[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"nsclc-non-small-cell-lung-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:nsclc-non-small-cell-lung-cancer":28},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,47,0,25,[9,42,85,130,165,239,265,290,317,352,397,442,479,504,524,548,593,614,638,673,700,725,754,773,794],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100637847","phase-2-hypofractionated-chemoradiotherapy-with-tislelizumab-and-surufatinib-for-unresectable-stage-iii-nsclc-100637847",false,"NCT07609121","Hypofractionated Chemoradiotherapy With Tislelizumab and Surufatinib for Unresectable Stage III NSCLC","A Randomized Phase 2 Study of Hypofractionated Concurrent Chemoradiotherapy Combined With Tislelizumab and Surufatinib in Patients With Unresectable Stage III Non-Small Cell Lung Cancer","Inclusion Criteria:\n\n* Males or females aged 18 to 75 years or older;\n* Patients must have histologically or cytologically confirmed non-small cell lung cancer (NSCLC);\n* Unresectable Stage III disease according to AJCC 8th staging system;\n* Negative for known driver gene mutations；\n* Newly diagnosed patients or patients treated with ≤ 4 cycles of chemotherapy combined with or without immunotherapy;\n* Expected survival ≥ 12 weeks;\n* WHO Performance Status (PS) score of 0 or 1;\n* Female subjects must not be breastfeeding;\n* Women of childbearing potential (WOCBP) must agree to use contraception during the study treatment and for 5 months after the last dose of study drug (i.e., 30 days \\[one ovulation cycle\\] plus approximately five half-lives of the study drug);\n* Adequate organ and bone marrow function as defined by the following criteria:\n* Forced Expiratory Volume in 1 second (FEV1) ≥ 800 mL;\n* Absolute neutrophil count ≥ 1.5 × 10⁹\u002FL;\n* Platelets ≥ 100 × 10⁹\u002FL;\n* Hemoglobin ≥ 9.0 g\u002FdL;\n* Creatinine clearance ≥ 50 mL\u002Fmin as calculated by the Cockcroft-Gault formula (Cockcroft and Gault, 1976);\n* Serum bilirubin ≤ 1.5 × upper limit of normal (ULN);\n* AST and ALT ≤ 2.5 × ULN.\n\nExclusion Criteria:\n\n* Concurrent enrolment in another clinical study, unless it is an observational(non-interventional) clinical study;\n* Mixed small cell and non-small cell lung cancer histology;\n* Recent major surgery within 4 weeks prior to entry into the study (excluding the placement of vascular access;\n* Active or prior documented autoimmune disease within the past 2 years;\n* Active or prior documented inflammatory bowel disease (eg. Crohn's disease, ulcerative colitis);\n* History of primary immunodeficiency;\n* History of organ transplant that requires therapeutic immunosuppression;\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, active peptic ulcer disease or gastritis, active bleeding diatheses including any patient known to have hepatitis B, hepatitis C or human immunodeficiency virus (HIV), or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements or compromise the ability of the patient to give written informed consent;\n* Known history of tuberculosis;\n* History of another primary malignancy within 5 years prior to starting treatment, except for adequately treated basal or squamous cell carcinoma of the skin or cancer of the cervix in situ and the disease under study;\n* Female patients who are pregnant, breast-feeding or male or female patients of reproductive potential who are not employing an effective method of birth control.","ALL","18 Years","75 Years",{"count":21,"type":22},160,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","This phase II trial employs a prospective, randomized, parallel-group design to evaluate the efficacy and safety of hypofractionated radiotherapy combined with tislelizumab and surufatinib. Eligible patients are randomly assigned to one of two arms: Experimental Group A receives hypofractionated chemoradiotherapy plus concurrent tislelizumab and surufatinib, followed by consolidation therapy with tislelizumab plus surufatinib; Experimental Group B receives the same hypofractionated chemoradiotherapy plus concurrent tislelizumab alone, followed by tislelizumab consolidation.",[28],"NSCLC (Non-small Cell Lung Cancer)","RECRUITING","2026-06-29",{"date":32,"type":33},"2026-07-01","ACTUAL",{"date":35,"type":33},"2026-06-01",{"date":37,"type":22},"2029-05-31",{"name":39,"class":40},"Sun Yat-sen University","OTHER",1,{"id":43,"slug":44,"hasResults":12,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":12,"sex":17,"minAge":49,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":23,"phases":52,"briefSummary":54,"conditions":55,"keywords":68,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":76,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":84},"100480603","phase-1-a-study-to-learn-about-the-study-medicine-called-pf-07799544-as-monotherapy-or-in-combination-in-people-with-advanced-solid-tumors-100480603","NCT05538130","A Study to Learn About the Study Medicine Called PF-07799544 as Monotherapy or in Combination in People With Advanced Solid Tumors","A PHASE 1A\u002FB OPEN-LABEL MASTER STUDY OF PF-07799544 AS A SINGLE-AGENT AND IN COMBINATION WITH OTHER TARGETED AGENTS IN PARTICIPANTS WITH BRAF-MUTANT MELANOMA AND OTHER SOLID TUMORS","Phase 1b Inclusion Criteria:\n\n* Diagnosis of advanced\u002Fmetastatic solid tumor (excluding colorectal cancer)\n* Measurable disease by RECIST version 1.1\n* Evidence of a BRAF V600 mutation\n* Prior therapy per tumor cohort\n* Adequate organ function per protocol\n\nPhase 1b Exclusion Criteria:\n\n* Other active malignancy within 3 years\n* Presence of leptomeningeal disease\n* History or current evidence of retinal vein occlusion (RVO) or history of retinal degenerative disease\n* Concurrent neuromuscular disorder associated with elevated creatine kinase (CK)\n* Active gastrointestinal disease as defined per protocol\n* History of interstitial lung disease as defined per protocol","16 Years",{"count":51,"type":22},124,[53],"PHASE1","The purpose of this clinical trial is to learn the safety and effects of the study medicine (PF-07799544) alone or in combination as a potential cancer treatment for adults with advanced solid tumors. The study will be conducted in two parts: PF-07799544 as a single agent (Phase 1a) and PF-07799544 in combination with another study medicine called PF-07799933 (Phase 1b).\n\nPhase 1a is no longer open for enrollment. In Phase1b (noted as \"this study\"), we are seeking participants who have:\n\n* a solid tumor which is metastatic or recurrent (excluding colorectal cancer)\n* tumor with the mutation (abnormal gene) called \"BRAF V600\"\n* received required prior treatment for cancer per cohort assigned.\n\nAll participants in this study will receive both study medicines. Both study medicines are tablets that are taken by mouth at home twice a day.\n\nParticipants will receive study medicines until their cancer is no longer responding, unacceptable side effects, or 2 years. Participants may continue to receive study therapy beyond 2 years. We will examine the experiences of people receiving the study medicines. This will help us determine if the study medicines are safe and effective.",[56,57,58,59,60,61,62,63,64,65,66,67,28],"Melanoma","Glioma","Thyroid Cancer","Non-Small Cell Lung Cancer","Malignant Neoplasms","Brain Neoplasms","Advanced or Metastatic Solid Tumors","HGG","LGG","Low Grade Glioma","High Grade Glioma","Differentiated Thyroid Cancer",[69,70,71,72,73,74,75],"solid tumors","BRAF","advanced solid tumors","B-Raf","MAPK","neoplasms","BRAF V600",{"date":32,"type":33},{"date":78,"type":33},"2022-11-30",{"date":80,"type":22},"2029-06-18",{"name":82,"class":83},"Pfizer","INDUSTRY",83,{"id":86,"slug":87,"hasResults":12,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":91,"eligibilityCriteria":92,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":93,"targetDuration":4,"studyType":95,"phases":4,"briefSummary":96,"conditions":97,"keywords":113,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":129},"100618120","predicting-response-to-immunotherapy-from-analysis-of-live-tumor-biopsies-elephas-05-100618120","NCT07327489","Predicting Response to Immunotherapy From Analysis of Live Tumor Biopsies (ELEPHAS-05)","Predicting Response to Immunotherapy From Analysis of Live Tumor Biopsies","ELEPHAS-05","Inclusion Criteria:\n\n1. Able and willing to provide informed consent for participation\n2. Age ≥18 years at time of consent.\n3. Have a suspected or confirmed cancer diagnosis that is to be evaluated by means of a biopsy.\n4. Subjects who are newly diagnosed or have suspected cancer must be treatment-naïve at the time of biopsy. All other subjects should have the biopsy performed before starting their next line of treatment.\n\nExclusion Criteria:\n\n1. Have a known auto-immune disease or prior condition (prior organ transplant, chronic kidney or liver disease) that renders them ineligible for immunotherapy (IO) treatment.\n2. Severely immunocompromised person(s). Examples include patients on immunosuppressants, HIV positive patients on antiretrovirals, post transplantation patients.\n3. Pregnant person(s).",{"count":94,"type":22},2000,"OBSERVATIONAL","This study will collect tumor specimens with correlated clinical and demographic data from patients who are undergoing a biopsy or similar procedure to obtain tumor tissue as a normal course of their medical management or diagnostic work-up for suspected or confirmed cancer.",[98,99,100,101,102,103,104,105,106,107,108,109,110,111,112],"Cancer","Immunotherapy","Advanced Solid Tumors Cancer","Bladder Cancer","TNBC, Triple Negative Breast Cancer","Colorectal Cancer","DMMR Colorectal Cancer","MSI-H Colorectal Cancer","Endometrial Cancer","Head and Neck Cancer","Kidney Cancer","Liver Cancer","NSCLC (Non-small-cell Lung Cancer)","Skin Cancer","Melanoma (Skin Cancer)",[99,114,115,98,116,117,118,119,120,121],"Live Tumor Biopsy","Elephas","Imaging","Tumor Cutting","Treatment Response","Core Needle Biopsy","Forceps Biopsy","Punch Biopsy","2026-06-25",{"date":30,"type":33},{"date":125,"type":33},"2025-04-14",{"date":127,"type":22},"2038-04",{"name":115,"class":83},8,{"id":131,"slug":132,"hasResults":12,"nctId":133,"briefTitle":134,"officialTitle":135,"acronym":136,"eligibilityCriteria":137,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":138,"targetDuration":4,"studyType":23,"phases":140,"briefSummary":142,"conditions":143,"keywords":147,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":156,"lastUpdatePostDateStruct":157,"startDateStruct":158,"completionDateStruct":160,"leadSponsor":162,"locationsCount":164},"100583857","phase-3-study-of-daraxonrasib-rmc-6236-in-patients-with-ras-mutated-nsclc-rasolve-301-100583857","NCT06881784","Study of Daraxonrasib (RMC-6236) in Patients With RAS Mutated NSCLC (RASolve 301)","RASolve 301: Phase 3 Multicenter, Open Label, Randomized Study of RMC-6236 Versus Docetaxel in Patients With Previously Treated Locally Advanced or Metastatic RAS[MUT] NSCLC","RASolve 301","Inclusion Criteria:\n\n* At least 18 years old and has provided informed consent.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Pathologically confirmed NSCLC, either locally advanced or metastatic, not amenable to curative surgery or radiotherapy.\n* Measurable disease per RECIST v1.1.\n* Adequate organ function (bone marrow, liver, kidney, coagulation).\n* One to two prior lines of therapy including an anti-PD-1\u002Fanti-PD(L)-1 agent and platinum-based chemotherapy.\n* Documented RAS mutation status, defined as Nonsynonymous mutations in KRAS, NRAS, or HRAS at codons 12, 13, or 61 (G12, G13, or Q61).\n* Able to take oral medications.\n\nExclusion Criteria:\n\n* Prior therapy with direct RAS-targeted therapy or docetaxel.\n* Untreated central nervous system (CNS) metastases.\n* Medically significant comorbidities (significant cardiovascular disease, lung disease, or impaired GI function).\n* Ongoing anticancer therapy.\n* Pregnant or breastfeeding.",{"count":139,"type":22},590,[141],"PHASE3","The purpose of this study is to evaluate the safety and efficacy of a novel RAS(ON) inhibitor compared to docetaxel.",[28,59,144,145,146],"NSCLC","NSCLC (Non-small Cell Lung Carcinoma)","NSCLC (Advanced Non-small Cell Lung Cancer)",[144,59,148,149,150,151,152,153,154,155],"Lung Cancer","RAS","KRAS","HRAS","NRAS","RAS Q61 Mutation","RAS G12 Mutation","RAS G13 Mutation","2026-06-24",{"date":122,"type":33},{"date":159,"type":33},"2025-05-06",{"date":161,"type":22},"2030-12-01",{"name":163,"class":83},"Revolution Medicines, Inc.",151,{"id":166,"slug":167,"hasResults":12,"nctId":168,"briefTitle":169,"officialTitle":170,"acronym":4,"eligibilityCriteria":171,"healthyVolunteers":12,"sex":17,"minAge":172,"maxAge":4,"enrollmentInfo":173,"targetDuration":4,"studyType":23,"phases":175,"briefSummary":176,"conditions":177,"keywords":201,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":156,"lastUpdatePostDateStruct":230,"startDateStruct":232,"completionDateStruct":234,"leadSponsor":236,"locationsCount":238},"100407463","phase-1-the-evaluation-of-pc14586-in-patients-with-advanced-solid-tumors-harboring-a-tp53-y220c-mutation-pynnacle-100407463","NCT04585750","The Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)","A Phase 1\u002F2 Open-label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of PC14586 in Patients With Locally Advanced or Metastatic Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)","Inclusion Criteria:\n\n* At least 18 years of age or 12 to 17 years of age after Safety Review Committee approval.\n* Locally advanced or metastatic solid malignancy with a TP53 Y220C mutation\n* Eastern Cooperative Oncology Group (ECOG) status of 0 or 1\n* Previously treated with one or more lines of anticancer therapy and progressive disease\n* Adequate organ function\n* Measurable disease per RECIST v1.1 (Phase 2)\n\nAdditional Criteria for Inclusion in Phase 1b (rezatapopt) + pembrolizumab combination)\n\n* Anti-PD-1\u002FPD-L1 naive or must have progressed on treatment\n* Measurable disease\n\nExclusion Criteria:\n\n* Anti-cancer therapy within 21 days (or 5 half-lives) of receiving the study drug\n* Radiotherapy within 14 days of receiving the study drug\n* Primary CNS tumor\n* History of leptomeningeal disease or spinal cord compression\n* Brain metastases, unless neurologically stable and do not require steroids to treat associated neurological symptoms\n* Stroke or transient ischemic attack within 6 months prior to screening\n* Heart conditions such as unstable angina within 6 months prior to screening, uncontrolled hypertension, a heart attack within 6 months prior to screening, congestive heart failure, prolongation of QT interval, or other rhythm abnormalities\n* Strong CYP3A4 inducers and strong CYP2C9 inhibitors\u002Finducers within 14 days of first dose of rezatapopt\n* History of gastrointestinal (GI) disease that may interfere with absorption of study drug or patients unable to take oral medication\n* History of prior organ transplant\n* Known, active malignancy, except for treated cervical intraepithelial neoplasia, or non-melanoma skin cancer\n* Known, active uncontrolled Hepatitis B, Hepatitis C, or human immunodeficiency virus infection\n\nAdditional Criteria for Exclusion from Phase 2 (rezatapopt monotherapy)\n\n* Known KRAS mutation, defined as a single nucleotide variant (SNV) (Phase 2)\n\nAdditional Criteria for Exclusion from Phase 1b (rezatapopt) + pembrolizumab combination)\n\n* Received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor and discontinued from that treatment due to a Grade 3 or higher immune-related AE (irAE)\n* Received a live or live-attenuated vaccine within 30 days prior to the first dose of study intervention\n* Diagnosis of immunodeficiency or receiving chronic systemic steroid therapy within 7 days prior to the first dose of study drug\n* Hypersensitivity (≥ Grade 3) to pembrolizumab and\u002For any of its excipients\n* Active autoimmune disease that has required systemic treatment in past 2 years\n* History of radiation pneumonitis\n* History of (non-infectious) or active pneumonitis \u002F interstitial lung disease that required steroids\n* Active infection requiring systemic therapy\n* Known history of HIV infection\n* Has previously received rezatapopt","12 Years",{"count":174,"type":22},300,[53,25],"The Phase 2 monotherapy portion of this study is currently enrolling and will evaluate the efficacy and safety of PC14586 (INN rezatapopt) in participants with locally advanced or metastatic solid tumors harboring a TP53 Y220C mutation. The Phase 1 portion of the study will assess the safety, tolerability and preliminary efficacy of multiple dose levels of rezatapopt as monotherapy and in Phase 1b in combination with pembrolizumab.",[178,179,180,181,148,182,106,183,103,184,185,186,107,187,188,189,190,144,28,191,192,193,194,195,59,196,197,198,199,200],"Advanced Solid Tumor","Advanced Malignant Neoplasm","Metastatic Cancer","Metastatic Solid Tumor","Ovarian Cancer","Prostate Cancer","Breast Cancer","Other Cancer","Locally Advanced","Gall Bladder Cancer","Small Cell Lung Cancer","Small Cell Lung Cancer ( SCLC )","Small Cell Lung Carcinoma","SCLC","Non-Small Cell Lung Carcinoma","Triple Negative Breast Cancer","TNBC","HER2+ Breast Cancer","ER\u002FPR Positive Breast Cancer","HER2- Breast Cancer","HER2-positive Breast Cancer","HER2-negative Breast Cancer","ER\u002FPR(+), Her2(-) Breast Cancer",[202,203,204,205,206,207,208,209,210,211,212,213,214,215,216,217,218,219,220,221,222,223,224,225,226,227,228,229],"PC14586","p53","Y220C","Phase 1","Phase 1\u002F2","PMV","PMV Pharma","p53 mutation","TP53","TP53 mutation","p53 mutant","p53 reactivator","pembrolizumab","Keytruda","combination","PD-1","PD-L1","anti-PD-1","Merck","MSD","IgG4","mAb","Phase 1b","NGS","Next Generation Sequencing","precision","Phase 2","Rezatapopt",{"date":231,"type":33},"2026-06-26",{"date":233,"type":33},"2020-10-29",{"date":235,"type":22},"2027-12-31",{"name":237,"class":83},"PMV Pharmaceuticals, Inc",77,{"id":240,"slug":241,"hasResults":12,"nctId":242,"briefTitle":243,"officialTitle":244,"acronym":4,"eligibilityCriteria":245,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":246,"targetDuration":4,"studyType":23,"phases":247,"briefSummary":248,"conditions":249,"keywords":251,"overallStatus":256,"whyStopped":4,"lastUpdateSubmitDate":257,"lastUpdatePostDateStruct":258,"startDateStruct":259,"completionDateStruct":261,"leadSponsor":263,"locationsCount":41},"100643968","phase-3-a-study-to-evaluate-gfh375-versus-docetaxel-in-participants-with-non-small-cell-lung-cancer-with-kras-g12d-mutation-100643968","NCT07668752","A Study to Evaluate GFH375 Versus Docetaxel in Participants With Non-Small Cell Lung Cancer With KRAS G12D Mutation","A Phase III, Randomized, Open-Label, Multicenter Study to Evaluate GFH375 Versus Docetaxel in Participants With Locally Advanced and Unresectable or Metastatic Non-Small Cell Lung Cancer With KRAS G12D Mutation Failed Prior Standard Therapy","Inclusion Criteria:\n\n* 1\\. Voluntary participation in the study and signed informed consent form (ICF).