[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"carcinoma-non-small-cell-lung\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:carcinoma-non-small-cell-lung":27},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,79,0,25,[9,46,78,141,166,203,231,254,278,298,318,348,370,389,408,428,450,468,527,556,606,627,656,685,727],{"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":28,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100563996","a-study-of-pembrolizumab-mk-3475-with-or-without-intismeran-autogene-v940-in-participants-with-non-small-cell-lung-cancer-v940-009interpath-009-100563996",false,"NCT06623422","A Study of Pembrolizumab (MK-3475) With or Without Intismeran Autogene (V940) in Participants With Non-small Cell Lung Cancer (V940-009\u002FINTerpath-009)","A Phase 3 Randomized Double-blind Study of Adjuvant Pembrolizumab With or Without V940 in Participants With Resectable Stage II to IIIB (N2) NSCLC Not Achieving pCR After Receiving Neoadjuvant Pembrolizumab With Platinum-based Doublet Chemotherapy (INTerpath-009)","Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Has histologically\u002Fcytologically confirmed diagnosis of previously untreated and pathologically confirmed resectable clinical Stage II, IIIA, or IIIB (N2) non-small cell lung cancer (NSCLC) \\[American Joint Committee on Cancer (AJCC) 8th Edition\\]\n* Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days before the first dose of study intervention\n* Participants who have not achieved a pathological complete response (pCR) following completion of neoadjuvant chemotherapy and pembrolizumab followed by surgery will be eligible\n* Confirmation that epidermal growth factor receptor (EGFR)-directed therapy is not indicated as primary therapy (documentation of absence of tumor-activating EGFR mutations \\[eg, DEL19 or L858R\\])\n* Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on anti-retroviral 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 prior to randomization\n* Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Diagnosis of small cell lung cancer (SCLC) or, for mixed tumors, presence of small cell elements, or has a neuroendocrine tumor with large-cell components, or a sarcomatoid carcinoma, or a pancoast tumor\n* Documentation by local test report indicating presence of anaplastic lymphoma kinase (ALK) gene rearrangements\n* Received prior neoadjuvant therapy for their current NSCLC diagnosis\n* Received prior therapy with an anti-programmed cell death 1 (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 \\[CTLA-4\\], OX-40, CD137)\n* Received prior systemic anticancer therapy including investigational agents other than what is specified in this protocol\n* Received prior treatment with a cancer vaccine\n* Received prior radiotherapy within 2 weeks of start of study intervention, or has radiation-related toxicities, requiring corticosteroids\n* Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention","ALL","18 Years",{"count":20,"type":21},680,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","The goal of this study is to learn if people who receive intismeran autogene and pembrolizumab after surgery are cancer-free longer than people who receive placebo and pembrolizumab. Researchers want to know if giving intismeran autogene and pembrolizumab after surgery can help prevent the cancer from coming back in people with non-small cell lung cancer (NSCLC) whose tumors did not respond completely to treatment before surgery (neoadjuvant treatment).",[27],"Carcinoma, Non-Small-Cell Lung",[29,30,31,32],"Programmed Cell Death-1 (PD1, PD-1)","Programmed Cell Death 1 Ligand 1 (PDL1, PD-L1)","Programmed Cell Death 1 Ligand 2 (PDL2, PD-L2)","Individualized neoantigen therapy (INT)","RECRUITING","2026-08-20",{"date":36,"type":37},"2026-08-21","ACTUAL",{"date":39,"type":37},"2024-10-21",{"date":41,"type":21},"2038-01-26",{"name":43,"class":44},"Merck Sharp & Dohme LLC","INDUSTRY",241,{"id":47,"slug":48,"hasResults":12,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":56,"conditions":57,"keywords":63,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":77},"100610052","phase-3-symbiotic-lung-01--a-study-to-learn-about-the-study-medicine-called-pf-08634404-in-combination-with-chemotherapy-in-adult-participants-with-locally-advanced-or-metastatic-non-small-cell-lung-cancer-100610052","NCT07222566","Symbiotic-Lung-01 : A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Adult Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer","AN INTERVENTIONAL PHASE 3, DOUBLE-BLIND, RANDOMIZED STUDY TO EVALUATE EFFICACY AND SAFETY OF PF-08634404 IN COMBINATION WITH CHEMOTHERAPY VERSUS PEMBROLIZUMAB IN COMBINATION WITH CHEMOTHERAPY IN ADULT PARTICIPANTS WITH LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER","Inclusion Criteria:\n\n* 18 years of age or older at screening.\n* Have pathologically confirmed locally advanced (Stage IIIB\u002FIIIC) or metastatic (Stage IV)squamous or non-squamous NSCLC and not be a candidate for complete surgical resection and curative concurrent\u002Fsequential chemoradiotherapy (according to the 9th edition of the Union for International Cancer Control and American Joint Committee on Cancer lung cancer Tumor, lymph nodes, metastasis (TNM) staging system).\n* Have tumor tissue available, either paraffin block or slides from a core, excisional or fine needle biopsy\n* PD-L1 status available based on local testing results\n* Measurable disease based on RECIST v1.1 per investigator.\n* Eastern Cooperative Oncology Group performance status (ECOG) score of 0 or 1\n* Expected survival ≥12 weeks\n\nExclusion Criteria:\n\n* Participants with known actionable genomic alteration (AGAs), including estimated glomerular filtration rate (EGFR), anaplastic lymphoma kinase (ALK), Repressor of Silencing 1 (ROS1), neurotrophic tyrosine receptor kinase (NTRK), v-raf murine sarcoma viral oncogene homolog B1 (BRAF), rearranged during transfection (RET), and mesenchymal-epithelial transition (MET), for which there are available first-line therapies per local standard-of-care (SOC) are ineligible. Documented negative results for EGFR, ALK, and ROS1 AGAs are required for participants with non-squamous histology.\n* Known active CNS lesions are excluded. Participants with definitively treated brain metastases (surgery and\u002For radiotherapy) may be eligible. Clinically inactive brain metastases of longest diameter \\\u003C 1 cm are permitted.\n* Participants with clinically significant risk of hemorrhage or fistula are excluded.\n* Participants with any history of another malignancy within 3 years before the first dose of study intervention, or any evidence of residual disease from a previously diagnosed malignancy.\n* Unresolved toxicities from prior anti-tumor therapy, that did not recover to NCI CTCAE v5.0 Grade 0 or 1.\n* Known to have a history of a severe allergy to any component of the study intervention, or a history of severe allergic reaction to chimeric or humanized antibody.\n* History of allogeneic organ \u002F hematopoietic stem cell transplantation.\n* Participants with any of the following respiratory conditions:\n* Evidence of noninfectious or drug-induced interstitial lung disease (ILD) or pneumonitis\n* Grade ≥3 pulmonary disease unrelated to underlying malignancy\n* History of uncontrolled comorbidities within 6 months prior to the first dose including uncontrolled cardiac and cerebrovascular conditions, hypertension, diabetes, significant vascular disease or arterial\u002Fsevere venous thromboembolic events.\n* Major surgery \\\u003C 4 weeks or minor surgery \\\u003C 3 days prior to first dose of study intervention.\n* History of severe bleeding tendency or coagulation dysfunction\n* History of esophageal varices, severe ulcers, unhealed wounds, gastrointestinal perforation, abdominal fistula, gastrointestinal obstruction, intra-abdominal abscess, or acute gastrointestinal bleeding within 6 months prior to the first dose.\n* Participants with acute, chronic or symptomatic infections including participants positive for active HIV, hepatitis B virus (HBV), or Hepatitis C virus (HCV).\n* Participants with history of immunodeficiency\n* Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation\u002Fbehavior (in the past 5 years) or laboratory abnormality that may increase the risk of study participation or make the participant inappropriate for the study.\n* Previous systemic anti-tumor therapy including:\n\n  1. Prior systemic therapy, including anti-PD-(L)1 therapy, for locally advanced, unresectable, or metastatic NSCLC.\n  2. Previous treatment with immunotherapy\n  3. Prior radiotherapy \\> 30 Gy to the lung \\\u003C 6 months of first dose of study intervention\n  4. Palliative local therapy \\\u003C 2 weeks before the first dose of study intervention;\n  5. Non-specific immunomodulatory therapy \\\u003C 2 weeks before the first dose.\n  6. Prior systemic anti-angiogenic therapy\n* Prior immune-related AE that led to anti-PD-(L)1 treatment discontinuation, adverse events from prior immunotherapy not improved to Grade 1 before screening, or required treatment with systemic immunosuppressive therapy.\n* Prior and concomitant therapy:\n\n  1. therapeutic oral or parenteral anticoagulants or thrombolytic agents \\\u003C 10 days to the first dose.\n  2. chronic antiplatelet therapy \\\u003C7 days to randomization.\n  3. live or attenuated live vaccine \\\u003C 4 weeks to the first dose.\n  4. current high-dose systemic corticosteroids.\n  5. prohibited concomitant medication(s) \\\u003C 21 days to the first dose.\n* Breastfeeding participants, participants of childbearing potential, and male participants who are unwilling to follow contraceptive measures.",{"count":54,"type":21},1410,[24],"This study is being done to find out if a new medicine called PF-08634404, when given with chemotherapy, works better than the present standard treatment (pembrolizumab with chemotherapy) for adults with a type of lung cancer called non-small cell lung cancer (NSCLC) that is either locally advanced (spread to nearby tissues) or has spread to other parts of the body.\n\nTo join the study, participants must meet the following conditions:\n\n* Be 18 years or older.\n* Have locally advanced (Stage IIIB\u002FIIIC) or metastatic (Stage IV) squamous or non-squamous NSCLC.\n* Is not a candidate for complete surgical resection or curative chemoradiotherapy.\n* Do not have known actionable genomic alterations\n* Be treatment naïve for advanced or metastatic disease\n\nParticipants in this study will be assigned to two different parts of the study depending on their type of tumor: participants with squamous NSCLC will be assigned to Part 1, while participants with non-squamous NSCLC will be assigned to Part 2.\n\nEach participant will be randomly assigned (like a flip of the coin) to one of two treatment groups in a blinded fashion:\n\n* Part 1 - Arm A or Part 2 - Arm C (Experimental Group): Will receive a new study medicine called PF-08634404 along with a kind of chemotherapy specific to the type of tumor.\n* Part 1 - Arm B or Part 2 - Arm D (Control Group): Will receive an approved medicine called pembrolizumab along with a kind of chemotherapy specific to the type of tumor.\n\nParticipants will receive their assigned treatment through intravenous (IV) infusions, which means the medicine is given directly into a vein. The treatment will be given in cycles, participants will receive PF-08634404 or Pembrolizumab in combination with chemotherapy followed by maintenance with either PF-08634404 or Pembrolizumab monotherapy (Part 1) or PF-08634404 or Pembrolizumab in combination with a chemotherapeutic drug (Part 2). Participants will continue receiving treatment if it is helping and not experiencing serious side effects.\n\nThe study will include regular visits for:\n\n* Treatment and health checks: while participant continues receiving treatment.\n* Tests to monitor how cancer responds: every 6 weeks during the first 48 weeks, then every 12 weeks thereafter.",[58,59,27,60,61,62],"Advanced Non-Small Cell Lung Cancer","Non-Small Cell Lung Cancer","Carcinoma, Non-Small-Cell Lung (NSCLC)","Metastatic Non Small Cell Lung Cancer","Lung Cancer",[64,65,66,67],"non-squamous NSCLC","squamous NSCLC","metastatic (Stage IV) squamous or non-squamous NSCLC","Advanced or Metastatic Non-Small Cell Lung Cancer","2026-08-14",{"date":70,"type":37},"2026-08-17",{"date":72,"type":37},"2026-01-06",{"date":74,"type":21},"2032-08-26",{"name":76,"class":44},"Pfizer",440,{"id":79,"slug":80,"hasResults":12,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":12,"sex":17,"minAge":86,"maxAge":4,"enrollmentInfo":87,"targetDuration":4,"studyType":22,"phases":89,"briefSummary":91,"conditions":92,"keywords":113,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":140},"100626796","phase-2-determine-trial-treatment-arm-07-dabrafenib-in-combination-with-trametinib-in-adult-paediatric-and-teenageyoung-adult-patients-with-braf-v600-mutation-positive-cancers-100626796","NCT07440290","DETERMINE Trial Treatment Arm 07: Dabrafenib in Combination With Trametinib in Adult, Paediatric and Teenage\u002FYoung Adult Patients With BRAF V600 Mutation-Positive Cancers.","DETERMINE (Determining Extended Therapeutic Indications for Existing Drugs in Rare Molecularly Defined Indications Using a National Evaluation Platform Trial): An Umbrella-Basket Platform Trial to Evaluate the Efficacy of Targeted Therapies in Rare Adult, Paediatric and Teenage\u002FYoung Adult (TYA) Cancers With Actionable Genomic Alterations, Including Common Cancers With Rare Actionable Alterations. Treatment Arm 07: Dabrafenib in Combination With Trametinib in Adult, Paediatric and TYA Patients With BRAF V600 Mutation-Positive Cancers.","DETERMINE","THE PATIENT MUST FULFIL THE ELIGIBILITY CRITERIA WITHIN THE DETERMINE MASTER PROTOCOL (NCT05722886) AND WITHIN THE TREATMENT ARM 07 (DABRAFENIB AND TRAMETINIB) OUTLINED BELOW\\* \\*When dabrafenib- and trametinib-specific inclusion\u002Fexclusion criteria or precautions below differ from those specified in the Master Protocol, the dabrafenib- and trametinib-specific criteria will take precedence.\n\nInclusion criteria:\n\nA. Confirmed diagnosis of a malignancy harbouring an oncogenic alteration in BRAF V600, including Langerhans cell histiocytosis, using an analytically validated next-generation sequencing method.\n\nB. Patients ≥1 year old and ≥8 kg in body weight.\n\nC. Women of childbearing potential are eligible provided that they meet the following criteria:\n\n• Have a negative serum or urine pregnancy test before enrolment and;\n\n• Agree to use one form of a non-hormonal highly effective contraception method (a method that can achieve a failure rate of \\\u003C1% when used consistently and correctly; the requirement for non-hormonal method is because dabrafenib may decrease the efficacy of oral or any systemic hormonal contraceptives), such as: i. intrauterine device (IUD), ii. bilateral tubal occlusion, bilateral tubal ligation (at least six weeks before taking trial treatment), iii. vasectomised partner, iv. total sexual abstinence. Effective from the first administration of dabrafenib and trametinib (whichever is first), throughout the trial and for two weeks following discontinuation of dabrafenib and for 16 weeks following discontinuation of trametinib (whichever is later).