on treatment\n* Measurable disease\n\nExclusion Criteria:\n\n* Anti-cancer therapy within 21 days (or 5 half-lives) of receiving the study drug\n* Radiotherapy within 14 days of receiving the study drug\n* Primary CNS tumor\n* History of leptomeningeal disease or spinal cord compression\n* Brain metastases, unless neurologically stable and do not require steroids to treat associated neurological symptoms\n* Stroke or transient ischemic attack within 6 months prior to screening\n* Heart conditions such as unstable angina within 6 months prior to screening, uncontrolled hypertension, a heart attack within 6 months prior to screening, congestive heart failure, prolongation of QT interval, or other rhythm abnormalities\n* Strong CYP3A4 inducers and strong CYP2C9 inhibitors\u002Finducers within 14 days of first dose of rezatapopt\n* History of gastrointestinal (GI) disease that may interfere with absorption of study drug or patients unable to take oral medication\n* History of prior organ transplant\n* Known, active malignancy, except for treated cervical intraepithelial neoplasia, or non-melanoma skin cancer\n* Known, active uncontrolled Hepatitis B, Hepatitis C, or human immunodeficiency virus infection\n\nAdditional Criteria for Exclusion from Phase 2 (rezatapopt monotherapy)\n\n* Known KRAS mutation, defined as a single nucleotide variant (SNV) (Phase 2)\n\nAdditional Criteria for Exclusion from Phase 1b (rezatapopt) + pembrolizumab combination)\n\n* Received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor and discontinued from that treatment due to a Grade 3 or higher immune-related AE (irAE)\n* Received a live or live-attenuated vaccine within 30 days prior to the first dose of study intervention\n* Diagnosis of immunodeficiency or receiving chronic systemic steroid therapy within 7 days prior to the first dose of study drug\n* Hypersensitivity (≥ Grade 3) to pembrolizumab and\u002For any of its excipients\n* Active autoimmune disease that has required systemic treatment in past 2 years\n* History of radiation pneumonitis\n* History of (non-infectious) or active pneumonitis \u002F interstitial lung disease that required steroids\n* Active infection requiring systemic therapy\n* Known history of HIV infection\n* Has previously received rezatapopt","12 Years",{"count":295,"type":21},300,[131,51],"The Phase 2 monotherapy portion of this study is currently enrolling and will evaluate the efficacy and safety of PC14586 (INN rezatapopt) in participants with locally advanced or metastatic solid tumors harboring a TP53 Y220C mutation. The Phase 1 portion of the study will assess the safety, tolerability and preliminary efficacy of multiple dose levels of rezatapopt as monotherapy and in Phase 1b in combination with pembrolizumab.",[299,300,301,302,110,139,141,303,304,305,306,307,228,308,309,310,311,27,312,224,313,314,315,316,104,317,318,319,320,321],"Advanced Solid Tumor","Advanced Malignant Neoplasm","Metastatic Cancer","Metastatic Solid Tumor","Prostate Cancer","Colorectal Cancer","Breast Cancer","Other Cancer","Locally Advanced","Gall Bladder Cancer","Small Cell Lung Cancer","Small Cell Lung Cancer ( SCLC )","Small Cell Lung Carcinoma","NSCLC (Non-small Cell Lung Cancer)","Non-Small Cell Lung Carcinoma","Triple Negative Breast Cancer","TNBC","HER2+ Breast Cancer","ER\u002FPR Positive Breast Cancer","HER2- Breast Cancer","HER2-positive Breast Cancer","HER2-negative Breast Cancer","ER\u002FPR(+), Her2(-) Breast Cancer",[323,324,325,326,327,328,329,330,331,332,333,334,335,336,337,338,339,340,341,342,343,344,345,346,347,348,349,350],"PC14586","p53","Y220C","Phase 1","Phase 1\u002F2","PMV","PMV Pharma","p53 mutation","TP53","TP53 mutation","p53 mutant","p53 reactivator","pembrolizumab","Keytruda","combination","PD-1","PD-L1","anti-PD-1","Merck","MSD","IgG4","mAb","Phase 1b","NGS","Next Generation Sequencing","precision","Phase 2","Rezatapopt",{"date":248,"type":32},{"date":353,"type":32},"2020-10-29",{"date":355,"type":21},"2027-12-31",{"name":357,"class":39},"PMV Pharmaceuticals, Inc",77,{"id":360,"slug":361,"hasResults":12,"nctId":362,"briefTitle":363,"officialTitle":363,"acronym":4,"eligibilityCriteria":364,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":365,"targetDuration":4,"studyType":22,"phases":367,"briefSummary":368,"conditions":369,"keywords":4,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":375,"lastUpdatePostDateStruct":376,"startDateStruct":377,"completionDateStruct":379,"leadSponsor":381,"locationsCount":4},"100650481","phase-2-adaptive-chemotherapy-for-pd-l1-high-resectable-nsclc-a-chemo-phree-trial-100650481","NCT07746388","Adaptive Chemotherapy for Pd-l1 High REsEctablE NSCLC: A Chemo-PHREE Trial","Inclusion Criteria:\n\n1. Age 18 years or older at time of study entry\n2. Eastern cooperative oncology group (ECOG) performance status of 0 or 1\n3. Participants with histologically confirmed stage II-IIIB(N2) NSCLC (per the 9th International Association for the Study of Lung Cancer) with disease that is considered resectable prior to initiation of systemic therapy.\n4. Subject cases must be reviewed in a multidisciplinary thoracic tumor board setting prior to enrollment to allow for adequate discussion regarding the appropriateness for resection.\n5. Participants must have a tumor tissue sample available for biomarker testing, including PD-L1 IHC testing and sequencing to confirm EGFR\u002FALK status. Assessment of PD-L1 IHC, EGFR\u002FALK status may be performed locally through a CLIA approved laboratory testing method.\n\n   a. Tissue source may be a formalin fixed paraffin block (FFPE) of a previous tumor biopsy sample. Source of biomarker testing may be obtained from archived tissue if adequate or from a new biopsy, if needed and clinically indicated.\n6. Participants must have established PD-L1 Tumor Proportion Score (TPS) expression \\> or equal to 50%, assessed locally through a CLIA approved laboratory testing method.\n7. All suspicious mediastinal\u002Fhilar lymph nodes including those that are pathologically enlarged or FDG avid on PET\u002FCT require further sampling for pathological confirmation if accessible by mediastinoscopy, thoracoscopy, or EBUS.\n8. Absence of major associated pathologies that increase the surgery risk to an unacceptable level\n9. Pulmonary function capacity (eg. FVC, FEV1, TLC, and DLCO) capable of tolerating proposed lung resection according to surgeon.\n10. Adequate normal organ and marrow function defined below:\n\n    1. Platelet count \\> or equal to 100,000\u002Fmm3\n    2. Hemoglobin \\> or equal to 8 g\u002FdL\n    3. Absolute neutrophil count (ANC) \\> or equal to 1000\u002Fmm3\n    4. Creatinine ≤ 1.5 x ULN or creatinine clearance (CrCl) \\> or equal to 40 mL\u002Fmin\n    5. Total bilirubin ≤ 1.5 x ULN (except subjects with Gilbert Syndrome who can have total bilirubin \\\u003C 3.0 mg\u002FdL)\n\nAST, ALT, Alkaline phosphatase ≤ 3 x ULN per local testing 11. Subjects are deemed capable of giving informed consent and must have signed and dated an IRB approved written informed consent form. This written consent must be obtained before the performance of any protocol related procedures that are not part of normal standard of care. 12. Women of childbearing potential (WOCBP) must have negative serum or urine pregnancy testing within 30 days of study start\n\nExclusion Criteria:\n\n1. Presence of locally advanced unresectable (regardless of stage) or metastatic disease (stage IV).\n2. Participants with large-cell neuroendocrine carcinoma tumor or small cell carcinoma histology, including those with presence of mixed histology.\n3. Participants with known sensitizing EGFR mutations (L858R, Exon 19 deletion, Exon 20 insertion, atypical mutations including G719X L861Q, S768I) or ALK translocation via local CLIA approved testing methods.\n\n   a. For patients in whom more comprehensive testing is performed, those with identified targetable alterations in ROS1, NTRK, RET, METex14, HER2 genes will also be excluded. Screening for these specific alterations (ROS1\u002FNTRK\u002FRET\u002FMETex14\u002FHER2), however, are not required for enrollment.\n4. Participants with brain metastases are excluded from this study. All patients should have pre-study MRI brain or CT head with contrast to confirm the absence of intracranial disease, per standard of care staging procedures.\n5. Prior therapy with an anti-PD-(L)1, anti-CTLA-4 antibody or any other antibody targeting t-cell co-regulatory pathways.\n6. Active prior malignancy within the previous 3 years, except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the prostate, cervix or breast.\n7. History of allogeneic organ transplantation.\n8. Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.\n9. 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 Transient ischemic attack or stroke within 1 year\n10. 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.\n11. Ongoing or significant autoimmune disease that required treatment with systemic immunosuppressive treatments within the last 5 years. Note: 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.\n12. Any infection requiring hospitalization or treatment with IV anti-infectives within 2 weeks of first dose of study medication\n13. Uncontrolled infection with HIV, hepatitis B or hepatitis C infection, diagnosis of immunodeficiency, and\u002For tuberculosis (active or latent).\n\n    1. 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    2. 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    3. 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    4. Participants who are HCV Ab+ who have controlled infection (undetectable HCV RNA by PCR either spontaneously or in eligible\n14. Receipt of a live vaccine within 4 weeks of start of study medication\n15. 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.\n16. Known hypersensitivity to the active substances or to any of the excipients.\n17. 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 4 months after the last dose of cemiplimab. 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. \\*\\*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 4 months after the last dose of cemiplimab. Sperm donation is also prohibited during the same period. Vasectomy success must be confirmed by semen analysis. †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. ‡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.",{"count":366,"type":21},30,[51],"This research study is being done to find out if a drug called cemiplimab is safe in adult patients who have non-small cell lung cancer (NSCLC) that can be surgically removed (resectable Stage II, IIIA, or select IIIB NSCLC). The purpose of this study is also to look at how well the study drug works and whether certain patients can skip chemotherapy before their surgery. The goal is to see if they can safely avoid the harsh side effects of chemo and still have a successful outcome.\n\nThe investigators are doing this study because the investigators want to find out if this treatment approach is better or worse than the usual approach for early-stage NSCLC that can be surgically removed. The usual approach for the participants type of cancer is treatment with a combination of platinum-doublet chemotherapy and an immune checkpoint inhibitor (ICI) such as cemiplimab (LIBTAYO®) given before the tumor is surgically removed. (Immune checkpoint is a normal part of the immune system used to prevent an immune response from becoming so strong that it inadvertently destroys healthy cells in the body).\n\nCemiplimab is given via infusion and will be administered at the study center. Everyone on the study will get the active study drug, cemiplimab. No one will get placebo. Placebos look like the study drug but don't have medicine in them.