\n* 2\\. Age ≥ 18 years at the time of signing the ICF; male or female.\n* 3\\. Histologically or cytologically confirmed locally advanced unresectable or metastatic non small cell lung cancer (NSCLC).\n* 4\\. Participants must provide adequate and qualified tumor tissue slides samples or agree to undergo tumor biopsy to obtain tissue samples for central laboratory confirmation of KRAS G12D mutation.\n* 5\\. Disease progression or intolerance to toxicity after at least one prior line of platinum based chemotherapy and anti PD 1\u002FPD L1 antibody therapy.\n* 6\\. At least one measurable target lesion according to RECIST version 1.1.\n* 7\\. Investigator assessed life expectancy ≥ 12 weeks.\n* 8\\. Adequate organ function.\n* 9\\. Ability to communicate well, comply with scheduled follow up visits, and adhere to protocol requirements.\n\nExclusion Criteria:\n\n* 1\\. Presence of other driver gene mutations in NSCLC, or concurrent other KRAS or RAS mutations.\n* 2\\. Other malignancy that has progressed or required treatment within 3 years prior to randomization.\n* 3\\. Leptomeningeal metastasis, or symptomatic or progressive central nervous system (CNS) metastasis.\n* 4\\. Existing or potential severe bone injury due to bone metastasis, or uncontrolled pain related to bone metastasis.\n* 5\\. Prior treatment with KRAS G12D targeted therapy or pan RAS\u002FKRAS targeted therapy.\n* 6\\. Prior treatment with docetaxel as part of systemic therapy.\n* 7\\. Radiotherapy within 4 weeks prior to randomization, or other local anti tumor therapy within 4 weeks prior to randomization.\n* 8\\. Other anti tumor therapy within 28 days or 5 half lives prior to randomization, or cell therapy within 3 months prior to randomization.\n* 9\\. Clinically significant severe cardiovascular disease.\n* 10\\. Stroke or other severe cerebrovascular disease within 6 months prior to randomization.\n* 11\\. Major acute or chronic infectious disease.\n* 12\\. Other poorly controlled systemic diseases.\n* 13\\. Severe psychiatric or psychological disorder, or history of drug abuse, or severe alcohol abuse.\n* 14\\. Pregnancy or breastfeeding.\n* 15\\. Any other condition that, in the investigator's judgment, makes the participant unsuitable for the study.",{"count":174,"type":22},[141],"The purpose of this study is to compare the effectiveness, safety and tolerability of GFH375 versus docetaxel in participants with KRAS G12D-mutant non-small cell lung cancer (NSCLC).\n\nGFH375 is an oral, highly selective, non-covalent small-molecule inhibitor targeting the KRAS G12D mutation. Preclinical studies showed GFH375 strongly blocks KRAS-driven signaling and cancer cell growth, and demonstrated anti-tumor activity in NSCLC animal models. Docetaxel is a chemotherapy drug for locally advanced or metastatic NSCLC.\n\nThis is an open-label, randomized controlled trial. Both participant and study doctor will know which study medication each participant receives.\n\nAfter enrollment, participant will be randomly assigned to either the GFH375 group or docetaxel group by chance. Neither participant nor study doctor can pick your treatment group. You have a two-thirds chance to receive GFH375 and a one-third chance to receive docetaxel.\n\n* GFH375 group: Take GFH375 tablets by mouth once daily as scheduled; each treatment cycle lasts 21 days.\n* Docetaxel group: Receive docetaxel via intravenous infusion at 75 mg\u002Fm² once every 3 weeks.\n\nStudy treatment will continue until cancer gets worse, participant can't tolerate the study treatment, or other conditions make participant unable to keep receiving study treatment.\n\nSome participants on docetaxel may be able to switch to GFH375 during the study if their cancer becomes worse. There will be safety checks at each visit, and the doctors will continue to check for medical problems and participant 's wellbeing throughout the study. Participants will continue to have scans of their tumor every 6 weeks for the first year, then every 9 weeks until their cancer becomes worse. After participant's cancer becomes worse, clinic staff will telephone participant every 3 mouths to check on their cancer.",[250,28],"KRAS G12D Mutation",[252,253,254,255],"GFH375","Docetaxel","Non-small cell lung cancer (NSCLC)","KRAS G12D","NOT_YET_RECRUITING","2026-06-23",{"date":122,"type":33},{"date":260,"type":22},"2026-07-15",{"date":262,"type":22},"2031-04-30",{"name":264,"class":83},"Genfleet Therapeutics (Shanghai) Inc.",{"id":266,"slug":267,"hasResults":12,"nctId":268,"briefTitle":269,"officialTitle":270,"acronym":271,"eligibilityCriteria":272,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":273,"targetDuration":4,"studyType":23,"phases":275,"briefSummary":277,"conditions":278,"keywords":279,"overallStatus":256,"whyStopped":4,"lastUpdateSubmitDate":257,"lastUpdatePostDateStruct":283,"startDateStruct":284,"completionDateStruct":286,"leadSponsor":288,"locationsCount":41},"100641208","bright-light-therapy-in-patients-with-melanoma-or-non-small-cell-lung-cancer-nsclc-who-are-receiving-first-line-immune-checkpoint-blockade-100641208","NCT07661966","Bright Light Therapy in Patients With Melanoma or Non-small Cell Lung Cancer (NSCLC) Who Are Receiving First-Line Immune Checkpoint Blockade","A Pilot Trial of Bright Light Therapy in Patients Receiving First Line Immune Checkpoint Blockade","IIT BLT","Inclusion Criteria:\n\n1. Age ≥18 years.\n2. Histologically confirmed diagnosis of advanced, unresectable melanoma or NSCLC.\n3. Presence of measurable tumor burden.\n4. Scheduled to receive first-line cancer-directed therapy with an immune checkpoint blockade-containing regimen, as monotherapy or combination (e.g. pembrolizumab, ipilimumab + nivolumab, ICB + chemotherapy).\n5. ECOG performance status 0-2.\n6. Able to provide informed consent.\n7. Access to reliable internet connection via WiFi or personal hotspot\n\nExclusion Criteria:\n\n1. Previous exposure to immune checkpoint blockade.\n2. Pregnant or breastfeeding.\n3. Use of melatonin or pharmacologic sleep aids (e.g., zolpidem, trazodone, benzodiazepines) within 14 days prior to enrollment.\n4. Diagnosis of bipolar disorder or history of mania or hypomania.\n5. Active psychosis, suicidal ideation, or recent psychiatric hospitalization (\\\u003C3 months).\n6. Poorly controlled seizures.\n7. Chronotype classified as extremely early or extremely late, based on the Munich Chronotype Questionnaire (MSFsc \\\u003C 2:00 or \\> 5:00).\n8. Night shift work within the past 30 days or expected during the intervention.\n9. Travel across ≥2 time zones within the past 14 days.\n10. Diagnosed or suspected untreated moderate to severe obstructive sleep apnea.\n11. Migraine with photophobia.\n12. Presence of ocular or photosensitivity conditions affecting vision (i.e. advanced bilateral cataracts not yet operated, advanced glaucoma with substantial visual field loss, optic nerve disease, ocular surgery within the past 3 months with unresolved visual symptoms, color blindness).",{"count":274,"type":22},12,[276],"NA","This study is being done to test whether bright light therapy can be used to synchronize patients' circadian rhythms and allow ICB (immune-checkpoint blockade) therapy to be administered at a time in the circadian rhythm that optimizes clinical outcomes. This trial will test the feasibility of delivering bright light therapy (BLT) to patients undergoing ICB therapy.\n\nThis trial asks participants to spend 60 minutes every morning receiving daily bright light therapy for at least 7 days prior to starting Immune Checkpoint blockade-containing regimens (e.g. anti-PD-1 and\u002For anti-CTLA-4 alone or in combination with chemotherapy). The bright light therapy will be delivered via the Circadian OS iPad application.\n\nThere is evidence that a person's circadian rhythm can affect the response to immunotherapy. The circadian rhythm is a natural, internal process that regulates the sleep-wake cycle. Many patients with cancer have disrupted circadian rhythms and it's possible that disrupted circadian rhythms decrease the likelihood of responding to immunotherapy.\n\nThe idea is to use bright light therapy, delivered via the Circadian OS iPad application, for an hour in the morning to synchronize your circadian rhythm for a week before your planned immunotherapy. The investigators hope that this will increase the likelihood of a response to immunotherapy, however in this study, the investigators are mainly concerned with whether the bright light therapy is tolerable to patients.",[112,28],[271,280,281,282],"Bright Light Therapy","Circadian","Circadian Rhythm",{"date":231,"type":33},{"date":285,"type":22},"2026-06",{"date":287,"type":22},"2027-12",{"name":289,"class":40},"Weill Medical College of Cornell University",{"id":291,"slug":292,"hasResults":12,"nctId":293,"briefTitle":294,"officialTitle":295,"acronym":4,"eligibilityCriteria":296,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":297,"targetDuration":4,"studyType":23,"phases":299,"briefSummary":300,"conditions":301,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":307,"lastUpdatePostDateStruct":308,"startDateStruct":310,"completionDateStruct":312,"leadSponsor":314,"locationsCount":316},"100557993","phase-1-study-of-xb010-in-subjects-with-solid-tumors-100557993","NCT06545331","Study of XB010 in Subjects With Solid Tumors","A Dose-Escalation and Expansion Study of XB010 as a Single Agent and Combination Therapy in Subjects With Locally Advanced or Metastatic Solid Tumors","* Age 18 years or older on the day of consent.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1.\n* Adequate organ and marrow function.\n* Cytologically or histologically and radiologically confirmed solid tumor that is inoperable, locally advanced, metastatic, or recurrent.\n\n  * The Cohort Expansion stage will enroll subjects with multiple tumor types (non-small cell lung cancer, hormone-receptor-positive breast cancer, head and neck cancer, esophageal squamous cell, triple-negative breast cancer).\n* Capable of understanding and complying with the protocol requirements and must have signed the informed consent document.",{"count":298,"type":22},396,[53],"This is a FIH study is to evaluate the safety, tolerability, PK, immunogenicity, and preliminary antitumor activity of XB010 as a single agent and in combination with pembrolizumab in subjects with locally advanced or metastatic solid tumors for whom alternative therapies do not exist or available therapies are intolerable or no longer effective.",[302,303,304,28,305,306],"Locally Advanced or Metastatic Solid Tumors","Esophageal Squamous Cell Cancer","Head and Neck Squamous Cell Cancer","Hormone-receptor-positive Breast Cancer","Triple Negative Breast Cancer (TNBC)","2026-06-17",{"date":309,"type":33},"2026-06-22",{"date":311,"type":33},"2024-08-06",{"date":313,"type":22},"2027-10-20",{"name":315,"class":83},"Exelixis",20,{"id":318,"slug":319,"hasResults":12,"nctId":320,"briefTitle":321,"officialTitle":322,"acronym":4,"eligibilityCriteria":323,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":324,"targetDuration":4,"studyType":23,"phases":326,"briefSummary":327,"conditions":328,"keywords":341,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":342,"lastUpdatePostDateStruct":343,"startDateStruct":345,"completionDateStruct":347,"leadSponsor":349,"locationsCount":351},"100628495","phase-1-a-phase-1-study-of-epi-326-in-egfr-mutant-nsclc-and-hnscc-100628495","NCT07462377","A Phase 1 Study of EPI-326 in EGFR-mutant NSCLC and HNSCC","A First-in-Human, Open-label, Multicenter, Phase 1 Study of EPI-326 in Patients With Epidermal Growth Factor Receptor-Mutant Non-small Cell Lung Cancer and Head and Neck Squamous Cell Carcinoma","Inclusion Criteria:\n\n1. Participant has a life expectancy \\> 12 weeks at Day 1.\n2. Participant has an ECOG performance status of 0-2.\n3. Participant has pathologically confirmed NSCLC or HNSCC.\n\n   o For NSCLC: the tumor harbors any documented EGFR mutation, insertion, or deletion.\n4. Participant has locally advanced or metastatic NSCLC or HNSCC.\n5. Participant has adequate organ function\n\nExclusion Criteria:\n\n1. Participant has history of uncontrolled illness.\n2. Participant has symptomatic brain metastases.\n3. Participant has a diagnosis of any secondary malignancy within 3 years prior to enrollment, except for those patients treated with curative intent and no evidence of active disease.",{"count":325,"type":22},110,[53],"A phase 1 study to determine the safety, tolerability, PK, PD, and preliminary anti-tumor activity of ascending doses of EPI-326 administered to patients with locally advanced or metastatic HNSCC and to patients with any documented EGFR-mutant locally advanced or metastatic NSCLC.",[329,330,331,332,333,334,335,107,336,304,337,338,28,339,340],"Epidermal Growth Factor","Epidermal Growth Factor Receptor","Epidermal Growth Factor Receptor Gene Mutation","Non Small Cell","Non Small Cell Lung","Non Small Cell Lung Cancer","Head and Neck","Head and Neck Cancers","Head and Neck Squamous Cell Carcinoma","Head and Neck Squamous Cell Carcinoma HNSCC","HNSCC","EGFR",[337,339,331,340,334,144],"2026-06-08",{"date":344,"type":33},"2026-06-10",{"date":346,"type":33},"2026-03-31",{"date":348,"type":22},"2029-07",{"name":350,"class":83},"EpiBiologics",6,{"id":353,"slug":354,"hasResults":12,"nctId":355,"briefTitle":356,"officialTitle":357,"acronym":4,"eligibilityCriteria":358,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":359,"targetDuration":4,"studyType":23,"phases":361,"briefSummary":362,"conditions":363,"keywords":367,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":342,"lastUpdatePostDateStruct":390,"startDateStruct":391,"completionDateStruct":393,"leadSponsor":395,"locationsCount":274},"100580305","phase-1-a-study-to-learn-about-study-medicine-alta3263-in-adults-with-advanced-solid-tumors-with-kras-mutations-100580305","NCT06835569","A Study to Learn About Study Medicine ALTA3263 in Adults With Advanced Solid Tumors With KRAS Mutations","A Phase 1\u002F1b Multiple Cohort Trial of ALTA3263 in Patients With Advanced Solid Tumors With KRAS Mutations","Inclusion Criteria:\n\n* Histologically confirmed diagnosis of a solid tumor malignancy harboring a KRAS mutation identified through molecular testing (NGS- or PCR-based) with a Clinical Laboratory Improvement Amendments-certified (or equivalent) diagnostic test.\n* Unresectable or metastatic disease.\n* Progressed on, intolerant to, or declined prior standard-of-care therapy (including targeted therapy, if applicable) appropriate to tumor type and stage\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Adequate organ function\n\nExclusion Criteria:\n\n* Prior treatment with a KRAS inhibitor, certain exceptions are described in the full study protocol\n* Known condition that prohibits the ability to swallow or absorb an oral medication.