\n\nPatients who are breastfeeding must be willing to discontinue breastfeeding from the start of treatment, throughout the trial and for two weeks following discontinuation of dabrafenib and for 16 weeks following discontinuation of trametinib (whichever is later).\n\nD. Male patients with partners who are women of childbearing potential are eligible provided that they agree to the following, from the first administration of dabrafenib and trametinib (whichever is first), throughout the trial and for two weeks after the last administration of dabrafenib and 16 weeks after the last administration of trametinib (whichever is later):\n\n* Agree to take measures not to father children by using a barrier method of contraception (male condom plus spermicide) or to sexual abstinence.\n* Non-vasectomised male partners with partners who are women of childbearing potential should also be advised of the benefit for their partner of using a highly effective method of contraception, such as:\n\n  i. combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation \\[oral, intravaginal or transdermal\\]), ii. progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable or implantable), iii. IUD, iv. intrauterine hormone-releasing system (IUS), v. bilateral tubal occlusion, vi. total sexual abstinence.\n* Male patients with pregnant or breastfeeding partners must be advised to use barrier method contraception (male condom) to prevent drug exposure of the foetus or neonate, even if vasectomised.\n* Male patients must refrain from donating sperm for the same period.\n\nE. Patients must be able and willing to undergo a fresh tissue biopsy at baseline and blood samples for translational research. Note that for patients with haematological malignancies or neuroblastomas, blood, bone marrow aspiration and\u002For trephine or lymph node biopsy samples may be taken.\n\nF. Adequate organ function as per haematological and biochemical indices within the ranges defined in the protocol. These measurements should be performed to confirm the patient's eligibility\n\nExclusion criteria:\n\nA. Diagnosis of one of the following BRAF V600E mutation-positive cancers:\n\n* Colorectal cancer in adult (≥18 years) patients;\n* Unresectable or metastatic melanoma in adult (≥18 years) patients;\n* Advanced non-small cell lung cancer in adult (≥18 years) patients;\n* Gliomas harbouring a BRAF V600E mutation in paediatric (1 to \\\u003C16 years) or TYA (16 to \\\u003C18 years) patients.\n\nB. Previous treatment with dabrafenib and trametinib in combination (or other BRAF and MEK inhibitors in combination) for the current indication.\n\nC. Female patients who are pregnant, breastfeeding or planning to become pregnant during the trial or for two weeks following their last dose of dabrafenib or 16 weeks following their last dose of trametinib, whichever is later.\n\nD. Known hypersensitivity to dabrafenib or trametinib or any of the excipients. See the current relevant SmPCs (UK) for the full lists.\n\nE. Patients with a history of retinal vein occlusion.\n\nF. Any impairment of gastrointestinal (GI) function of uncontrolled GI disease that may significantly alter the administration or absorption of dabrafenib and\u002For trametinib (e.g. history of diverticulitis, metastases to the GI tract, uncontrolled Crohn's disease, uncontrolled ulcerative diseases, uncontrolled nausea, vomiting, diarrhoea, malabsorption syndrome or short gut syndrome).\n\nG. Clinically significant cardiac or cerebrovascular disease as defined by:\n\n* Unstable angina within three months prior to screening;\n* Myocardial infarction within three months prior to screening;\n* History of documented congestive heart failure (New York Heart Association functional classification III\u002FIV) etc.\n\nPatients with a cerebrovascular event (including stroke or transient ischaemic attack \\[TIA\\]) within three months prior to screening.\n\n• Patients with primary central nervous system (CNS) tumours may be considered unless intratumoural bleeding has occurred within two weeks prior to the first dose of dabrafenib and trametinib, and patients with punctate CNS haemorrhages \\\u003C3 mm may be considered.\n\nH. Patients who were administered a live, attenuated vaccine within 28 days prior to initiation of treatment, or anticipation of need for such a vaccine during investigational medicinal product (IMP) treatment or within six months after the final dose of dabrafenib and trametinib.\n\nI. Known active infections (bacterial, fungal or viral) that would interfere with the assessment of safety or efficacy of dabrafenib and trametinib including human immunodeficiency virus (HIV) positivity. Patients with history of testing positive for HIV infection are eligible provided that each of the following conditions are met:\n\n* CD4 count ≥350\u002FµL;\n* Undetectable viral load;\n* Receiving antiretroviral therapy (ART) that does not interact with IMP (patients should be on established ART for at least four weeks); and\n* No HIV\u002Facquired immune deficiency syndrome associated opportunistic infection in the last 12 months.\n\nJ. Any clinically significant concomitant disease or condition (or its treatment) that could interfere with the conduct of the trial (including absorption of oral medications) that would, in the opinion of the Investigator, pose an unacceptable risk to the patient in this trial.","1 Year",{"count":88,"type":21},30,[90,24],"PHASE2","This clinical trial is looking at two drugs called dabrafenib and trametinib. Dabrafenib and trametinib are approved as standard of care treatment for adult patients with melanoma (a type of skin cancer) or lung cancer and in children with glioma (a type of brain tumour). This means they have gone through clinical trials and been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK. Dabrafenib and trametinib work in patients with a particular mutation in their cancer known as BRAF V600.\n\nInvestigators now wish to find out if they will be useful in treating patients with other cancer types which have the same mutation. If the results are positive, the study team will work with the NHS and the Cancer Drugs Fund to see if these drugs can be routinely accessed for patients in the future.\n\nThis trial is part of a trial programme called DETERMINE. The programme will also look at other anti-cancer drugs in the same way, through matching the drug to rare cancer types or ones with specific mutations.",[93,94,95,96,97,98,99,100,101,102,103,104,105,106,107,108,109,110,111,112],"Haematological Malignancy","Malignant Neoplasm","Lymphoproliferative Disorders","Neoplasms by Histologic Type","Neoplasms by Site","Gastrointestinal Cancer","Non-Melanoma Skin Cancer (NMSC)","Langerhans Cell Histiocytosis (LCH)","Cancer","Erdheim-Chester Disease","Thyroid Carcinoma, Papillary","Ovarian Neoplasms","Colorectal Neoplasms","Laryngeal Neoplasms","Carcinoma, Non-Small Cell-Lung","Glioma","Multiple Myeloma","Thyroid Carcinoma, Anaplastic","Solid Tumour","Pancreatic Diseases",[114,115,101,116,117,118,119,120,121,122,97,123,124,125,126,127,128,129,130],"Adult","Antineoplastic Agents","Child","Dabrafenib","Malignancy","Malignant Neoplasms","Molecular Targeted Therapy","Mutation","Neoplasms by Histologic Site","Paediatric","Precision Medicine","Proto-Oncogene Proteins B-raf","Protein Kinase Inhibitors","Rare","Trametinib","Tumour-Agnostic","Young adult","2026-08-13",{"date":70,"type":37},{"date":134,"type":37},"2026-04-01",{"date":136,"type":21},"2029-10",{"name":138,"class":139},"Cancer Research UK","OTHER",27,{"id":142,"slug":143,"hasResults":12,"nctId":144,"briefTitle":145,"officialTitle":146,"acronym":4,"eligibilityCriteria":147,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":148,"targetDuration":4,"studyType":22,"phases":150,"briefSummary":151,"conditions":152,"keywords":153,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":158,"startDateStruct":159,"completionDateStruct":161,"leadSponsor":163,"locationsCount":165},"100583360","phase-3-a-study-of-adagrasib-plus-pembrolizumab-plus-chemotherapy-vs-placebo-plus-pembrolizumab-plus-chemotherapy-in-participants-with-previously-untreated-non-squamous-non-small-cell-lung-cancer-with-kras-g12c-mutation-krystal-4-100583360","NCT06875310","A Study of Adagrasib Plus Pembrolizumab Plus Chemotherapy vs. Placebo Plus Pembrolizumab Plus Chemotherapy in Participants With Previously Untreated Non-squamous Non-small Cell Lung Cancer With KRAS G12C Mutation (KRYSTAL-4)","A Randomized, Double-Blind, Phase 3 Trial of Adagrasib Plus Pembrolizumab Plus Chemotherapy vs. Placebo Plus Pembrolizumab Plus Chemotherapy in Participants With Previously Untreated, Locally Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer With KRAS G12C Mutation (KRYSTAL-4)","Inclusion Criteria:\n\n* Histologically or cytologically confirmed diagnosis of non-squamous NSCLC with evidence of KRAS G12C mutation via tumor sample and\u002For circulating tumor deoxyribonucleic acid (ctDNA).\n* Locally advanced or metastatic disease.\n* Measurable disease via computed tomography (CT) or magnetic resonance imaging (MRI) per RECIST v1.1 criteria of at least 1 lesion.\n* No prior systemic anti-cancer therapy given for advanced or metastatic disease.\n* Not a candidate for definitive therapy (eg, chemoradiation or complete surgical resection).\n* Participants with brain metastases are eligible for enrollment, including those with untreated brain metastases. Brain metastases must be asymptomatic and not in need of immediate local therapy. Any untreated brain metastases must be ≤ 20 mm in diameter.\n* Any PD-L1 expression (0 to 100%) as determined by VENTANA PD-L1 (SP263) assay, Agilent PD-L1 IHC 22C3 pharmDx, or Agilent PD-L1 IHC 28-8 pharmDx.\n\nExclusion Criteria:\n\n* Participants with an active autoimmune or inflammatory disease requiring systemic treatment within 2 years.\n* Uncontrolled or significant cardiovascular conditions within 6 months prior to enrollment that are ongoing or with risk of recurrence.\n* Inadequate bone marrow or liver function or electrocardiogram (ECG) abnormalities.\n* Ongoing treatment with concomitant medication known to cause prolonged QTc interval and that cannot be switched to alternative treatment prior to study entry.\n* Treatment targeting KRAS G12C mutation (eg, sotorasib, adagrasib) in any setting.\n* Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration.\n* Other protocol-defined Inclusion\u002FExclusion criteria apply.",{"count":149,"type":21},630,[24],"This is a trial to evaluate the efficacy, safety, and tolerability of adagrasib plus pembrolizumab plus platinum-doublet chemotherapy versus placebo plus pembrolizumab plus platinum-doublet chemotherapy in participants with previously untreated, locally advanced or metastatic NSCLC with KRAS G12C mutation",[27],[154,155,156,157],"Immunotherapy","KRAS","KRAS G12C","Targeted therapy",{"date":68,"type":37},{"date":160,"type":37},"2025-04-24",{"date":162,"type":21},"2032-04-30",{"name":164,"class":44},"Mirati Therapeutics Inc.",351,{"id":167,"slug":168,"hasResults":12,"nctId":169,"briefTitle":170,"officialTitle":171,"acronym":4,"eligibilityCriteria":172,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":173,"targetDuration":4,"studyType":22,"phases":175,"briefSummary":176,"conditions":177,"keywords":179,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":194,"lastUpdatePostDateStruct":195,"startDateStruct":196,"completionDateStruct":198,"leadSponsor":200,"locationsCount":202},"100604805","phase-2-a-study-to-investigate-ubamatamab-with-and-without-regn7075-in-adult-participants-with-advancedmetastatic-non-small-cell-lung-cancer-nsclc-100604805","NCT07154290","A Study to Investigate Ubamatamab With and Without Marlotamig (REGN7075) in Adult Participants With Advanced\u002FMetastatic Non-Small Cell Lung Cancer (NSCLC)","A Phase 2 Study to Investigate Ubamatamab With and Without Marlotamig (REGN7075) in Treatment-Experienced Participants With Advanced\u002FMetastatic Non-Small Cell Lung Cancer (NSCLC)","Key Inclusion Criteria:\n\n1. Has histologically or cytologically confirmed diagnosis of advanced (stage IIIB not amenable to definitive chemoradiotherapy or stage IIIC) or metastatic (stage IV) NSCLC\n2. Has received appropriate first line standard of care treatment for advanced or metastatic NSCLC, as described in the protocol\n3. If platinum doublet chemotherapy was not administered as first line therapy, it is required in a later line of therapy prior to enrollment unless there is a documented reason why it is not appropriate\n4. Has tumor tissue (archival or fresh) available for testing MUC16 expression by immunohistochemistry inclusion (IHC), as described in the protocol\n5. Has at least 1 radiographically measurable lesion by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) per RECIST v1.1 criteria. Target lesions may be located in a previously irradiated field if there is documented (radiographic) disease progression in that site\n6. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n\nKey Exclusion Criteria:\n\n1. Has progression of disease fewer than 84 days from starting initial anti-Programmed Cell Death (PD)-(L) 1 therapy\n2. Experienced toxicity related to prior treatment that has not resolved to grade 1 prior to initiation of study intervention (except alopecia, hearing loss, grade 2 neuropathy, or endocrinopathy managed with hormone replacement therapy)\n3. Has untreated or active primary brain tumor, Central Nervous System (CNS) metastases, leptomeningeal disease, or spinal cord compression, as described in the protocol\n4. Current participation OR past participation in another investigational study in which an investigational intervention (eg, drug, vaccine, invasive device) was administered within 4 weeks before planned first dose of study intervention in this clinical study\n5. Has received prior monoclonal antibody against PD-(L)1 within 21 days of the first dose of study intervention\n6. Has had other prior anti-cancer immunotherapy within 21 days prior to study intervention, as described in the protocol\n7. Has received prior cytotoxic chemotherapy within 21 days of the first dose of study intervention\n8. Has received an anti-EGFR antibody therapy within the following drug-specific window prior to first dose of study intervention (approximately 5 half-lives), as described in the protocol\n\nNOTE: Other protocol defined inclusion \u002F exclusion criteria apply",{"count":174,"type":21},300,[90],"This study will evaluate two study drugs called ubamatamab and marlotamig, to see if they can help treat advanced or metastatic Non-Small Cell Lung Cancer (NSCLC), and sarilumab, to evaluate to see if it can help with immune-related side effects from ubamatamab.