\n\nInfusion of cemiplimab will be given for 2 cycles followed by an evaluation. An evaluation means that participants will have imaging studies (\"scans\") done to see if the tumor has changed. After the scans, participants may receive one final cycle of cemiplimab followed by resection (surgery to remove the tumor) or combination chemotherapy plus cemiplimab for 2 cycles followed by resection.",[370,371,372,373,374],"Nsclc","NSCLC Stage II","NSCLC, Stage III","NSCLC Stage IIIB","Resectable Lung Non-Small Cell Carcinoma","2026-08-04",{"date":251,"type":32},{"date":378,"type":21},"2026-09-01",{"date":380,"type":21},"2031-09-01",{"name":382,"class":62},"University of Maryland, Baltimore",{"id":384,"slug":385,"hasResults":12,"nctId":386,"briefTitle":387,"officialTitle":388,"acronym":389,"eligibilityCriteria":390,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":391,"targetDuration":4,"studyType":22,"phases":393,"briefSummary":394,"conditions":395,"keywords":397,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":375,"lastUpdatePostDateStruct":401,"startDateStruct":403,"completionDateStruct":405,"leadSponsor":407,"locationsCount":408},"100583857","phase-3-study-of-daraxonrasib-rmc-6236-in-patients-with-ras-mutated-nsclc-rasolve-301-100583857","NCT06881784","Study of Daraxonrasib (RMC-6236) in Patients With RAS Mutated NSCLC (RASolve 301)","RASolve 301: Phase 3 Multicenter, Open Label, Randomized Study of RMC-6236 Versus Docetaxel in Patients With Previously Treated Locally Advanced or Metastatic RAS[MUT] NSCLC","RASolve 301","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 confirmed NSCLC, either locally advanced or metastatic, not amenable to curative surgery or radiotherapy.\n* Measurable disease per RECIST v1.1.\n* Adequate organ function (bone marrow, liver, kidney, coagulation).\n* One to two prior lines of therapy including an anti-PD-1\u002Fanti-PD(L)-1 agent and platinum-based chemotherapy.\n* Documented RAS mutation status, defined as Nonsynonymous mutations in KRAS, NRAS, or HRAS at codons 12, 13, or 61 (G12, G13, or Q61).\n* Able to take oral medications.\n\nExclusion Criteria:\n\n* Prior therapy with direct RAS-targeted therapy or docetaxel.\n* Untreated central nervous system (CNS) metastases.\n* Medically significant comorbidities (significant cardiovascular disease, lung disease, or impaired GI function).\n* Ongoing anticancer therapy.\n* Pregnant or breastfeeding.",{"count":392,"type":21},590,[73],"The purpose of this study is to evaluate the safety and efficacy of a novel RAS(ON) inhibitor compared to docetaxel.",[312,104,27,396,269],"NSCLC (Non-small Cell Lung Carcinoma)",[27,104,110,105,106,108,107,398,399,400],"RAS Q61 Mutation","RAS G12 Mutation","RAS G13 Mutation",{"date":402,"type":32},"2026-08-06",{"date":404,"type":32},"2025-05-06",{"date":406,"type":21},"2030-12-01",{"name":120,"class":39},152,{"id":410,"slug":411,"hasResults":12,"nctId":412,"briefTitle":413,"officialTitle":413,"acronym":414,"eligibilityCriteria":415,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":416,"targetDuration":4,"studyType":22,"phases":418,"briefSummary":419,"conditions":420,"keywords":422,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":423,"lastUpdatePostDateStruct":424,"startDateStruct":426,"completionDateStruct":428,"leadSponsor":430,"locationsCount":40},"100624623","precise-exercise-regimen-for-cancer-care-percc-a-pilot-study-100624623","NCT07412041","Precise Exercise Regimen for Cancer Care (PERCC): A Pilot Study","PERCC","Inclusion Criteria:\n\n* Age ≥18 years at time of diagnosis; due to the rarity of the disease in those \\\u003C18 years, this age bracket will not be included.\n* Histologically diagnosed with stage II or III non-small cell lung cancer (NSCLC) and has not started lung cancer treatment.\n* Patient's treatment plan is to receive neoadjuvant therapy (defined as chemotherapy, chemotherapy and immunotherapy, or chemotherapy and radiation therapy) followed by surgical treatment. Patients will be enrolled at least three weeks prior to receiving their first neoadjuvant treatment.\n* Ability to follow directions and complete questionnaires in English and\u002For Spanish.\n* Ability to understand and the willingness to sign a written informed consent document prior to any study-related procedures.\n* Willing to travel to DFCI for necessary data collection.\n\nExclusion Criteria:\n\n* Patients who are morbidly obese (BMI\\>40 kg\u002Fm2) or Anorexic (BMI\\\u003C17 kg\u002Fm2).\n* Unstable comorbidities that contraindicate participation in exercise program compliance. Patients with unstable comorbidities may develop unexpected adverse events from exercise. For the purpose of patients' safety, as well as because part of this study involves remote, home-based exercise where close supervision is not possible, patients with unstable medical conditions are excluded. Study staff will identify untreated or unmanaged conditions when screening and treating MDs must provide clearance prior to patient enrollment.\n* Patients with alcohol or drug abuse, significant mental or emotional problems that would interfere with compliance (assessed by NCCN Distress Thermometer).\n* Patients scheduled to receive single modality cancer treatment (unimodal therapy), scheduled surgery within 2 weeks of the pre-treatment clinic visit, or for whom treatment has already started.\n* Patients who are pregnant, or plan to become pregnant during study duration will be excluded due to the unknown nature of exercise on developing fetuses.\n* Subjects who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study.",{"count":417,"type":21},20,[24],"The purpose of this study is to test the feasibility of the Precise Exercise Regimen for Cancer Care (PERCC) exercise program in participants with stage II-III primary lung cancer.",[421,110,76,27],"Stage II Lung Cancer",[421,110,76,27],"2026-08-03",{"date":425,"type":32},"2026-08-05",{"date":427,"type":32},"2026-01-22",{"date":429,"type":21},"2028-03-30",{"name":431,"class":62},"Dana-Farber Cancer Institute",{"id":433,"slug":434,"hasResults":12,"nctId":435,"briefTitle":436,"officialTitle":437,"acronym":438,"eligibilityCriteria":439,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":440,"targetDuration":4,"studyType":22,"phases":442,"briefSummary":443,"conditions":444,"keywords":454,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":472,"lastUpdatePostDateStruct":473,"startDateStruct":474,"completionDateStruct":476,"leadSponsor":478,"locationsCount":4},"100646600","a-multicenter-randomized-open-label-trial-evaluating-ctdna-guided-interruption-versus-standard-of-care-immune-checkpoint-inhibitor-ici-therapy-in-patients-with-advanced--metastatic-solid-tumors-100646600","NCT07689812","A Multicenter Randomized Open-Label Trial Evaluating ctDNA-Guided Interruption Versus Standard of Care Immune-Checkpoint Inhibitor (ICI) Therapy In Patients With Advanced \u002F Metastatic Solid Tumors.","A Multicenter Randomized Open-Label Trial Evaluating ctDNA-Guided Interruption Versus Standard of Care Continuous Immune-Checkpoint Inhibitor (ICI) Therapy In Patients With Advanced\u002FMetastatic Solid Tumors","SIGNAL-IO 301","Inclusion Criteria:\n\nGeneral inclusion criteria includes the following selection criteria to be eligible for inclusion in any aspect of the study. Eligibility will be assessed by the investigator:\n\n1. Signed Informed consent\n2. Age ≥ 18 years\n3. ECOG 0-2.\n4. Histologically confirmed advanced\u002Fmetastatic solid tumors including:\n\n   1. Melanoma: Unresectable recurrent, advanced, or metastatic\n   2. NSCLC: Advanced or metastatic\n   3. MSI-High\u002FdMMR CRC: Metastatic\n   4. RCC: Unresectable recurrent, advanced, or metastatic\n   5. Other: Metastatic solid tumors\n5. Received first line ICI monotherapy or dual-ICI therapy (e.g., PD-1\u002FCTLA-4 combination therapy) for a minimum of 12 months (maximum of 15 months) for NSCLC, RCC \\& other metastatic solid tumors, or for a minimum of 6 months (maximum of 9 months) for melanoma and MSI-High \u002FdMMR CRC. Exceptions permitted:\n\n   * For patients with NSCLC: First line platinum-based chemo-ICI regimens if on maintenance ICI +\u002F- pemetrexed.\n   * For patients with melanoma: nivolumab\u002Frelatlimab is permissible.\n6. Radiographic CR\u002FPR: Participants must have CR or PR at the last assessment performed within 6 weeks before randomization according to RECIST v1.1 using a diagnostic CT and\u002For MRI. Radiographic assessment must be confirmed by the BICR prior to randomization.\n7. Known ctDNA-negative with a tissue-informed assay\n\n   * ≥ 2 consecutive ctDNA-negative results at least 6 weeks apart; last test within 1 month of enrollment.\n   * Note: A confirmatory Signatera Genome negative test must be completed at enrollment if previous ctDNA testing performed for clinical care was done with a test other than Signatera Genome.\n8. Adequate organ function:\n\n   1. Hematology: ANC ≥1500\u002FμL; Platelets ≥100000\u002FμL;Hemoglobin ≥9.0g\u002FdL;\n   2. Renal: Serum Cr ≤1.5×ULN or calculated CrCl ≥60 mL\u002Fmin (using Cock-Gault formula);\n   3. Hepatic: Total bilirubin ≤1.5 ×ULN or, for participants with total bilirubin levels \\>1.5×ULN, direct bilirubin within normal limits; AST (SGOT) and ALT (SGPT) ≤2.5×ULN;\n   4. Coagulation: INR or PT, activated partial thromboplastin time (APTT) ≤1.5×ULN Note: Laboratory assessments performed as part of standard of care evaluations during immunotherapy treatment administration may be used to satisfy these eligibility criteria, provided they are obtained within 28 days of enrollment.\n9. Recovery to baseline or ≤ Grade 1 common terminology criteria for adverse events (CTCAE) v6 from AE(s) related to any prior treatments unless AE(s) are deemed clinically non-significant (e.g., Grade 2 alopecia) by the Investigator and\u002For stable on supportive therapy.\n10. No prior malignancy, with the exception of basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, or in situ cancer, or has undergone potentially curative therapy with no evidence of that disease recurrence for 5 years since completion of definitive therapy\n11. Participants must be willing and able to comply with study visits, treatment plans, laboratory tests, and other study procedures\n12. Women of child-bearing potential (WOCBP) and male participants partnering with WOCBP must agree to use highly effective contraception during the treatment phase and at least 180 days post last dose\n13. Patients must be willing to discontinue clinically-directed ctDNA testing for treatment response monitoring during the period of clinical trial testing as dictated by the protocol.\n\nExclusion Criteria\n\nPatients are not eligible for the study if they meet any of the following criteria, as assessed by the investigator:\n\n1. Available alternate treatment options with curative intent, e.g. surgery and \u002F or RT and \u002F or Chemotherapy.\n2. Symptomatic or progressing CNS metastases; or presence of leptomeningeal disease.\n3. Patient has active autoimmune disease that required systemic treatment in the past 2 years, is immunocompromised in the opinion of the Investigator, or is receiving systemic immunosuppressive treatment. (Note: Participants with splenectomy are allowed.) Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc) is not considered a form of systemic treatment.\n4. Patient is receiving systemic steroid therapy ≤3 days prior to enrollment or receiving any other form of immunosuppressive medication with the exception of daily steroid replacement therapy. Note: Use of inhaled corticosteroids, local steroid injection, or steroid eye drops is allowed.\n5. Had allogeneic tissue\u002Fsolid organ transplantation.