\n\nOther inclusion\u002Fexclusion criteria may apply.",{"count":360,"type":22},448,[53],"The purpose of this study is to characterize the safety and tolerability of ALTA3263 in adults with advanced solid tumors with KRAS mutations.",[98,364,28,365,366],"PDAC - Pancreatic Ductal Adenocarcinoma","CRC (Colorectal Cancer)","Advanced Solid Tumors",[368,144,369,370,371,372,373,374,375,150,376,377,378,379,380,381,382,383,384,385,386,387,388,389],"KRAS mutation","Non-small cell lung cancer","Colorectal cancer","Pancreatic ductal adenocarcinoma","Colorectal carcinoma","Pancreatic cancer","Pancreatic carcinoma","Solid tumors","Mutation","Metastatic","Advanced unresectable","Neoplasms","Neoplasms by Site","Carcinoma","Non-small cell lung carcinoma","Non-small cell lung neoplasm","Pancreatic neoplasm","Lung neoplasm","Colorectal neoplasm","Colon neoplasm","Mutant KRAS","KRAS amplification",{"date":344,"type":33},{"date":392,"type":33},"2025-03-05",{"date":394,"type":22},"2029-08",{"name":396,"class":83},"Alterome Therapeutics, Inc.",{"id":398,"slug":399,"hasResults":12,"nctId":400,"briefTitle":401,"officialTitle":402,"acronym":4,"eligibilityCriteria":403,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":404,"targetDuration":4,"studyType":23,"phases":406,"briefSummary":407,"conditions":408,"keywords":420,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":432,"lastUpdatePostDateStruct":433,"startDateStruct":435,"completionDateStruct":437,"leadSponsor":439,"locationsCount":441},"100535595","phase-1-a-phase-11b-study-of-iam1363-in-her2-cancers-100535595","NCT06253871","A Phase 1\u002F1b Study of IAM1363 in HER2 Cancers","A Phase 1\u002F1b Study of IAM1363 in Participants With Advanced Cancers Harboring HER2 Alterations","Key Inclusion Criteria:\n\n* Age ≥ 18 years\n* Have relapsed\u002Frefractory HER2-altered malignancy; for selected cohorts, prospective confirmation of HER2 alteration by central testing is required\n* Have progression of disease after the last systemic therapy, or be intolerant of last systemic therapy\n* Have radiographically measurable disease by RECIST v1.1 and\u002For RANO-BM\n* Eastern Cooperative Oncology Group (ECOG) performance score 0-1\n* Have adequate baseline hematologic, liver and renal function\n* Have left ventricular ejection fraction (LVEF) ≥ 50%\n* Able to swallow oral medication\n\nKey Exclusion Criteria:\n\n* Clinically significant cardiac disease\n* Infection with human immunodeficiency virus (HIV)-1 or HIV-2. Exception: Participants with well-controlled HIV (e.g., CD4 \\>350\u002Fmm3 and undetectable viral load) are eligible\n* Current active liver disease including hepatitis A, hepatitis B , or hepatitis C\n* Refractory nausea and vomiting, malabsorption, external biliary shunt, or significant small bowel resection that would preclude adequate absorption\n* Uncontrolled diabetes\n* History of solid organ transplantation\n* History of Grade ≥2 CNS hemorrhage, or any CNS hemorrhage within 28 days before C1D1\n* Prior history of non-infectious interstitial lung disease (ILD). (Exceptions: participants with prior grade 1 ILD that has completely resolved are eligible)\n* Participants requiring immediate local therapy for brain metastases",{"count":405,"type":22},383,[53],"This is a Phase 1\u002F1b open-label, multi-center dose escalation and dose optimization study designed to evaluate the safety and preliminary efficacy of IAM1363 in participants with advanced cancers that harbor HER2 alterations.",[409,410,198,411,412,413,414,415,28,416,417,418,419],"HER2 Mutation-Related Tumors","HER2","HER2 + Breast Cancer","Brain Metastases From Solid Tumors","Brain Metastases From HER2 and Breast Cancer","CNS Metastases","HER2-Positive Solid Tumors","HER2-positive Bladder Cancer","HER2-positive Colorectal Cancer","HER2 + Gastric Cancer","HER2-positive Gastroesophageal Cancer",[421,422,423,424,425,426,427,428,429,430,410,431],"ERBB2 protein, human","Molecular Targeted Therapy","Genes, erbB-2","Receptor, ErbB-2 \u002F antagonists & inhibitors","Neoplasms \u002F drug therapy","HER2 positive","HER2 overexpressing","HER2 altered","Human epidermal growth factor receptor","ErbB Receptors","brain metastases","2026-06-02",{"date":434,"type":33},"2026-06-04",{"date":436,"type":33},"2024-03-25",{"date":438,"type":22},"2028-12",{"name":440,"class":83},"Iambic Therapeutics, Inc",53,{"id":443,"slug":444,"hasResults":12,"nctId":445,"briefTitle":446,"officialTitle":447,"acronym":4,"eligibilityCriteria":448,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":449,"targetDuration":4,"studyType":23,"phases":451,"briefSummary":452,"conditions":453,"keywords":456,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":471,"startDateStruct":472,"completionDateStruct":474,"leadSponsor":476,"locationsCount":478},"100497019","phase-1-dose-finding-and-dose-expansion-study-of-ose-279-in-subjects-with-advanced-solid-tumors-or-lymphomas-100497019","NCT05751798","Dose-finding and Dose Expansion Study of OSE-279 in Subjects With Advanced Solid Tumors or Lymphomas","A Multicenter, Phase 1\u002F2, Dose-finding and Dose Expansion Study of OSE-279, a PD-1 Blocking Monoclonal Antibody, in Subjects With Advanced Solid Tumors or Lymphomas","Parts B and C - INCLUSION CRITERIA\n\n1. Male or female, aged ≥ 18 years\n2. Signed and dated informed consent form (ICF) prior to any trialspecific procedures.\n3. ECOG performance status 0-1\n4. Patients must be affiliated to a social security system or an equivalent system, if applicable as per local regulations.\n5. Patients expressing HLA-A2 phenotype on blood sample performed by an experienced laboratory using a validated test (PCR or NGS). Additional patients HLA-A2 negative will be included in PART C.\n6. Tumor type: a) Histologically or cytologically documented Stage IV squamous or non-squamous NSCLC not eligible for definite surgery or radiation, without EGFR sensitizing mutation or ALK and ROS1 gene alterations eligible for targeted therapy or other mutations for which an approved therapy exists in 1st line metastatic (see protocol); b) PD-L1 expression by TPS ≥ 50% (local)\n7. Patients with NO prior systemic therapy including immunotherapy in the first-line metastatic setting. In case of neoadjuvant\u002Fadjuvant therapy, therapy was completed at least 6 months prior to the diagnosis of metastatic disease.\n8. Patients with at least one measurable lesion according to RECIST v1.1.\n9. Adequate organ function:\n\n   1. Bone marrow: neutrophils ≥ 1.5 x 109\u002FL, hemoglobin ≥ 90 g\u002FL, platelets ≥ 100 x 109\u002FL\n   2. Renal function: serum creatinine ≤ 1.5 ULN or CKDEPI creatinine clearance ≥ 30 mL\u002Fmin\n   3. Liver function: AST and ALT ≤ 3 ULN, bilirubin ≤ 1.5 ULN. In case of liver metastasis: AST and ALT ≤ 5 ULN. For patients with Gilbert's syndrome total bilirubin ≤ 3 ULN or direct bilirubin ≤ 1.5 ULN.\n\nParts B and C - NON-INCLUSION CRITERIA\n\n1. Patient eligible to surgical resection or another approved therapeutic regimen known to provide clinical benefit; Known hypersensitivity to the active substances or to any of the excipients of OSE2101 or docetaxel.\n2. Patient previously treated with approved\u002Finvestigational anti-PD-1\u002FPD-L1\n3. Patient with active autoimmune disease or a documented history of autoimmune disease requiring systemic treatment (i.e., corticosteroids or immunosuppressive drugs); see exceptions in protocol\n4. Patient participating in another clinical trial with a medicinal product\n5. Patients who have not recovered from AEs (i.e. \\> G1 according to CTCAE v5.0) due to prior treatment with anti-cancer agents with exception of G2 neuropathy or any Grade alopecia. (see protocol)\n6. Patients with known additional malignancy progressing or requiring active treatment. Basal cell carcinoma, squamous cell carcinoma of the skin, or in situ cervical cancer are not non-inclusion criteria\n7. Patients with known active central nervous system metastases and\u002For carcinomatous meningitis. Patients with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least 4 weeks prior to C1D1 and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids (at doses \\> 10 mg\u002Fday methylprednisolone or equivalent) for 4 weeks prior C1D1\n8. Patients with active or history of non-infectious pneumonitis requiring steroids, or interstitial lung disease\n9. Patients with a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the duration of the study\n10. Patients with a history of uncontrolled or symptomatic, clinically significant cardiovascular disease: stroke, myocardial infarction, angina pectoris, arrhythmias, congestive heart failure (NYHA Class \\>2), or myocarditis within 6 months prior to first study drug administration",{"count":450,"type":22},41,[53,25],"This is a phase 1\u002F2, multicenter, dose-finding and dose expansion study of OSE-279, a PD-1 blocking monoclonal antibody, in subjects with advanced solid tumors or lymphomas.",[454,455,28],"Solid Advanced Tumor","Lymphoma",[457,455,458,459,460,461,462,463,464,465,466,467,468,469,470],"Solid advanced tumor","Rare tumor","PD-L1 positive tumor","PD-1 blocking monoclonal antibody","NSCLC (non-small cell lung cancer)","Cancer vaccine","Immune check point inhibitor","TEDOPI","OSE2101","OSE-2101","OSE 2101","OSE-279","OSE 279","HLA-A2",{"date":434,"type":33},{"date":473,"type":33},"2022-12-20",{"date":475,"type":22},"2029-12",{"name":477,"class":83},"OSE Immunotherapeutics",11,{"id":480,"slug":481,"hasResults":12,"nctId":482,"briefTitle":483,"officialTitle":484,"acronym":4,"eligibilityCriteria":485,"healthyVolunteers":12,"sex":17,"minAge":486,"maxAge":4,"enrollmentInfo":487,"targetDuration":4,"studyType":23,"phases":489,"briefSummary":490,"conditions":491,"keywords":492,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":496,"lastUpdatePostDateStruct":497,"startDateStruct":499,"completionDateStruct":500,"leadSponsor":502,"locationsCount":41},"100637853","phase-2-serplulimab-monotherapy-in-elderly-patients-with-nsclc-and-pd-l1-tps--50-100637853","NCT07596121","Serplulimab Monotherapy in Elderly Patients With NSCLC and PD-L1 TPS ≥ 50%","Multicenter, Single-arm, Phase II Exploratory Study of Serplulimab Monotherapy in Elderly Patients With NSCLC and PD-L1 TPS ≥ 50%","Inclusion Criteria:\n\n* 1.Voluntary participation and informed consent: Subjects must voluntarily join the study, sign the written informed consent form (ICF), and demonstrate good compliance.\n\n  2.Age and Gender: Aged ≥65 years at the time of signing the ICF, regardless of gender.\n\n  3.Diagnosis and Staging: Histologically or cytologically confirmed Stage IIIB (ineligible for definitive chemoradiotherapy), Stage IIIC, or Stage IV NSCLC according to the AJCC 8th edition staging system.\n\n  4.PD-L1 Expression: Tumor tissue confirmed as PD-L1 TPS≥50% by a central laboratory or a validated local laboratory, using SP263 or 22C3 assays (a formal test report must be provided).\n\n  5.Driver Gene Status: Known absence of actionable driver mutations, including but not limited to EGFR sensitive mutations, ALK fusions, and ROS1 fusions.\n\n  6.Measurable Disease: At least one measurable target lesion per RECIST v1.1 criteria (lesions must not have received prior radiotherapy).\n\n  7.Prior Treatment History: No prior systemic therapy for advanced or metastatic disease. For patients who received adjuvant or neoadjuvant chemotherapy, inclusion is permitted if disease recurrence occurred ≥6 months after the completion of the last dose.\n\n  8.Performance Status: Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0-2.\n\n  9.Adequate organ and bone marrow function (no blood transfusions or hematopoietic stimulating factor therapy within 14 days prior to the first dose):\n  * Absolute Neutrophil Count (ANC)≥1.5 x 10\\^9\u002F\u002FL\n  * Platelet Count (PLT)≥100 x 10\\^9\u002F\u002FL\n  * Hemoglobin (Hb)≥90 g\u002FL\n  * Serum Creatinine (Cr) ≤ 1.5 x Limit of Normal (ULN) or Creatinine Clearance ≥ 50mL\u002Fmin\n  * Total Bilirubin (TBIL) ≤ 1.5 x ULN\n  * Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT)≤ 2.5 x ULN(≤ 5 x ULN for patients with liver metastases)\n\nExclusion Criteria:\n\n* 1\\. Hypersensitivity: Known hypersensitivity to serplulimab or any of its excipients.\n\n  2\\. Prior Immunotherapy: Prior treatment with any anti-PD-1, anti-PD-L1, anti-CTLA-4, or other immune checkpoint inhibitors (ICIs).\n\n  3\\. Autoimmune Disease: Active autoimmune disease requiring systemic treatment (e.g., corticosteroids or immunosuppressants) within the past 2 years. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement for adrenal or pituitary insufficiency) is permitted.\n\n  4\\. Lung Disease\u002FPneumonitis: Active interstitial lung disease (ILD) or pneumonitis, or a history of (non-infectious) pneumonitis requiring steroid treatment.\n\n  5\\. Infections: Active infection requiring systemic therapy. 6. CNS Metastases: Known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis. However, patients with treated (via surgery or radiotherapy) and stable brain metastases are eligible, provided they are radiographically stable for at least 4 weeks prior to the first dose, have no evidence of new or enlarged brain lesions, and have discontinued glucocorticoids for at least 14 days.\n\n  7\\. Pregnancy and Breastfeeding: Pregnant or breastfeeding women. 8. Investigator Discretion: Any other condition that, in the investigator's opinion, may interfere with the evaluation of the study drug, jeopardize subject safety, or confound the interpretation of study results.","65 Years",{"count":488,"type":22},60,[25],"This prospective clinical study aims to evaluate and observe the efficacy and safety of Serplulimab Monotherapy in Elderly Patients with NSCLC and PD-L1 TPS ≥ 50% using a multicenter, single-arm, phase II design.\n\nThe study is planned to be conducted in Shaanxi Province, China, with an initial target enrollment of 60 patients. The study commenced in May 2026, and recruitment is expected to conclude around May 2026, with the trial anticipated to end by May 2027.\n\nAssuming no occurrences such as withdrawal of informed consent by subjects, intolerable adverse drug reactions, or investigator-assessed unsuitability for further participation, each participant's estimated duration of study treatment will continue until radiographically confirmed tumor progression.",[28],[144,493,494,495],"Serplulimab","PD-L1 TPS≥50%","Monotherapy","2026-05-13",{"date":498,"type":33},"2026-05-19",{"date":496,"type":33},{"date":501,"type":22},"2027-05-31",{"name":503,"class":40},"Tang-Du Hospital",{"id":505,"slug":506,"hasResults":12,"nctId":507,"briefTitle":508,"officialTitle":509,"acronym":4,"eligibilityCriteria":510,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":511,"targetDuration":4,"studyType":23,"phases":512,"briefSummary":513,"conditions":514,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":515,"lastUpdatePostDateStruct":516,"startDateStruct":518,"completionDateStruct":520,"leadSponsor":522,"locationsCount":41},"100633560","phase-2-microwave-ablation-plus-tislelizumab-and-docetaxel-in-advanced-nsclc-after-first-line-immunotherapy-failure-100633560","NCT07528274","Microwave Ablation Plus Tislelizumab and Docetaxel in Advanced NSCLC After First-Line Immunotherapy Failure","Microwave Ablation in Combination With Tislelizumab and Docetaxel in Patients With Advanced Non-Small Cell Lung Cancer After Progression Following First-Line Immunotherapy Plus Chemotherapy: A Prospective, Single-Arm, Phase II Study","Inclusion Criteria:\n\n* Patients with cytologically or histologically confirmed non-small cell lung cancer (NSCLC), classified as stage IIIB, IIIC, or IV (AJCC 9th edition) and not eligible for curative treatment.\n* Male or female patients aged ≥18 years who have provided written informed consent.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2, with an expected survival of more than 6 months, and deemed suitable for microwave ablation by the investigator.\n* Patients must have previously received first-line treatment with tislelizumab in combination with chemotherapy and have documented disease progression based on imaging assessments prior to enrollment. Disease progression must occur ≥6 months after initiation of first-line tislelizumab plus chemotherapy, with or without concomitant anti-angiogenic therapy.\n* Adequate organ and bone marrow function, defined as follows:\n\nAbsolute neutrophil count (ANC) ≥1.5 × 10⁹\u002FL Platelet count ≥100 × 10⁹\u002FL Hemoglobin ≥90 g\u002FL White blood cell count ≥3.0 × 10⁹\u002FL\n\nHepatic function:\n\nTotal bilirubin \\\u003C1.5 × the upper limit of normal (ULN) Aspartate aminotransferase (AST\u002FSGOT), alanine aminotransferase (ALT\u002FSGPT), and alkaline phosphatase (ALP) ≤2.5 × ULN In patients with liver metastases: AST and ALT ≤5.0 × ULN In patients with liver and\u002For bone metastases: ALP ≤5.0 × ULN\n\nRenal function:\n\nSerum creatinine ≤1.5 × ULN Urine protein \\\u003C2+ on urinalysis; if baseline urine protein is ≥2+, a 24-hour urine protein ≤1.0 g is required\n\nCoagulation function:\n\nInternational normalized ratio (INR) ≤1.5 Activated partial thromboplastin time (aPTT) ≤1.5 × ULN\n\n* Cardiac function defined as left ventricular ejection fraction (LVEF) ≥50%.\n* Ability to communicate effectively with the investigator and to comply with study-related visits, treatment, laboratory tests, and other study requirements.\n\nExclusion Criteria:\n\nParticipants meeting any of the following criteria will be excluded from the study:\n\n* Diagnosis of small cell lung cancer (SCLC), including mixed small cell and non-small cell lung cancer.\n* Presence of symptomatic brain metastases at the start of treatment.\n* Concurrent participation in another interventional clinical trial for cancer treatment.\n* History of tracheoesophageal fistula, gastrointestinal perforation, gastrointestinal fistula, or intra-abdominal abscess within 6 months prior to treatment initiation.\n* Presence of severe cardiovascular or cerebrovascular disease, including but not limited to:\n\nCerebrovascular accident (CVA), transient ischemic attack (TIA), myocardial infarction, or significant vascular disease (including but not limited to aortic aneurysm requiring surgical repair or recent arterial thrombosis) within 6 months prior to randomization; Unstable angina; Heart failure classified as New York Heart Association (NYHA) class ≥ II; Mean resting corrected QT interval (QTc) \\>470 ms; Any clinically significant resting electrocardiogram (ECG) rhythm, conduction, or morphological abnormalities, such as complete left bundle branch block, third-degree atrioventricular (AV) block, second-degree AV block, or PR interval \\>250 ms; Any factors that increase the risk of QTc prolongation or arrhythmic events, including heart failure, electrolyte abnormalities (serum\u002Fplasma potassium \\\u003C LLN; magnesium \\\u003C LLN; calcium \\\u003C LLN), congenital long QT syndrome, family history of long QT syndrome, unexplained sudden death of a first-degree relative before the age of 40, or concomitant use of medications known to prolong the QT interval and induce torsades de pointes.\n\n* Major surgical procedures performed within 4 weeks prior to enrollment or planned during the study period.\n* Bleeding tendency, high risk of bleeding, or coagulation disorders, including thrombotic events within 6 months prior to randomization and\u002For history of hemoptysis within 3 months prior to randomization (defined as ≥2.5 mL per episode).\n* Presence of unhealed wounds, active gastrointestinal ulcers, or fractures (excluding healed historical fractures).\n* Known or suspected hypersensitivity to tislelizumab and\u002For any of its excipients.\n* Pregnant or breastfeeding women.