\n\nThe study is looking at:\n\n* How well ubamatamab and marlotamig work(s)\n* The side effects that ubamatamab and marlotamig might cause\n* How much ubamatamab and marlotamig is in the blood at different times\n* If the body makes antibodies to ubamatamab and\u002For marlotamig, this may cause the ubamatamab to not work as well",[59,58,178,27],"Metastatic Non-Small Cell Lung Cancer",[180,181,182,183,184,185,186,187,188,62,189,190,191,192,193],"Mucin-16 (MUC16)","Ubamatamab","Epidermal Growth Factor Receptor (EGFR)","REGN7075","Stage IIIB, IIIC or IV","Marlotamig","NSCLC","Advanced NSCLC","Metastatic NSCLC","Advanced Lung Cancer","Metastatic Lung Cancer","Stage IV NSCLC","Recurrent NSCLC","Unresectable NSCLC","2026-08-11",{"date":131,"type":37},{"date":197,"type":37},"2026-03-18",{"date":199,"type":21},"2030-06-10",{"name":201,"class":44},"Regeneron Pharmaceuticals",15,{"id":204,"slug":205,"hasResults":12,"nctId":206,"briefTitle":207,"officialTitle":208,"acronym":4,"eligibilityCriteria":209,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":210,"targetDuration":4,"studyType":212,"phases":4,"briefSummary":213,"conditions":214,"keywords":215,"overallStatus":221,"whyStopped":4,"lastUpdateSubmitDate":222,"lastUpdatePostDateStruct":223,"startDateStruct":225,"completionDateStruct":227,"leadSponsor":229,"locationsCount":4},"100651443","a-multicenter-observational-pms-study-assessing-durvalumab-safety-in-indian-adults-with-resectable-nsclc-100651443","NCT07760519","A Multicenter Observational PMS Study Assessing Durvalumab Safety in Indian Adults With Resectable NSCLC","A Prospective, Observational, Multicenter, Post Marketing Surveillance Study to Assess Safety of Durvalumab in Indian Adult Patients With Resectable Non-Small Cell Lung Cancer (NSCLC)","Inclusion Criteria:\n\n1. Patients with newly diagnosed previously untreated resectable NSCLC (tumors ≥ 4 cm and\u002For node positive) and no known EGFR mutations or ALK rearrangements prescribed with durvalumab as per local prescriber information.\n2. Provision of signed, written and dated informed consent\n\nExclusion Criteria:\n\n1. Presence of unresectable or metastatic disease.\n2. Prior treatment with durvalumab for any other indications\n3. Requires concurrent treatment for cancers other than resectable NSCLC\n4. Concurrently participating in any other clinical trial\n5. Patients with active or prior autoimmune disease or with medical conditions that required systemic corticosteroids or immunosuppressants\n6. Any condition that, in the opinion of the investigator, would interfere with the patient's participation in the study.",{"count":211,"type":21},78,"OBSERVATIONAL","This will be a single-arm, multicenter, prospective, observational, real-world study and the data source is the patients' medical record at each site. A total of 78 patients will be enrolled in the study.",[27],[216,186,217,218,219,220],"Durvalumab","post marketing surveillance","Real-world","Observational","Indian","NOT_YET_RECRUITING","2026-08-10",{"date":224,"type":37},"2026-08-12",{"date":226,"type":21},"2026-09-30",{"date":228,"type":21},"2030-04-30",{"name":230,"class":44},"AstraZeneca",{"id":232,"slug":233,"hasResults":12,"nctId":234,"briefTitle":235,"officialTitle":236,"acronym":237,"eligibilityCriteria":238,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":239,"targetDuration":4,"studyType":22,"phases":241,"briefSummary":242,"conditions":243,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":244,"lastUpdatePostDateStruct":245,"startDateStruct":247,"completionDateStruct":249,"leadSponsor":251,"locationsCount":253},"100584534","phase-3-study-of-olomorasib-ly3537982-in-combination-with-standard-of-care-in-participants-with-resected-or-unresectable-kras-g12c-mutant-non-small-cell-lung-cancer-100584534","NCT06890598","Study of Olomorasib (LY3537982) in Combination With Standard of Care in Participants With Resected or Unresectable KRAS G12C-mutant Non-Small Cell Lung Cancer","A Phase 3, Multicenter, Double-Blind, Placebo-controlled Study Assessing the Efficacy and Safety of Olomorasib in Combination With Standard of Care Immunotherapy in Participants With Resected or Unresectable KRAS G12C-Mutant, Non-Small Cell Lung Cancer - SUNRAY-02","SUNRAY-02","Inclusion Criteria:\n\n* Histological or cytological confirmation of NSCLC.\n\n  * Part A\n\n    1. Clinical Stage II-IIIB (N0, N1, N2) treated with presurgical chemoimmunotherapy, with residual tumor present at time of surgery. Patients with a pathologic complete response are not eligible.\n    2. Pathologic Stage II-IIIB (N0, N1, N2) NSCLC treated with initial upfront resection.\n  * Part B - Clinical Stage III, unresectable NSCLC, without progression on concurrent platinum-based chemoradiotherapy.\n* Must have disease with evidence of KRAS G12C mutation.\n* Must have known programmed death-ligand 1 (PD-L1) expression\n* Must have an ECOG performance status of 0 or 1.\n* Able to swallow oral medication.\n* Must have adequate laboratory parameters.\n* Contraceptive use should be consistent with local regulations for those participating in clinical studies.\n* Women of childbearing potential must\n\n  * Have a negative pregnancy test.\n  * Not be breastfeeding during treatment\n\nExclusion Criteria:\n\n* Have known, actionable changes in the EGFR or ALK genes.\n* Have another type of cancer that is progressing or required active treatment within the past 2 years before screening.\n* Have an active autoimmune disease that required systemic treatment in the past 2 years. Endocrine replacement therapy is allowed.\n* Had any immune-related side effect or allergic reaction (Grade 3 or higher) from a previous immunotherapy medicine, or any immune-related side effect greater than Grade 1 that has not resolved. This does not apply for people with hormone-related diseases who are now on stable hormone replacement therapy.",{"count":240,"type":21},700,[24],"The main purpose of this study is to assess if olomorasib in combination with pembrolizumab is more effective than the pembrolizumab and placebo combination in part A in participants with resected KRAS G12C-mutant NSCLC and to assess if olomorasib in combination with durvalumab is more effective than the durvalumab and placebo combination in part B in participants with unresectable KRAS G12C-mutant non-small cell lung cancer. The study may last up to 3 years for each participant.",[27],"2026-08-06",{"date":246,"type":37},"2026-08-07",{"date":248,"type":37},"2025-03-27",{"date":250,"type":21},"2032-02",{"name":252,"class":44},"Eli Lilly and Company",370,{"id":255,"slug":256,"hasResults":12,"nctId":257,"briefTitle":258,"officialTitle":259,"acronym":4,"eligibilityCriteria":260,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":261,"targetDuration":4,"studyType":22,"phases":263,"briefSummary":265,"conditions":266,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":269,"lastUpdatePostDateStruct":270,"startDateStruct":271,"completionDateStruct":273,"leadSponsor":275,"locationsCount":277},"100555738","phase-1-a-study-of-dm005-in-patients-with-advanced-solid-tumors-100555738","NCT06515990","A Study of DM005 in Patients With Advanced Solid Tumors","A Phase I\u002FIIa, Multicenter, Open-label, First-in-human, Dose Escalation and Expansion Study of DM005 in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n* Common inclusion criteria for both Parts\n\n  1. Participants must have the ability to understand and willingness to sign a written informed consent document.\n  2. Participants who have pathologically or cytologically documented metastatic\u002Fadvanced NSCLC, gastroesophageal cancer, CRC, HCC, pancreatic cancer, or HNSCC, not curable with standard local therapies (i.e., surgery and\u002For radiation) and have progressed on standard therapy, or intolerant to standard therapy.\n  3. Participants must be ≥18 years of age on the day of signing the informed consent form (ICF).\n  4. Participants must have an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 to 2.\n  5. Has a life expectancy ≥3 months.\n  6. Has measurable disease based on response evaluation criteria in solid tumors (RECIST) version 1.1.\n\nExclusion Criteria:\n\n* Participants are excluded from the study if any of the following criteria apply:\n\n  1. Participants have another active invasive malignancy within 5 years, with the following exceptions and notes:\n\n     * History of noninvasive malignancy, such as cervical cancer in situ, in situ melanoma, or ductal carcinoma in situ of the breast that is in complete remission years after treatment with curative intent is allowed.\n     * Malignancies with a negligible risk of metastasis or death (such as adequately treated basal or squamous cell skin cancer and localized prostate cancer).\n  2. Current or history of hematologic malignancy.\n  3. Anticancer therapy (chemotherapy, immunotherapy, hormonal therapy, targeted therapy, biologic therapy, or other anti-cancer therapies, except for hormones for hypothyroidism or estrogen replacement therapy, anti-estrogen analogs, agonists required to suppress serum testosterone levels) within 28 days or 5 half-lives, whichever is shorter, prior to the first study dose. Radiotherapy with a wide field of radiation within 28 days, or radiotherapy with a limited field of radiation for palliation within 14 days of the first study dose. Major surgery, other than diagnostic surgery, within 4 weeks of the first study dose.\n  4. Primary central nervous system (CNS) malignancies or CNS metastases. Individuals with brain metastases can be enrolled only if treated, non-progressive brain metastases and off high-dose steroids (\\>20 mg prednisone or equivalent) for at least 4 weeks.\n  5. Presence of bulky disease (defined as any single mass \\>7 cm in its greatest dimension). Individuals with a mass \\>7 cm, but otherwise eligible, may be considered for enrollment after discussion and approval with the medical monitor.\n  6. Has an uncontrolled infection requiring IV injection of antibiotics, antivirals, or antifungals.\n  7. Has clinically significant corneal disease.\n  8. Has a corrected QT interval (QTcF) prolongation to \\>470 ms (for both genders) based on average of the Screening triplicate 12-lead ECG determinations; no concomitant medications that would prolong the QT interval; no known family history of long QT syndrome.\n  9. Left ventricular ejection fraction (LVEF) \\\u003C50% by either an echocardiogram (ECHO) or a multigated acquisition (MUGA) scan within 28 days before first dose of the study drug.\n  10. Known active hepatitis B (HBV) or hepatitis C (HCV) infection. Chronic carriers of HBV infection (HBsAg-positive, undetectable HBV DNA or HBV DNA ≤2500 copies\u002Fml or 500 IU\u002Fml) receive prophylactic treatment during the study can be enrolled. Participants with a history of HCV infection have completed curative antiviral treatment and HCV viral load below the limit of quantification and HCV antibody positive but HCV ribonucleic acid (RNA) negative due to prior treatment or natural resolution should be eligible.\n  11. Known human immunodeficiency virus (HIV) infection which is not well controlled. participants should be tested for HIV prior to enrollment if required by local regulations or institutional review board (IRB)\u002Fethics committee. All the following criteria are required to define an HIV infection (positive HIV1\u002F2 antibodies test) that is well controlled: HIV viral load \\\u003C400 copies\u002FmL, CD4+ T-cell counts ≥350 cells\u002FμL, no history of acquired immunodeficiency syndrome \\[AIDS\\])-defining opportunistic infection within the past 12 months, and stable viral load for at least 4 weeks on same anti-HIV retroviral medications.\n  12. Participants from endemic area will be specifically screened for tuberculosis. Participants with active tuberculosis are excluded. Participants who have received bacille Calmette-Guerin (BCG) vaccination may have a false positive result in the purified protein derivative (PPD) skin test. These participants are eligible if they have a negative Interferon Gamma Release Assay (IGRA).\n  13. Has received a live vaccine within 30 days prior to the first dose of study drug.\n  14. Has unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia and anemia) not yet resolved to NCI-CTCAE version 5.0, ≤Grade 1 or baseline. Note: Participants may be enrolled with chronic, stable Grade 2 toxicities (defined as no worsening to \\>Grade 2 for at least 3 months prior to enrollment\u002Frandomization and managed with the standard treatment) that the Investigator deems related to previous anticancer therapy, following discussion with the Sponsor's medical monitor, such as the following: Grade 2 chemotherapy-induced neuropathy, hypothyroidism, hyperglycemia.\n  15. Females who are pregnant or lactating or who intend to become pregnant during participation in the study.\n  16. Participants who are of reproductive potential refuse to use effective methods of birth control during participation of the study and within 7 months for female (and 4 months for male) after the last dose administration.",{"count":262,"type":21},208,[264,90],"PHASE1","The goal of this clinical trial is to find out about the safety, efficacy, and tolerability of DM005 for patients with the advanced solid tumors. DM005 is an experimental drug which is not approved by health authorities for the treatment of advanced solid tumors. For each participant, there will be a screening period of up to 28 days, a treatment period consisting of 21-day cycles, an end of treatment (EOT) Visit (+7 days), and a Follow-up Visit at 30 days (±7 days) after the EOT Visit.