\n6. Interstitial lung disease or history of pneumonitis that has required oral or IV steroids. Note: Patients with lymphangitic carcinomatosis secondary to NSCLC can be considered as eligible.\n7. Has received or will receive a live vaccine within 30 days prior to enrollment (seasonal flu vaccines that do not contain live vaccine are permitted).\n8. Active infection requiring intravenous systemic therapy.\n9. Known history of human immunodeficiency virus (HIV).\n10. Known active Hepatitis B or C.\n11. Pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the study.\n12. Currently participating or has participated in a study of an investigational agent or using an investigational device within 4 weeks of enrollment.\n13. Use of any commercial ctDNA or liquid biopsy monitoring outside of the study protocol during the treatment monitoring phase within the protocol.",{"count":441,"type":21},920,[24],"This is a multicenter, open-label, randomized (1:1) trial designed to evaluate whether ctDNA-guided interruption of immune-checkpoint inhibitor (ICI) therapy provides comparable survival to standard of care (SoC) continuous ICI therapy in patients with histologically confirmed advanced\u002Fmetastatic non-small cell lung cancer (NSCLC), melanoma, microsatellite instability-high (MSI-High)\u002FDeficient Mismatch Repair (dMMR) colorectal cancer (CRC), renal cell carcinoma (RCC) and other solid tumors. This study will be conducted in up to 100 sites.",[269,312,396,27,445,446,226,447,448,449,450,451,452,223,453],"Melanoma (Skin Cancer)","Melanoma (Skin) Stage IV","MSI High Colorectal Cancer","DMMR Colorectal Cancer","RCC, Renal Cell Cancer","RCC","Solid Tumors","Metastatic Solid Tumors","Advanced Solid Tumors Cancer",[455,456,457,458,459,27,460,461,462,304,226,463,450,464,465,466,467,468,469,470,471],"ctDNA","Circulating tumor DNA","Immune checkpoint inhibitor","ICI","Non-small cell lung cancer","Melanoma","Microsatellite Instability-High\u002Fdeficient Mismatch Repair","MSI-High\u002FdMMR","Renal cell carcinoma","Metastatic solid tumors","Signatera","Molecular residual disease","MRD","Biomarker-guided therapy","Adjuvant therapy","Tumor-informed assay","Advanced solid tumor","2026-07-31",{"date":375,"type":32},{"date":475,"type":21},"2026-12",{"date":477,"type":21},"2034-03",{"name":479,"class":39},"Natera, Inc.",{"id":481,"slug":482,"hasResults":12,"nctId":483,"briefTitle":484,"officialTitle":485,"acronym":4,"eligibilityCriteria":486,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":487,"targetDuration":4,"studyType":22,"phases":489,"briefSummary":490,"conditions":491,"keywords":494,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":495,"lastUpdatePostDateStruct":496,"startDateStruct":497,"completionDateStruct":499,"leadSponsor":501,"locationsCount":502},"100623492","phase-1-study-of-rason-inhibitors-in-combination-with-ivonescimab-in-patients-with-solid-tumors-100623492","NCT07397338","Study of RAS(ON) Inhibitors in Combination With Ivonescimab in Patients With Solid Tumors","A Phase 1\u002F2 Open-Label, Multicenter Study of RAS(ON) Inhibitors in Combination With Ivonescimab With or Without Other Anti-Cancer Agents in Patients With 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* Histologically confirmed, locally advanced or metastatic solid tumor malignancy with documented RAS mutation in KRAS, HRAS, or NRAS.\n* Received and progressed or been intolerant to prior standard therapy (Part 1 Dose Exploration).\n* Non-squamous NSCLC without a treatable driver mutation in other oncogenes that has not received prior systemic treatment (Arms A \\& B for Part 2 Dose Expansion).\n* Solid tumor or CRC previously treated with no more than 2 prior lines of therapy for advanced disease and progressed or been intolerant to prior standard therapies (Arm C for Part 2 Dose Expansion).\n* Measurable disease per RECIST v1.1\n* Adequate organ function (bone marrow, liver, kidney, coagulation, endocrine).\n* Able to take oral medications.\n\nExclusion Criteria:\n\n* Head and neck squamous cell carcinoma.\n* Any conditions that may affect the ability to take or absorb study drug.\n* Major surgery within 4 weeks prior to receiving study drug(s).\n* Patient is unable or unwilling to comply with protocol-required study visits or procedures.\n* Other inclusion\u002Fexclusion criteria may apply.",{"count":488,"type":21},370,[131,51],"The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of RAS(ON) inhibitors in combination with ivonescimab in adults with advanced or metastatic solid tumors with a RAS mutation.",[223,452,492,27,493,226],"Non-small Cell Lung Cancer (NSCLC)","Colorectal Cancer (CRC)",[223,452,76,27,304,226,105,107,106,108,109],"2026-07-30",{"date":423,"type":32},{"date":498,"type":32},"2026-01-30",{"date":500,"type":21},"2029-05",{"name":120,"class":39},9,{"id":504,"slug":505,"hasResults":12,"nctId":506,"briefTitle":507,"officialTitle":508,"acronym":4,"eligibilityCriteria":509,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":510,"targetDuration":4,"studyType":22,"phases":512,"briefSummary":513,"conditions":514,"keywords":520,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":529,"lastUpdatePostDateStruct":530,"startDateStruct":532,"completionDateStruct":534,"leadSponsor":536,"locationsCount":538},"100326192","phase-1-a-study-of-bispecific-antibody-mcla-158-in-patients-with-advanced-solid-tumors-100326192","NCT03526835","A Study of Bispecific Antibody MCLA-158 in Patients With Advanced Solid Tumors","Phase 1\u002F2 Dose Escalation and Cohort Expansion Study Evaluating MCLA-158 (Petosemtamab) as Single Agent or in Combination in Advanced Solid Tumors","Inclusion Criteria:\n\n* Histologically or cytologically confirmed solid tumors with evidence of metastatic or locally advanced disease not amenable to standard therapy with curative intent.\n* A baseline fresh tumor sample (FFPE) from a metastatic or primary site (if safe\u002Ffeasible).\n* Amenable for biopsy (if safe\u002Ffeasible).\n* Measurable disease as defined by RECIST version 1.1 by radiologic methods.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Life expectancy ≥ 12 weeks, as per investigator.\n* Left ventricular ejection fraction (LVEF) ≥ 50% by echocardiogram (ECHO) or multiple gated acquisition scan (MUGA).\n* Adequate organ function\n* Expansion cohorts: patients with locally advanced unresectable or metastatic disease for the following indications:\n\nSINGLE AGENT:\n\n* SECOND-\u002FTHIRD-LINE HNSCC PATIENTS (cohort closed to enrolment): patients who have progressed on or after, or are intolerant to, anti-PD-(L)1 therapy and platinum therapy as monotherapy or in combination with other agents and no previous exposure to EGFR inhibitors. Patients treated with platinum-containing therapy only in the adjuvant setting, or in the context of multimodal therapy for locally advanced disease should have disease progression within 6 months of the last dose of platinum containing therapy. Patients with no more than 2 prior lines of treatment in recurrent or metastatic disease. • Human papilloma virus (HPV) status determined by p16 immunohistochemistry (IHC) or molecular HPV test for all oropharyngeal tumors should be reported when available.\n* The eligible HNSCC primary tumor locations are oropharynx, oral cavity, hypopharynx, and larynx.\n* 3L+ mCRC (cohort open to enrolment) patients must have:\n* No oncogenic missense mutations in KRAS, NRAS, BRAF, or EGFR ectodomain, and no HER2 (ERBB2) or KRAS amplification, as detected in plasma by ctDNA NGS central testing performed during screening.\n* A microsatellite stable (MSS) tumor.\n* Received ≥2 and no more than 4 lines of prior therapy in the metastatic setting including:\n\n  1. Chemotherapy with oxaliplatin, irinotecan, and a fluoropyrimidine,\n  2. Targeted therapy with an anti-VEGF therapy\n\nCOMBINATION:\n\n* FIRST-LINE HNSCC (cohort closed to enrolment): patients eligible to receive pembrolizumab as first-line monotherapy with tumors expressing programmed cell death protein ligand 1 (PD-L1), combined positive score (CPS) ≥1, as determined by a Food and Drug Administration (FDA) approved test in the US, or by an approved equivalent test in other countries; patients should not have previous systemic therapy administered in the recurrent or metastatic setting, although previous systemic therapy as part of multimodal treatment for locally advanced disease is allowed if ended ≥6 months prior to signing the ICF. The eligible HNSCC primary tumor locations are oropharynx, oral cavity, hypopharynx, and larynx. Previous treatments with anti PD-(L)1 or anti-EGFR therapies are not allowed.\n* mCRC (cohorts open to enrolment): Patients should have been previously diagnosed with histologically or cytologically confirmed unresectable or metastatic adenocarcinoma of the colon or rectum. Patients must be RAS\u002F RAF WT as determined using tumor tissue (primary or metastatic) by an appropriate tumor tissue based assay, to be confirmed by the sponsor, and must have an MSS tumor. Patients must be naive to prior anti-EGFR therapy.\n\n  i. Cohort to be treated with petosemtamab and FOLFIRI: patients may have received up to 1 prior chemotherapy regimen for the metastatic setting, consisting of 1L fluoropyrimidine-oxaliplatin-based chemotherapy ± bevacizumab.\n\nii. Cohort to be treated with petosemtamab and FOLFOX: patients may have received up to 1 prior chemotherapy regimen in the metastatic setting consisting of 1L fluoropyrimidine-irinotecan-based chemotherapy ± bevacizumab\n\nExclusion Criteria:\n\n* Central nervous system metastases that are untreated or symptomatic, or require radiation, surgery, or continued steroid therapy to control symptoms within 14 days of study entry.\n* Known leptomeningeal involvement.\n* Participation in another clinical study or treatment with any investigational drug within 4 weeks prior to study entry.\n* Any systemic anticancer therapy within 4 weeks or 5 half-lives whichever is shorter of the first dose of study treatment. For cytotoxic agents that have major delayed toxicity ( e.g. mitomycin C,nitrosoureas), or anticancer immunotherapies, a washout period of 6 weeks is required.\n* Requirement for immunosuppressive medication (e.g. methotrexate, cyclophosphamide)\n* Major surgery or radiotherapy within 3 weeks of the first dose of study treatment. Patients who received prior radiotherapy to ≥25% of bone marrow are not eligible, irrespective of when it was received.\n* Persistent grade \\>1 clinically significant toxicities related to prior antineoplastic therapies (except for alopecia); stable sensory neuropathy ≤ grade 2 NCI-CTCAE v4.03 is allowed.\n* History of hypersensitivity reaction to any of the excipients of petosemtamab, human proteins or any non-IMP treatment required for this study.\n* Uncontrolled hypertension (systolic blood pressure \\[BP\\] \\> 150 mmHg and\u002For diastolic BP \\> 100 mmHg) with appropriate treatment or unstable angina. History of congestive heart failure of Class II-IV New York Heart Association (NYHA) criteria, or serious cardiac arrhythmia requiring treatment (except atrial fibrillation, paroxysmal supraventricular tachycardia). History of myocardial infarction within 6 months of study entry.\n* History of prior malignancies with the exception of excised cervical intraepithelial neoplasia or nonmelanoma skin cancer, or curatively treated cancer deemed at low risk for recurrence with no evidence of disease for 3 years.\n* Current dyspnea at rest of any origin, or other diseases requiring continuous oxygen therapy. Patients with a history of interstitial lung disease (e.g., pneumonitis or pulmonary fibrosis) or evidence of ILD on baseline chest computerized tomography (CT) scan.