\n* Women of childbearing potential or male participants who are unwilling to use effective contraception during the study and for 6 months after the last dose of study treatment.\n* Any other condition that, in the opinion of the investigator, would render the participant unsuitable for enrollment in this study.",{"count":316,"type":22},[25],"The purpose of this clinical trial is to evaluate progression-free survival (PFS) of microwave ablation in combination with tislelizumab and docetaxel in patients with advanced non-small cell lung cancer (NSCLC) who have progressed following first-line immunotherapy combined with chemotherapy.\n\nParticipants with advanced NSCLC who experienced disease progression after first-line immunotherapy plus chemotherapy will receive the following treatments:\n\n1. Tislelizumab: 200 mg administered intravenously every 3 weeks (Q3W)\n2. Docetaxel: 75 mg\u002Fm² administered intravenously every 3 weeks (Q3W) for 4-6 cycles\n3. Microwave ablation, administered per protocol",[28,146],"2026-04-07",{"date":517,"type":33},"2026-04-14",{"date":519,"type":22},"2026-05-01",{"date":521,"type":22},"2028-12-31",{"name":523,"class":40},"Tianjin Medical University Cancer Institute and Hospital",{"id":525,"slug":526,"hasResults":12,"nctId":527,"briefTitle":528,"officialTitle":529,"acronym":530,"eligibilityCriteria":531,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":532,"targetDuration":4,"studyType":23,"phases":533,"briefSummary":534,"conditions":535,"keywords":536,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":346,"lastUpdatePostDateStruct":541,"startDateStruct":543,"completionDateStruct":545,"leadSponsor":547,"locationsCount":41},"100620164","phase-1-neoadjuvant-therapy-with-ensartinib-combined-with-chemotherapy-for-alk-positive-non---small-cell-lung-cancer-nsclc-100620164","NCT07354061","Neoadjuvant Therapy With Ensartinib Combined With Chemotherapy for ALK-positive Non - Small Cell Lung Cancer (NSCLC)","A Single-arm, Multicenter Clinical Study of Ensartinib Combined With Chemotherapy as Neoadjuvant Therapy for ALK-positive Non-small Cell Lung Cancer (NSCLC) (TD-ENSEMBLE Study)","TD-ENSEMBLE","Inclusion Criteria:\n\n1. Provide informed consent prior to any study-specific procedures.\n2. Aged between 18 and 75 years old (inclusive).\n3. Histologically or cytologically confirmed lung adenocarcinoma via biopsy performed within 60 days prior to study enrollment.\n4. Surgically resectable Stage II-IIIB (N2) lung adenocarcinoma (AJCC 8th Edition TNM Staging).\n5. Confirmed ALK fusion mutation by detection methods recommended by NCCN guidelines.\n6. Presence of at least one accurately measurable lesion, with the longest diameter ≥10 mm on baseline computed tomography (CT) scan (or lymph nodes with a short axis ≥15 mm) and suitable for accurate repeated measurements.\n7. ECOG performance status of 0-1.\n8. Adequate hematological, biochemical, and organ function:\n\n   1. Hemoglobin ≥90 g\u002FL (can be maintained or exceeded via transfusion);\n   2. Absolute neutrophil count ≥1.5×10⁹\u002FL;\n   3. Platelet count ≥90×10⁹\u002FL;\n   4. Total bilirubin ≤2× upper limit of normal (ULN);\n   5. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5× ULN;\n   6. Creatinine ≤1.5× ULN; and creatinine clearance ≥60 mL\u002Fmin.\n9. Adequate cardiopulmonary function suitable for surgical treatment (assessed by ECG, echocardiography, pulmonary function tests, or blood gas analysis).\n10. For female subjects of childbearing potential: Must use highly effective contraception for at least 2 weeks prior to initiation of study drug, have a negative pregnancy test, and not be breastfeeding at the start of dosing. Alternatively, must meet one of the following criteria at screening to demonstrate non-childbearing potential:\n\n    1. Postmenopausal, defined as over 50 years old with amenorrhea for at least 12 months following cessation of all exogenous hormonal therapy.\n    2. Women under 50 years old may be considered postmenopausal if they have amenorrhea for 12 months or more following cessation of exogenous hormone therapy and have luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels within the postmenopausal range.\n    3. Documented irreversible surgical sterilization by hysterectomy, bilateral oophorectomy, or bilateral salpingectomy, but not including tubal ligation.\n11. For male subjects with partners of childbearing potential: Must agree to use effective contraceptive methods during the study period and for 3 months after the last dose of study drug\n\nExclusion Criteria:\n\n1. Presence of squamous cell carcinoma, large cell neuroendocrine carcinoma, or small cell carcinoma components.\n2. Prior exposure to other anti-tumor therapies before enrollment.\n3. Patient is pregnant or breastfeeding.\n4. Current use of (or inability to discontinue use at least 3 weeks prior to receiving the first dose of study treatment) drugs or herbal supplements known to be strong inducers of CYP3A4. All patients must try to avoid concomitant use or ingestion of any drugs, herbal supplements, and\u002For foods known to have CYP3A4 induction effects.\n5. Evidence of any severe or uncontrolled systemic disease, including uncontrolled hypertension and active bleeding, which in the investigator's opinion would compromise the patient's participation in the study or protocol compliance, or active infections including hepatitis B, hepatitis C, and human immunodeficiency virus (HIV). Screening for chronic conditions is not required.\n6. Prior history of interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis requiring steroid treatment, or any current evidence of active ILD.\n7. History of hypersensitivity to active or inactive excipients of Ensartinib or drugs with similar chemical structures or classes to Ensartinib, as well as uncontrollable nausea and vomiting, chronic gastrointestinal diseases, inability to swallow formulated medication, or prior extensive bowel resection that would preclude adequate absorption of Ensartinib.\n8. Intolerance to chemotherapy or refusal of chemotherapy.\n9. Any of the following cardiac criteria:\n\n   1. Mean resting corrected QT interval (QTc) \\> 470 msec obtained from three ECGs using the screening ECG machine's QTc value.\n   2. Any clinically significant abnormalities in rhythm, conduction, or morphology of resting ECG, such as left bundle branch block, third-degree heart block, or second-degree heart block.\n   3. Any factors that increase the risk of QTc prolongation or arrhythmic events, such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome, unexplained sudden death under 40 years of age in first-degree relatives, or any concomitant medication known to prolong the QT interval.\n10. History of definite neurological or psychiatric disorders, including epilepsy or dementia.\n11. Any other conditions deemed by the investigator as unsuitable for enrollment.",{"count":316,"type":22},[53,25],"The goal of this clinical trial is to learn if Ensartinib combined with chemotherapy works as a neoadjuvant treatment for patients with stage II-IIIB (N2) ALK-positive non-small cell lung cancer (NSCLC). It will also learn about the safety of this combination therapy. The main questions it aims to answer are:\n\n* Does Ensartinib combined with chemotherapy lead to a pathological complete response (pCR) in surgically removed tumor tissue after neoadjuvant treatment?\n* What medical problems do participants have when taking Ensartinib combined with chemotherapy? This is a single-arm study, meaning all participants will receive the investigational treatment. There is no placebo or active comparator group. The study will be conducted in two stages; the second stage will proceed only if no special, unexpected, or serious adverse events related to Ensartinib occur during the first stage involving 5 participants.\n\nParticipants will:\n\n* Receive neoadjuvant treatment with Ensartinib (taken orally once daily) plus Pemetrexed and Carboplatin (administered intravenously every 3 weeks) for 9 weeks (3 cycles).\n* Undergo surgical resection within 4 weeks after completing neoadjuvant therapy.\n* Attend regular clinic visits for check-ups, blood tests, and imaging scans (CT, MRI) according to a detailed schedule during the neoadjuvant, surgical, and long-term follow-up periods (up to 10 years).\n* Be monitored for adverse events and survival outcomes.",[28],[537,538,539,540],"Ensartinib","neoadjuvant","ALK - positive","Resectable",{"date":542,"type":33},"2026-04-01",{"date":544,"type":33},"2026-03-25",{"date":546,"type":22},"2030-12-30",{"name":503,"class":40},{"id":549,"slug":550,"hasResults":12,"nctId":551,"briefTitle":552,"officialTitle":553,"acronym":554,"eligibilityCriteria":555,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":556,"targetDuration":4,"studyType":23,"phases":558,"briefSummary":559,"conditions":560,"keywords":566,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":584,"lastUpdatePostDateStruct":585,"startDateStruct":587,"completionDateStruct":589,"leadSponsor":590,"locationsCount":592},"100607539","phase-1-177lu-betabart-in-patients-with-relapsedrefractory-locally-advanced-inoperable-or-metastatic-solid-tumors-100607539","NCT07189871","177Lu-BetaBart in Patients With Relapsed\u002FRefractory, Locally Advanced Inoperable, or Metastatic Solid Tumors","A Phase 1\u002F2a Study of the Safety, Tolerability, and Preliminary Clinical Activity of 177LuBetaBart, a 177Lu-Labeled Anti-B7-H3 Monoclonal Antibody, in Patients With Relapsed\u002FRefractory, Locally Advanced Inoperable, or Metastatic Solid Tumors","BetaBart","Inclusion Criteria:\n\n1. Willing and able to provide informed consent prior to start of any study procedures and assessments and must be willing to comply with all study procedures.\n2. Participants ≥ 18 years of age.\n3. Participants with a documented history of histopathologically confirmed CRPC\\*, CRC, NSCLC, SCLC, HNSCC, ovarian cancer, cervical cancer, endometrial cancer, TNBC, or ESCC. (Note: inclusion or exclusion criteria below marked with \\* refer to CRPC only, criteria without \\* refer to all tumor indications including CRPC)\n\n   a. \\*Progressive CRPC defined as castrate levels of testosterone and progressing by at least one of the following criteria: i. Serum PSA progression consisting of two consecutive increases in PSA measured at least 1 week apart. The minimal baseline value is 2.0 ng\u002FmL.\n\n   ii. Soft tissue progression defined as a ≥20% increase in the sum of the diameter (short axis for nodal lesions and long axis for non-nodal lesions) of all target lesions based on the smallest sum of the diameter since the previous treatment was started or the appearance of one or more new lesions by computed tomography (CT)\u002Fmagnetic resonance imaging (MRI).\n\n   iii. Progression of bone disease defined by Prostate Cancer Working Group 3 (PCWG3) as evaluable disease or new bone lesions by bone scan.\n\n   iv. Identification of new soft tissue or bone lesions on prostate-specific membrane antigen (PSMA) positron emission tomography (PET) imaging.\n\n   b. \\*Metastatic disease defined as either or both of the following: i. Documented M1 disease on conventional imaging (CT\u002FMRI of the chest\u002Fabdomen\u002Fpelvis and\u002For Technetium 99m \\[99mTc\\] whole-body bone scan) ii. Identification of bone lesion(s), extra-pelvic soft tissue lesion(s), or visceral metastases on PSMA PET imaging with an FDA-approved imaging agent (e.g., 68Ga-PSMA-11, 18F-DCFPyL, or 18F-rhPSMA-7.3) c. \\*Progression following treatment with ADT and at least one ARSI (e.g., enzalutamide, apalutamide, darolutamide, and\u002For abiraterone acetate). If a participant is currently on ADT, they should continue ADT for the duration of their participation in the study but will not be permitted to start a new therapy or ADT regimen. If a participant has progressed on an ARSI, they will have the option to remain on the same ARSI or discontinue therapy. If they discontinue the ARSI, a 28-day washout period will be required prior to initiating study intervention.\n\n   d. Prior definitive and palliative external beam radiation therapy and stereotactic body radiation therapy is allowed.\n\n   Note: Participants with extended external beam radiation therapy to the axial skeleton, which in the opinion of the Investigator may pose a risk for increased myelotoxicity, will be discussed with the Sponsor to determine eligibility.\n\n   e. Participants with liver metastases are eligible if they meet the following criteria: i. ≤3 lesions i. All lesions must be ≤2 cm in the short axis ii. SUVmean ≥2 x that of liver parenchyma f. \\*Prior treatment with one taxane-based chemotherapy is allowed but not required. A taxane-based chemotherapy is defined as a minimum exposure of two cycles of a taxane chemotherapy.\n4. Participants must have documented disease progression during or after their most recent line of anticancer therapy. Participants must be refractory to or intolerant of standard of care therapy or have no standard of care therapy available that is likely to provide clinical benefit. Any number of prior treatment lines are allowed.\n5. Must have at least 1 measurable target lesion according to RECIST v1.1. (Note: this does not apply for CRPC)\n6. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2\n7. Participants must have a life expectancy of ≥ 4 months in the opinion of the Investigator.\n8. Participants of child-bearing potential (CBP) must have a negative β-hCG test and must not be breastfeeding. Participants of CBP are defined as those who are not surgically sterile or post-menopausal. Participants will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause. Participants \\\u003C 50 years of age who meet the criteria for post-menopausal status without previous surgical sterilization should be considered for further investigation with luteinizing hormone (LH) and follicle stimulating hormone (FSH) levels to confirm serological post-menopausal status.\n9. Participants of CBP must agree to use a highly effective method of contraception during the study and for 6 months after the last dose of 177Lu-BetaBart, as described in Appendix 4.\n10. Male participants who are able to father a child must agree to avoid impregnating a partner and to adhere to a highly effective method of contraception during the study and for 6 months after the last dose of 177Lu-BetaBart, as described in Appendix 4. All male participants must agree to not donate sperm during the study and for 6 months after the last dose of 177Lu-BetaBart.\n11. Participants who have received prior radiation therapy \\>28 days before the first dose of 177Lu-BetaBart are permitted. Documentation of the dates the radiotherapy was received, the cumulative dose, and the absorbed dose to critical organs, if available, should be provided.\n12. Participants with previously treated brain metastases are eligible to participate if:\n\n    * they are neurologically and radiologically stable (no evidence of progression by imaging; same imaging modality \\[MRI or CT scan\\] must be used for each assessment) for at least 28 days prior to the first dose of 177Lu-BetaBart; and\n    * do not require corticosteroids to treat associated neurological symptoms or if required, are on a stable dose of corticosteroids not exceeding 10 mg\u002Fday of prednisone (or equivalent), and\n    * have no history of leptomeningeal disease or spinal cord compression.\n\nExclusion Criteria:\n\n1. History of prior organ transplant.\n2. Any other known, active malignancy, except for treated cervical intraepithelial neoplasia, or non-melanoma skin cancer. Participants with a history of malignancies of low recurrence potential who have received curative-intent therapy may be approved on a case-by-case basis in discussion with the Sponsor, if it is determined not to put the participant at an increased risk of adverse drug effects and\u002For interfere with the integrity of the study outcome.\n3. Have any medical condition that would, in the Investigator's judgment, prevent the participant's full participation in the clinical study due to safety concerns or compliance with clinical study procedures such as participants with severe claustrophobia who are unresponsive to oral anxiolytics, participants with low back pain who cannot lie comfortably on an imaging table, participants who are hyperactive or hyperkinetic such that they cannot tolerate lying still for multiple time point imaging procedures, etc.\n4. Residual toxicity ≥ Grade 2 from prior anti-cancer therapy (except alopecia and peripheral sensory neuropathy).\n5. History of uncontrolled allergic reactions and\u002For known or expected hypersensitivity to protein therapeutics, 177Lu-BetaBart, or any of its excipients.\n6. Inadequate organ functions as reflected in laboratory parameters:\n\n   * Estimated glomerular filtration rate (eGFR) \\\u003C 50 mL\u002Fmin adjusted for participant's body surface area using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI 2021) formula\n   * Platelet count of \\\u003C 100 x 109\u002FL\n   * Absolute neutrophil count (ANC) \\\u003C 1.5 x 109\u002FL\n   * Hemoglobin \\\u003C 9 g\u002FdL\n   * Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\> 3 x upper limit of normal (ULN), or \\> 5 x ULN for participants with known liver metastases\n   * Total bilirubin \\> 1.5 x ULN, except for participants with documented Gilbert's syndrome who are eligible if total bilirubin ≤ 3 x ULN\n   * For participants not taking warfarin or other anticoagulants: INR ≤1.5 or PT ≤1.5 x ULN; and either PTT or aPTT ≤1.5 x ULN. Participants taking warfarin must be on a stable dose that results in a stable INR \\\u003C3.5. Among participants receiving other anticoagulant therapy, PT or aPTT must be within the intended therapeutic range of the anticoagulant.\n7. Participants requiring blood product transfusion within 2 weeks of first dose of 177Lu-BetaBart are not eligible to participate.