\n\nParticipants with advanced solid malignant tumors will be treated with DM005 on Day 1 of each cycle (every 3 weeks, Q3W). An initial dose of DM005 will be infused intravenously (IV) into each participant for approximately 60 minutes (±10) on Cycle1 Day 1. If there is no infusion-related reaction (IRR) during or after the initial dose, with the Investigator's confirmation and supervision, the subsequent dosing of DM005 in the following cycles maybe infused IV for approximately 30 minutes ( ±5). A 21-day observation period (Cycle 1) will then occur, at the end of which all relevant safety data will be reviewed.",[27,267,268],"Squamous Cell Carcinoma of Head and Neck","Solid Carcinoma","2026-08-05",{"date":246,"type":37},{"date":272,"type":37},"2024-10-31",{"date":274,"type":21},"2027-09",{"name":276,"class":44},"Doma Biopharmaceutical（Suzhou）Co., Ltd.",6,{"id":279,"slug":280,"hasResults":12,"nctId":281,"briefTitle":282,"officialTitle":283,"acronym":4,"eligibilityCriteria":284,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":285,"targetDuration":4,"studyType":212,"phases":4,"briefSummary":287,"conditions":288,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":289,"lastUpdatePostDateStruct":290,"startDateStruct":291,"completionDateStruct":293,"leadSponsor":295,"locationsCount":297},"100582404","real-world-clinical-outcomes-of-resected-alk-positive-early-stage-nsclc-patients-treated-with-alectinib-as-adjuvant-therapy-100582404","NCT06862869","Real World Clinical Outcomes of Resected ALK-Positive Early Stage NSCLC Patients Treated With Alectinib as Adjuvant Therapy","Real World Clinical Outcomes of Resected ALK-Positive Early Stage NSCLC Patients Treated With Alectinib as Adjuvant Therapy in China: A Multicenter, Prospective Cohort Study","Inclusion Criteria:\n\n* Histologically-confirmed stage II-IIIA or selected IIIB (T3N2) NSCLC as per the American Joint Committee on Cancer and International Union Against Cancer (UICC\u002FAJCC), 8th edition\n* ALK positive\n* Postoperative NSCLC patients who have undergone complete resection\n* Had taken Alectinib monotherapy without prior systemic therapy (including other ALK-TKIs or chemotherapy) as adjuvant† therapy for resected stage II-IIIB ALKpositive NSCLC and the time from the first dose to enrollment was no more than 28 days\n\nExclusion Criteria:\n\n* Patients participating in interventional study of adjuvant treatment\n* Pregnant, lactating, or breastfeeding women",{"count":286,"type":21},800,"This study is a multicenter, prospective, cohort study designed to evaluate the clinical outcomes and characteristics of resected stage II-IIIB anaplastic lymphoma kinase (ALK)-positive non-small-cell lung cancer (NSCLC) adult patients treated with Alectinib as adjuvant therapy in China.",[27],"2026-08-04",{"date":244,"type":37},{"date":292,"type":37},"2025-04-30",{"date":294,"type":21},"2029-04-30",{"name":296,"class":44},"Hoffmann-La Roche",44,{"id":299,"slug":300,"hasResults":12,"nctId":301,"briefTitle":302,"officialTitle":303,"acronym":304,"eligibilityCriteria":305,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":306,"targetDuration":4,"studyType":212,"phases":4,"briefSummary":308,"conditions":309,"keywords":4,"overallStatus":221,"whyStopped":4,"lastUpdateSubmitDate":310,"lastUpdatePostDateStruct":311,"startDateStruct":313,"completionDateStruct":314,"leadSponsor":316,"locationsCount":4},"100645280","a-real-world-study-of-participants-with-non-small-cell-lung-cancer-nsclc-with-epidermal-growth-factor-receptor-mutation-egfrm-100645280","NCT07680907","A Real World Study of Participants With Non-Small Cell Lung Cancer (NSCLC) With Epidermal Growth Factor Receptor Mutation (EGFRm)","Characterization of the Population, Treatment Patterns and Outcomes of Patients With Advanced\u002FMetastatic Non-Small Cell Lung Cancer (NSCLC) With Epidermal Growth Factor Receptor Mutation (EGFRm) - Multicenter Retrospective Cohort Study","LuCaRTE","Inclusion criteria:\n\n* Histologically or cytologically confirmed diagnosis of advanced or metastatic unresectable non-small cell lung cancerNSCLC (TNM stages IIIB-IV), and a documented EGFR mutation, between 01 July 2018 and 31 March 2022\n* Diagnosed and treated at one of the participating study centers within the defined study period\n\nExclusion criteria:\n\n* Participants who received any systemic cancer treatment outside the participating treatment centers\n* Participants diagnosed with any other malignancy within the 5 years prior to or during the study period, with the exception of cutaneous basal cell carcinoma or squamous cell carcinoma\n* Participants enrolled in clinical trials during the study period.",{"count":307,"type":21},250,"This study aims to better understand people who have advanced or metastatic non-small cell lung cancer (NSCLC) with an EGFR mutation. NSCLC is an advanced stage cancer of the lung, occurring due to mutations (changes) in the EGFR gene. The study will assess the participant demographic background (that is age, gender etc.), the treatments they receive, how well those treatments work, and their health outcomes.",[27],"2026-07-31",{"date":312,"type":37},"2026-08-03",{"date":226,"type":21},{"date":315,"type":21},"2026-11-30",{"name":317,"class":44},"Janssen-Cilag Farmaceutica Ltda.",{"id":319,"slug":320,"hasResults":12,"nctId":321,"briefTitle":322,"officialTitle":323,"acronym":324,"eligibilityCriteria":325,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":326,"targetDuration":4,"studyType":22,"phases":328,"briefSummary":329,"conditions":330,"keywords":332,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":310,"lastUpdatePostDateStruct":341,"startDateStruct":342,"completionDateStruct":344,"leadSponsor":346,"locationsCount":347},"100582820","phase-3-a-global-phase-iii-study-of-rilvegostomig-or-pembrolizumab-monotherapy-for-first-line-treatment-of-pd-l1-high-metastatic-non-small-cell-lung-cancer-100582820","NCT06868277","A Global Phase III Study of Rilvegostomig or Pembrolizumab Monotherapy for First-Line Treatment of PD-L1-high Metastatic Non-small Cell Lung Cancer","A Phase III, Randomized, Double-blind, Multicenter, Global Study of Rilvegostomig or Pembrolizumab Monotherapy for the First-line Treatment of Patients With PD-L1-high Metastatic Non-small Cell Lung Cancer (ARTEMIDE-Lung04)","ARTEMIDELung04","Inclusion Criteria:\n\n* Histologically or cytologically documented NSCLC (non small lung cancer), including all histological subtypes.\n* Stage IV mNSCLC (metastatic non-small cell lung cancer) (based on the American Joint Committee on Cancer Edition 8) not amenable to curative treatment.\n* Absence of sensitizing EGFR (epidermal growth factor) mutations and ALK (anaplastic lymphoma kinase) and ROS1 (c-ros oncogene 1) rearrangements. Negative assay result is required for all non-squamous histology subtypes.\n* Absence of documented tumor genomic mutation results from tests conducted as part of standard local practice in any other actionable driver oncogenes for which there are locally approved targeted 1L (first line) therapies.\n* WHO (World Health Organization)\u002FECOG (Eastern Cooperative Oncology Group) performance status of 0 or 1, with no deterioration over the previous 2 weeks prior to baseline at screening and prior to randomization.\n* Minimum life expectancy of 12 weeks.\n* Provision of acceptable tumor sample for the central testing prior to randomization.\n* At least one lesion not previously irradiated that qualifies as a RECIST 1.1 (Response Evaluation Criteria in Solid Tumors, Version 1.1) TL (target lesion) at baseline and can be accurately measured at baseline as ≥ 10 mm in the longest diameter (except lymph nodes, which must have short axis ≥ 15 mm) with CT (computed tomography) or MRI (magnetic resonance imaging) and is suitable for accurate repeated measurements.\n* Adequate organ and bone marrow function\n\nExclusion Criteria:\n\n* As judged by the investigator, any severe or uncontrolled systemic diseases, makes it undesirable for the participant to participate in the study or that would jeopardize compliance with the protocol.\n* History of organ transplant.\n* Active or prior documented autoimmune or inflammatory disorders requiring chronic treatment with steroids or other immunosuppressive treatment.\n* History of another primary malignancy except for malignancy treated with curative intent with no known active disease ≥ 2 years before the first dose of study intervention and of low potential risk for recurrence.\n* Presence of small cell and neuroendocrine histology components.\n* Brain metastases unless asymptomatic, stable, and not requiring steroids or anticonvulsants for at least 4 weeks prior to start of study intervention.\n* Active primary immunodeficiency\u002Factive infectious disease(s)\n* Active tuberculosis infection\n* Any prior systemic therapy received for advanced or mNSCLC (metastatic non-small cell lung cancer).\n* Any prior exposure to an anti-TIGIT (T-cell immunoglobulin and immunoreceptor tyrosine-based inhibitory motif domain) therapy or any other anticancer therapy targeting immune-regulatory receptors or mechanisms.\n* Any prior treatment with an anti-PD-1 (programmed cell death protein 1) or anti-PD-L1 (anti-programmed death-ligand 1) agent.",{"count":327,"type":21},830,[24],"The purpose of ARTEMIDE-Lung04 is to assess the efficacy and safety of rilvegostomig compared with pembrolizumab monotherapy as 1L treatment in participants with mNSCLC and whose tumors express PD-L1.",[331],"Carcinoma, Non-Small Cell Lung",[333,334,335,336,337,338,339,340],"ARTEMIDE-Lung04","Rilvegostomig (AZD2936)","Non-small cell lung cancer (NSCLC)","Bi-specific antibody","T-cell immunoglobulin and immunoreceptor tyrosine-based inhibitory motif domain (TIGIT)","EGFR, ALK and ROS1 testing","Programmed cell death protein (PD-L1)","Pembrolizumab",{"date":312,"type":37},{"date":343,"type":37},"2025-04-10",{"date":345,"type":21},"2030-12-02",{"name":230,"class":44},304,{"id":349,"slug":350,"hasResults":12,"nctId":351,"briefTitle":352,"officialTitle":353,"acronym":354,"eligibilityCriteria":355,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":356,"targetDuration":4,"studyType":22,"phases":358,"briefSummary":359,"conditions":360,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":361,"lastUpdatePostDateStruct":362,"startDateStruct":363,"completionDateStruct":365,"leadSponsor":367,"locationsCount":369},"100643295","phase-2-a-study-of-neoadjuvant-amivantamab-with-either-lazertinib-or-chemotherapy-in-participants-with-resectable-egfr-mutated-nsclc-100643295","NCT07586202","A Study of Neoadjuvant Amivantamab With Either Lazertinib or Chemotherapy in Participants With Resectable EGFR-Mutated NSCLC","A Phase 2 Study Evaluating the Safety and Efficacy of Neoadjuvant Amivantamab in Combination With Lazertinib or Chemotherapy in Resectable EGFR-Mutated Non-Small Cell Lung Cancer","AmiNA","Inclusion Criteria:\n\n* Participant must have histologically or cytologically confirmed non-squamous non-small cell lung cancer (NSCLC) with completely resectable Stage II-IIIB N2 disease\n* Complete surgical resection of the primary NSCLC must be deemed achievable, as assessed by a multidisciplinary team evaluation\n* Participant must consent to a screening biopsy, if clinically feasible, if no adequate tumor tissue is available for a baseline sample\n* Participant may have a prior or concurrent second malignancy (other than the disease under study) which natural history or treatment is unlikely to interfere with any study endpoints of safety or the efficacy of the study treatment(s). Prior or concurrent second malignancies must be reviewed and agreed to with the medical monitor\n* Have an eastern cooperative oncology group (ECOG) performance status of 0 or 1\n\nExclusion Criteria:\n\n* History of uncontrolled illness\n* Medical history of (non-infectious) interstitial lung disease (ILD)\u002Fpneumonitis, or has current interstitial lung disease (ILD)\u002Fpneumonitis, or where suspected ILD\u002Fpneumonitis cannot be ruled out by imaging at screening\n* Suspected or known allergies, hypersensitivity, or intolerance to excipients of: the combination of amivantamab and lazertinib or carboplatin and pemetrexed\n* Presence of primary driver mutations (anaplastic lymphoma kinase \\[ALK\\], mesenchymal-epithelial transition \\[MET\\], human epidermal growth factor receptor 2 \\[HER2\\], proto-oncogene tyrosine-protein kinase ROS \\[ROS1\\], neurotrophic tyrosine receptor kinase \\[NTRK\\], B-Raf proto-oncogene \\[BRAF\\], REarranged during transfection \\[RET\\], or kirsten rat sarcoma viral oncogene homolog \\[KRAS\\]) , besides EGFR Exon 19del or Exon 21 L858R mutations, as determined by local genomic testing\n* Prior treatment with any systemic anti-cancer therapy for NSCLC including EGFR-tyrosine kinase inhibitor (TKI) therapy, chemotherapy, biologic therapy, immunotherapy, or any investigational drug",{"count":357,"type":21},68,[90],"The purpose of this study is to assess the ability to slow down or stop the growth of cancer with amivantamab combined with either lazertinib or chemotherapy (carboplatin and pemetrexed) in participants with resectable, epidermal growth factor receptor (EGFR) mutated, Stage II-IIIB non-small cell lung cancer (NSCLC). NSCLC is the most common type of lung cancer. NSCLC may occur due to mutations (changes) in many genes, including EGFR.",[27],"2026-07-30",{"date":310,"type":37},{"date":364,"type":37},"2026-07-28",{"date":366,"type":21},"2028-04-03",{"name":368,"class":44},"Janssen Research & Development, LLC",8,{"id":371,"slug":372,"hasResults":12,"nctId":373,"briefTitle":374,"officialTitle":375,"acronym":376,"eligibilityCriteria":377,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":378,"targetDuration":4,"studyType":212,"phases":4,"briefSummary":380,"conditions":381,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":361,"lastUpdatePostDateStruct":382,"startDateStruct":383,"completionDateStruct":385,"leadSponsor":387,"locationsCount":388},"100610677","a-study-of-clinical-outcomes-in-participants-with-egfr-mutated-advanced-non-small-cell-lung-cancer-nsclc-in-a-real-world-setting-100610677","NCT07230691","A Study of Clinical Outcomes in Participants With EGFR Mutated Advanced Non-Small Cell Lung Cancer (NSCLC) in a Real-World Setting","Prospective, Multi Country, Observational Study of Clinical Outcomes in EGFR-mutated, Advanced Non-Small Cell Lung Cancer (NSCLC) Patients Treated With Approved Amivantamab-containing Regimens Under Standard Clinical Practice","LEPIDOPTERA","Inclusion Criteria:\n\n* Participant has a confirmed diagnosis of common epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC) (EGFR exon 19 deletions or exon 21 L858R substitution) and is eligible for an amivantamab-containing regimen per the judgment of the treating physician and in alignment with the approved amivantamab indications and recommended prophylactic and reactive medication as described in the local specific summary of product characteristics (SmPC) for amivantamab\n* Participants or their legally acceptable representative, where applicable, must sign a participation agreement\u002FInformed consent form (ICF) allowing source data verification in accordance with local requirements\n* Participant is being planned to be initiated with an amivantamab-containing regimen for the first time within 4 weeks following the visit for start of data collection\n* Decision to administer an amivantamab-containing regimen has been made prior to participant's enrollment in the study and is separate from the physician's decision to include the participant in the current study\n\nExclusion criteria:\n\n* At the time of the initiation of the amivantamab-containing regimen, the participant is receiving an active systemic anticancer treatment for advanced NSCLC that is not included in the locally approved combination regimen with amivantamab (regardless of whether it is part of an interventional study). One cycle of platinum-based chemotherapy (for example, carboplatin-pemetrexed) is permitted prior to the first dose of amivantamab in a 1L while awaiting biopsy results\n* Participant has received prior treatment with amivantamab in a clinical trial or for compassionate use\n* Participants who are not receiving amivantamab but are being treated with a biosimilar or a non-original biologic agent\n* Participants with conditions listed in the contraindications of the SmPC for amivantamab or other agents essential for the applicable amivantamab-containing treatment regimen (lazertinib\u002F platinum\u002F pemetrexed)",{"count":379,"type":21},380,"The purpose of this study is to describe the clinical and health-related outcomes of amivantamab-containing regimens for the treatment of common epidermal growth factor receptor (EGFR) mutated non-small cell lung cancer (NSCLC; most common type of lung cancer) in a real-world setting. Metastatic NSCLC is when this disease spreads to other parts of body. NSCLC may occur due to mutations (changes) in many genes including epidermal growth factor receptor (EGFR).",[27],{"date":310,"type":37},{"date":384,"type":37},"2025-12-03",{"date":386,"type":21},"2030-12-17",{"name":368,"class":44},80,{"id":390,"slug":391,"hasResults":12,"nctId":392,"briefTitle":393,"officialTitle":394,"acronym":395,"eligibilityCriteria":396,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":397,"targetDuration":4,"studyType":22,"phases":399,"briefSummary":400,"conditions":401,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":361,"lastUpdatePostDateStruct":402,"startDateStruct":403,"completionDateStruct":405,"leadSponsor":406,"locationsCount":407},"100610395","phase-1-a-study-of-amivantamab-and-olomorasib-combination-therapy-in-participants-with-metastatic-non-small-cell-lung-cancer-100610395","NCT07227025","A Study of Amivantamab and Olomorasib Combination Therapy in Participants With Metastatic Non-Small Cell Lung Cancer","A Phase 1\u002F2 Study Evaluating the Safety and Efficacy of Amivantamab and Olomorasib Combination Therapy in Metastatic Non-small Cell Lung Cancer","KaRAnaSa","Inclusion criteria:\n\n* Participant must have histologically or cytologically confirmed metastatic NSCLC characterized by a KRAS G12C mutation at the time of enrollment. For Phase 1: Participant must have progressed on or after, or have intolerance to, platinum-based chemotherapy and Programmed Death-Ligand 1 (PD-L1)-targeted immunotherapy given in combination or sequentially. Receipt of additional lines of prior therapy is permitted. Progression must have occurred on or after the most recent line of systemic anticancer therapy. For Phase 2: Participant must have progressed on or after platinum-based chemotherapy and PD-L1-targeted immunotherapy given in combination or sequentially. Progression must have occurred on or after the most recent line of systemic anticancer therapy. Receipt of additional lines of prior therapy is not permitted\n* Participant must have at least 1 measurable lesion, according to RECIST version.1.1, that has not been previously irradiated\n* May have brain metastases only if previously definitively, locally treated, and participant is clinically stable and asymptomatic for greater than (\\>) 2 weeks and is off or receiving low-dose corticosteroid treatment for at least 2 weeks prior to start of study treatment\n* Can have a prior or concurrent second malignancy (other than the disease under study) with natural history or treatment course that is unlikely to interfere with any study endpoints of safety or the efficacy of the study treatment(s)\n* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n\nExclusion criteria:\n\n* Participant has history of uncontrolled illness\n* Suspected or known allergies, hypersensitivity, or intolerance to amivantamab excipients or olomorasib excipients\n* Medical history of (non-infectious) interstitial lung disease (ILD)\u002Fpneumonitis, or has current ILD\u002Fpneumonitis, or where suspected ILD\u002Fpneumonitis cannot be ruled out by imaging at screening\n* Presence of primary driver mutations (epidermal growth factor receptor \\[EGFR\\], anaplastic lymphoma kinase \\[ALK\\], mesenchymal-epithelial transition \\[MET\\], human epidermal growth factor receptor 2 \\[HER2\\], ROS1, neurotrophic tyrosine receptor kinase \\[NTRK\\], B-Raf proto-oncogene \\[BRAF\\], rearranged during Transfection \\[RET\\], neuroblastoma RAS viral oncogene homolog \\[NRAS\\], and other KRAS mutations besides G12C) as determined by local genomic testing\n* Prior treatment with any KRAS inhibitor",{"count":398,"type":21},60,[264,90],"The main purpose of this study is to find out the most suitable dose (recommended phase 2 combination dose \\[RP2CD\\]) of amivantamab and olomorasib combination therapy and to assess how well the combination slows down or prevents the growth of tumors in participants with KRAS G12C mutant metastatic non-small cell lung cancer (NSCLC: the most common type of lung cancer; metastatic: has spread to other parts of the body; KRAS G12C mutant: mutation \\[change\\] in the kirsten rat sarcoma viral oncogene homolog \\[KRAS\\] gene in tumor cells in which glycine \\[G\\] at position 12 is replaced with cystine \\[C\\]).",[27],{"date":310,"type":37},{"date":404,"type":37},"2026-03-03",{"date":294,"type":21},{"name":368,"class":44},13,{"id":409,"slug":410,"hasResults":12,"nctId":411,"briefTitle":412,"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":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":361,"lastUpdatePostDateStruct":421,"startDateStruct":422,"completionDateStruct":424,"leadSponsor":426,"locationsCount":427},"100567352","phase-2-a-study-of-amivantamab-in-combination-with-lazertinib-or-amivantamab-in-combination-with-platinum-based-chemotherapy-for-common-epidermal-growth-factor-receptor-egfr-mutated-locally-advanced-or-metastatic-non-small-cell-lung-cancer-nsclc-100567352","NCT06667076","A Study of Amivantamab in Combination With Lazertinib, or Amivantamab in Combination With Platinum-Based Chemotherapy, for Common Epidermal Growth Factor Receptor (EGFR)-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)","A Phase 2b, Open-Label, Two-cohort Study of Subcutaneous Amivantamab in Combination With Lazertinib as First-Line Treatment, or Subcutaneous Amivantamab in Combination With Platinum-Based Chemotherapy as Second-line Treatment, for Common EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer","COPERNICUS","Inclusion Criteria:\n\n* Have histologically or cytologically confirmed advanced or metastatic non-small cell lung cancer (NSCLC) that is not amenable to curative intent therapy\n* Epidermal growth factor resistance-mutation (EGFRm) must be an Ex19del or Ex21 L858R substitution, as detected by food and drug administration (FDA)-approved or other validated test in a clinical laboratory improvement amendments (CLIA)-certified laboratory (sites in the US), or an accredited local laboratory (sites outside of the US) in accordance with site standard of care. In the European union (EU), the local test must be Conformité Européenne (CE)-marked or an in-house laboratory-developed test from health institutions in the EU in accordance with Article 5(5) of the in vitro diagnostic regulations (IVDR ) 2071\u002F746, as amended\n* Have at least 1 measurable lesion, according to RECIST version (v)1.1, that has not been previously irradiated\n* Any toxicities from prior systemic anticancer therapy must have resolved to national cancer institute common terminology criteria for adverse events (NCI-CTCAE) version 5.0 grade 1 or baseline level (except for alopecia \\[any grade\\], grade \\\u003C=2 peripheral neuropathy, or grade \\\u003C=2 hypothyroidism stable on hormone replacement)\n* Have an eastern cooperative oncology group (ECOG) performance status of 0 to 1\n\nExclusion Criteria:\n\n* Medical history of active interstitial lung disease (ILD), including drug-induced ILD or radiation pneumonitis. Participants with medical history of radiation pneumonitis, including radiation pneumonitis which required steroid treatment, should consult with the medical monitor and eligibility be assessed on a case-by-case basis\n* Had major surgery excluding placement of vascular access or tumor biopsy or had significant traumatic injury within 4 weeks before the first dose of anticancer treatments or will not have fully recovered from surgery, or has surgery planned during the time the participant is expected to participate in the study\n* Participant has uncontrolled tumor-related pain (symptomatic lesions amenable to palliative radiotherapy should be treated prior to first dosing)\n* Received an investigational treatment that has not been cleared (based on at least 5 half lives of any pharmaceutical treatment) before the planned first dose of study treatment or is currently enrolled in an investigational study\n* Has a prior or concurrent second malignancy (other than the disease under study) which natural history or treatment could likely interfere with any study endpoints of safety or the efficacy of the study treatment(s)",{"count":417,"type":21},480,[90],"The primary purpose of the study is to assess how well amivantamab in combination with lazertinib or in combination with chemotherapy works (antitumor activity) in participants with epidermal growth factor receptor mutated (EGFRm) non-small cell lung cancer (NSCLC; that is one of the major types of lung cancer).",[27],{"date":310,"type":37},{"date":423,"type":37},"2024-12-16",{"date":425,"type":21},"2030-12-26",{"name":368,"class":44},203,{"id":429,"slug":430,"hasResults":12,"nctId":431,"briefTitle":432,"officialTitle":433,"acronym":4,"eligibilityCriteria":434,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":435,"targetDuration":4,"studyType":22,"phases":437,"briefSummary":438,"conditions":439,"keywords":440,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":442,"lastUpdatePostDateStruct":443,"startDateStruct":444,"completionDateStruct":446,"leadSponsor":448,"locationsCount":449},"100375176","phase-1-keymaker-u01-substudy-01a-efficacy-and-safety-study-of-pembrolizumab-mk-3475-with-or-without-chemotherapy-when-used-with-investigational-agents-in-treatment-nave-participants-with-stage-iv-non-small-cell-lung-cancer-nsclc-mk-3475-01akeymaker-u01a-100375176","NCT04165070","KEYMAKER-U01 Substudy 01A: Efficacy and Safety Study of Pembrolizumab (MK-3475) With or Without Chemotherapy When Used With Investigational Agents in Treatment-naïve Participants With Stage IV Non-small Cell Lung Cancer (NSCLC) (MK-3475-01A\u002FKEYMAKER-U01A)","KEYMAKER-U01 Substudy 01A: A Phase 1\u002F2, Umbrella Study With Rolling Arms of Investigational Agents With Pembrolizumab With or Without Chemotherapy in Treatment-Naive Participants With Stage IV Non-small Cell Lung Cancer (NSCLC)","Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Has histologically- or cytologically-confirmed diagnosis of Stage IV squamous or nonsquamous NSCLC\n* Participants with nonsquamous NSCLC who are not eligible for an approved targeted therapy\n* Is able to provide archival tumor tissue sample collected either within 5 years or within the interval from completion of last treatment but before entering the screening period or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated obtained within 90 days of treatment initiation\n* Has not received prior systemic treatment for their metastatic NSCLC\n* Is able to complete all screening procedures within the 35-day screening window for Part A and 28-day screening window for Part B\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Has a diagnosis of small cell lung cancer\n* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days before the first dose of study treatment\n* Has a known additional malignancy that is progressing or has required active treatment within the past 2 years\n* Has known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis\n* Has an active autoimmune disease that has required systemic treatment in the past 2 years\n* Has a history of (noninfectious) pneumonitis that required steroids or has current pneumonitis\n* Has an active infection requiring systemic therapy\n* Has clinically significant cardiac disease, including unstable angina, acute myocardial infarction within 6 months from Day 1 of study treatment administration, or New York Heart Association Class III or IV congestive heart failure\n* Has a known history of human immunodeficiency virus (HIV) infection. Well-controlled HIV with anti-retroviral therapy (ART) is not excluded\n* Has a known history of Hepatitis B (HPV) or known active Hepatitis C virus infection. Hepatitis B surface antigen (HBsAg) positive is eligible if on HBV antiviral therapy for at least 4 weeks and HBV viral load is undetectable prior to randomization\n* Has had major surgery \\\u003C3 weeks before the first dose of study treatment\n* Is expected to require any other form of antineoplastic therapy while on study\n* Has a history or current evidence of a gastrointestinal (GI) condition (e.g. inflammatory bowel disease, Crohn's disease, ulcerative colitis) or impaired liver function or diseases that in the opinion of the investigator may significantly alter the absorption or metabolism of oral medications\n* Is getting chemotherapy and has clinically active diverticulitis, intra-abdominal abscess, GI obstruction, or peritoneal carcinomatosis\n* Has preexisting neuropathy that is moderate in intensity\n* Has received prior systemic cytotoxic chemotherapy or other targeted or biological antineoplastic therapy for metastatic disease\n* Is unable or unwilling to take folic acid or vitamin B12 supplementation, for participants who will receive pemetrexed\n* Has a known sensitivity to any component of carboplatin, paclitaxel, pemetrexed or any of their excipients\n* Has received prior radiation therapy to the lung that is \\>30 Gray (Gy) within 6 months of the first dose of study treatment\n* Has received a live vaccine within 30 days before the first dose of study treatment. Any licensed COVID-19 vaccine (including for Emergency Use) in a particular country is allowed as long as they are messenger ribonucleic acid (mRNA) vaccines, adenoviral vaccines, or inactivated vaccines. Investigational vaccines (ie, those not licensed or approved for Emergency Use) are not allowed\n* Has received any prior immunotherapy and was discontinued from that treatment due to a severe or worse immune-related adverse event (irAE)\n* Has had chemotherapy or biological cancer therapy within 4 weeks before the first dose of study treatment or has not recovered to Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 or better from the AEs due to cancer therapeutics administered more than 4 weeks before the first dose of study treatment (including participants who had previous immunomodulatory therapy with residual irAEs)\n* Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks before the first dose of study treatment\n* Previously had a severe hypersensitivity reaction to treatment with monoclonal antibodies (including pembrolizumab) and\u002For any of their excipients\n* Has had an allogenic tissue\u002Fsolid organ transplant",{"count":436,"type":21},450,[264,90],"The purpose of this study is to assess the efficacy and safety of pembrolizumab (MK-3475) with or without chemotherapy in combination with vibostolimab (MK-7684), boserolimab (MK-5890), MK-4830, MK-0482, I-DXd, or HER3-DXd in treatment-naïve participants with advanced squamous or non-squamous NSCLC.