\n* Current serious illness or medical conditions including, but not limited to uncontrolled active infection,clinically significant pulmonary, metabolic or psychiatric disorders.\n* Patients with known infectious diseases:\n\n  i. Active hepatitis B infection (hepatitis B surface antigen \\[HBsAg\\] positive) without receiving antiviral treatment.\n\nii. Positive test for hepatitis C ribonucleic acid (HCV) RNA).\n\n• Pregnant or breastfeeding patients; patients of childbearing potential must use highly effective contraception methods prior to study entry, for the duration of study participation, and for 6 months after the last dose of MCLA-158.",{"count":511,"type":21},560,[131,51],"This is a Phase 1\u002F2 open-label, multi-center, multi-national study with an initial dose escalation part to determine the recommended Phase II dose (RP2D) of MCLA-158 single agent in patients with mCRC.\n\nThe dose escalation part has been completed and the RP2D will be further evaluated in an expansion part of the study. Cohorts of selected solid tumor indications for which there is evidence of EGFR dependency and potential sensitivity to EGFR inhibition will be evaluated including head and neck cancer and metastatic colorectal cancer (mCRC).\n\nThe study will further assess the safety, tolerability, PK, PD, immunogenicity, and anti-tumor activity of MCLA-158 in monotherapy or in combination with other therapies.",[515,304,516,517,27,134,518,519],"Advanced\u002FMetastatic Solid Tumors","Gastric Cancer","Gastroesophageal-junction Cancer","Head and Neck Squamous Cell Carcinoma","Esophageal Cancer",[521,522,523,524,525,526,527,199,528],"Bispecific antibody","First-in-human","MCLA-158","Antibodies","Bispecific","immunologic factors","Cytokines","LGR5","2026-07-28",{"date":531,"type":32},"2026-07-29",{"date":533,"type":32},"2018-05-02",{"date":535,"type":21},"2028-11",{"name":537,"class":39},"Merus B.V.",54,{"id":540,"slug":541,"hasResults":12,"nctId":542,"briefTitle":543,"officialTitle":543,"acronym":4,"eligibilityCriteria":544,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":545,"targetDuration":4,"studyType":22,"phases":547,"briefSummary":548,"conditions":549,"keywords":4,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":550,"lastUpdatePostDateStruct":551,"startDateStruct":553,"completionDateStruct":555,"leadSponsor":557,"locationsCount":4},"100648970","phase-2-multimodal-ablation-combined-with-perioperative-tislelizumab-and-chemotherapy-for-resectable-ii-iiib-nsclc-100648970","NCT07729670","Multimodal Ablation Combined With Perioperative Tislelizumab and Chemotherapy for Resectable II-IIIB NSCLC","Inclusion Criteria:\n\n* Age \\>= 18 years, either gender;\n* Pathologically confirmed stage II-IIIB (N2) squamous or non-squamous non-small cell lung cancer (NSCLC) according to the 9th edition of the AJCC\u002FUICC NSCLC staging system;\n* Presence of lesions suitable for ablation therapy confirmed by imaging evaluation;\n* Evaluated as resectable with R0 resection before enrollment, and consent to undergo radical surgical resection;\n* ECOG performance status score of 0-1;\n* Eligible for platinum-based doublet chemotherapy;\n* Adequate cardiopulmonary function to meet the requirements of curative surgical resection;\n* Sufficient organ function confirmed by laboratory tests within 28 days before enrollment:\n\n  * Blood routine: WBC \\>= 3.0×10\\^9\u002FL; ANC \\>= 1.5×10\\^9\u002FL; PLT \\>= 100×10\\^9\u002FL; HGB \\>= 90 g\u002FL.\n  * Liver function: AST \\\u003C= 5.0×ULN; ALT \\\u003C= 5.0×ULN; TBIL \\\u003C= 1.5×ULN;\n  * Renal function: Cr \\\u003C= 1.5×ULN;\n  * For patients receiving cisplatin: creatinine clearance \\>= 60 mL\u002Fmin.\n  * For patients receiving carboplatin: creatinine clearance \\>= 45 mL\u002Fmin.\n  * Coagulation function: INR \\\u003C= 1.5×ULN (\\\u003C=3×ULN for patients on anticoagulants; anticoagulants must be discontinued for one week before ablation); APTT \\\u003C= 1.5×ULN;\n* Fully understand the study and voluntarily sign the informed consent form (ICF).\n\nExclusion Criteria:\n\n* Tumor is adjacent to the hilum, invades major blood vessels, or has contraindications for surgery;\n* History of interstitial lung disease, non-infectious pneumonia, or uncontrolled pulmonary diseases including pulmonary fibrosis and acute lung disease;\n* Previous allogeneic stem cell transplantation or organ transplantation;\n* Previous radiotherapy or chemotherapy;\n* Previous local treatment (e.g., radioactive seed implantation, ablation) for the target ablation lesion;\n* Previous treatment with immune checkpoint inhibitors, including but not limited to anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies;\n* Complicated with severe cardiac, pulmonary, hepatic, renal insufficiency, or coagulation disorders;\n* Clinically significant cardio-cerebrovascular diseases, including but not limited to acute myocardial infarction within 6 months before enrollment, heart failure of NYHA class III or IV, ventricular arrhythmia ≥ grade 2, any history of cerebrovascular accident;\n* Underwent any major surgical procedure requiring general anesthesia within 28 days before enrollment;\n* Previous severe immune system diseases or active infection;\n* Pregnant or lactating female;\n* Complicated with other malignancies (un cured within 5 years);\n* Confirmed positive EGFR or ALK driver genes by genetic testing;\n* Any condition requiring systemic therapy with corticosteroids (\\>10 mg prednisone per day or equivalent) or other immunosuppressive drugs before enrollment;\n* Severe chronic or active infection requiring systemic antibacterial, antifungal, or antiviral therapy, including tuberculosis;\n* Known history of HIV infection;\n* Untreated chronic hepatitis B patients, chronic hepatitis B virus (HBV) carriers with HBV DNA ≥ 500 IU\u002FmL, or active hepatitis C virus (HCV) patients; (Note: Inactive hepatitis B surface antigen carriers, treated and stable hepatitis B patients (HBV DNA \\\u003C 500 IU\u002FmL), and cured hepatitis C patients are eligible.);\n* Received live vaccine within 28 days before enrollment;\n* Simultaneously participating in another therapeutic clinical study;\n* Other conditions considered unsuitable for participation in this study by the investigator.",{"count":546,"type":21},42,[51],"This is a prospective, open-label, single-center, single-arm phase II clinical trial evaluating the efficacy and safety of multimodal ablation in combination with perioperative tislelizumab and chemotherapy in patients with pathologically confirmed resectable stage II-IIIB (N2) non-small cell lung cancer (NSCLC).",[27],"2026-07-23",{"date":552,"type":32},"2026-07-27",{"date":554,"type":21},"2026-06",{"date":556,"type":21},"2031-06",{"name":558,"class":62},"Cancer Institute and Hospital, Chinese Academy of Medical Sciences",{"id":560,"slug":561,"hasResults":12,"nctId":562,"briefTitle":563,"officialTitle":564,"acronym":4,"eligibilityCriteria":565,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":566,"enrollmentInfo":567,"targetDuration":4,"studyType":22,"phases":569,"briefSummary":570,"conditions":571,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":574,"lastUpdatePostDateStruct":575,"startDateStruct":576,"completionDateStruct":578,"leadSponsor":580,"locationsCount":40},"100572814","phase-2-the-efficacy-and-safety-of-narlumosbart-in-combination-with-stereotactic-body-radiation-therapy-to-improve-the-efficacy-of-first-line-chemotherapy-combined-with-immunotherapy-in-patients-with-bone-metastases-from-advanced-non-small-cell-lung-cancer-100572814","NCT06738160","The Efficacy and Safety of Narlumosbart in Combination With Stereotactic Body Radiation Therapy to Improve the Efficacy of First-line Chemotherapy Combined With Immunotherapy in Patients With Bone Metastases From Advanced Non-small Cell Lung Cancer","Efficacy and Safety of Narlumosbart in Combination With Stereotactic Body Radiation Therapy Followed by First-line Chemotherapy Combined With Immunotherapy in Advanced Driver Gene-negative Non-small Cell Lung Cancer Patients With Bone Metastases: A Phase II, Single-arm, Single-center Clinical Trial Protocol","Inclusion Criteria:\n\n* Signed informed consent prior to the implementation of any trial-related procedures;\n* Age 18-80 years old;\n* Histologically or cytologically confirmed stage IV NSCLC according to the TNM Classification of Malignant Tumours, 9th edition；\n* Histologically confirmed bone metastases requiring local radiotherapy；\n* Patients who have not undergone systemic drug therapy for lung cancer (including chemotherapy, targeting, immunotherapy, etc.);\n* Driver genes (EGFR, ALK, ROS-1) negative in adenocarcinoma patients (genetic testing not required for squamous cell carcinoma) ;\n* At least one evaluable non-bone lesion (refer to RECIST1.1);\n* Bone metastases other than the lesions to be radiotherapy do not require local treatment (surgery or radiotherapy) intervention after evaluation;\n* ECOG score 0-1 points;\n* Expected survival time \\> 3 months;\n* Adequate organ function, defined as meeting all of the following laboratory criteria within 14 days prior to enrollment: 1) ANC ≥1.5×10⁹\u002FL (no G-CSF); 2) Platelets ≥100×10⁹\u002FL (no transfusion); 3) Haemoglobin ≥9 g\u002FdL (no transfusion\u002FEPO); 4) Bilirubin ≤1.5×ULN; 5) AST\u002FALT ≤2.5×ULN (≤5×ULN if liver metastases); 6) Creatinine ≤1.5×ULN or CrCl ≥60 mL\u002Fmin; 7) INR\u002FPT ≤1.5×ULN; 8) TSH within normal limits (or FT3\u002FFT4 normal if TSH abnormal); 9) Cardiac enzymes (troponin I, CK-MB) ≤ ULN (isolated abnormalities not clinically significant are permitted).\n\nExclusion Criteria:\n\n* The pathology is small cell lung cancer (SCLC), including lung cancer mixed with SCLC and NSCLC;\n* The lesion is an isolated lesion and can be treated radically;\n* Patients who need surgical treatment after the evaluation of the study are not allowed to enroll;\n* The radiotherapy lesion to be treated has been treated with radiotherapy or the lesion to be treated cannot be treated with radiotherapy after evaluation;\n* Presence of active brain metastases;\n* Other malignancies within 5 years (except cured non-melanoma skin cancer or carcinoma in situ);\n* Prior treatment with anti-PD-1, anti-PD-L1, or RANKL-targeting agents;or used investigational device treatment within 4 weeks prior to the first dose;\n* Active autoimmune disease requiring systemic therapy;\n* Presence of clinically uncontrollable pleural effusion\u002Fascites effusion (subjects who do not need to drain the effusion or stop draining for 3 days without significant increase in effusion can be enrolled);\n* Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation;\n* Presence of active bone metabolism disease (Paget bone disease, Cushing's syndrome, and hyperprolactinemia), rheumatoid arthritis, uncontrolled hyper\u002Fhypothyroidism, hyperparathyroidism\u002Fhypoparathyroidism;\n* Those who are known to be allergic to the active ingredients or excipients such as sintilimab, pemetrexed, nalusopaimab, carboplatin, cisplatin, paclitaxel, etc., of the drug in this study;\n* Have not recovered adequately from toxicity and\u002For complications induced by any of the interventions (i.e., ≤ grade 1 or to baseline, excluding fatigue or alopecia, prior to initiation of treatment);\n* Known history of human immunodeficiency virus (HIV) infection (i.e., HIV 1\u002F2 antibody positive);\n* Untreated active hepatitis B (defined as HBsAg positive and HBV-DNA copy number detected at the same time greater than the upper limit of normal in the laboratory department of the research center);\n* Hypocalcemia cannot be improved after treatment;\n* Previous or current osteomyelitis or osteonecrosis