\n8. \\*Participants with CRPC who have received prior Lu-177-PSMA radioligand therapy.\n9. Clinically significant cardiovascular disease including but not limited to:\n\n   * Unstable angina\n   * Acute myocardial infarction within 6 months prior to screening\n   * New York Heart Association (NYHA) Class II or greater congestive heart failure\n   * Clinically significant abnormalities in rhythm, conduction or morphology on resting ECG (e.g., complete left bundle branch block, third degree heart block)\n   * Known left ventricular ejection fraction \\\u003C 50%\n   * QTcF \\> 480 msec on screening electrocardiogram (ECG), or congenital long QT syndrome.\n10. Participation in any other interventional investigational trial for treatment of underlying malignancy at the time of informed consent signature.\n11. Participants who are pregnant or breastfeeding.\n12. Major surgery within 4 weeks prior to first dose of 177Lu-BetaBart.\n13. Received anti-cancer therapy, including chemotherapy, immunotherapy, radiation therapy, biologic, herbal therapy, or any investigational therapy or investigational device, ≤ 28 days (or 5 half-lives for biologic\u002Fnon-cytotoxic agents, whichever is shorter), prior to the first dose of 177Lu-BetaBart.\n14. Known active hepatitis B (defined as hepatitis B surface antigen \\[HBsAg\\] reactive) or known active hepatitis C virus (defined as HCV RNA \\[qualitative\\] is detected) infection.\n\n    * Active viral (any etiology) hepatitis participants are excluded.\n    * Participants with serologic evidence of chronic hepatitis B virus (HBV) infection (defined by a positive hepatitis B surface antigen test and a positive anti hepatitis core antigen antibody test) who have a viral load below the limit quantification (HBV DNA titer \\\u003C 1000 cps\u002FmL or 200 IU\u002FmL) and are not currently on viral suppressive therapy may be eligible and should be discussed with the Sponsor's Medical Monitor (or designee).\n    * Note, participants with a history of HCV infection should have completed curative antiviral treatment and have a viral load below the limit of quantification to be eligible to enroll into the study.\n    * No testing for HBV or HCV is required unless mandated by local health authority.\n15. Any uncontrolled intercurrent illness or clinically significant uncontrolled condition(s), including but not limited to active bacterial, fungal, or viral infections requiring systemic therapy.\n16. Untreated moderate to severe hydronephrosis. If hydronephrosis is corrected via stent or nephrostomy, hydronephrosis will be considered resolved.\n17. \\*Prescence of a superscan by nuclear medicine\u002F99mTc bone scan.\n18. Active autoimmune disease that has required systemic treatment within 90 days (i.e., with the use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid \\[stable \u002F low doses of ≤10 mg\u002Fday prednisone or equivalent dose\\]) for adrenal or pituitary insufficiency is allowed.\n19. Any other clinically significant comorbidities, such as uncontrolled pulmonary disease, active infection, or any other condition, which in the judgment of the investigator could compromise compliance with the protocol, interfere with the interpretation of study results, or predispose the subject to safety risks.",{"count":557,"type":22},61,[53,25],"A Phase 1\u002F2a Dose Escalation and Expansion Study of the Safety, Tolerability, and Preliminary Clinical Activity of 177LuBetaBart, a 177Lu-Labeled Anti-B7-H3 Monoclonal Antibody, in Patients with Relapsed\u002FRefractory, Locally Advanced Inoperable, or Metastatic Solid Tumors",[561,103,28,182,562,106,102,563,564,565],"Castration-Resistant Prostate Cancer (CRPC)","Cervical Cancer","Small Cell Lung Cancer (SCLC )","Head &Amp; Neck Squamous Cell Carcinoma (HNSCC)","Esophageal Squamous Cell Carcinoma (ESCC)",[567,568,569,570,571,572,573,574,575,576,577,578,579,580,581,582,583],"Castration-resistant prostate cancer (CRPC)","colorectal cancer (CRC)","non-small-cell lung cancer (NSCLC)","small-cell lung cancer (SCLC)","head and neck squamous cell carcinoma (HNSCC)","ovarian cancer","cervical cancer","endometrial cancer","triple negative breast cancer (TNBC)","esophageal squamous cell carcinoma (ESCC)","B7-H3","177Lu","radiotheranostics","radioligand therapy","radioimmunotherapy","monoclonal antibody","metastatic solid tumors","2026-03-24",{"date":586,"type":33},"2026-03-27",{"date":588,"type":33},"2026-02-23",{"date":287,"type":22},{"name":591,"class":83},"Radiopharm Theranostics, Ltd",4,{"id":594,"slug":595,"hasResults":12,"nctId":596,"briefTitle":597,"officialTitle":598,"acronym":599,"eligibilityCriteria":600,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":601,"targetDuration":4,"studyType":23,"phases":603,"briefSummary":604,"conditions":605,"keywords":606,"overallStatus":256,"whyStopped":4,"lastUpdateSubmitDate":607,"lastUpdatePostDateStruct":608,"startDateStruct":609,"completionDateStruct":611,"leadSponsor":613,"locationsCount":4},"100626666","phase-2-study-of-sacituzumab-tirumotecan-combined-with-toripalimab-for-resectable-stage-ii-iiib-nsclc-100626666","NCT07438600","Study of Sacituzumab Tirumotecan Combined With Toripalimab for Resectable Stage II-IIIB NSCLC","A Single-center, Phase II Clinical Study of Sacituzumab Tirumotecan Combined With Toripalimab as Neoadjuvant Therapy for Resectable Stage II-IIIB NSCLC","TianjinCIH","Inclusion Criteria:\n\n1. Age ≥18 years at the time of informed consent signing, either sex;\n2. ECOG performance status score of 0-1 within 7 days prior to dosing;\n3. Histologically or cytologically confirmed NSCLC;\n4. Negative for EGFR sensitive mutations (no exon 19 deletion or exon 21 L858R substitution mutation) and negative for ALK fusion gene;\n5. No prior local treatment (surgery or radiotherapy) for NSCLC and no prior systemic antineoplastic therapy, including cytotoxic therapy, targeted therapy (including tyrosine kinase inhibitors or monoclonal antibodies), cellular therapy, immunotherapy, traditional Chinese medicine therapy, and any other investigational drug therapy;\n6. Patients with resectable stage II-IIIB NSCLC as assessed by MDT (according to UICC\u002FAJCC 8th edition TNM staging);\n7. At least one measurable lesion (according to RECIST 1.1 criteria);\n8. Patients who agree to undergo radical surgical treatment;\n9. Surgical evaluation confirms operability with no contraindications to surgery;\n10. Adequate organ and bone marrow function (no transfusion, recombinant human thrombopoietin, or colony-stimulating factor treatment within 2 weeks prior to first dosing), defined as follows:\n\n    1. Hematology: Absolute neutrophil count (NEUT#) ≥ 1.5×10⁹\u002FL; Platelets (PLT) ≥ 100×10⁹\u002FL; Hemoglobin ≥ 90 g\u002FdL;\n    2. Hepatic function: Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Alkaline phosphatase (ALP) ≤ 2.5×upper limit of normal (ULN); Total bilirubin (TBIL) ≤ 1.5×ULN;\n    3. Renal function: Creatinine clearance (Ccr) ≥ 60 ml\u002Fmin (Cockcroft-Gault formula, see Appendix);\n    4. Coagulation function: International normalized ratio (INR), Activated partial thromboplastin time (APTT), and Prothrombin time (PT) ≤ 1.5×ULN;\n    5. Cardiac function: Echocardiography (ECHO) or Multiple gated acquisition (MUGA) scan showing left ventricular ejection fraction (LVEF) ≥ 50%;\n11. For female subjects of childbearing potential and male subjects with partners of childbearing potential, must agree to use effective medical contraception from the time of informed consent signing until 6 months after the last dose (see Appendix 2 for details);\n12. Subjects voluntarily participate in this study, sign informed consent, and are able to comply with protocol-specified visits and related procedures.\n\nExclusion Criteria:\n\n1. Histologically or cytologically confirmed combined small cell lung cancer, neuroendocrine carcinoma, or carcinosarcoma components;\n2. Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibodies, or any other antibodies or drugs specifically targeting T-cell co-stimulation or checkpoint pathways;\n3. Prior treatment with TROP2-targeted therapy and\u002For topoisomerase I inhibitors;\n4. Requirement for strong inhibitors or inducers of cytochrome P450 3A4 enzyme (CYP3A4) within 2 weeks prior to first dosing and during the study (strong CYP3A4 inhibitors or inducers are not permitted in this study; Appendix 6 lists representative drugs of strong CYP3A4 inhibitors or inducers); all subjects must avoid concomitant use of any drugs, herbal supplements, and\u002For foods known to induce CYP3A4.\n5. Other malignancies within the past 5 years, excluding cured cervical carcinoma in situ, basal cell carcinoma, or cutaneous squamous cell carcinoma;\n6. Known history of hypersensitivity to study drugs and their components, history of immunodeficiency, or history of organ transplantation;\n7. History of interstitial lung disease (ILD) or non-infectious pneumonitis requiring steroid treatment (non-infectious), current ILD or non-infectious pneumonitis, or suspected ILD or non-infectious pneumonitis that cannot be excluded by imaging at screening; clinically significant pulmonary impairment due to pulmonary comorbidities, including but not limited to any underlying pulmonary disease (such as pulmonary embolism within 3 months prior to dosing, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, pleural effusion, etc.) or any autoimmune, connective tissue, or inflammatory disease that may involve the lungs (i.e., rheumatoid arthritis, Sjögren's syndrome, sarcoidosis, etc.), or prior pneumonectomy;\n8. Active autoimmune disease requiring systemic treatment within the past 2 years (hormone replacement therapy is not considered systemic treatment, such as type 1 diabetes, hypothyroidism requiring only thyroid hormone replacement therapy, adrenal or pituitary insufficiency requiring only physiologic doses of glucocorticoid replacement therapy);\n9. Active infection requiring systemic treatment within 2 weeks prior to first dosing;\n10. Active hepatitis B \\[hepatitis B surface antigen (HBsAg) positive, HBV-DNA testing required; HBV-DNA ≥ 500 IU\u002FmL or above the lower limit of detection, whichever is higher\\] or hepatitis C (hepatitis C antibody positive, and HCV-RNA above the lower limit of detection). Note: For HBsAg-positive subjects, anti-hepatitis B virus treatment is required during study treatment;\n11. Positive human immunodeficiency virus (HIV) test or history of acquired immunodeficiency syndrome (AIDS); known active syphilis infection;\n12. Severe concomitant diseases that endanger patient safety or affect study completion, as judged by the investigator, including but not limited to uncontrolled hypertension with medication, severe diabetes, active infection, etc.;\n13. Documented severe dry eye syndrome, severe meibomian gland disease and\u002For blepharitis, or history of corneal disease that prevents delayed corneal healing;\n14. Pregnant or lactating women;\n15. Any condition that interferes with the evaluation of study drugs, subject safety, or interpretation of study results, or any other condition deemed by the investigator as unsuitable for participation in this study.",{"count":602,"type":22},38,[25],"This is a prospective, open, single-center, single-arm phase II clinical study in non-small cell lung cancer (NSCLC) without common EGFR-sensitive mutations (Ex19del and L858R) or ALK fusion variants identified in the central laboratory. To evaluate the efficacy and safety of neoadjuvant therapy of sacituzumab tirumotecan combined with toripalimab.",[28],[144],"2026-03-23",{"date":586,"type":33},{"date":610,"type":22},"2026-02-24",{"date":612,"type":22},"2028-02-28",{"name":523,"class":40},{"id":615,"slug":616,"hasResults":12,"nctId":617,"briefTitle":618,"officialTitle":619,"acronym":4,"eligibilityCriteria":620,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":621,"targetDuration":4,"studyType":23,"phases":623,"briefSummary":624,"conditions":625,"keywords":626,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":629,"lastUpdatePostDateStruct":630,"startDateStruct":632,"completionDateStruct":634,"leadSponsor":636,"locationsCount":41},"100602342","early-feasibility-study-efs-of-the-carol-for-treatment-of-lung-cancer-stage-1-100602342","NCT07122258","Early Feasibility Study (EFS) of the 'CAROL' for Treatment of Lung Cancer Stage 1","To Investigate the Safety of the CAROL Device for Lung Tumour Treatment in Patients With Non-small Cell Lung Cancer Tumours(s) ≤ 2 cm (cT1b)","Inclusion Criteria:\n\nThose who meet all the following criteria are eligible to participate in the clinical trial.\n\n1. Adults 18 years of age or older at the time of screening\n2. NSCLC tumour(s)≤ 2 cm (cT1b) suitable for resection\n3. Suitable candidate for resection per standard of practice (Lobectomy)\n4. NSCLC is confirmed pathologically for the tissue that will be ablated\n5. Location of tumour:\n\n   * ① in outer one thirds of lung (between outermost 1\u002F3 measured by tumour centre),\n   * ② if the centre of the tumour is located within the outermost 1\u002F3, inclusion will proceed,\n   * ③ anticipation that resection (lobectomy) would remove all gross tumour and ablation with grossly negative margins,\n   * ④ one or more radiofrequency ablation (RFA) applications would target entire margin according to the RFA plan\n6. Signed free and informed consent as prescribed by hospital policies.\n\nExclusion Criteria:\n\nThose who meet any of the following criteria are excluded from this clinical trial.\n\n1. Centralised tumour (inner most one third) not amenable to resection (abutting main stem bronchus, main pulmonary artery branches, oesophagus or trachea)\n2. Other primary lung tumours\n3. Tumour is associated with vulnerable zone of pleural effusion\n4. If the centre of the tumour is not located within the outermost 1\u002F3, exclusion will proceed\n5. PFT: post-bronchodilator forced expired volume in on second (FEV1) or forced vital capacity (FVC) ≤60% predicted, diffusing capacity of the lung for carbon monoxide (DLCO) ≤ 50% predicted\n6. Patients with evidence of severe chronic pulmonary disease including asthma, Chronic Obstructive Pulmonary Disease (COPD), or Interstitial Lung Disease (ILD).\n7. Requirement of supplemental oxygen at rest or exercise\n8. Hospitalization for cardiac disease within the preceding 3 months\n9. Liver enzymes (Alanine Aminotransferase \\[ALT\\], Alkaline Phosphatase \\[ALP\\], Aspartate Aminotransferase \\[AST\\]) or total bilirubin \\>1.5 upper limit of normal (ULN)\n10. Serum creatinine \\> 2 mg\u002Fdl\n11. Recent infection (within 30 days)\n12. Receiving immunosuppressive medication or prednisone \\> 20 mg\u002Fday (or equivalent)\n13. Pre-existing implants - either within the airways or any other location - that impede navigation to or visualisation of the target lesion, in the opinion of the investigator\n14. Pregnant or breastfeeding women and those of childbearing potential who are not practicing a reliable form of contraception.\n15. Disorder of coagulation, history of severe haemoptysis, or receiving anticoagulant medication. Antiplatelet medication is permitted provided that the medication can be held a minimum of 7 days prior to the procedures and 10 days post-procedures, where this refers to both the ablation and surgical procedures\n16. Any condition or anatomical factor that, in the opinion of the investigator or reviewer, may interfere with the safety of the patient, the conduct of the procedure, or evaluation of the study objectives (e.g. severe bronchial narrowing, wall compromise)\n17. Any tumour characteristic that in the opinion of the investigator or reviewers may interfere with the safety of the patient or evaluation of the study objectives\n18. Contraindication to complete neuromuscular blockade during the ablation procedure\n19. Implantable cardiac devices such as pacemakers or defibrillators, especially with unipolar electrode configurations\n20. Known hypersensitivity or allergy to gallium, indium, or other components of the conformable electrode\n21. Medically inoperable conditions\n22. Participant who is currently participating in, or planning to participate in (during the course of the trial), another non-observational clinical research study\n23. Participants who have participated in a non-observational clinical research study within either the past 30 days or who are still within the intervention's wash-out period (whichever is longer)\n24. Participant who, in the opinion of the investigator, is not suitable for participation in the study",{"count":622,"type":22},7,[276],"This study aims to evaluate the safety of the CAROL device for treating lung tumors in patients diagnosed with non-small cell lung cancer (NSCLC) with tumor size ≤ 2 cm (cT1b). The primary objective is to assess safety by monitoring and grading adverse events using the CTCAE v5.0 criteria at one month following the procedure.",[28],[627,628],"CAROL","TAU MEDICAL","2026-03-03",{"date":631,"type":33},"2026-03-05",{"date":633,"type":22},"2026-03-01",{"date":635,"type":22},"2027-06-01",{"name":637,"class":83},"Tau Medical Australia Pty Ltd",{"id":639,"slug":640,"hasResults":12,"nctId":641,"briefTitle":642,"officialTitle":642,"acronym":4,"eligibilityCriteria":643,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":644,"targetDuration":4,"studyType":23,"phases":646,"briefSummary":647,"conditions":648,"keywords":653,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":665,"lastUpdatePostDateStruct":666,"startDateStruct":667,"completionDateStruct":669,"leadSponsor":671,"locationsCount":274},"100506384","phase-1-a-phase-1-clinical-study-of-nxp900-in-subjects-with-advanced-cancers-100506384","NCT05873686","A Phase 1 Clinical Study of NXP900 in Subjects With Advanced Cancers","Part A\n\nInclusion Criteria:\n\n1. Provide written informed consent.\n2. 18 years old or older.