\n\nThis study is one of the pembrolizumab substudies being conducted under one pembrolizumab umbrella master protocol (MK-3475-U01\u002FKEYMAKER-U01).",[27],[29,441],"Programmed Death-Ligand 1 (PDL1, PD-L1)","2026-07-29",{"date":361,"type":37},{"date":445,"type":37},"2019-12-19",{"date":447,"type":21},"2032-10-13",{"name":43,"class":44},46,{"id":451,"slug":452,"hasResults":12,"nctId":453,"briefTitle":454,"officialTitle":455,"acronym":4,"eligibilityCriteria":456,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":457,"targetDuration":4,"studyType":212,"phases":4,"briefSummary":459,"conditions":460,"keywords":461,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":364,"lastUpdatePostDateStruct":462,"startDateStruct":463,"completionDateStruct":464,"leadSponsor":466,"locationsCount":467},"100375232","keymaker-u01-umbrella-master-study-studies-of-investigational-agents-with-either-pembrolizumab-mk-3475-alone-or-with-pembrolizumab-plus-chemotherapy-in-participants-with-non-small-cell-lung-cancer-nsclc-mk-3475-u01keymaker-u01-100375232","NCT04165798","KEYMAKER-U01 Umbrella Master Study: Studies of Investigational Agents With Either Pembrolizumab (MK-3475) Alone or With Pembrolizumab PLUS Chemotherapy in Participants With Non-small Cell Lung Cancer (NSCLC) (MK-3475-U01\u002FKEYMAKER-U01)","KEYMAKER-U01 Master Study: A Phase 1\u002F2, Umbrella Study With Rolling Arms of Investigational Agents, Pembrolizumab, and Chemotherapy, Alone or in Combination, in Participants With Non-small Cell Lung Cancer (NSCLC)","Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Has histologically- or cytologically-confirmed diagnosis of Stage IV squamous or nonsquamous NSCLC\n* Has measurable disease per Response Evaluation Criteria in Solid Tumors version 1.1\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Has an active autoimmune disease that has required systemic treatment in the past 2 years\n* Has a history of (noninfectious) pneumonitis\u002Finterstitial lung disease that required steroids or has current pneumonitis\u002Finterstitial lung disease\n* Has an active infection requiring systemic therapy",{"count":458,"type":21},1065,"This study is referred to as the \"umbrella master protocol\" for pembrolizumab (MK-3475) in the treatment of non-small cell lung cancer (NSCLC). This pembrolizumab NSCLC umbrella master protocol uses a platform design and consists of this master screening study and additional substudies. Each substudy will enroll a different population of NSCLC participants.",[27],[29,441],{"date":361,"type":37},{"date":445,"type":37},{"date":465,"type":21},"2032-02-13",{"name":43,"class":44},47,{"id":469,"slug":470,"hasResults":12,"nctId":471,"briefTitle":472,"officialTitle":473,"acronym":474,"eligibilityCriteria":475,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":476,"targetDuration":4,"studyType":22,"phases":478,"briefSummary":479,"conditions":480,"keywords":487,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":518,"lastUpdatePostDateStruct":519,"startDateStruct":521,"completionDateStruct":523,"leadSponsor":525,"locationsCount":369},"100619019","phase-1-intratumoral-n17350-in-advanced-solid-tumors-100619019","NCT07339176","Intratumoral N17350 in Advanced Solid Tumors","A Phase 1\u002F2 Open-Label, Dose Finding and Expansion Study to Investigate the Safety and Effectiveness and Determination of the Optimal Dose of N17350 Administered Intratumorally in Participants With Advanced Solid Tumors","OP-NEU-101","Inclusion Criteria:\n\n1. Age ≥18 years (or legal age of consent in the study jurisdiction).\n2. Able to provide written informed consent and willing\u002Fable to comply with study procedures, visits, and follow-up.\n3. Advanced solid tumor malignancy (excluding lymphoma and other hematologic malignancies), with disease that has progressed on, is intolerant of, or is ineligible for standard therapies known to provide clinical benefit, or for whom no standard therapy is available.\n4. ECOG performance status 0-1.\n5. Measurable disease per IT-RECIST (Parts A1\u002FA2) and RECIST v1.1 (Part A3), as applicable.\n6. At least one injectable tumor lesion, meeting superficial or visceral criteria and deemed safe\u002Faccessible for injection:\n\n   1. Superficial lesions: ≥10 mm in longest diameter (or multiple lesions each ≥5 mm with aggregate longest diameter ≥10 mm), and ≤80 mm, accessible for direct injection (± ultrasound guidance).\n   2. Visceral lesions: ≥10 mm and ≤50 mm in longest diameter, accessible for direct injection.\n   3. Injected lesions must not involve\u002Fencase major blood vessels or otherwise pose an unacceptable bleeding\u002Fvascular risk, per investigator assessment and imaging review (as applicable).\n   4. Expansion (Part A3): at least 1 measurable lesion and at least 1 additional injectable lesion suitable for injection.\n7. Adequate recovery from prior therapy: toxicities from prior anticancer treatment resolved to Grade ≤1 or baseline (except alopecia, controlled endocrine toxicities, or other stable toxicities as allowed per protocol\u002Fsponsor).\n8. Adequate organ function, including hepatic, renal, and coagulation parameters per protocol-defined thresholds.\n9. Adequate bone marrow function without transfusion support within 7 days prior to enrollment, per protocol-defined thresholds.\n10. Tumor tissue requirements: willingness to provide a pre-treatment tumor biopsy and on-study post-treatment biopsy, if an accessible lesion is available and safe for biopsy, and biopsy does not interfere with injection\u002Fresponse assessment; and\u002For availability of archival tumor tissue (obtained within 2 years prior to treatment), per protocol.\n11. Contraception requirements: participants of reproductive potential agree to use effective contraception and avoid pregnancy\u002Ffathering children from screening through 30 days after last dose; women of childbearing potential must have a negative pregnancy test within 14 days prior to first dose, per protocol.\n\nExclusion Criteria:\n\n1. Serious psychiatric, medical, or other condition that would interfere with study participation or protocol procedures, in the investigator's judgment.\n2. History of solid organ transplant.\n3. Alpha-1 antitrypsin deficiency.\n4. Hereditary or acquired bleeding disorder\u002Fcoagulation factor deficiency.\n5. Active autoimmune disease requiring systemic treatment within the past 6 months, except clinically stable autoimmune conditions in remission not requiring systemic therapy (per protocol).\n6. Baseline QTcF \\>480 ms.\n7. Pregnant or breastfeeding.\n8. Prior severe immune-mediated adverse event (imAE) from immunotherapy: ≥Grade 3 imAE within the past 16 weeks, any Grade 4 life-threatening imAE, or any neurologic\u002Focular AE of any grade (except controlled endocrine AEs on stable replacement therapy per protocol).\n9. Another active malignancy (current or within the past 2 years) other than the disease under study, except specified low-risk cancers treated with curative intent or under active surveillance (per protocol).\n10. Recent anticancer therapy: receipt of systemic anticancer therapy (including investigational agents) within 2 weeks prior to first dose (or 4 weeks for monoclonal antibodies\u002FADCs\u002Fother long half-life biologics), or within 5 half-lives, whichever is shorter.\n11. Recent radiotherapy within 2 weeks prior to first dose.\n12. Unresolved toxicity from prior anticancer therapy to \\>Grade 1 or not at baseline (except Grade ≤2 neuropathy and other allowed exceptions per protocol).\n13. Uncontrolled or unstable brain metastases (eligible only if neurologically stable for ≥4 weeks, and off steroids or on stable\u002Fdecreasing steroids ≤10 mg\u002Fday prednisone equivalent; carcinomatous meningitis excluded).\n14. Active infection requiring systemic antibacterial, antifungal, or antiviral therapy within 14 days prior to first dose.\n15. Chronic viral infections not meeting protocol criteria:\n\n    1. HBV with detectable DNA unless on appropriate antiviral therapy\n    2. Active HCV with detectable HCV RNA (treated HCV permitted if RNA undetectable)\n    3. HIV infection with CD4+ count \\\u003C300\u002FμL, detectable viral load, or HIV-related illness within 6 months\n16. Use of systemic anticoagulants (e.g., warfarin, LMWH, DOACs) within 14 days prior to first dose.\n17. Chronic systemic corticosteroids \\>10 mg\u002Fday prednisone equivalent, or systemic immunosuppressive\u002Fanti-inflammatory medications within 4 weeks prior to first dose, except permitted topical\u002Finhaled\u002Flocal formulations or short courses for premedication per protocol.\n18. Known allergy\u002Fhypersensitivity to N17350 or any excipients.",{"count":477,"type":21},275,[264,90],"The goal of this clinical trial is to learn if N17350 works to treat advanced solid tumors in adults. It will also learn about the safety of N17350 and help determine the best dose to use in future studies.\n\nThe main questions it aims to answer are:\n\n1. Does N17350 cause tumors to shrink or stop growing in some participants with advanced solid tumors?\n2. Are there any side effects for participants when taking N17350?\n3. What is the safest dose of N17350 and the dose that should be used for further study?\n4. Researchers will give N17350 directly into tumor lesions using a needle (intratumoral injection). This is an open-label study, meaning all participants will receive N17350 and there is no placebo.\n\nParticipants will:\n\n1. Receive injections of N17350 into tumor lesions every second week for 8 or 12 weeks\n2. Visit the clinic regularly for checkups, blood tests, and monitoring for side effects\n3. Have imaging scans (such as CT or MRI) to measure tumors and assess response\n4. Provide blood samples and, when required, tumor samples to help researchers understand how N17350 affects the tumor and the immune system",[481,482,483,484,485,486,27],"Neoplasms, Solid Tumor","Breast Neoplasms, Triple-Negative","Squamous Cell Carcinoma of Skin","Melanoma","Head and Neck Neoplasms","Carcinoma, Squamous Cell",[488,489,490,491,492,493,494,495,496,497,498,499,500,501,484,502,503,474,504,505,506,507,508,509,510,511,512,513,514,515,516,517],"N17350","Intratumoral injection","Intralesional injection","Dose escalation","Dose finding","Dose expansion","Phase 1","Open-label","Safety","Tolerability","Biomarkers","Advanced solid tumors","Triple-negative breast cancer","Cutaneous squamous cell carcinoma","Head and neck squamous cell carcinoma","Non-small cell lung cancer","Onchilles","Onchilles Pharma","ELANE","Phase 2","ELANE pathway","TNBC","cuSCC","HNSCC","SCCHN","metastatic","elastase","therapeutic elastase","neutrophil elastase","New cancer therapy","2026-07-24",{"date":520,"type":37},"2026-07-27",{"date":522,"type":37},"2026-05-25",{"date":524,"type":21},"2029-11",{"name":526,"class":44},"Onchilles Pharma Inc",{"id":528,"slug":529,"hasResults":12,"nctId":530,"briefTitle":531,"officialTitle":532,"acronym":4,"eligibilityCriteria":533,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":534,"targetDuration":4,"studyType":22,"phases":536,"briefSummary":537,"conditions":538,"keywords":540,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":547,"lastUpdatePostDateStruct":548,"startDateStruct":550,"completionDateStruct":552,"leadSponsor":554,"locationsCount":555},"100610416","phase-1-symbiotic-lung-20-a-study-to-learn-about-the-study-medicine-called-pf-08634404-in-combination-with-different-anticancer-agents-in-advanced-cancers-100610416","NCT07227298","Symbiotic-Lung-20: A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Different Anticancer Agents in Advanced Cancers","AN INTERVENTIONAL OPEN-LABEL PHASE 1B\u002F2 STUDY TO EVALUATE THE SAFETY, PHARMACOKINETICS, AND PRELIMINARY EFFICACY OF PF-08634404 IN COMBINATION WITH DIFFERENT ANTICANCER AGENTS IN PARTICIPANTS WITH ADVANCED SOLID TUMORS","Inclusion Criteria:\n\n* Pathologically confirmed locally advanced (Stage IIIB\u002FIIIC) or metastatic (Stage IV) squamous or non-squamous NSCLC and are not a candidate for complete surgical resection and curative concurrent\u002Fsequential chemoradiotherapy\n* PD-L1 status available\n* Part B only: PD-L1 ≥ TPS 1%\n* Measurable disease based on RECIST v1.1 per investigator.\n* Eastern Cooperative Oncology Group performance status of 0 or 1.\n* Adequate organ function\n\nExclusion Criteria:\n\n* Participants with known AGAs including EGFR, ALK and ROS1, NTRK, BRAF, and MET\n* History of another malignancy within 3 years before the first dose of study intervention, or any evidence of residual disease from a previously diagnosed malignancy\n* Known active CNS lesions, including brainstem, meningeal, or spinal cord metastases or compression\n* Leptomeningeal disease\n* Active autoimmune diseases requiring systemic treatment within the past 2 years\n* Previous systemic anti-tumor therapy for locally advanced, unresectable, or metastatic NSCLC\n* Previous treatment with immunotherapy (exception is (neo)adjuvant anti-PD-(L)1), ADCs containing MMAE payload, systemic anti-angiogenic therapy, or prior radiotherapy to the lung within 6 months of first dose of study intervention",{"count":535,"type":21},162,[264,90],"This study is being done to learn more about a new medicine called PF-08634404 and how it works when used with other cancer medicines in people who have advanced solid tumors. An advanced solid tumor is a type of cancer that has spread beyond its original location and cannot be removed by surgery or cured with standard treatments.\n\nTo join in the study, participants must:\n\n* Be 18 years or older\n* Participants with advanced non-small cell lung cancer (NSCLC), a type of lung cancer that has spread\n\nThe study will look at:\n\n* Whether PF-08634404 is safe to use with other cancer medicines.\n* What side effects may happen. A side effect is anything the medicine does to your body that is not part of treating your disease.\n* Whether the combination of PF-08634404 and other cancer medicines can help treat solid tumors.\n\nThe study has different parts, each testing PF-08634404 with a different cancer medicine:\n\n* Part A will test PF-08634404 with a medicine called sigvotatug vedotin.\n* Part B of the study will look at how well the new medicine PF-08634404 works when used together with another medicine.\n\nParticipants will receive the study medicines through an intravenous (IV) infusion (injected into the vein) at the study clinic. All treatments will take place at clinical trial sites, where trained medical staff will monitor participants during and after each visit.",[539,331,59],"Advanced\u002FMetastatic Non-Small Cell Lung Cancer",[541,186,542,543,544,545,546],"non-small cell lung cancer","advanced solid tumors","metastatic non-small cell lung cancer","locally advanced non-small cell lung cancer","squamous non-small cell lung cancer","non-squamous non-small cell lung cancer","2026-07-21",{"date":549,"type":37},"2026-07-22",{"date":551,"type":37},"2026-01-30",{"date":553,"type":21},"2033-08-23",{"name":76,"class":44},73,{"id":557,"slug":558,"hasResults":12,"nctId":559,"briefTitle":560,"officialTitle":561,"acronym":4,"eligibilityCriteria":562,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":563,"targetDuration":4,"studyType":22,"phases":565,"briefSummary":566,"conditions":567,"keywords":580,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":547,"lastUpdatePostDateStruct":600,"startDateStruct":601,"completionDateStruct":603,"leadSponsor":605,"locationsCount":88},"100599900","phase-1-a-study-to-learn-about-the-study-medicine-called-pf-08046876-in-people-with-advanced-solid-tumors-100599900","NCT07090499","A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors","A Phase 1 Open-label Study to Investigate PF-08046876 in Adult Participants With Advanced Solid Tumors.","Inclusion Criteria:\n\n* 18 years of age or older\n* Advanced cancer of the bladder, lung, head and neck, esophagus, or pancreas\n* Measurable disease\n* ECOG Performance status 0-1\n* Part 1: progression or relapse following standard treatments\n* Part 2: maximum of 2 prior lines of systemic therapy in the advanced setting\n* Resolution of acute effects of prior anticancer therapy to baseline or Grade 1\n* Consent to submit required pre-treatment tumor tissue as medically feasible\n\nExclusion criteria:\n\n* Received prior treatment with an antibody drug conjugate with a camptothecin-class payload (e.g. sacituzumab govitecan, trastuzumab deruxtecan )\n* Active anorexia, nausea or vomiting, and\u002For signs of intestinal obstruction meeting protocol exclusion\n* Pulmonary disease meeting protocol exclusion\n* Other unacceptable abnormalities as defined by protocol",{"count":564,"type":21},310,[264],"The purpose of the study is to explore the safety and effects of the study drug (PF-08046876) in people diagnosed with advanced cancer of the bladder, lung, head and neck, esophagus, or pancreas. PF-08046876 is an investigational anticancer therapy called an 'antibody drug conjugate' or 'ADC'. ADCs are anticancer drugs designed to stick to cancer cells and kill them.