of the jaw; Dental surgery or oral surgery that does not heal; Acute dental or jaw disease requiring oral surgery; Those who plan to undergo invasive dental surgery during the study;\n* Use of any of the following anti-bone metabolizing agents within 6 months prior to enrollment: Parathyroid hormone (PTH) or derivatives; Calcitonin; Osteoprotein; Vaccination with a live vaccine within 30 days prior to the first dose (Cycle 1, Day 1);\n* Pregnant or lactating women;\n* Presence of any serious or uncontrollable systemic disease, such as:\n\n  1. Resting ECG has major abnormalities in rhythm, conduction or morphology and severe symptoms that are difficult to control, such as complete left bundle branch block, heart block above degree II, ventricular arrhythmia or atrial fibrillation;\n  2. unstable angina, congestive heart failure, New York Heart Association (NYHA) classification ≥ grade 2 chronic heart failure;\n  3. myocardial infarction within 6 months prior to enrollment;\n  4. unsatisfactory blood pressure control;\n  5. History of non-infectious pneumonitis requiring glucocorticoid therapy within 1 year prior to the first dose, or current presence of clinically active interstitial lung disease;\n  6. active tuberculosis;\n  7. Presence of active or uncontrolled infection requiring systemic therapy;\n  8. Presence of clinically active diverticulitis, abdominal abscess, gastrointestinal obstruction;\n  9. Liver diseases such as cirrhosis, decompensated liver disease, acute or chronic active hepatitis;\n  10. poorly controlled diabetes mellitus (fasting blood glucose (FBG) \\>10mmol\u002FL);\n  11. Those whose urine routine showed a urine protein ≥++, and confirmed that the 24-hour urine protein was \\> 1.0 g;\n  12. Subjects with mental disorders who are unable to cooperate with treatment; Medical history or evidence of disease, abnormal treatment or laboratory test values that may interfere with the results of the trial, prevent the subject from participating in the study throughout the study, or other conditions that are considered by the investigator to be unsuitable for enrollment in the opinion of the investigator are not suitable for participation in this study.","80 Years",{"count":568,"type":21},27,[51],"Introduction: Immunotherapy in combination with chemotherapy have been recommended as the first-line treatment of driver-negative advanced non-small cell lung cancer (NSCLC), but the efficacy is worse in NSCLC patients with bone metastases due to the immunosuppressive microenvironment. Studies have shown that not only the nuclear factor kappa-B ligand (RANKL) inhibitors but also Stereotactic Body Radiation Therapy (SBRT) play a significant role in improving the tumor immune microenvironment. Therefore, narlumosbart，a monoclonal antibody (mAb) targeting RANKL，in combination with SBRT may have synergistic effects and improve efficacy of immunotherapy and chemotherapy in driver-negative advanced NSCLC patients with bone metastases.\n\nMethods: This single-arm, single-center phase II clinical trial will enroll NSCLC patients with bone metastases who have not received any systemic therapy. Patients will receive narlumosbart and bone target lesion SBRT in combination with first-line treatment immunotherapy and chemotherapy after screening eligible subjects. Narlumosbart, 120mg\u002Ftime, subcutaneous injection, will be administered every 4 weeks. For the treatment of SBRT for bone metastases, the dose of 24Gy\u002F3F is used for spinal metastases, and 30Gy\u002F5F or 35Gy\u002F5F is used for non-spinal lesions. Chemotherapy combined with immune checkpoint inhibitor therapy will be used in accordance with the guidelines. The primary endpoint is to assess the objective response rate of NSCLC patients with bone metastases from narlumosbart combined with SBRT and first-line chemotherapy and immunotherapy. The secondary endpoints include safety and tolerability, progression-free survival, overall survival, bone-related events, pain score, and quality of life. Sample size was calculated using the Simon's Two-Stage method. 9 patients will be enrolled in the first stage. If ≥ 2 patients achieve CR\u002FPR, the second stage of enrollment will be performed. If fewer than 2 patients achieve CR\u002FPR, the trial will be terminated. In the second phase, 15 patients will be enrolled. 27 subjects will be enrolled in this project, considering the dropout rate of 10%.\n\nWangjun Yan AND Zhengfei Zhu are the Co-Principal Investigators of this study.",[27,572,573],"Stereotactic Body Radiation Therapy (SBRT)","Immunotherapy","2026-07-21",{"date":550,"type":32},{"date":577,"type":32},"2025-02-15",{"date":579,"type":21},"2028-12-30",{"name":581,"class":62},"Fudan University",{"id":583,"slug":584,"hasResults":12,"nctId":585,"briefTitle":586,"officialTitle":587,"acronym":4,"eligibilityCriteria":588,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":589,"targetDuration":4,"studyType":22,"phases":591,"briefSummary":593,"conditions":594,"keywords":597,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":607,"lastUpdatePostDateStruct":608,"startDateStruct":610,"completionDateStruct":611,"leadSponsor":613,"locationsCount":40},"100644477","early-phase-1-imaging-study-in-metastatic-uc-hr-and-her2--breast-cancer-tnbc-and-nsclc-100644477","NCT07671092","Imaging Study in Metastatic UC, HR+ and HER2- Breast Cancer, TNBC, and NSCLC","A Phase 0 Imaging Study to Assess the Feasibility, Biodistribution, and Dosimetry of the Imaging Agent in Metastatic Urothelial Cancer (UC), Hormone Receptor-Positive (HR+) and Human Epidermal Growth Factor Receptor 2-Negative (HER2-) Breast Cancer, Triple-Negative Breast Cancer (TNBC), and Non-Small-Cell Lung Cancer (NSCLC)","Inclusion Criteria:\n\n* Are at least 18 years old at the time of signing the informed consent form (ICF)\n* Have biopsy proven metastatic UC, HR+ and HER2- breast cancer, TNBC, or NSCLC\n\nExclusion Criteria:\n\n* For Women of Childbearing Potential: Are pregnant or breastfeeding\n\nNote: Additional criteria may apply and will be assessed by the study site",{"count":590,"type":21},40,[592],"EARLY_PHASE1","This imaging study aims to assess the feasibility, biodistribution, and dosimetry of the imaging agent in subjects with metastatic UC, HR+ and HER2- breast cancer, TNBC, or NSCLC.",[595,305,225,596,27],"Metastatic Urothelial Carcinoma","Hormone Receptor Positive HER-2 Negative Breast Cancer",[598,599,305,600,314,315,601,602,603,604,605,606],"HR+","HER2-","Non Small Cell Lung Cancer","RayzeBio","Rayze","BMS","Bristol Myers Squibb","RPT","Imaging Agent","2026-07-14",{"date":609,"type":32},"2026-07-16",{"date":554,"type":21},{"date":612,"type":21},"2027-10",{"name":614,"class":39},"RayzeBio, Inc.",{"id":616,"slug":617,"hasResults":12,"nctId":618,"briefTitle":619,"officialTitle":620,"acronym":4,"eligibilityCriteria":621,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":622,"targetDuration":4,"studyType":22,"phases":624,"briefSummary":625,"conditions":626,"keywords":631,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":633,"lastUpdatePostDateStruct":634,"startDateStruct":636,"completionDateStruct":638,"leadSponsor":640,"locationsCount":502},"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":623,"type":21},574,[131],"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.",[492,493,627,628,629,226,27,630,100,223],"Pancreatic Adenocarcinoma","Pancreatic Ductal Adenocarcinoma (PDAC)","PDAC","Pancreatic Cancer",[223,630,632,629,304,226,110,76,27,105,106,109],"Pancreatic Ductal Adenocarcinoma","2026-07-08",{"date":635,"type":32},"2026-07-10",{"date":637,"type":32},"2026-01-08",{"date":639,"type":21},"2028-10",{"name":120,"class":39},{"id":642,"slug":643,"hasResults":12,"nctId":644,"briefTitle":645,"officialTitle":646,"acronym":4,"eligibilityCriteria":647,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":47,"enrollmentInfo":648,"targetDuration":4,"studyType":22,"phases":650,"briefSummary":651,"conditions":652,"keywords":653,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":656,"lastUpdatePostDateStruct":657,"startDateStruct":659,"completionDateStruct":661,"leadSponsor":663,"locationsCount":40},"100643885","phase-2-skb264-plus-glecirasib-in-advanced-kras-g12c-mutant-nsclc-a-phase-ii-study-100643885","NCT07670013","SKB264 Plus Glecirasib in Advanced KRAS G12C-Mutant NSCLC: A Phase II Study","A Multicenter, Single-Arm, Phase II (Simon Two-Stage) Study of Sacituzumab Tirumotecan (SKB264) Plus Glecirasib (KRAS G12C Inhibitor) as First-Line Treatment for KRAS G12C-Mutated Advanced NSCLC","Inclusion Criteria:\n\n* Voluntarily participate in the study and sign the informed consent form (ICF).\n* Male or female subjects aged ≥18 years and ≤75 years at the time of signing the ICF.\n* Expected survival time of ≥3 months.\n* Histologically or cytologically confirmed non-squamous non-small cell lung cancer (NSCLC) with unresectable locally advanced stage (Stage ⅢB\u002FⅢC), metastatic or recurrent stage (Stage Ⅳ) that is not eligible for radical concurrent chemoradiotherapy, in accordance with the 8th edition of the TNM --Staging System for Lung Cancer by the International Association for the Study of Lung Cancer (IASLC) and the American Joint Committee on Cancer (AJCC).\n\nConfirmed KRAS G12C mutation-positive by a qualified laboratory (CAP\u002FCLIA or nationally accredited) using next-generation sequencing (NGS) or an equivalent method; positivity in either tissue samples or plasma circulating tumor DNA (ctDNA) is acceptable. If plasma testing is negative and tissue testing is feasible, supplementary tissue testing is recommended.\n\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 to 1.\n* Definition for first-line systemic therapy of advanced disease: No prior systemic anti-tumor therapy for metastatic\u002Fadvanced disease. For subjects who previously received radical post-surgical therapy, chemoradiotherapy or immunotherapy alone, enrollment is permitted only if the interval from the last dose to disease recurrence is ≥6 months.\n* Presence of at least one measurable lesion in accordance with the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1; measurable lesions within a prior radiotherapy field or after local treatment may be selected as target lesions if disease progression is documented.\n* Sufficient organ and bone marrow function, including the following:\n\nAdequate hematopoietic function: Absolute neutrophil count (ANC) ≥1.5×10⁹\u002FL, platelet count ≥100×10⁹\u002FL, hemoglobin ≥9 g\u002FdL. No blood transfusion or treatment with granulocyte colony-stimulating factor (G-CSF), thrombopoietin (TPO), erythropoietin (EPO) or other similar agents is allowed within 14 days prior to blood routine testing.\n\n* Adequate liver function: Total bilirubin (TBIL) \\\u003C1.5×upper limit of normal (ULN), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \\\u003C2.5×ULN; for subjects with Gilbert's syndrome, TBIL \\\u003C2×ULN is acceptable; for subjects with liver metastases from tumor, AST and ALT \\\u003C5.0×ULN is required; for subjects with extrahepatic obstruction confirmed by direct bilirubin (DBIL) testing, TBIL \\\u003C3.0×ULN is permitted.\n* Adequate renal function: Serum creatinine (Cr) ≤1.5×ULN, or if Cr \\>1.5×ULN, creatinine clearance (CrCl) ≥60 mL\u002Fmin calculated by the Cockcroft-Gault formula.\n* Adequate coagulation function: Prothrombin time (PT)\u002Factivated partial thromboplastin time (APTT) \\\u003C1.5×ULN, and international normalized ratio (INR) \\\u003C1.5 or within the target range for anticoagulant therapy.\n\nSerum magnesium level within the normal range.