\n3. Advanced, metastatic, and\u002For progressive solid tumors for whom there is no authorized or effective therapy available, or for whom such therapies are considered inappropriate by the Investigator.\n4. Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.\n5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n\nExclusion Criteria:\n\n1. Subjects with known human epidermal growth factor receptor 2 (HER2+) overexpressing malignancies.\n2. Radiotherapy (except for palliative reasons), endocrine therapy, chemotherapy, or investigational agent within 28 days, (42 days for nitrosoureas, mitomycin-C) of first dose of NXP900. Subjects can continue to receive bisphosphonates due to metastatic bone disease or GnRH agonists if they have prostate cancer.\n3. Ongoing toxic manifestations of previous treatments \\> Grade 2 with the exception of alopecia and neuropathy.\n4. Subjects with treated brain metastases with evidence of progression within 28 days after central nervous system (CNS)-directed treatment, as ascertained by clinical examination and brain imaging (magnetic resonance imaging \\[MRI\\] or computed tomography \\[CT\\] scan) during the Screening period.\n5. Female subjects who can become pregnant (or are already pregnant or lactating), unless they have a negative serum pregnancy test before enrollment and agree to use at least one highly effective form of contraception .\n6. Male subjects with partners of childbearing potential, unless they agree to take measures not to father children by using a barrier method of contraception (condom plus spermicide).\n7. Major surgery from which the subject has not yet recovered.\n\nPart B:\n\nInclusion Criteria:\n\n1. Provide written informed consent.\n2. 18 years old or older.\n3. Advanced, metastatic, and\u002For progressive solid tumors with pathogenic molecular alterations:\n\n   1. Non-small cell lung cancer (adenocarcinoma); YES1, TYMS amplification or FAT1 pathogenic mutation\n   2. Non-small cell lung cancer (squamous cell carcinoma); YES1, TYMS amplification or FAT1 pathogenic mutation\n   3. Renal cancer; NF2 pathogenic mutation\n   4. Mesothelioma; NF2 pathogenic mutation\n   5. Other solid tumors with a NF2, FAT1 or LATS1 pathogenic gene mutation or TYMS, YAP1, YES1, TAZ1 gene amplification\n4. Must have received 1-3 prior therapies appropriate for their tumor type and stage of disease\n5. Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.\n6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n\nExclusion Criteria:\n\n1. Subjects with the following combination of cancer type and pathogenic molecular alterations are excluded:\n\n   1. Subjects with colorectal cancer, glioma, melanoma, or anaplastic thyroid conditions with BRAF mutations.\n   2. Subjects with NSCLC with BRAF, EGFR or HER2 alterations.\n   3. Subjects with breast cancer, gastric cancer, esophageal junction adenocarcinoma or biliary cancer with HER2 alterations,\n2. Subjects with anal, penile, cervical or head and neck cancers with a prior history of human papilloma virus (HPV) infection.\n3. Radiotherapy (except for palliative reasons), endocrine therapy, chemotherapy, or investigational agent within 28 days (42 days for nitrosoureas, mitomycin-C) prior to first dose of NXP900. Subjects can continue to receive bisphosphonates due to metastatic bone disease or GnRH agonists if they have prostate cancer.\n4. Ongoing toxic manifestations of previous treatments \\> Grade 2 with the exception of alopecia and neuropathy.\n5. Female subjects who can become pregnant (or are already pregnant or lactating), unless they have a negative serum pregnancy test before enrollment and agree to use at least one highly effective form of contraception .\n6. Male subjects with partners of childbearing potential, unless they agree to take measures not to father children by using a barrier method of contraception (condom plus spermicide).\n7. Major surgery from which the subject has not yet recovered.",{"count":645,"type":22},140,[53],"This is a multi-center, first-in-human, open label, dose escalation (Part A) and expansion (Part B) Phase 1 study in subjects with advanced solid tumors and in subjects with solid tumors with selected genetic alterations that are either direct (YES1 amplification) or dependent (Hippo Pathway alterations) targets of NXP900.",[178,28,649,650,651,652],"Renal Cancer","Mesothelioma","Non-Small Cell Squamous Lung Cancer","Non-small Cell Lung Adenocarcinoma",[654,381,379,655,656,657,658,659,660,661,662,663,664],"Solid Tumor","Adenocarcinoma","YES1","YAP1","TAZ1","NF2","FAT1","LATS1","TYMS","gene amplification","gene mutation","2026-02-27",{"date":629,"type":33},{"date":668,"type":33},"2023-10-26",{"date":670,"type":22},"2027-07",{"name":672,"class":83},"Nuvectis Pharma, Inc.",{"id":674,"slug":675,"hasResults":12,"nctId":676,"briefTitle":677,"officialTitle":678,"acronym":679,"eligibilityCriteria":680,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":681,"targetDuration":4,"studyType":95,"phases":4,"briefSummary":683,"conditions":684,"keywords":687,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":690,"lastUpdatePostDateStruct":691,"startDateStruct":693,"completionDateStruct":695,"leadSponsor":697,"locationsCount":699},"100626923","single-fraction-pulmonary-ablative-radiotherapy-outcomes-and-quality-of-life-workup-100626923","NCT07441941","Single-Fraction Pulmonary Ablative Radiotherapy Outcomes and Quality-of-life Workup","Quality-of-Life Assessment Following Single-Fraction Stereotactic Radiotherapy (SF-SBRT) for Inoperable Primary and Oligometastatic Lung Tumor","SPARROW","Inclusion Criteria:\n\n* Age: ≥ 18 years\n* Patient receiving single-fraction stereotactic body radiation therapy (SBRT)\n* Stage T1-2 N0 M0 non-small cell lung cancer (NSCLC) (AJCC 6th edition) or oligometastatic lung tumor defined by ≤ 3 lung metastasis.\n* Inoperability: Tumor is inoperable or patient refuses surgery\n* Tumor size: ≤ 3 cm\n* Peripheral tumors: \\> 2 cm from proximal bronchial tree but ≥ 0.5 cm from the wall\n* Histologically proven or with evolution criteria (CT scan and PET scan)\n* ECOG performance status: 0-2\n* Ability to comply: Willingness and ability to comply with scheduled visits and other study procedures\n* Informed consent: Written informed consent obtained\n* Insurance: Patient is affiliated with a French health insurance plan\n\nExclusion Criteria:\n\n* Tumors invading the pleura or mediastinum.\n* Concurrent infectious pneumonia or pericarditis.\n* Prior radiotherapy to the treatment field.\n* Presence of neoadjuvant treatment for the present cancer.\n* Substance abuse, medical, psychological, or social conditions that may interfere with the patient's participation in the study or evaluation of the study results\n* Patients under guardianship, curatorship or safeguard of justice,\n* Pregnant or breast-feeding subjects\n* Concomitant participation or participation within the last 30 days in another clinical trial\n* Patient with an estimated life expectancy of less than 6 months.",{"count":682,"type":22},190,"Pulmonary tumors, whether primary or metastatic, represent a major challenge in oncology.\n\nPrimary lung cancers are responsible for nearly 37,000 deaths per year in France, highlighting the critical importance of their management. Moreover, secondary pulmonary lesions are present in 20% of solid cancers and show wide variability in prognosis. Oligometastatic disease (≤ 3 to 5 lesions) is associated with a better prognosis, justifying the development of local treatments for these lesions, particularly stereotactic radiotherapy.\n\nDuring the COVID-19 pandemic, single-fraction protocols (30-34 Gy) were implemented to limit patient exposure, showing outcomes equivalent to multi-fraction regimens for both primary and secondary lesions.\n\nHowever, the impact of these treatments on quality of life remains poorly documented-especially for non-small cell lung carcinoma-and needs to be further explored to optimize their integration into routine clinical practice.\n\nThe primary objective of this study is to assess the impact of single-fraction stereotactic body radiotherapy (SBRT) for pulmonary lesions on quality of life.\n\nTo this end, patients will complete a standardized French-language quality of life questionnaire, the EORTC QLQ-C30 and LC-29, before treatment and at 1 month (M1), 3 months (M3), 6 months (M6), 9 months (M9), and 12 months (M12) after treatment.\n\nThis validated, disease-specific questionnaire comprises 59 items: 30 assessing overall quality of life (QLQ-C30) and 29 addressing aspects related to lung cancer treatments (LC-29). It includes questions on respiratory symptoms, chest pain, fatigue, and the functional impact of the treatment.",[685,28,686],"Oligometastatic Lung Tumor","SBRT",[688,686,689],"Quality of life","Lung tumor","2026-02-26",{"date":692,"type":33},"2026-03-02",{"date":694,"type":33},"2026-01-14",{"date":696,"type":22},"2028-11-30",{"name":698,"class":40},"Institut du Cancer de Montpellier - Val d'Aurelle",2,{"id":701,"slug":702,"hasResults":12,"nctId":703,"briefTitle":704,"officialTitle":705,"acronym":706,"eligibilityCriteria":707,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":708,"targetDuration":4,"studyType":23,"phases":710,"briefSummary":711,"conditions":712,"keywords":714,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":717,"lastUpdatePostDateStruct":718,"startDateStruct":720,"completionDateStruct":722,"leadSponsor":723,"locationsCount":41},"100621906","phase-1-a-phase-1-study-of-tgi-5-as-monotherapy-and-in-combination-with-nivolumab-in-subjects-with-locally-advancedmetastatic-solid-tumors-100621906","NCT07376707","A Phase 1 Study of TGI-5 as Monotherapy and in Combination With Nivolumab in Subjects With Locally Advanced\u002FMetastatic Solid Tumors","A Phase 1 Study to Investigate the Safety, Tolerability, Pharmacokinetics\u002FPharmacodynamics, and Antitumor Activity of TGI-5 as Monotherapy and in Combination With Nivolumab in Subjects With Locally Advanced\u002FMetastatic Solid Tumors","TGI5","Inclusion Criteria:\n\n* 1\\. Male or female subject age ≥18 years at the time of informed consent. 2. Phase 1a and dose escalation part of Phase 1b: Subjects with histologically or cytologically diagnosed unresectable locally advanced\u002Fmetastatic solid tumors, mainly but not limited to CRC, HCC, melanoma, NSCLC.\n\nDose expansion part of Phase 1b:\n\n* Cohort 1: Subjects with histologically or cytologically diagnosed unresectable locally advanced and\u002For metastatic CRC.\n* Cohort 2: Subjects with histologically or cytologically diagnosed unresectable locally advanced and\u002For metastatic melanoma.\n* Cohort 3: Subjects with histologically or cytologically diagnosed unresectable locally advanced and\u002For metastatic NSCLC.\n* Cohort 4: Subjects with other histologically or cytologically diagnosed unresectable locally advanced\u002Fmetastatic solid tumors.\n\n  3\\. Subjects should have documented progression of disease despite all standard therapy or are intolerant of all standard therapy, or for whom no effective standard therapy exists. (Standard therapies are defined as treatments recommended by local guidelines, including but not limited to, chemotherapy, radiation, target therapies based on mutation status, immunotherapy, and surgery in general).\n\nDose expansion part of Phase 1b:\n\n* Cohort 1: Subjects with unresectable locally advanced and\u002For metastatic CRC o At least 2 prior standard chemotherapy\u002Ftherapy regimens are required with documented progression or intolerability to the treatment.\n\n  * Standard chemotherapy regimens include all the following ones (if eligible and no contraindication): Fluoropyrimidine-containing regimen, and\u002For oxaliplatin-containing regimen, and\u002For irinotecan-containing regimen (treatment with a FOLFIRINOX regimen will count as 2 regimens).\n  * With or without an anti-VEGF therapy (e.g., bevacizumab).\n  * At least one of the anti-EGFR monoclonal antibodies (cetuximab or panitumumab) for KRAS wild-type subjects if clinically indicated.\n  * For subjects with a known microsatellite instability high (MSI-H):\n\n    1. Prior treatment with an at least 2 doses of approved or investigational immune checkpoint inhibitor is required with documented progression or intolerability to the treatment.\n    2. Demonstrated disease progression after immune checkpoint inhibitor treatment as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (Appendix 5). The initial evidence of disease progression is to be confirmed by a second assessment no less than 4 weeks from the date of the first documented disease progression, in the absence of rapid clinical progression. Once disease progression is confirmed, the initial date of disease progression documentation will be considered the date of disease progression.\n    3. Progressive disease that has been documented within 12 weeks from the last dose of immune checkpoint inhibitor.\n\n       Note: a line of therapy is generally considered \\>2 cycles of exposure to the same regimen followed by radiographically documented progression. Agents that are mechanistically similar (e.g., 5-fluorouracil and capecitabine) and are used interchangeably due to tolerability but not progression may be considered as components of the same regimen upon discussion with the medical monitor.\n  * Subjects must have progressed while receiving or after of the last administration of their last line of standard therapy or be unable to tolerate any of these standard treatments.\n  * Subjects who progressed on\u002Fwithin 3 months of adjuvant therapy with anti-PD-1 antibody will be allowed; subjects who received adjuvant chemotherapy and had recurrence\u002Fprogression with development of unresectable or metastatic disease during or within 6 months of completion of the adjuvant chemotherapy can count this as a line of therapy.\n* Cohort 2: Subjects with anti-PD-(L)1 antibody PD-1 relapsed\u002Frefractory melanoma\n\n  * PD-1 refractory disease as defined as progression on treatment with anti-PD-1 antibody administered either as monotherapy or in combination with other checkpoint inhibitors (anti-CTLA4 antibody or anti-LAG-3 antibody) or other therapies. Anti-PD-1 treatment progression is defined by meeting all of the following criteria:\n\n    1\\) Has received at least 2 doses of an approved or investigational anti-PD-1 antibody with documented progression or intolerability to the treatment.\n\n    2\\) Demonstrated disease progression after anti-PD-1 treatment as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (Appendix 5). The initial evidence of disease progression is to be confirmed by a second assessment no less than 4 weeks from the date of the first documented disease progression, in the absence of rapid clinical progression. Once disease progression is confirmed, the initial date of disease progression documentation will be considered the date of disease progression.\n\n    3\\) Progressive disease that has been documented within 12 weeks from the last dose of anti-PD-1 antibody.\n  * Subjects who progressed on\u002Fwithin 3 months of adjuvant therapy with anti-PD-1 antibody will be allowed; an adjuvant therapy will count as 1 prior line of therapy if received within the prior 6 months.\n  * For patients with BRAF V600 mutations, treatment with BRAF and MEK inhibitors prior to initiation on trial is required, unless patients are intolerant of BRAF targeted therapy.\n  * Treatment must have been discontinued for disease progression or intolerance to therapy.\n* Cohort 3: Subjects with anti-PD-(L)1 antibody relapsed\u002Frefractory NSCLC\n\n  o Anti-PD-(L)1 antibody refractory disease as defined as progression on treatment with anti-PD-(L)1 inhibitor administered either as monotherapy or in combination with platinum-based chemotherapy or other therapies. Anti PD (L)1 treatment progression is defined by meeting all of the following criteria:\n  1. Has received at least 2 doses of an approved or investigational anti-PD-(L)1 inhibitor with documented progression or intolerability to the treatment.\n  2. Has demonstrated disease progression after anti-PD-(L)1 inhibitor as defined by RECIST v1.1 (Appendix 5). The initial evidence of disease progression is to be confirmed by a second assessment no less than 4 weeks from the date of the first documented disease progression, in the absence of rapid clinical progression. Once disease progression is confirmed, the initial date of disease progression documentation will be considered the date of disease progression.\n  3. Progressive disease has been documented within 12 weeks from the last dose of anti-PD-(L)1 inhibitor.\n\n     o Subjects who progressed on\u002Fwithin 3 months of adjuvant therapy with anti PD (L)1 inhibitor will be allowed; an adjuvant therapy will count as 1 prior line of therapy if received within the prior 6 months.\n\n     o Documented disease progression during or after platinum-based chemotherapy alone or intolerability to the treatment for subjects with contraindications to anti PD (L)1 inhibitors.\n     * Patients with NSCLC with known oncogenic driver (including but not limited to EGFR, ALK, ROS, MET alterations) must have received and progressed past driver-specific therapy.\n     * Treatment must have been discontinued for disease progression or intolerance to therapy.\n* Cohort 4: Subjects with other histologically or cytologically diagnosed unresectable locally advanced\u002Fmetastatic solid tumors All subject in Phase 1b must meet PD-L1 expression ≥1%. 4. Subjects must have at least one evaluable lesion in Phase 1a or at least one measurable lesion in Phase 1b as defined by RECIST v1.1 (Appendix 5) which has not received radiotherapy (or progressive disease after radiotherapy).\n\n  5\\. ECOG PS (Appendix 6) of 0\\~2. 6. Life expectancy ≥3 months. 