\n\nThe study drug will be given to participants through a needle in a vein (intravenous infusion). This study includes multiple parts. In the first part of the study, there will be different groups of people receiving different doses of the study drug. The study may also test different schedules.",[568,569,570,58,571,572,573,574,575,576,577,578,579],"Advanced\u002FMetastatic Solid Tumors","Bladder Cancer","Urothelial Carcinoma","Carcinoma, Non Small Cell Lung","Carcinoma, Squamous Cell of Head and Neck","Head and Neck Cancer","Esophageal Cancer","Gastroesophageal Junction Adenocarcinoma","Esophageal Squamous Cell Carcinoma","Esophageal Adenocarcinoma","Pancreatic Adenocarcinoma","Pancreatic Cancer",[581,582,583,584,585,586,541,186,587,511,512,588,589,590,591,592,593,594,595,596,597,598,599],"B6C","integrin beta 6","ADC","antibody drug conjugate","bladder cancer","urothelial carcinoma","head and neck cancer","esophageal cancer","EC","esophageal squamous cell carcinoma","gastroesophageal junction adenocarcinoma","pancreatic cancer","PDAC","pancreatic adenocarcinoma","esophageal adenocarcinoma","lung adenocarcinoma","lung squamous cell carcinoma","integrin alpha-v beta-6 receptor","ITGB6",{"date":549,"type":37},{"date":602,"type":37},"2025-08-20",{"date":604,"type":21},"2029-07-08",{"name":76,"class":44},{"id":607,"slug":608,"hasResults":12,"nctId":609,"briefTitle":610,"officialTitle":611,"acronym":612,"eligibilityCriteria":613,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":614,"targetDuration":4,"studyType":22,"phases":616,"briefSummary":617,"conditions":618,"keywords":619,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":547,"lastUpdatePostDateStruct":620,"startDateStruct":621,"completionDateStruct":623,"leadSponsor":625,"locationsCount":626},"100574370","phase-3-this-is-a-study-to-learn-about-how-the-combination-of-the-study-medicines-sigvotatug-vedotin-plus-pembrolizumab-works-in-people-with-non-small-cell-lung-cancer-with-high-levels-of-pd-l1-100574370","NCT06758401","This is a Study to Learn About How the Combination of the Study Medicines Sigvotatug Vedotin Plus Pembrolizumab Works in People With Non-small Cell Lung Cancer With High Levels of PD-L1.","AN OPEN-LABEL, RANDOMIZED, CONTROLLED PHASE 3 STUDY OF SIGVOTATUG VEDOTIN IN COMBINATION WITH PEMBROLIZUMAB COMPARED WITH PEMBROLIZUMAB MONOTHERAPY AS FIRST-LINE TREATMENT IN PARTICIPANTS WITH PD-L1 HIGH (≥50% OF TUMOR CELLS EXPRESSING PD-L1), LOCALLY ADVANCED, UNRESECTABLE, OR METASTATIC NON-SMALL CELL LUNG CANCER (BE6A LUNG-02)","Be6A Lung-02","Inclusion Criteria:\n\n1. Participants must meet the following criteria:\n\n   1. Have pathologically confirmed Stage IIIB or IIIC NSCLC and not be a candidate for surgical resection or definitive chemoradiation, or Stage IV NSCLC per the AJCC Staging Manual (Version 8.0) and the UICC Staging System (Eighth edition).\n   2. Participants with non-squamous histology must have documented negative test results for EGFR, ALK, and ROS1 AGAs and no known AGAs in NTRK, BRAF, RET, MET, or other AGAs with approved front-line therapies per local standard of care.\n   3. Large cell neuroendocrine carcinoma is excluded.\n   4. Candidate for treatment with pembrolizumab monotherapy per local guidelines.\n2. Tumor has PD-L1 expression in ≥50% of tumor cells (TPS ≥50%) as determined by local testing\n3. Measurable disease based on RECIST v1.1 per investigator.\n4. Resolution of acute effects of any prior therapy to either baseline severity or NCI CTCAE Grade 1 or less (except for AEs not constituting a safety risk in the investigator's judgment), unless otherwise excluded.\n\nExclusion Criteria:\n\n1. Life expectancy of \\\u003C3 months in the opinion of the investigator.\n2. Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation\u002Fbehavior or laboratory abnormality that may increase the risk of study participation or make the participant inappropriate for the study.\n3. Participants with any history of another malignancy within 3 years before the first dose of study intervention, or any evidence of residual disease from a previously diagnosed malignancy.\n4. Known or suspected hypersensitivity, intolerance, or contraindication to any excipient contained in the drug formulation of sigvotatug vedotin or pembrolizumab.\n5. Participants with any of the following respiratory conditions:\n\n   1. Evidence of noninfectious or drug-induced ILD or pneumonitis\n   2. Known DLCO (adjusted for hemoglobin) \\\u003C50% predicted.\n   3. Grade ≥3 pulmonary disease unrelated to underlying malignancy\n6. Known active CNS lesions are excluded. Participants with definitively treated brain metastases (surgery and\u002For radiotherapy) may be eligible. Clinically inactive brain metastases of longest diameter \\\u003C0.5 cm are permitted.\n7. Major surgery (defined as a surgery requiring inpatient hospitalization of at least 48 hours) within 21 days or minor surgery within 7 days prior to first dose of study intervention.\n8. Receipt of a live vaccine within 30 days prior to first dose of study intervention.\n9. Pre-existing peripheral neuropathy Grade ≥2 per NCI CTCAE v5.0.\n10. Uncontrolled diabetes mellitus, defined as HbA1c ≥8.0% or HbA1c between 7.0% and 8.0% with associated diabetes symptoms (polyuria or polydipsia) that are not otherwise explained.\n11. Prior immune-related AE that led to anti-PD-(L)1 treatment discontinuation, required a high-dose steroid taper (≥0.5 mg\u002Fkg prednisone or equivalent per day) for \\>2 weeks, or required treatment with systemic immunosuppressive therapy.\n12. History of autoimmune disease that has required systemic treatment in the past 2 years\n13. Participants with prior solid organ or bone marrow transplantation.\n14. Currently receiving a high-dose steroid (\\>10 mg prednisone or equivalent per day) or other immune suppressant or has a condition requiring a chronic high-dose steroid or immune suppressant.\n15. Prior and concomitant therapy:\n\n    1. Any prior treatment with MMAE-derived drugs or IB6 targeting agents.\n    2. Prior systemic therapy, including anti-PD-(L)1 therapy, for locally advanced, unresectable, or metastatic NSCLC.\n\n       * (Neo)adjuvant anti-PD-(L)1 is allowed if recurrence or progression occurred ≥9 months after the last dose.\n       * Other (neo)adjuvant or definitive therapy is allowed if recurrence or progression occurred ≥6 months after the last dose.\n    3. Prior radiotherapy to the lung within 6 months of first dose of study intervention, referencing the last date radiotherapy was received.\n    4. Chemotherapy, biologics, and\u002For other antitumor treatment with immunotherapy not specifically prohibited that is completed less than 4 weeks prior to first dose of study intervention, or 2 weeks for palliative radiotherapy.\n    5. Any prior therapy with an immune-oncology agent directed to a stimulatory or co-inhibitory T-cell receptor\n16. History of or current ongoing infection, including participants positive for active HIV, HBV, or HCV.\n17. Severe uncontrolled cardiac or cerebrovascular condition within the previous 6 months",{"count":615,"type":21},714,[24],"The purpose of the study is to compare how the new combination treatment (Sigvotatug Vedotin plus pembrolizumab) works compared to pembrolizumab alone in patients with non-small cell lung cancer (NSCLC) with high levels of PD-L1. This is a protein that acts as a kind of \"brake\" to keep the body's immune responses under control.\n\nThe study is seeking for participants who:\n\n* Are confirmed to have NSCLC (Stage 3 or 4).\n* Have PD-L1 levels in more than 50% of the cancer cells.\n\nAll participants in this study will receive pembrolizumab at the study clinic once every 6 weeks as an intravenous (IV) infusion (give directly into a vein). In addition, half of the participants will also receive Sigvotatug Vedotin once every 2 weeks as an IV infusion in addition to receiving pembrolizumab.\n\nParticipants may receive pembrolizumab for up to about two years. Those participants taking Sigvotatug Vedotin can continue until their NSCLC is no longer responding. The study team will monitorsee how each participant is doing with the study treatment during regular visits at the clinic.",[59,27,60],[62,27,59],{"date":549,"type":37},{"date":622,"type":37},"2025-07-23",{"date":624,"type":21},"2029-03-01",{"name":76,"class":44},372,{"id":628,"slug":629,"hasResults":12,"nctId":630,"briefTitle":631,"officialTitle":632,"acronym":4,"eligibilityCriteria":633,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":634,"targetDuration":4,"studyType":22,"phases":636,"briefSummary":637,"conditions":638,"keywords":642,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":547,"lastUpdatePostDateStruct":648,"startDateStruct":649,"completionDateStruct":651,"leadSponsor":653,"locationsCount":655},"100526215","phase-1-a-study-of-sgn-ceacam5c-in-adults-with-advanced-solid-tumors-100526215","NCT06131840","A Study of SGN-CEACAM5C in Adults With Advanced Solid Tumors","An Open-label Phase 1 Study to Investigate PF-08046050 (SGN-CEACAM5C) in Adults With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Tumor type:\n\n   * Participants in Part A (dose escalation) and Part B (dose optimization) must have histologically- or cytologically-confirmed metastatic or unresectable solid tumor malignancy. Must have relapsed, refractory, or progressive disease, and should have no appropriate standard therapy available.\n\n     * Participants in Part A must have one of the following tumor types: colorectal cancer (CRC); gastric carcinoma (GC) or gastroesophageal junction adenocarcinoma (GEJ); non-small cell lung cancer (NSCLC); or pancreatic ductal adenocarcinoma (PDAC).\n     * The tumor types to be enrolled in Part B will be identified by the sponsor from among those specified in Part A.\n   * Participants in Part C (dose expansion) must have one of the following histologically- or cytologically-confirmed metastatic or unresectable solid tumor malignancies.\n\n     * CRC (adenocarcinoma of the colon or rectum) and must have received no more than 2 prior chemotherapy regimens for the treatment of advanced colorectal cancer and evidence of either progressive disease or intolerance to their last regimen.\n     * PDAC with one or more metastatic lesions measurable by computed tomography\u002Fmagnetic resonance imaging according to RECIST v1.1 criteria; and must have received no more than 1 prior chemotherapy regimen for the treatment of advanced PDAC and evidence of either progressive disease or intolerance to that regimen.\n     * GC or GEJ and must have received prior platinum and fluoropyrimidine-based chemotherapy.\n     * NSCLC and must have received platinum-based therapy. If eligible and consistent with local standard of care must have received a PD-1\u002FPD-L1 inhibitor. In addition, participants with tumor genomic mutations\u002Falterations for which approved targeted therapies are available per local standard of care, must have received such therapies.\n     * Small cell lung cancer (SCLC) and must have received platinum-based therapy for extensive-stage disease and no more than 3 prior lines of therapy. If eligible and consistent with local standard of care must have received a PD 1\u002FPD-L1 inhibitor.\n   * CRC participants in Part D and Part E (bevacizumab combination therapy) must have histologically confirmed unresectable or metastatic adenocarcinoma of the colon or rectum. Received a maximum of 2 prior chemotherapy regimens for the treatment of advanced colorectal cancer and had demonstrated progressive disease or intolerance to their last regimen.\n   * CRC participants in Part D and Part E (5FU\u002FLV + bevacizumab and 5FU\u002FLV + oxaliplatin + bevacizumab combination therapy) must have histologically confirmed unresectable or metastatic adenocarcinoma of the colon or rectum. Must not have received a prior TOPO1 inhibitor (such as irinotecan or nanoliposomal irinotecan) in any setting. 1L cohorts: No prior chemotherapy for advanced disease. 2L cohorts (applicable to 5FU\u002FLV + bevacizumab combination only): 1 prior chemotherapy regimen for the treatment of advanced disease, which must have included a fluoropyrimidine and oxaliplatin.\n\n   \\> 2L PDAC participants in Part E (5FU\u002FLV combination therapy) must have histologically or cytologically confirmed metastatic pancreatic ductal adenocarcinoma. One or more metastatic lesions measurable by computed tomography\u002Fmagnetic resonance imaging according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria.\n\n   \\> 1L PDAC participants in Part E (5FU\u002FLV + oxaliplatin combination therapy) must have histologically or cytologically confirmed metastatic pancreatic ductal adenocarcinoma that has not been previously treated in the metastatic setting. One or more metastatic lesions measurable by computed tomography\u002Fmagnetic resonance imaging according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria. No prior chemotherapy for PDAC with the following exception: Patients who received adjuvant\u002Fneoadjuvant chemotherapy and who had recurrence more than 12 months after completion of adjuvant\u002Fneoadjuvant chemotherapy are eligible.\n2. Participants enrolled in the following study parts should have a tumor site that is accessible for biopsy(ies) and agree to biopsy(ies) and\u002For submission of archival tissue:\n\n   * Monotherapy dose optimization (Part B)\n   * Monotherapy (Part C) and combination therapy (Part E) disease-specific expansion cohorts\n3. An Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1\n4. Measurable disease per Response Evaluation in Solid Tumors (RECIST) v1.1 at baseline.\n\nExclusion Criteria:\n\n1. Previous exposure to CEACAM5-targeted therapy.\n2. Prior treatment with a TOPO1-targeting ADC (CPT payload), such as Enhertu (trastuzumab deruxtecan) or Trodelvy (sacituzumab govitecan).\n3. History of another malignancy within 3 years before the first dose of study intervention, or any evidence of residual disease from a previously diagnosed malignancy.\n4. Active cerebral\u002Fmeningeal disease related to the underlying malignancy. Participants with a history of cerebral\u002Fmeningeal disease related to the underlying malignancy are allowed if prior central nervous system disease has been treated and the participant is clinically stable (defined as not having received steroid treatment for symptoms related to cerebral\u002Fmeningeal disease for at least 2 weeks prior to enrollment and with no ongoing related AEs).