\n\n* Toxic effects from prior anti-tumor therapy must have recovered to baseline levels (excluding residual alopecia) or grade ≤1 at enrollment (grade ≤2 neurotoxicity is acceptable). For immune-related adverse events (irAEs) involving the endocrine system caused by prior immunotherapy (e.g., immune-related hypothyroidism), subjects with well-controlled symptoms under stable-dose hormone replacement therapy or physiological-dose corticosteroid therapy may be enrolled if the investigator assesses that the treatment does not interfere with the administration of study drugs and safety evaluation.\n* Female subjects of childbearing potential and male subjects whose partners are of childbearing potential must adopt effective contraceptive measures from the time of signing the ICF until 6 months after the last dose of study drug. Female subjects of childbearing potential must have a negative blood pregnancy test result within 7 days (inclusive) prior to the first dose of study drug. If a urine pregnancy test result is inconclusive, a blood pregnancy test is required.\n* The investigator judges that the subject is capable of effective communication, complying with scheduled follow-up visits and completing the study in accordance with the protocol requirements.\n\nExclusion Criteria:\n\n* Prior treatment with a KRAS G12C inhibitor or TROP2-ADC; any prior systemic anti-tumor therapy (chemotherapy, immunotherapy, targeted therapy, etc.) for advanced non-small cell lung cancer (NSCLC).\n* Positive for other clinically approved first-line targetable oncogenic drivers: classic sensitizing EGFR mutations (19del\u002FL858R), ALK\u002FROS1\u002FRET\u002FNTRK fusions, BRAF V600E mutation, MET exon 14 skipping mutation, and other mutations for which guideline-recommended approved first-line targeted therapies are available (to avoid conflict with current standard of care); concurrent mutations such as KRAS combined with STK11\u002FKEAP1 are not exclusion criteria.\n* Histologically or cytologically confirmed mixed NSCLC with small cell carcinoma components or predominantly squamous cell carcinoma components.\n* Significant cardiovascular and cerebrovascular diseases, including:\n\nA confirmed major cardiovascular adverse event within 6 months, such as myocardial infarction, angina pectoris, heart failure, severe arrhythmia, or receipt of angioplasty, vascular stenting, coronary artery bypass grafting, or other similar procedures; -Clinically significant prolonged QT\u002FQTcF interval on electrocardiogram (QTcF \\>470 ms in females or QTcF \\>450 ms in males); A confirmed major cerebrovascular adverse event within 3 months, such as intracerebral hemorrhage or cerebral infarction.\n\nUncontrolled central nervous system (CNS) disease: active CNS metastases requiring urgent local therapy; meningeal carcinomatosis.\n\n-Interstitial lung disease (ILD)\u002Fdrug-induced pneumonitis: active ILD\u002Fpneumonitis or a history of ILD\u002Fpneumonitis requiring systemic corticosteroid therapy; baseline chest imaging showing active ILD-like changes.",{"count":649,"type":21},43,[51],"This is a multicenter, single-arm, phase II (Simon two-stage) prospective interventional clinical study. The primary objective is to evaluate the efficacy and safety of SKB264 in combination with Glecirasib (a KRAS G12C inhibitor) as first-line treatment in patients with KRAS G12C-mutated locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC). Specifically, the primary endpoint is the objective response rate (ORR) assessed by investigators per RECIST 1.1 to verify the core antitumor activity of the combination regimen. Secondary objectives include comprehensive evaluation of overall efficacy via disease control rate (DCR), duration of response (DoR), time to response (TTR), progression-free survival (PFS), and overall survival (OS). Safety will be monitored in accordance with NCI CTCAE 5.0, including the incidence and severity of adverse events (AEs) and serious adverse events (SAEs), to characterize the safety profile of the combination and the feasibility of dose modifications. This study aims to provide scientific evidence for the use of this combination regimen as first-line therapy for KRAS G12C-mutated advanced NSCLC and to explore a more optimal treatment option for this patient population.",[27],[654,655],"SBK264","Goleirex","2026-07-03",{"date":658,"type":32},"2026-07-07",{"date":660,"type":32},"2026-04-01",{"date":662,"type":21},"2028-06",{"name":664,"class":62},"Second Affiliated Hospital, School of Medicine, Zhejiang University",{"id":666,"slug":667,"hasResults":12,"nctId":668,"briefTitle":669,"officialTitle":669,"acronym":670,"eligibilityCriteria":671,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":47,"enrollmentInfo":672,"targetDuration":4,"studyType":22,"phases":674,"briefSummary":675,"conditions":676,"keywords":4,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":677,"lastUpdatePostDateStruct":678,"startDateStruct":680,"completionDateStruct":682,"leadSponsor":684,"locationsCount":40},"100646242","phase-1-a-phase-ib-study-of-tislelizumab-plus-sys6010-in-immunotherapy-pretreated-locally-advanced-or-metastatic-nsclc-100646242","NCT07692048","A Phase Ib Study of Tislelizumab Plus SYS6010 in Immunotherapy-Pretreated Locally Advanced or Metastatic NSCLC","SYS6010","Inclusion Criteria:\n\n* Subjects must meet all of the following inclusion criteria to be eligible for enrollment in this study:\n\nHave histologically or cytologically confirmed locally advanced or metastatic NSCLC that is not amenable to curative surgery or radiotherapy.\n\nHave no known EGFR mutations, ALK rearrangements, or ROS1 rearrangements.\n\nHave experienced radiographic disease progression per RECIST v1.1 after prior treatment with an anti-PD-(L)1 antibody for locally advanced or metastatic NSCLC, with prior therapy including:\n\nProgression on anti-PD-(L)1 antibody combined with platinum-based chemotherapy (second-line); or\n\nProgression on platinum-based chemotherapy following prior anti-PD-(L)1 monotherapy (third-line); or\n\nProgression on anti-PD-(L)1 monotherapy and considered unfit for platinum-based chemotherapy (second-line); or\n\nProgression on anti-PD-(L)1-containing therapy following prior platinum-based chemotherapy (third-line).\n\na. Adjuvant or neoadjuvant therapy is counted as one prior line of therapy if the time between the last dose of chemotherapy and tumour recurrence is ≤ 6 months.\n\nHave at least one evaluable tumour lesion per RECIST v1.1 (see Appendix 1).\n\nHave an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (see Appendix 2).\n\nHave a life expectancy of ≥ 3 months as assessed by the investigator.\n\nAgree to undergo tumour tissue biopsy before the first study treatment and during the treatment period, whenever clinically feasible.\n\nHave adequate bone marrow, hepatic, renal, and coagulation function confirmed by laboratory tests obtained within 7 days before the first dose (transfusion or growth factor support is not permitted within 2 weeks prior to the screening assessment):\n\nBone marrow function: Absolute neutrophil count ≥ 1.5 × 10⁹\u002FL; platelet count ≥ 100 × 10⁹\u002FL; haemoglobin ≥ 90 g\u002FL.\n\nHepatic function: Total bilirubin ≤ 1.5 × upper limit of normal (ULN) (or ≤ 3 × ULN in the presence of liver metastases); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN (or ≤ 5.0 × ULN in the presence of liver metastases); albumin ≥ 28 g\u002FL.\n\nRenal function: Serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 50 mL\u002Fmin (calculated using the Cockcroft-Gault formula; see Appendix 3).\n\nCoagulation function: International normalised ratio (INR) and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN.\n\nSubjects with chronic hepatitis B virus (HBV) infection must have HBV-DNA \\\u003C 1000 IU\u002FmL and be willing to receive antiviral therapy throughout the study period.\n\nToxicities from prior therapy must have recovered to ≤ Grade 1 (CTCAE v5.0) or to a stable condition per investigator assessment at the time of the first study dose (alopecia and pigmentation excepted).\n\nSubjects of childbearing potential must agree to use highly effective contraceptive methods (including vasectomy, abstinence, etc.; see Appendix 4) throughout the study period (from signing the ICF until 6 months after the last dose of investigational product).\n\nSubjects must be able to communicate well with the investigator and comply with protocol-required follow-up.\n\nExclusion Criteria:\n\n* Inclusion Criteria\n\nSubjects must meet all of the following inclusion criteria to be eligible for enrollment in this study:\n\nHave histologically or cytologically confirmed locally advanced or metastatic NSCLC that is not amenable to curative surgery or radiotherapy.\n\nHave no known EGFR mutations, ALK rearrangements, or ROS1 rearrangements.\n\nHave experienced radiographic disease progression per RECIST v1.1 after prior treatment with an anti-PD-(L)1 antibody for locally advanced or metastatic NSCLC, with prior therapy including:\n\nProgression on anti-PD-(L)1 antibody combined with platinum-based chemotherapy (second-line); or\n\nProgression on platinum-based chemotherapy following prior anti-PD-(L)1 monotherapy (third-line); or\n\nProgression on anti-PD-(L)1 monotherapy and considered unfit for platinum-based chemotherapy (second-line); or\n\nProgression on anti-PD-(L)1-containing therapy following prior platinum-based chemotherapy (third-line).\n\na. Adjuvant or neoadjuvant therapy is counted as one prior line of therapy if the time between the last dose of chemotherapy and tumour recurrence is ≤ 6 months.\n\nHave at least one evaluable tumour lesion per RECIST v1.1 (see Appendix 1).\n\nHave an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (see Appendix 2).\n\nHave a life expectancy of ≥ 3 months as assessed by the investigator.\n\nAgree to undergo tumour tissue biopsy before the first study treatment and during the treatment period, whenever clinically feasible.\n\nHave adequate bone marrow, hepatic, renal, and coagulation function confirmed by laboratory tests obtained within 7 days before the first dose (transfusion or growth factor support is not permitted within 2 weeks prior to the screening assessment):\n\nBone marrow function: Absolute neutrophil count ≥ 1.5 × 10⁹\u002FL; platelet count ≥ 100 × 10⁹\u002FL; haemoglobin ≥ 90 g\u002FL.\n\nHepatic function: Total bilirubin ≤ 1.5 × upper limit of normal (ULN) (or ≤ 3 × ULN in the presence of liver metastases); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN (or ≤ 5.0 × ULN in the presence of liver metastases); albumin ≥ 28 g\u002FL.\n\nRenal function: Serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 50 mL\u002Fmin (calculated using the Cockcroft-Gault formula; see Appendix 3).\n\nCoagulation function: International normalised ratio (INR) and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN.\n\nSubjects with chronic hepatitis B virus (HBV) infection must have HBV-DNA \\\u003C 1000 IU\u002FmL and be willing to receive antiviral therapy throughout the study period.\n\nToxicities from prior therapy must have recovered to ≤ Grade 1 (CTCAE v5.0) or to a stable condition per investigator assessment at the time of the first study dose (alopecia and pigmentation excepted).\n\nSubjects of childbearing potential must agree to use highly effective contraceptive methods (including vasectomy, abstinence, etc.; see Appendix 4) throughout the study period (from signing the ICF until 6 months after the last dose of investigational product).