7. Subjects have sufficient baseline organ function and laboratory data meet the following criteria at enrollment:\n* Hematological (without need for hematopoietic growth factor or transfusion support within 2 weeks prior to enrollment):\n\n  1\\) ANC ≥1.5×109\u002FL. 2) Hemoglobin (HGB) ≥90 g\u002FL. 3) Platelet (PLT) ≥75×109\u002FL.\n* Hepatic:\n\n  1\\) AST and ALT ≤2.5×ULN (≤5×ULN for subjects with liver metastases). 2) Total bilirubin (TBil) ≤1.5×ULN, or TBil ≤3.0×ULN for subjects with liver cancer or liver metastases. Subjects with Gilbert's syndrome may enroll if direct bilirubin ≤1.5×ULN.\n* Renal:\n\n  1\\) Creatinine apparent clearance (CL) \\>50 mL\u002Fmin according to modification Cockcroft-Gault equation (140-age \\[year\\])×body weight \\[kg\\]×1.23×(0.85 if female)\u002Fserum creatinine \\[μmol\u002FL\\]).\n* Coagulation:\n\n  1\\) International normalized ratio (INR) ≤1.5. 2) Activated partial thromboplastin time (APTT) ≤1.5×ULN. 8. Woman of child-bearing potential must have a negative serum pregnancy test within 7 days prior to treatment. A female subject of nonchildbearing potential will have had at least 12 continuous months of natural (spontaneous) amenorrhea, follicle stimulating hormone level ≥40 mIU\u002FmL at screening, and an appropriate clinical profile (e.g., age appropriate, history of vasomotor symptoms), or have had surgical bilateral oophorectomy, hysterectomy, or tubal ligation ≥6 weeks prior to screening.\n\n  9\\. Female subjects of childbearing potential or male subjects with a partner of childbearing potential must agree to use effective contraception at the time of informed consent and continuing through the study until 6 months after the last dose of study treatment (Appendix 4).\n\nExclusion Criteria:\n\n* 1\\. Subject with known active central nervous system (CNS) primary tumor or metastases.\n\nNote: Subject with previously treated CNS primary tumor\u002Fmetastases can participate provided they are clinically stable for at least 2 weeks, have no evidence of new or enlarging brain metastases, and there has been no increase in steroid dose for 14 days prior to the first dose of TGI-5 to manage CNS symptoms. Subjects with carcinomatous meningitis or leptomeningeal spread, or spinal cord compression are excluded regardless of clinical stability.\n\n2\\. History of intercurrent severe chronic or active infections:\n\n1. Subjects with active hepatitis B, defined as: if hepatitis B virus surface antigen (HbsAg) positive, hepatitis B virus (HBV) deoxyribonucleic acid (DNA) assay should be performed, and HBV DNA is above the limit quantification.\n2. Subjects with active hepatitis C, defined as: if hepatitis C virus (HCV) antibody positive, HCV ribonucleic acid (RNA) assay should be performed, and HCV RNA is positive.\n3. Known history of acquired immune deficient syndrome (AIDS) or human immunodeficiency virus (HIV) infection.\n4. Subjects with HIV infection may be eligible if CD4+ T cell counts ≥350 cells\u002FµL and without a history of AIDS-defining opportunistic infections.\n5. Other severe chronic within 4 weeks prior to the first dose of TGI-5, including but not limited to hospitalization for complications of infection, bacteremia, severe pneumonia, or active tuberculosis. Or uncontrolled active infections or unexplained fever \\>38°C within 7 days prior to first dose of TGI-5.\n\n3\\. Has a history of active autoimmune diseases such as systemic lupus erythematosus, rheumatoid arthritis, vasculitis, or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 14 days prior the first dose of study drug.\n\nWith the following exceptions: clinically stable autoimmune thyroid disease; treatment with inhaled or topical corticosteroids such as ocular, intra-articular, and intranasal ≤10 mg daily of prednisone equivalent; short-term use of corticosteroids (no more than 7 days) for prophylaxis (e.g., to prevent contrast medium allergy or non-autoimmune allergic diseases); and replacement therapy (e.g., thyroxine for hypothyroidism, insulin for diabetes, physiologic corticosteroid replacement for adrenal or pituitary insufficiency).\n\n4\\. Has a history of symptomatic interstitial lung disease. 5. Toxicities of prior therapies have not been resolved to Grade ≤1 or baseline as per NCI-CTCAE v5.0, except for alopecia, skin hyperpigmentation, Grade 2 neuropathy and Grade 2 endocrinopathy that is well controlled by replacement therapy.\n\n6\\. Subjects with severe or uncontrolled cardiovascular disorder requiring treatment, including any of the following:\n\n1. New York Heart Association (NYHA) class III or IV congestive heart failure.\n2. Left ventricular ejection fraction (LVEF) \\\u003C50% assessed by multiple-gated acquisition (MUGA) scan or echocardiogram (ECHO).\n3. Mean ECG QT interval corrected by Fridericia's formula (QTcF) \\>480 milliseconds (ms) obtained from triplicate 12-lead ECGs, or congenital long QT syndrome.\n4. Any of the following within 6 months prior to screening: Grade \\>2 ventricular arrhythmia, myocardial infarction, severe\u002Funstable angina (even if controlled with medication), coronary artery bypass graft, congestive heart failure, cerebrovascular accident, or transient ischemic attack.\n5. Presence of uncontrolled hypertension (systolic blood pressure \\>160 mmHg or diastolic blood pressure \\>100 mmHg). Subjects with a history of hypertension are allowed if blood pressure is controlled to within these limits by anti-hypertensive treatment.\n6. Symptomatic pulmonary embolism within 6 months prior to initiation of study treatment.\n\n7\\. Prior allogenic or autologous bone marrow transplantation or other solid organ transplantation.\n\n8\\. Has a known additional malignancy that is progressing or has required active treatment within the past 3 years (Note: Subjects with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and localized prostate cancer who have undergone potentially curative therapy. These subjects are not excluded).\n\n9\\. Evidence of clinically significant immunosuppression such as the following:\n\n1. Primary immunodeficiency state such as severe combined immunodeficiency disease (SCID).\n2. Concurrent opportunistic infection. 10. Presence of uncontrolled pleural effusion, pericardial effusion or ascites requiring recurrent drainage procedures (monthly or more frequently).\n\n11\\. Previously treated with the following antitumor therapy (prior to the first dose of TGI-5):\n\n1\\) Previous treated with TIGIT-targeting therapy. 2) Chemotherapy, target therapy, immunotherapy, or other anticancer therapy within 28 days or 5 half-lives, whichever is shorter, prior to the first dose of study treatment, except:\n\n1. Washout period for nitrosoureas or mitomycin is ≤6 weeks.\n2. ≤5 half-lives or 2 weeks (whichever is longer) for fluoropyrimidines or small-molecule targeted agents.\n3. Washout period for herbal therapy with anticancer indications is ≤2 weeks.\n4. Anti-PD-1\u002FPD-L1 antibody therapy within 6 weeks. 3) Prior radiotherapy ≤4 weeks prior to the first dose of study treatment, with the exception of a single fraction of radiotherapy for the purposes of palliation, which is permitted.\n\n   4\\) Subject participated in any other clinical study and has received an investigational product within 28 days prior to the first dose of TGI-5.\n\n   12\\. Has received systematic immunomodulatory drugs within 14 days before the first dose of study drug, such as thymosin, IL-2, and IFN.\n\n   13\\. Has received a live vaccine within 4 weeks prior to the first dose of study drug.\n\n   14\\. Has a recent major surgery within 4 weeks prior to the first dose of study drug or is expected to undergo major surgery during the study.\n\n   15\\. Subject requiring anticoagulant treatment which cannot be safely interrupted, if medically needed for a study procedure (e.g., biopsy) based on the opinion of the investigator.\n\n   16\\. Subjects who have experienced Grade ≥3 irAEs from prior immunotherapies or who discontinue immunotherapy due to immune-related toxicities.\n\n   Note: Subjects with stable hypothyroidism on hormone replacement therapy are eligible.\n\n   17\\. Has a known psychiatric or substance abuse disorder that would interfere with the subject's ability to cooperate with the requirements of the study.\n\n   18\\. Pregnancy or lactation. Women who are willing to discontinue breastfeeding prior to administration of study drug and do not intend to resume breastfeeding may be enrolled.\n\n   19\\. Has known hypersensitivity to either the drug substances or inactive ingredients in the drug product.\n\n   20\\. Pre-existing other serious medical conditions (e.g., active or chronic inflammatory lung disease have not resolved, uncontrolled acute or chronic nephropathy, uncontrolled pancreatitis, uncontrolled hepatopathy, uncontrolled diabetes mellitus, active gastric ulcer, gastrointestinal hemorrhage, uncontrolled epileptic seizure, and signs and symptoms of severe coagulopathy), familial or endemic disease that, in the opinion of the investigator, will interfere with planned staging, treatment, and follow-up, subject compliance, or will place the subject at high risk for treatment-related complications.\n\n   21\\. Subjects who are unwilling or unable to comply with study procedures and study restrictions, or in the judgment of the investigator, would make the subject inappropriate for entry into this study.\n\n   22\\. Subjects who have contraindication for use of PD-1\u002FPD-L1 antibody (only for Phase 1b).",{"count":709,"type":22},194,[53],"This is a Phase 1, multicenter, open-label, two-parts, FIH study to evaluate the tolerability, safety, PK\u002FPD, and preliminary antitumor activity of TGI-5 as monotherapy and in combination with Nivolumab in subjects with unresectable locally advanced\u002Fmetastatic solid tumors.\n\nThe study consists of two parts: TGI-5 monotherapy (Phase 1a: including a dose escalation part and a dose expansion part), TGI-5 in combination with a fixed dose of Nivolumab (Phase 1b: including a dose escalation part and a dose expansion part).",[365,112,713,28],"HCC - Hepatocellular Carcinoma",[715,716],"TGI-5","Locally Advanced\u002FMetastatic Solid Tumors","2026-01-21",{"date":719,"type":33},"2026-01-29",{"date":721,"type":33},"2025-06-12",{"date":235,"type":22},{"name":724,"class":40},"Hefei TG ImmunoPharma Co., Ltd.",{"id":726,"slug":727,"hasResults":12,"nctId":728,"briefTitle":729,"officialTitle":730,"acronym":731,"eligibilityCriteria":732,"healthyVolunteers":12,"sex":17,"minAge":733,"maxAge":19,"enrollmentInfo":734,"targetDuration":4,"studyType":23,"phases":736,"briefSummary":737,"conditions":738,"keywords":742,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":745,"lastUpdatePostDateStruct":746,"startDateStruct":748,"completionDateStruct":750,"leadSponsor":752,"locationsCount":699},"100602222","phase-2-adaptive-adjuvant-sintilimab-therapy-guided-by-mrd-adapt-lung-100602222","NCT07120698","Adaptive Adjuvant Sintilimab Therapy Guided by MRD (ADAPT Lung)","Adaptive Adjuvant Sintilimab Therapy Guided by MRD in II-IIIB Stage NSCLC Patients With Non-pCR Pathological Response After Neoadjuvant Immunotherapy Combined With Chemotherapy: a Prospective, Multi-center, Single-arm, Phase II Trial","CTONG 2508","Inclusion Criteria:\n\n1. Signed written informed consent prior to the initiation of any trial-related procedures.\n2. Male or female aged ≥18 years and ≤75 years.\n3. Histologically or cytologically confirmed non-small cell lung cancer (NSCLC).\n4. Received 3-4 cycles of neoadjuvant immunotherapy (PD-1 inhibitor) combined with chemotherapy.\n5. Underwent radical surgical treatment (R0), with surgical procedures including lobectomy or sleeve lobectomy. All gross tumors must be completely resected at the end of surgery, and all surgical margins of the resected tumors must be negative. Systemic lymph node dissection is required.\n6. Clinical stage II, IIIA, or IIIB (limited to resectable N2) according to the AJCC 8th edition TNM classification for lung cancer. Resectable N2 refers to non-massive (defined as short-axis diameter \\\u003C3 cm), discrete, or single-station N2 involvement. If clinically suspected of N2 or N3, pathological confirmation is recommended whenever feasible.\n7. Patients with pathological response assessment of 1%-90% residual viable tumor (RVT).\n8. No EGFR mutations, ROS1 fusions, ALK fusions, or RET fusions. Other potentially targetable driver gene alterations will be determined in consultation with the sponsor.\n9. No prior anti-tumor treatment other than PD-1 inhibitors and chemotherapy before radical surgery for lung cancer.\n10. Completed radical surgery for lung cancer 4-12 weeks prior to study enrollment, with pathological confirmation of R0 resection and radiological evidence of no residual tumor foci 1 month after radical surgery.\n11. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n12. Life expectancy \\>6 months.\n13. Adequate organ function:\n\n1\\. Absolute neutrophil count (ANC) ≥1.5×10\\^9\u002FL without the use of granulocyte colony-stimulating factor within the past 14 days.\n\n2\\. Platelets ≥100×10\\^9\u002FL without transfusion within the past 14 days. 3. Hemoglobin \\>9 g\u002FdL without transfusion or use of erythropoiesis-stimulating agents within the past 14 days.\n\n4\\. Total bilirubin ≤1.5× upper limit of normal (ULN). 5. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5×ULN (subjects with liver metastases are allowed to have ALT or AST ≤5×ULN).\n\n6\\. Serum creatinine ≤1.5×ULN and creatinine clearance (calculated using the Cockcroft-Gault formula) ≥60 ml\u002Fmin.\n\n7\\. Good coagulation function, defined as international normalized ratio (INR) or prothrombin time (PT) ≤1.5×ULN.\n\n8\\. Normal thyroid function, defined as thyroid-stimulating hormone (TSH) within the normal range. Subjects with baseline TSH outside the normal range are eligible if total T3 (or free T3) and free T4 are within the normal range.\n\n9\\. Cardiac enzyme profile within the normal range (subjects with isolated laboratory abnormalities deemed not clinically significant by the investigator are also eligible).\n\n14\\. For female subjects of childbearing potential, a negative urine or serum pregnancy test must be obtained within 3 days prior to the first administration of the study drug (Day 1 of Cycle 1). If the urine pregnancy test result is inconclusive, a serum pregnancy test is required. Postmenopausal women are defined as those who have been amenorrheic for at least 1 year, or those who have undergone surgical sterilization or hysterectomy.\n\n15\\. All subjects (regardless of gender) at risk of conception must use contraception with a failure rate of less than 1% per year throughout the treatment period until 120 days after the last administration of the study drug (or 180 days after the last administration of chemotherapy).\n\n16\\. Provide samples for MRD assessment (surgical tissue + blood).\n\nExclusion Criteria:\n\n1. Diagnosis of any malignancy other than non-small cell lung cancer within 5 years prior to the first dose (excluding completely treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and\u002For carcinoma in situ that has been completely resected).\n2. Received adjuvant radiotherapy prior to dosing.\n3. Patients who underwent pneumonectomy.\n4. Currently participating in an interventional clinical study or received other investigational drugs or used investigational devices within 4 weeks prior to the first dose.\n5. Received neoadjuvant treatment with anti-tumor therapies other than chemotherapy and immunotherapy.\n6. Presence of unhealed surgical incisions, ulcers, or fractures.\n7. In the investigator's opinion, severe concomitant systemic diseases that may affect the subject's ability to complete the study. Subjects with positive autoimmune antibodies must be assessed and confirmed by the investigator to have no autoimmune diseases requiring systemic treatment before enrollment.\n8. Presence of primary immunodeficiency diseases.\n9. Receiving systemic corticosteroid therapy within 7 days prior to the first dose of the study (excluding intranasal, inhaled, or other topical corticosteroids). Note: The use of physiologic doses of corticosteroids (≤10 mg\u002Fday prednisone or equivalent) is permitted.\n10. Known allogeneic organ transplantation (excluding corneal transplantation) or allogeneic hematopoietic stem cell transplantation.\n11. Known allergy to the active ingredient or excipients of the study drug, sintilimab.