\n\n   \\> Criteria related to bevacizumab administration (participants in Parts D and E)\n5. History of allergic reactions or hypersensitivity to bevacizumab or any of its excipients.\n6. History of hypersensitivity to Chinese Hamster Ovary cell products or other recombinant human or humanized antibodies.\n7. Serious non-healing wound, non-healing ulcer, or non-healing bone fracture.\n8. Deep venous thromboembolic event within 4 weeks prior to enrollment\n9. Known coagulopathy that increases risk of bleeding, bleeding diatheses.\n10. History of any life-threatening VEGF-related adverse event",{"count":635,"type":21},914,[264],"This clinical trial is studying advanced solid tumors. Solid tumors are cancers that start in a part of your body like your lungs or liver instead of your blood. Once tumors have grown bigger in one place but haven't spread, they're called locally advanced. If your cancer has spread to other parts of your body, it's called metastatic. When a cancer has gotten so big it can't easily be removed or has spread to other parts of the body, it is called unresectable. These types of cancer are harder to treat.\n\nParticipants in this study must have cancer that has come back or did not get better with treatment. Participants must have a solid tumor cancer that can't be treated with standard of care drugs.\n\nThis clinical trial uses an experimental drug called PF-08046050. PF-08046050 is a type of antibody-drug conjugate or ADC. ADCs are designed to stick to cancer cells and kill them. They may also stick to some normal cells.\n\nThis study will test the safety of PF-08046050 in participants with solid tumors that are hard to treat or have spread throughout the body.\n\nThis study has 5 different study parts. Part A and Part B of the study will find out how much PF-08046050 should be given to participants. Part C will use the information from Parts A and B to see if PF-08046050 is safe and if it works to treat certain solid tumor cancers. Part D and E of the study, together with information from Parts A and B, will find out how much PF-08046050 should be given in combination with other anti-cancer agents. Part E will use the information from Parts A, B, and D to see if PF-08046050 is safe in combination with other anti-cancer agents and if it works to treat a certain solid tumor.",[105,27,639,640,575,641],"Stomach Neoplasms","Pancreatic Ductal Adenocarcinoma","Small Cell Lung Carcinoma",[643,186,593,644,645,646,647],"CRC","GC","GEJ","SCLC","Seattle Genetics",{"date":549,"type":37},{"date":650,"type":37},"2023-11-20",{"date":652,"type":21},"2030-09-12",{"name":654,"class":44},"Seagen, a wholly owned subsidiary of Pfizer",48,{"id":657,"slug":658,"hasResults":12,"nctId":659,"briefTitle":660,"officialTitle":661,"acronym":4,"eligibilityCriteria":662,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":663,"targetDuration":4,"studyType":22,"phases":664,"briefSummary":665,"conditions":666,"keywords":672,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":547,"lastUpdatePostDateStruct":678,"startDateStruct":679,"completionDateStruct":681,"leadSponsor":683,"locationsCount":684},"100455301","phase-1-a-study-of-pf-08046054sgn-pdl1v-in-advanced-solid-tumors-100455301","NCT05208762","A Study of PF-08046054\u002FSGN-PDL1V in Advanced Solid Tumors","A Phase 1 Study of PF-08046054\u002FSGN-PDL1V in Advanced Solid Tumors","Inclusion Criteria:\n\n* Parts A and B:\n\n  * Participants must have one of the following histologically- or cytologically-confirmed metastatic or unresectable solid tumor types\n\n    * Non-small cell lung cancer (NSCLC)\n    * Head and neck squamous cell carcinoma (HNSCC) (except nasopharyngeal cancer)\n    * Esophageal squamous cell carcinoma (SCC)\n    * Triple negative breast cancer (TNBC)\n  * Participants must have disease that is relapsed or refractory, that has progressed on approved therapies, be intolerant to or refused such therapies, or such and therapies are contraindicated and in the judgement of the investigator, should have no appropriate SoC therapeutic option\n  * Participants must have PD-L1 expression based on historical testing\n* Part C:\n\n  * Participants must have disease that is relapsed or refractory or be intolerant to SoC therapies and must have one of the following tumor types\n\n    * HNSCC\n\n      * Participants with HNSCC must have histologically or cytologically-confirmed HNSCC\n    * NSCLC\n\n      * Participants must have histologically or cytologically-confirmed NSCLC. Participants with SCC and non--SCC histology are eligible. Note: Participants with a neuroendocrine component or histology are not eligible.\n    * Esophageal SCC\n    * Pancreatic cancer\n    * Hepatocellular carcinoma\n    * TNBC\n    * Gastric cancer\n    * Endometrial cancer\n  * Participants must have been previously tested for PD-L1 expression and should have PD-L1 expression ≥1 or \\\u003C1 by CPS or TPS based on historical testing\n* Part D and Part E:\n\n  * Participants must have histologically or cytologically-confirmed disease of the HNSCC or NSCLC\n  * Participants must have PD-L1 expression based on historical testing\n  * Participants with NSCLC; PD-L1 expression ≥ 1% by TPS\n  * Participants with HNSCC; PD--L1 expression ≥1 by CPS\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1\n* Measurable disease per RECIST v1.1 at baseline\n\nExclusion Criteria:\n\n* History of another malignancy within 3 years of first dose of study treatment or any evidence of residual disease from a previously diagnosed malignancy.\n* Known active central nervous system metastases. Participants with previously-treated brain metastases may participate provided they:\n\n  * Are clinically stable for at least 4 weeks prior to study entry after brain metastasis treatment\n  * Have no new or enlarging brain metastases\n  * And are off of corticosteroids prescribed for symptoms associate with brain metastases for at least 7 days prior to first dose of study treatment\n* Lepto-meningeal disease\n* Prior treatment with an anti-PD-L1 agent within less than 5 half-lives. This duration of time will vary according to the half-life of the specific agent.\n* Previous receipt of an monomethylauristatin E (MMAE)-containing agent.\n* Pre-existing neuropathy ≥Grade 2 per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.\n\nThere are additional inclusion criteria. The study center will determine if criteria for participations are met.",{"count":615,"type":21},[264],"This study will test the safety of a drug called PF-08046054\u002FSGN-PDL1V alone and with pembrolizumab in participants with solid tumors. It will also study the side effects of this drug. A side effect is anything a drug does to your body besides treating your disease.\n\nParticipants will have solid tumor cancer that has spread through the body (metastatic) or cannot be removed with surgery (unresectable).\n\nThis study will have five parts. Parts A and B of the study will find out how much PF-08046054\u002FSGN- PDL1V should be given to participants. Part C will use the dose found in Parts A and B to find out how safe PF-08046054\u002FSGN-PDL1V is and if it works to treat solid tumor cancers. In Part D and E, participants will be given PF-08046054\u002FSGN-PDL1V with pembrolizumab to find out how safe this combination is and if it works to treat solid tumor cancers.",[27,667,576,668,669,670,578,671],"Squamous Cell Carcinoma of the Head and Neck","Triple Negative Breast Neoplasms","Gastric Cancer","Endometrial Cancer","Hepatocellular Carcinoma",[503,186,502,511,673,509,674,647,675,593,676,76,677],"Triple Negative Breast Cancer","Gastric cancer","HCC","Esophageal","Endometrial",{"date":549,"type":37},{"date":680,"type":37},"2022-10-25",{"date":682,"type":21},"2029-01-04",{"name":654,"class":44},62,{"id":686,"slug":687,"hasResults":12,"nctId":688,"briefTitle":689,"officialTitle":690,"acronym":691,"eligibilityCriteria":692,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":693,"targetDuration":4,"studyType":22,"phases":695,"briefSummary":696,"conditions":697,"keywords":699,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":718,"lastUpdatePostDateStruct":719,"startDateStruct":721,"completionDateStruct":723,"leadSponsor":725,"locationsCount":726},"100525272","phase-3-a-study-of-first-line-olomorasib-ly3537982-and-pembrolizumab-with-or-without-chemotherapy-in-patients-with-advanced-kras-g12c-mutant-non-small-cell-lung-cancer-100525272","NCT06119581","A Study of First-Line Olomorasib (LY3537982) and Pembrolizumab With or Without Chemotherapy in Patients With Advanced KRAS G12C-Mutant Non-small Cell Lung Cancer","SUNRAY-01, A Global Pivotal Study in Participants With KRAS G12C-Mutant, Locally Advanced or Metastatic Non-Small Cell Lung Cancer Comparing First-Line Treatment of LY3537982 and Pembrolizumab vs Placebo and Pembrolizumab in Those With PD-L1 Expression ≥50% or LY3537982 and Pembrolizumab, Pemetrexed, Platinum vs Placebo and Pembrolizumab, Pemetrexed, Platinum Regardless of PD-L1 Expression","SUNRAY-01","Inclusion Criteria:\n\n* Histologically or cytologically confirmed NSCLC with Stage IIIB-IIIC or Stage IV disease, not suitable for curative intent radical surgery or radiation therapy.\n* Part B and Safety Lead-In Part B: the histology of the tumor must be predominantly non-squamous (in line with pemetrexed label).\n* Must have disease with evidence of KRAS G12C mutation.\n* Must have known programmed death-ligand 1 (PD-L1) expression\n\n  * Part A: Greater than or equal to (≥)50 percent (%).\n  * Part B: 0% to 100%.\n  * Part C: \\\u003C50%.\n* Must have measurable disease per RECIST v1.1.\n* Must have an ECOG performance status of 0 or 1.\n* Estimated life expectancy ≥12 weeks.\n* Ability to swallow capsules.\n* Must have adequate laboratory parameters.\n* Contraceptive use should be consistent with local regulations for those participating in clinical studies.\n* Women of childbearing potential must\n\n  * Have a negative pregnancy test.\n  * Not be breastfeeding during treatment\n\nExclusion Criteria:\n\n* Have a documented additional validated targetable oncogenic driver mutation or alteration in genes such as epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), BRAF (V600E), human epidermal growth factor receptor 2 (HER2), MET (exon 14), ROS1, rearranged during transfection (RET), or neurotrophic tyrosine receptor kinase (NTRK)1\u002F2\u002F3.\n* Have had any of the following prior to randomization:\n\n  \\-- Prior systemic therapy (chemotherapy, immunotherapy, targeted therapy, or biological therapy) for advanced or metastatic NSCLC.\n\n  \\--- 1 cycle of standard-of-care treatment prior to study enrollment will be allowed for cases where immediate treatment is clinically indicated:\n* Have known active central nervous system metastases and\u002For carcinomatous meningitis.\n\nExclusion Criteria for Participants receiving Pemetrexed and Platinum (Part B and Safety Lead-In Part B)\n\n* Have predominantly squamous cell histology for NSCLC\n* Only for participants with mild to moderate renal insufficiency: Unable to avoid aspirin, ibuprofen, or other nonsteroidal anti-inflammatory drugs (NSAIDs) two days before (5 days for long acting NSAIDs), day of, and two days after administration of pemetrexed\n* Is unable or unwilling to take folic acid or vitamin B12 supplementation.",{"count":694,"type":21},1264,[24],"The purpose of this study is to assess if adding LY3537982 (olomorasib) in combination with standard of care anti-cancer drugs is more effective than standard of care in participants with untreated advanced NSCLC. NSCLC must have a change in a gene called KRAS G12C. Study participation, including follow-up, could last up to 3 years, depending on how you and your lung cancer are doing.",[27,698],"Neoplasm Metastasis",[58,700,189,190,701,702,703,704,705,706,707,708,709,698,59,710,115,711,712,97,713,714,715,716,717],"KRAS G12 Lung Cancer","KRAS G12C inhibitor","KRAS G12C Positive","KRAS Mutation","KRAS G12 Mutation","Lung Cancer Mutation","Olomorasib","Lung Diseases","Neoplastic Processes","Pathologic Processes","Non-Small Cell Lung Cancer (NSCLC)","Respiratory Tract Neoplasms","Thoracic Neoplasms","Neoplasms","Respiratory Tract Diseases","Carcinoma, Bronchogenic","Bronchial Neoplasms","Lung Neoplasms","2026-07-17",{"date":720,"type":37},"2026-07-20",{"date":722,"type":37},"2023-12-21",{"date":724,"type":21},"2031-01",{"name":252,"class":44},419,{"id":728,"slug":729,"hasResults":12,"nctId":730,"briefTitle":731,"officialTitle":732,"acronym":4,"eligibilityCriteria":733,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":734,"enrollmentInfo":735,"targetDuration":4,"studyType":22,"phases":737,"briefSummary":738,"conditions":739,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":740,"lastUpdatePostDateStruct":741,"startDateStruct":742,"completionDateStruct":744,"leadSponsor":746,"locationsCount":748},"100606846","phase-1-a-study-evaluating-bat3306-compared-with-keytruda-in-nsclc-cancer-participants-100606846","NCT07180862","A Study Evaluating BAT3306 Compared With Keytruda® in NSCLC Cancer Participants","A Phase 1, Randomized, Double-blind Study to Compare the Pharmacokinetics, Between BAT3306 and Keytruda® (Pembrolizumab) in Participants With Stage IB-IIIA Non-small Cell Lung Cancer Following Complete Resection","Inclusion Criteria:\n\n* Participants must meet all of the following criteria:\n\n  1. Male or female, aged ≥18 and ≤75 years on the day of signing the Informed Consent Form (ICF);\n  2. Participants are able to give voluntary informed consent and understand the study and are willing to follow and complete all the test procedures;\n  3. Pathologically confirmed non-small cell lung cancer (NSCLC) after surgery, with a clear histological type and a pathology report provided;\n\nExclusion Criteria:\n\n* Participants who meet any of the following criteria will be excluded from the study:\n\n  1. Presence of EGFR gene mutation;\n  2. Pathological diagnosis of small cell lung cancer or mixed tumors with small cell components, large cell neuroendocrine carcinoma (LCNEC), or sarcomatoid tumors;\n  3. Have previously received any of the following treatments:\n\n     Have received \\> 4 cycles of adjuvant chemotherapy. Prior neoadjuvant therapy. Major surgery within 4 weeks prior to randomization (including surgery for the primary neoplasm, but excluding vascular access procedures), or expected to undergo major surgery during the study.\n\n     Use of Chinese herbal medicine with anti-tumor indications within 14 days prior to randomization.\n\n     Use of growth factor support therapy or have received a transfusion within 14 days prior to randomization.\n  4. Prior anti-tumor treatment with anti-PD-1, anti-PD-L1\u002F2, anti-CD137, CTLA-4 modulators, or any other immunomodulatory agents.\n  5. Severe acute or chronic infection, including any active infection requiring systemic anti-infective therapy within 2 weeks prior to randomization;","75 Years",{"count":736,"type":21},160,[264],"Comparing the PK similarity of BAT3306 and Keytruda; in NSCLC participants who were completely removed by surgery as an auxiliary treatment",[27],"2026-07-15",{"date":718,"type":37},{"date":743,"type":37},"2025-10-14",{"date":745,"type":21},"2027-11-30",{"name":747,"class":44},"Bio-Thera Solutions",1]