\n\nSubjects must be able to communicate well with the investigator and comply with protocol-required follow-up.",{"count":673,"type":21},21,[131],"Introduction: Patients with driver gene-negative non-small cell lung cancer (NSCLC) who experience treatment failure following immune checkpoint inhibitor (ICI) therapy have limited subsequent treatment options, representing an unmet clinical need. EGFR is commonly expressed in EGFR wild-type NSCLC and represents a potential target for therapeutic intervention. Antibody-drug conjugates (ADCs) combine the high targeting specificity of antibodies with the potent cytotoxic effects of payloads. SYS6010 is an EGFR-targeting ADC conjugated to a topoisomerase I inhibitor. Preclinical and clinical studies suggest that the combination of ADCs and ICIs can synergistically enhance anti-tumor efficacy through multiple immunomodulatory mechanisms. Tislelizumab is an approved PD-1 inhibitor for advanced NSCLC. This study aims to evaluate the safety and efficacy of SYS6010 in combination with tislelizumab in patients with driver gene-negative NSCLC who have failed prior PD-1\u002FPD-L1 inhibitor therapy.\n\nMethods: This is an exploratory clinical trial enrolling patients with driver gene-negative NSCLC who have failed prior PD-1 or PD-L1 inhibitor therapy. The primary objective is to evaluate the safety of the combination therapy, with primary endpoints including the incidence, severity, and type of adverse events (AEs) according to NCI-CTCAE v6.0 criteria. Secondary objectives include assessing efficacy (objective response rate \\[ORR\\], disease control rate \\[DCR\\], duration of response \\[DOR\\], progression-free survival \\[PFS\\], overall survival \\[OS\\]) and exploring the association of potential predictive or prognostic biomarkers (e.g., EGFR and PD-L1 expression levels) with response to study treatment.",[27],"2026-07-02",{"date":679,"type":32},"2026-07-09",{"date":681,"type":21},"2026-06-30",{"date":683,"type":21},"2028-12-31",{"name":685,"class":62},"Sichuan University",{"id":687,"slug":688,"hasResults":12,"nctId":689,"briefTitle":690,"officialTitle":691,"acronym":4,"eligibilityCriteria":692,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":693,"targetDuration":4,"studyType":22,"phases":695,"briefSummary":696,"conditions":697,"keywords":4,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":681,"lastUpdatePostDateStruct":702,"startDateStruct":704,"completionDateStruct":706,"leadSponsor":707,"locationsCount":4},"100646924","phase-2-comparative-f-fdg-and-ga-my6349-petct-imaging-for-assessing-trop2-adc-therapeutic-efficacy-in-egfr-tki-resistant-advanced-nsclc-100646924","NCT07685197","Comparative ¹⁸F-FDG and ⁶⁸Ga-MY6349 PET\u002FCT Imaging for Assessing TROP2 ADC Therapeutic Efficacy in EGFR-TKI Resistant Advanced NSCLC","Efficacy Evaluation of TROP2 ADC Therapy in Patients With Advanced\u002FMetastatic NSCLC Resistant to EGFR-TKIs: A Comparative Imaging Study of ¹⁸F-FDG and ⁶⁸Ga-MY6349 PET\u002FCT","Inclusion Criteria:\n\n* Aged ≥18 years at the time of signing the informed consent form, with no restriction on gender.\n* Histologically or cytologically confirmed non-squamous non-small cell lung cancer (NSCLC), classified as locally advanced Stage IIIB\u002FIIIC or metastatic Stage IV NSCLC (per the 8th edition of UICC\u002FAJCC TNM staging system for lung cancer), and not eligible for curative resection and\u002For definitive radiotherapy (with or without concurrent chemotherapy).\n* Presence of EGFR sensitizing mutations (exon 19 deletion or exon 21 L858R point mutation).\n* Subjects who have received first-line third-generation EGFR-TKI therapy with documented treatment failure. For subjects previously treated with third-generation EGFR-TKIs in adjuvant, neoadjuvant or consolidation settings, such TKI therapy will be regarded as first-line treatment for locally advanced or metastatic disease if disease progression occurs within ≤6 months after the last dose.\n* At least one measurable lesion as defined by RECIST v1.1; previously irradiated lesions shall not be selected as target lesions. Subjects with only cutaneous or osseous lesions are not eligible for enrollment.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days prior to study drug administration.\n* Estimated life expectancy ≥12 weeks.\n* Adequate organ and bone marrow function (no blood transfusion, recombinant thrombopoietin or colony-stimulating factor administered within 2 weeks before dosing), defined as follows:\n\n  1. Hematology: Absolute neutrophil count (NEUT#) ≥1.5×10⁹\u002FL; platelets (PLT) ≥100×10⁹\u002FL; hemoglobin ≥90 g\u002FL.\n  2. Hepatic function: Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5×ULN; total bilirubin (TBIL) ≤1.5×ULN; albumin ≥30 g\u002FL. For subjects with hepatic metastases at baseline, ALT and AST ≤5×ULN, TBIL ≤3×ULN.\n  3. Renal function: Creatinine clearance ≥50 mL\u002Fmin (calculated using the standard Cockcroft-Gault formula).\n  4. Coagulation function: International normalized ratio (INR), activated partial thromboplastin time (APTT) and prothrombin time (PT) ≤1.5×ULN.\n* Females of childbearing potential and male subjects whose partners are of childbearing potential must agree to use effective medical contraception from the date of informed consent signature through 6 months after the last study drug administration.\n* The subject voluntarily participates in this study, signs the informed consent form, and is able to comply with all protocol-specified visits and relevant procedures.\n\nExclusion Criteria:\n\n* Tumor histology or cytology confirms mixed components including small cell lung cancer, neuroendocrine carcinoma, carcinosarcoma, or squamous cell carcinoma.\n* Subjects with known leptomeningeal metastases, brainstem metastases, spinal cord metastases\u002Fcompression, or symptomatic unstable central nervous system (CNS) metastases are excluded unless they are off steroid therapy and maintain stable neurological status for at least two weeks after completion of definitive radiotherapy and steroid tapering.\n* Prior systemic anti-tumor therapy for locally advanced or metastatic non-squamous NSCLC other than third-generation EGFR-TKIs (e.g., chemotherapy, immunotherapy).\n* Previous treatment with any TROP2-targeted agents or therapeutics containing topoisomerase I inhibitors, including antibody-drug conjugates (ADCs), whether administered in adjuvant, neoadjuvant, or metastatic disease settings.\n* Thoracic radiotherapy with a cumulative dose \\>30 Gy delivered within 6 months prior to the first dose; non-thoracic or extended-field radiotherapy with a cumulative dose \\>30 Gy administered within 4 weeks prior to the first dose. Palliative radiotherapy for symptom control is permitted only if completed at least 2 weeks before study drug initiation.\n* History of another primary malignant tumor within 3 years before the first dose, excluding malignancies cured by local therapy such as basal cell carcinoma of the skin, cutaneous squamous cell carcinoma, and cervical carcinoma in situ.\n* Presence of any of the following cardiovascular or cerebrovascular diseases or risk factors:\n\n  1. Myocardial infarction, unstable angina, acute or persistent myocardial ischemia, New York Heart Association (NYHA) Class III\u002FIV heart failure, symptomatic or poorly controlled severe arrhythmia, cerebrovascular accident, transient ischemic attack, or other severe cardiovascular\u002Fcerebrovascular events within 6 months before dosing.\n  2. Medical history of myocarditis, primary cardiomyopathy, or specific cardiomyopathies.\n  3. Deep vein thrombosis, peripheral arterial thromboembolism, pulmonary embolism, or other severe thromboembolic events within 3 months prior to dosing (subjects may be enrolled if stably treated with low-molecular-weight heparin or equivalent anticoagulants for ≥2 weeks).\n  4. Life-threatening major vascular diseases including aortic aneurysm or aortic dissection requiring surgical intervention within 6 months before dosing.\n  5. Corrected QT interval (QTcF) \\>470 ms.\n* Uncontrolled systemic diseases as judged by the investigator:\n\n  1. Poorly controlled diabetes mellitus (two consecutive fasting blood glucose readings ≥10 mmol\u002FL).\n  2. Uncontrolled hypertension (systolic blood pressure \\>160 mmHg and\u002For diastolic blood pressure \\>100 mmHg).\n  3. Clinically symptomatic pleural effusion, pericardial effusion, or ascites requiring repeated drainage more than once per week.\n* History of steroid-dependent non-infectious interstitial lung disease (ILD) or non-infectious pneumonitis; active ILD or non-infectious pneumonitis at screening; or suspicious ILD\u002Fpneumonitis that cannot be ruled out by screening imaging.\n* Documented severe dry eye syndrome, severe meibomian gland disease and\u002For blepharitis, or history of severe corneal disorders that hinder or delay corneal wound healing.\n* Clinically significant severe pulmonary impairment secondary to concurrent lung disorders, including but not limited to underlying lung diseases (e.g., severe asthma, advanced chronic obstructive pulmonary disease, restrictive lung disease within 3 months prior to dosing); autoimmune, connective tissue, or inflammatory disorders with pulmonary involvement (rheumatoid arthritis, Sjögren's syndrome, sarcoidosis, etc.); or prior pneumonectomy.\n* Active chronic inflammatory bowel disease, gastrointestinal obstruction, severe ulceration, gastrointestinal perforation, intra-abdominal abscess, or acute gastrointestinal hemorrhage.\n* Active gastrointestinal disorders or other conditions that substantially alter the absorption, distribution, metabolism, or excretion of oral study drugs (e.g., refractory nausea and vomiting, chronic gastrointestinal disease, inability to swallow oral medication, history of extensive intestinal resection).\n* Risk of esophagotracheal or esophagopleural fistula; tumor invasion or compression of vital adjacent organs and vessels (heart, esophagus, superior vena cava, etc.) accompanied by relevant clinical manifestations such as superior vena cava syndrome.\n* Toxicities from prior anti-tumor therapy that have not resolved to Grade ≤1 per NCI CTCAE v5.0 or the thresholds specified in eligibility criteria (alopecia, fatigue, and other toxicities judged low-risk by the investigator are exempted).\n* Severe infection occurring within 4 weeks before dosing, including but not limited to complications requiring hospitalization, sepsis, or severe pneumonia; active infection requiring systemic antimicrobial therapy within 2 weeks before dosing.\n* Confirmed active pulmonary tuberculosis. Subjects with suspected active tuberculosis must undergo clinical examinations to rule out infection before enrollment.\n* Active hepatitis B (HBsAg-positive with HBV-DNA ≥500 IU\u002FmL or above the lower limit of quantification, whichever is higher); active hepatitis C (anti-HCV positive with HCV-RNA above the lower limit of quantification); or concurrent HBV and HCV co-infection.\n* Positive human immunodeficiency virus (HIV) serology or history of acquired immunodeficiency syndrome (AIDS); known active syphilis infection.\n* History of allogeneic solid organ transplantation or allogeneic hematopoietic stem cell transplantation.\n* Major surgery performed within 4 weeks prior to dosing or major surgery planned during study participation.\n* Known hypersensitivity to the study drug or any of its excipients (including polysorbate 20); history of severe hypersensitivity reactions to other biologic agents.\n* Non-specific immunomodulatory therapy (including but not limited to interferon, IL-2) or proprietary Chinese medicines with approved anti-tumor indications administered within 2 weeks before dosing.\n* Current use (or inability to discontinue prior to the first study dose) of drugs or herbal supplements that are strong cytochrome P450 (CYP) 3A4 inducers, with a minimum 3-week washout period required. All subjects shall avoid concomitant use of any CYP3A4-inducing medications, herbal supplements, and\u002For relevant foods throughout the study.