\n12. Not fully recovered from toxicities and\u002For complications caused by any prior interventions prior to the start of treatment (i.e., ≤Grade 1 or returned to baseline, excluding fatigue or alopecia).","28 Years",{"count":735,"type":22},115,[25],"This is a multicenter, prospective, open-label Phase II study designed to evaluate the safety and efficacy of adjuvant sintilimab therapy guided by minimal residual disease (MRD) in patients with Stage II-IIIB non-small cell lung cancer (NSCLC) who have not achieved a pathological complete response (non-pCR) after neoadjuvant immunotherapy combined with chemotherapy. The study is being conducted at the Third People's Hospital of Chengdu and the Guangdong Provincial People's Hospital.",[28,739,740,741],"MRD","II-IIIB Stages","Adjuvant Immunotherapy",[739,743,461,744],"II-IIIB stages","adjuvant immunotherapy","2025-12-30",{"date":747,"type":33},"2026-01-05",{"date":749,"type":33},"2025-11-05",{"date":751,"type":22},"2029-07-26",{"name":753,"class":40},"Guangdong Association of Clinical Trials",{"id":755,"slug":756,"hasResults":12,"nctId":757,"briefTitle":758,"officialTitle":759,"acronym":4,"eligibilityCriteria":760,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":761,"targetDuration":4,"studyType":23,"phases":763,"briefSummary":764,"conditions":765,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":766,"lastUpdatePostDateStruct":767,"startDateStruct":769,"completionDateStruct":771,"leadSponsor":772,"locationsCount":41},"100618317","phase-2-wast-cell-docetaxel-combination-therapy-in-pd-1-inhibitor-resistant-advanced-nsclc-100618317","NCT07330050","WAST Cell-Docetaxel Combination Therapy in PD-1 Inhibitor-Resistant Advanced NSCLC","Phase II Clinical Trial Evaluating Whole Agonist-Stimulated T (WAST) Cells in Combination With Docetaxel as a Second-line Treatment for Advanced Non-small Cell Lung Cancer (NSCLC) Resistant to PD-1 Inhibitors","Inclusion Criteria:\n\n* At screening, patients must meet the following diagnostic and treatment criteria: 1) Histologically or cytologically confirmed NSCLC, 2) Advanced NSCLC as determined by imaging according to AJCC V8, 3) Disease progression after first-line treatment with a PD-1 inhibitor; Expected survival time greater than 3 months;\n* At screening, measurable target lesions on imaging with the longest diameter greater than 1.0 cm;\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 at screening;\n* Adequate bone marrow reserve at screening, defined as:\n\nAbsolute neutrophil count (ANC) \\>1.5×10⁹\u002FL; Absolute lymphocyte count (ALC) ≥0.3×10⁹\u002FL; Platelets (PLT) ≥100×10⁹\u002FL; Hemoglobin (HGB) ≥100g\u002FL;\n\n* Adequate organ function at screening, meeting the following criteria:\n\nAspartate aminotransferase (AST) ≤2.5 times the upper limit of normal (ULN) (≤5 ULN if due to tumor infiltration); Alanine aminotransferase (ALT) ≤2.5 times ULN (≤5 ULN if due to tumor infiltration); Total serum bilirubin ≤1.5 times ULN (≤3 ULN if due to tumor infiltration); Serum creatinine (Scr) ≤1.5 times ULN, or creatinine clearance rate ≥60 mL\u002Fmin; Minimum lung reserve level, defined as ≤Grade 1 dyspnea and oxygen saturation \\>91% without supplemental oxygen; International Normalized Ratio (INR) ≤1.5 times ULN, and activated partial thromboplastin time (APTT) ≤1.5 times ULN;\n\n* Women of childbearing potential must have a negative urine pregnancy test, and any male or female patient capable of having children must agree to use effective contraception throughout the study and for at least 1 year after the last dose of study treatment.\n\nExclusion Criteria:\n\n* Patients with symptomatic central nervous system (CNS) metastases at screening (patients with asymptomatic CNS metastases, or those who have been treated locally and are stable without symptoms for 4 weeks, are eligible);\n* History of CNS disorders prior to screening, such as epilepsy, cerebrovascular ischemia\u002Fhemorrhage, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar diseases, organic brain syndromes, psychiatric disorders, or any autoimmune diseases affecting the CNS;\n* Received immunotherapy, targeted therapy, chemotherapy, or radiotherapy within 4 weeks before screening, and deemed unsuitable for enrollment by the investigator;\n* Discontinued systemic corticosteroid therapy less than 72 hours before cell infusion; however, physiological replacement doses of steroids (e.g., prednisone \\\u003C10 mg\u002Fday or equivalent) are allowed;\n* Any history of adoptive cell therapy prior to screening;\n* History of organ\u002Ftissue transplantation prior to screening;\n* Known active systemic autoimmune diseases under treatment prior to screening;\n* At screening, meets any of the following criteria:\n\nHepatitis B surface antigen (HBsAg) and\u002For hepatitis B e antigen (HBeAg) positive; Hepatitis B e antibody (HBe-Ab) and\u002For hepatitis B core antibody (HBc-Ab) positive, with HBV-DNA copy numbers above the lower limit of quantification; Hepatitis C antibody (HCV-Ab) positive; Treponema pallidum antibody (TP-Ab) positive; HIV antibody test positive; EBV-DNA, CMV-DNA copy numbers above the lower limit of quantification;\n\n* Undergone major surgery within 4 weeks prior to screening and deemed unsuitable for enrollment by the investigator;\n* History of other malignancies within the past 2 years (except successfully treated non-melanoma skin cancer or in situ carcinoma);\n* At screening, meets any of the following cardiac conditions:\n\nLeft ventricular ejection fraction (LVEF) ≤50% (by ECHO); New York Heart Association (NYHA) class III or IV congestive heart failure; Uncontrolled hypertension (systolic blood pressure ≥140 mmHg and\u002For diastolic blood pressure ≥90 mmHg) or pulmonary hypertension despite standard treatment; Myocardial infarction or cardiac surgery within 12 months prior to cell infusion; Clinically significant valvular heart disease;\n\n* Tumor involvement of the atrium or ventricle at screening;\n* History of pulmonary interstitial fibrosis or severe chronic obstructive pulmonary disease (COPD);\n* Presence of clinical emergencies requiring urgent intervention due to tumor obstruction or compression (e.g., bowel obstruction or vascular compression) at screening;\n* Active bleeding at screening;\n* History of deep vein thrombosis or pulmonary embolism within 6 months prior to screening;\n* Vaccinated with live vaccines within 6 weeks prior to screening;\n* Active infection requiring treatment at screening;\n* Participation in another interventional clinical study within 4 weeks prior to screening;",{"count":762,"type":22},31,[25],"This prospective Phase II study aims to evaluate the preliminary efficacy and safety of WAST cells combined with docetaxel as second-line therapy in patients with advanced NSCLC resistant to PD-1 inhibitors.",[28],"2025-12-29",{"date":768,"type":33},"2026-01-09",{"date":770,"type":33},"2025-12-01",{"date":521,"type":22},{"name":523,"class":40},{"id":774,"slug":775,"hasResults":12,"nctId":776,"briefTitle":777,"officialTitle":777,"acronym":4,"eligibilityCriteria":778,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":779,"targetDuration":4,"studyType":23,"phases":781,"briefSummary":782,"conditions":783,"keywords":784,"overallStatus":256,"whyStopped":4,"lastUpdateSubmitDate":785,"lastUpdatePostDateStruct":786,"startDateStruct":788,"completionDateStruct":790,"leadSponsor":792,"locationsCount":41},"100615003","phase-2-stereotactic-body-radiotherapy-with-sequential-iparomlimab-and-tuvonralimab-ql1706--chemotherapy-as-neoadjuvant-therapy-in-patients-with-resectable-non-small-cell-lung-cancer-in-china-lung-nanjing01-a-single-arm-single-centre-phase-2-trial-100615003","NCT07286942","Stereotactic Body Radiotherapy With Sequential Iparomlimab and Tuvonralimab (QL1706) + Chemotherapy as Neoadjuvant Therapy in Patients With Resectable Non-small-cell Lung Cancer in China (LUNG-Nanjing01): a Single-arm, Single-centre, Phase 2 Trial","Inclusion Criteria:\n\n1. Voluntarily participates in the study and provides written informed consent;\n2. Aged 18-75 years, with no restriction on sex;\n3. Histologically or cytologically confirmed diagnosis of non-small-cell lung cancer (NSCLC);\n4. Has not received prior systemic therapy and is willing to undergo neoadjuvant treatment for stage cⅡ-Ⅲ (N2a) disease, according to the 9th edition of the AJCC staging system (Appendix 1);\n5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 (see Appendix 2 for scoring criteria);\n6. Considered by the thoracic surgeon to have adequate pulmonary reserve to tolerate the planned lung resection;\n7. Availability of tumor tissue prior to enrollment for pathological confirmation of EGFR\u002FALK wild-type status and PD-L1 expression assessment;\n8. No significant hematologic, cardiac, pulmonary, hepatic, renal, or immunologic dysfunction, with the following laboratory parameters meeting the specified criteria:\n\n   * Bone marrow function: absolute neutrophil count (ANC) ≥1.5×10⁹\u002FL; platelet count ≥80×10⁹\u002FL; hemoglobin ≥9 g\u002FdL;\n   * Liver function: total bilirubin ≤1.5× upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤1.5× ULN;\n   * Renal function: serum creatinine ≤1.5× ULN or creatinine clearance ≥60 mL\u002Fmin; blood urea nitrogen ≤200 mg\u002FL;\n9. Women of childbearing potential must have a negative serum pregnancy test within 3 days before the first dose of study treatment.\n\nExclusion Criteria:\n\n* 1\\. Presence of locally advanced unresectable or metastatic disease. Unresectable disease is defined according to the 2019 Multidisciplinary Consensus on Stage III Non-Small-Cell Lung Cancer (NSCLC), including certain stage IIIA and IIIB cases and all stage IIIC cases. Typically, this includes N2 disease with a single mediastinal lymph node ≥3 cm in short axis or multiple fused lymph nodes (≥2 cm in short axis on CT), as well as T4 lesions invading the esophagus, heart, aorta, or pulmonary veins, and all N3 disease.\n\n  2\\. Superior sulcus (Pancoast) NSCLC, large-cell neuroendocrine carcinoma (LCNEC), or sarcomatoid carcinoma.\n\n  3\\. Known EGFR-sensitive mutations or ALK rearrangements (non-squamous participants must have confirmed EGFR and ALK mutation status).\n\n  4\\. Prior systemic anticancer therapy for early-stage NSCLC, including investigational agents.\n\n  5\\. Active infection, or unexplained fever \\>38.5 °C within 2 weeks prior to screening (participants with tumor-related fever, as judged by the investigator, may be enrolled).\n\n  6\\. Male or female participants of reproductive potential who are unwilling to use effective contraception during the study; pregnant or breastfeeding women.\n\n  7\\. Any condition that, in the opinion of the investigator, could interfere with study participation or completion, including severe comorbidities (including psychiatric disorders) requiring concurrent treatment, or family or social factors that may compromise participant safety or data integrity.",{"count":780,"type":22},24,[25],"The primary objective of this study is to evaluate whether neoadjuvant SBRT as an immunomodulator in combination with apalolimab and toripalimab (QL1706) plus chemotherapy improves the pathological complete response (pCR) rate in patients with resectable stage IIA-IIIB LUAD. The secondary objectives include major pathological response (MPR), disease-free survival (DFS), R0 resection rate, the feasibility and safety. Moreover, the potential predictors for pathological response also will be explored.",[144,28],[144,686,538],"2025-12-03",{"date":787,"type":33},"2025-12-16",{"date":789,"type":22},"2025-12-18",{"date":791,"type":22},"2029-12-18",{"name":793,"class":40},"Jiangsu Cancer Institute & Hospital",{"id":795,"slug":796,"hasResults":12,"nctId":797,"briefTitle":798,"officialTitle":799,"acronym":800,"eligibilityCriteria":801,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":802,"targetDuration":4,"studyType":23,"phases":804,"briefSummary":805,"conditions":806,"keywords":808,"overallStatus":256,"whyStopped":4,"lastUpdateSubmitDate":832,"lastUpdatePostDateStruct":833,"startDateStruct":835,"completionDateStruct":837,"leadSponsor":839,"locationsCount":4},"100614037","phase-2-hyperprogression-in-pd-l1--50-nsclc-a-biomarker-guided-phase-2-trial-100614037","NCT07274384","Hyperprogression in PD-L1 ≥ 50% NSCLC: a Biomarker Guided Phase 2 Trial","Hyperprogression Upon Cemiplimab Alone or With Chemotherapy in PD-L1 ≥ 50% NSCLC: a Biomarker Guided Phase 2 Trial - HYPERBOLIC Trial","HYPERBOLIC","Inclusion Criteria:\n\n1. The participant (or legally acceptable representative) has provided documented informed consent to participation to the study and data protection consent form.\n2. Male or female aged 18 years or older.\n3. ECOG Performance Status of 0 - 2.\n4. Pathologically (histologically or cytologically) confirmed diagnosis of stage IV NSCLC (TNM 8th edition), who received no prior systemic treatment for recurrent or metastatic NSCLC. Mixed squamous\u002Fnon-squamous tumors are eligible.\n5. PD-L1 TPS ≥ 50% (by local test).\n6. Absence of targetable oncogene alterations (EGFR, ALK, ROS1).\n7. Circulating CD10- LDNs \\>30.5% at screening. LDNs will be defined as CD11b+CD15+ cells among live PBMC. Flow cytometry raw data will be centrally analyzed by the coordinating center.\n8. Measurable disease (RECIST 1.1) on two CT scans performed before randomization. The following criteria must be fulfilled:\n\n   * Participants must have at least one measurable lesion that has not been previously treated with radiotherapy.\n   * Chest and abdomen scans are mandatory\n   * Availability of measurable disease scans to be anonymized and sent for central independent confirmation by a radiologist of the coordinating center.\n   * A minimum 2-week interval and a maximum 12-week interval will be acceptable between the two pre-treatment CT scans.\n   * Availability to perform the baseline scan within a maximum 4-week interval before treatment start.\n9. Patient's willingness to undergo blood draws to provide plasma and blood samples for analysis according to study objectives.\n10. Adequate organ and marrow function as defined below:\n\n    * Absolute neutrophil count \\> 1.5 x 109\u002FL (1500\u002Fmm3)\n    * Platelets ≥100 x 109\u002FL (100 000\u002Fmm3)\n    * Haemoglobin ≥9.0 g\u002FdL (5.59 mmol\u002FL)\n    * Estimated glomerular filtration rate (according to CDK-EPI equation): ≥ 60ml\u002Fmin\u002F1.73 m2 for patients receiving cisplatin; ≥30 ml\u002Fmin\u002F1.73 m2 for patients receiving carboplatin.\n    * Serum bilirubin ≤1.5 x upper limit of normal (ULN). This will not apply to patients with confirmed Gilbert's syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of evidence of hemolysis or hepatic pathology) who will be allowed in consultation with their physician.\n    * AST and ALT ≤2.5 x ULN.\n11. Absence of a known severe hypersensitivity (≥ Grade 3) to any of the study chemotherapy agents and\u002For cemiplimab and\u002For to any of their excipients\n\nExclusion Criteria:\n\n1. Any infection requiring hospitalization or treatment with IV anti-infectives within 2 weeks of first dose of study medication\n2. Known uncontrolled infection with HIV, hepatitis B or hepatitis C infection, diagnosis of immunodeficiency, and\u002For tuberculosis (active or latent). No serological testing is required unless mandated by local health authority.\n3. Administration of live or live-attenuated vaccines within 30 days before the baseline LDNs assessment. Administration of killed vaccines is allowed. Receipt of COVID-19 vaccination within 1 week of planned start of study medication or for which the planned COVID-19 vaccinations would not be completed 1 week prior to start of study medication.\n4. History of interstitial lung disease (eg, idiopathic pulmonary fibrosis or organizing pneumonia), of active, noninfectious pneumonitis that required immune-suppressive doses of glucocorticoids to assist with management.\n5. Administration of radiotherapy within 7 days prior to the baseline LDNs assessment.\n6. Administration of colony-stimulating factors (e.g., G-CSF, GM-CSF) or recombinant erythropoietin within 28 days prior to the baseline LDNs assessment. Primary prophylaxis with G-CSF and pegylated G-CSF is not allowed. Secondary prophylaxis is not recommended and required case-by-case discussion with the coordinator center before G-CSF administration.\n7. Ongoing or recent evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments. The following are not exclusionary: vitiligo, childhood asthma that has resolved, endocrinopathies (such as hypothyroidism or type 1 diabetes) that require only hormone replacement, or psoriasis that does not require systemic treatment.\n8. Female patients who are pregnant, breast-feeding, male, or female patients of reproductive potential who are not employing an highly effective method of birth control.\n9. Any condition that, in the opinion of the investigator, would interfere with the evaluation of the study drug or interpretation of patient safety or study results.\n10. Any concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment (Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable).\n11. Allogenic tissue\u002Fsolid organ transplant.",{"count":803,"type":22},74,[25],"In metastatic NSCLC patients with PD-L1 expression ≥50%, a circulating immature (CD10-) LDNs level of ≥30.5% confers a high risk of hyperprogression (HPD) with first line single-agent immune-checkpoint inhibitors (SA-ICI). HPD is defined as a tumor growth rate (TGR) delta ≥50% between pre-treatment and post-treatment, and\u002For a TGR ratio ≥2. The combination of platinum-based chemotherapy (PCT) with ICI in this setting could prevent the occurrence of HPD and ultimately improve survival outcomes.\n\nThis randomized, multicentric, open-label, phase 2 trial will include patients with stage IV NSCL, without targetable oncogene drivers, PD-L1 TPS≥50%, and measurable disease on two CT scans performed before randomization. Participants will be randomized 1:1 to SA-ICI or ICI+PCT. Radiological evaluation will be performed by CT-scan at 6-8 weeks and subsequently according to the local investigators' schedule.\n\nIn the SA-ICI arm, ICI regimen will include cemiplimab. In the PCT+ICI arm, PCT regimens will include both carboplatin or cisplatin + pemetrexed (for non-squamous histology) or paclitaxel (for squamous histology) in combination with cemiplimab.\n\nPCT will be administered for three cycles. In case of stable disease or partial response according to RECIST v.1.1, cemiplimab will be performed as monotherapy from the third cycle until disease progression or unacceptable toxicity. If progression according to RECIST v.1.1 or HPD after three cycles of PCT+ICI, patients will be treated with standard second line therapy as local standard of care.",[28,807],"Hyperprogression",[809,810,811,812,813,814,815,816,817,818,819,820,821,822,823,218,824,825,826,827,828,829,830,831],"lung","cancer","hyperprogression","chemotherapy","immunotherapy","carboplatin","cisplatin","pemetrexed","paclitaxel","cemiplimab","risk","immune-checkpoint inhibitors","ldns","CD10-","nsclc","randomized","open-label","Lung Immune Prognostic Index","recist","progression","monotherapy","hpd","non small cell lung cancer","2025-11-27",{"date":834,"type":33},"2025-12-10",{"date":836,"type":22},"2026-01-01",{"date":838,"type":22},"2030-06-01",{"name":840,"class":40},"Università Vita-Salute San Raffaele"]