\n* Live vaccine administered within 30 days before dosing or planned live vaccination during study participation.\n* Rapid clinical deterioration during screening, such as marked decline in performance status.\n* Pregnant or breastfeeding women.\n* Local or systemic non-malignant diseases, or tumor-induced diseases\u002Fsymptoms that carry high medical risks and\u002For cause uncertainty in survival assessment, such as leukemoid reaction, cachexia, etc.\n* Any medical condition that, in the investigator's opinion, may confound the evaluation of the study drug, compromise subject safety, interfere with the interpretation of study results, or render the subject unsuitable for trial participation.",{"count":694,"type":21},100,[51],"The primary objective is to evaluate the correlation between ⁶⁸Ga-MY6349 PET\u002FCT-derived metrics reflecting tumoral TROP2 expression activity (including SUVmax, SUVmean, MTV, TLG, etc.) and progression-free survival (PFS) assessed per RECIST v1.1. This study plans to enroll 100 EGFR-mutant patients with advanced non-small cell lung cancer (NSCLC) who have developed resistance following first-line therapy with third-generation EGFR-TKIs.\n\nScreening assessments will be completed within 28 days after patients sign the informed consent form. Eligible subjects will undergo a baseline ⁶⁸Ga-MY6349 PET\u002FCT scan prior to study drug administration, with imaging coverage from mid-thighs to the vertex of the skull. All subjects will receive a ¹⁸F-FDG PET\u002FCT scan within 14 days after the ⁶⁸Ga-MY6349 PET\u002FCT. For patients who have undergone ¹⁸F-FDG PET\u002FCT within 14 days before the ⁶⁸Ga-MY6349 scan, the existing imaging data can be used for diagnostic performance evaluation, and repeat ¹⁸F-FDG PET\u002FCT is not required.\n\nSubsequently, subjects will receive monotherapy with sacituzumab govitecan at a dose of 5 mg\u002Fkg via intravenous infusion (IV) on Day 1 of each cycle, administered every 2 weeks (Q2W). Treatment will continue until investigator-confirmed radiological disease progression, intolerable adverse toxicity, voluntary treatment discontinuation by the subject, or any other protocol-specified treatment discontinuation criterion, whichever occurs first.\n\nAt 3 months after initiation of sacituzumab govitecan treatment, subjects will repeat the ⁶⁸Ga-MY6349 PET\u002FCT scan (coverage: mid-thighs to vertex), followed by a ¹⁸F-FDG PET\u002FCT examination within 14 days thereafter.\n\nEligible subjects will receive regular tumor assessments in accordance with RECIST v1.1. Within 48 weeks after the first dose, imaging-based tumor assessments will be performed every 6 weeks (±7 days). At Week 12 (±1 week), paired ⁶⁸Ga-MY6349 and ¹⁸F-FDG PET\u002FCT scans will be conducted without routine diagnostic CT. After Week 48, tumor assessments will be scheduled every 12 weeks (±7 days) until radiological disease progression, initiation of subsequent anti-tumor therapy, withdrawal of informed consent, loss to follow-up, death, or study termination by the sponsor, whichever comes first. Imaging assessments will follow the predetermined schedule regardless of dose delays or dose modifications.\n\nAfter the first documented complete response (CR) or partial response (PR), response confirmation imaging must be conducted no less than 4 weeks (28 days) later. For subjects discontinuing treatment for reasons other than radiological progression, death or loss to follow-up, if more than 4 weeks have passed since the last imaging evaluation, repeat imaging will be performed at the End-of-Treatment (EOT) visit. Subsequent imaging assessments will be conducted per schedule to the greatest extent feasible until radiological disease progression, initiation of new anti-tumor therapy, consent withdrawal, loss to follow-up, death, or sponsor-initiated study termination, whichever occurs earliest.\n\nAll ⁶⁸Ga-MY6349 PET\u002FCT images will be blindly and independently reviewed by two experienced nuclear medicine physicians who are not involved in this clinical trial (without access to any clinical data) to identify positive NSCLC lesions, as well as lesion location and count. In case of disagreement between the two independent readers regarding the presence of positive lesions, a blinded arbitration review by a senior nuclear medicine expert will be activated, and the arbitrator's reading results will serve as the final conclusion. All ¹⁸F-FDG PET\u002FCT images will undergo single blinded independent review by one nuclear medicine physician.\n\nUpon completion of treatment, all subjects will complete safety follow-up regardless of whether they receive subsequent anti-tumor therapy. Telephone-based survival follow-up visits will be conducted every 3 months (±14 days) after the last dose of study treatment to collect survival status and information on subsequent anti-tumor treatments, until subject withdrawal, loss to follow-up, death, or study closure, whichever occurs first.",[27,698,699,700,701],"EGFR Activating Mutation","EGFR-TKI-resistant Non-Small Cell Lung Cancer","Trop2","PET\u002FCT Imaging",{"date":703,"type":32},"2026-07-06",{"date":705,"type":21},"2026-07",{"date":181,"type":21},{"name":708,"class":62},"Zhou Chengzhi",{"id":710,"slug":711,"hasResults":12,"nctId":712,"briefTitle":713,"officialTitle":713,"acronym":4,"eligibilityCriteria":714,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":715,"targetDuration":4,"studyType":22,"phases":717,"briefSummary":718,"conditions":719,"keywords":720,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":724,"lastUpdatePostDateStruct":725,"startDateStruct":726,"completionDateStruct":728,"leadSponsor":730,"locationsCount":4},"100646897","phase-1-an-open-label-fixed-sequence-phase-i-clinical-trial-to-evaluate-the-effect-of-hs-10504-on-the-pharmacokinetics-of-midazolam-in-patients-with-non-small-cell-lung-cancer-100646897","NCT07685041","An Open-label, Fixed-sequence Phase I Clinical Trial to Evaluate the Effect of HS-10504 on the Pharmacokinetics of Midazolam in Patients With Non-small Cell Lung Cancer","Inclusion Criteria:\n\n1. Histologically or cytologically confirmed locally advanced or metastatic NSCLC\n2. Disease progression or intolerance to prior third-generation EGFR TKI therapy in patients with mNSCLC\n3. Confirmed EGFR mutation positivity in participants before enrollment.\n4. At least one target lesion according to RECIST 1.1\n5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1 with no deterioration in the 2 weeks prior to the first dose\n6. Minimum life expectancy greater than 12 weeks\n7. Female participants of childbearing potential must agree to use appropriate contraception (refer to section 12.5) from the time of signing informed consent until 6 months after the last dose, and should not breastfeed; male participants must agree to use barrier contraception (i.e., condoms) from the time of signing informed consent until 6 months after the last dose\n8. Willing to participate in this clinical trial, understand the study procedures, and be able to provide written informed consent.\n\nExclusion Criteria:\n\n1. Has received or is currently receiving the following treatments:\n\n   1. Prior or current treatment with a fourth-generation EGFR tyrosine kinase inhibitor.\n   2. Use of strong\u002Fmoderate inhibitors or strong\u002Fmoderate inducers of CYP3A4, CYP3A5, CYP2C8, and\u002For CYP2D6, or narrow therapeutic index drugs that are sensitive substrates of CYP3A4, CYP3A5, P-gp, and BCRP within 14 days or 5 half-lives (whichever is longer) prior to the first dose of investigational product; or need to continue these medications during the study period.\n   3. Use of drugs that affect gastric acid secretion or intragastric pH within 7 days prior to the first dose of investigational product.\n   4. Currently receiving treatment with drugs known to prolong the QT interval or that may cause torsade de pointes; or need to continue these medications during the study period\n2. Presence of toxicities from prior anti-tumor therapy that have not resolved to \\\u003C Grade 2 according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.\n3. History of other primary malignancies.\n4. Inadequate bone marrow reserve or hepatic\u002Frenal organ function.\n5. Meets any of the following cardiac criteria:\n\n   1. Mean Fridericia-corrected QT interval (QTcF) \\> 470 msec on resting electrocardiogram (ECG);\n   2. Resting ECG shows any clinically significant rhythm, conduction, or ECG morphological abnormality deemed important by the investigator (e.g., complete left bundle branch block, third-degree atrioventricular block, second-degree atrioventricular block, and PR interval \\> 250 msec, etc.);\n   3. Presence of any factors that increase the risk of QT prolongation or arrhythmic events, such as heart failure, refractory hypokalemia, congenital long QT syndrome, family history of long QT syndrome, unexplained sudden death in a first-degree relative under 40 years of age, or any concomitant medication that prolongs the QT interval;\n   4. Left ventricular ejection fraction (LVEF) \\\u003C 50%.\n6. Severe, uncontrolled, or active cardiovascular disease.\n7. Severe or poorly controlled diabetes mellitus.\n8. Severe or poorly controlled hypertension.\n9. Clinically significant bleeding symptoms or obvious bleeding tendency within 1 month prior to the first dose.\n10. Severe arterial thrombotic event within 3 months prior to the first dose.\n11. Severe infection within 4 weeks prior to the first dose.\n12. Continuous corticosteroid therapy for more than 30 days within 30 days prior to the first dose, or need for long-term corticosteroid therapy, or other acquired or congenital immunodeficiency diseases, or history of organ transplantation\n13. Known active infectious disease.\n14. Clinically severe gastrointestinal abnormalities that may affect drug intake, transport, or absorption.\n15. Hepatic encephalopathy, hepatorenal syndrome, or ≥C (incomplete in original).\n16. Other moderate to severe pulmonary diseases that seriously impair respiratory function and may interfere with the detection or management of drug-related pulmonary toxicity.\n17. Previous history of severe neurological or psychiatric disorders.\n18. Female participants who are pregnant, breastfeeding, or planning to become pregnant during the study period.\n19. History of severe allergies, or hypersensitivity to any component of HS-10504 tablets or midazolam oral solution, or history of hypersensitivity to drugs with a similar chemical structure or of the same class as HS-10504.\n20. History of ventilation difficulty or severe airway obstruction.\n21. Any severe or uncontrolled ocular condition that, in the physician's judgment, may increase the patient's risk; or ocular abnormalities requiring surgery or expected to require surgical treatment during the study period.\n22. Participants who, in the investigator's judgment, may have poor compliance with study procedures and requirements.\n23. In the investigator's judgment, presence of any life-threatening complication.",{"count":716,"type":21},24,[131],"This is an open-label, fixed-sequence Phase I clinical trial to evaluate the effect of HS-10504 on the pharmacokinetics of midazolam (CYP3A4 substrate) in patients with EGFR mutation-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) who have experienced disease progression during or after treatment with EGFR-TKIs.",[27],[721,722,723,27],"Phase I","Drug interaction","HS-10504","2026-06-29",{"date":703,"type":32},{"date":727,"type":21},"2026-06-27",{"date":729,"type":21},"2027-07-20",{"name":731,"class":39},"Jiangsu Hansoh Pharmaceutical Co., Ltd."]