{ "captured": "2026-09-27", "note": "", "total": 8, "items": [ { "nctId": "NCT06563999", "url": "https://clinicaltrials.gov/study/NCT06563999", "briefTitle": "Neoadjuvant Umbrella Trial for Patients With Unresectable Stage III NSCLC Harboring Rare Mutations.", "officialTitle": "Neoadjuvant Umbrella Trial Directed by Next Generation Sequencing for Patients With Unresectable Stage III NSCLC Harboring Rare Mutations (Without EGFR Sensitizing Mutations)", "acronym": "NUMER", "overallStatus": "RECRUITING", "statusVerifiedDate": "2026-04", "whyStopped": null, "studyType": "INTERVENTIONAL", "phases": [ "PHASE2" ], "conditions": [ "Lung Cancer Stage III", "Mutation" ], "keywords": [ "stage III NSCLC", "rare mutations", "umbrella trial", "neoadjuvant" ], "interventions": [ { "type": "DRUG", "name": "Sunvozertinib" }, { "type": "DRUG", "name": "Crizotinib" }, { "type": "DRUG", "name": "Pralsetinib" }, { "type": "DRUG", "name": "Larotrectinib" }, { "type": "DRUG", "name": "Savolitinib" }, { "type": "DRUG", "name": "Pyrotinib" }, { "type": "DRUG", "name": "Dabrafenib+Trametinib" }, { "type": "DRUG", "name": "Glecirasib" }, { "type": "DRUG", "name": "Ensartinib" } ], "leadSponsor": "Sun Yat-sen University", "leadSponsorClass": "OTHER", "collaborators": [], "enrollmentCount": 120, "enrollmentType": "ESTIMATED", "startDate": "2024-11-01", "primaryCompletionDate": "2027-11-01", "completionDate": "2029-11-01", "firstPostDate": "2024-08-21", "lastUpdatePostDate": "2026-04-21", "sex": "ALL", "minimumAge": "18 Years", "maximumAge": "75 Years", "healthyVolunteers": false, "eligibilityCriteria": "Inclusion Criteria:\n\n* Subjects must have treatment-naive unresectable stage III NSCLC according to the AJCC 8th edition staging;\n* Squamous or non-squamous NSCLC histology;\n* Subjects should have a rare mutation based on NGS, including mutations of EGFR exon20ins, ROS1 fusion, RET fusion, NTRK fusion, MET 14 exon, HER2, BRAF V600E, KRAS G12C, and ALK fusion.\n* Subjects should be without EGFR exon 19 deletions or exon 21 L858R activating mutation;\n* Male and female, aged 18-75 years;\n* Blood and specimens before and after treatment must be provided;\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;\n* Adequate hematological function: Absolute neutrophil count (ANC) ≥2.0 x 109/L, and Platelet count ≥100 x 109/L, and Hemoglobin ≥9 g/dL (may be transfused to maintain or exceed this level);\n* Adequate liver function: Total bilirubin ≤ 1.5 x upper limit of normal (ULN), Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 2.5 x ULN;\n* Adequate renal function: Serum creatinine ≤ 1.25 x ULN, or ≥ 60 ml/min;\n* Female subjects should not be pregnant or breast-feeding;\n* Written informed consent provided. Being willing and able to comply with the visits, treatment plan, laboratory examinations and other study procedures scheduled in the study.\n\nExclusion Criteria:\n\n* Not unresectable stage III disease according to the investigator;\n* Subjects with known EGFR sensitive mutations;\n* Previous treatment with systemic antitumor therapy for NSCLC;\n* Eye inflammation or eye infection not fully treated or conditions predisposing the subject to this.\n* History of another malignancy in the last 5 years with the exception of the following: other malignancies cured by surgery alone and having a continuous disease-free interval of 5 years are permitted. Cured basal cell carcinoma of the skin and cured in situ carcinoma of the uterine cervix are permitted.\n* Evidence of clinically active interstitial lung disease;\n* Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS);\n* Inability to comply with protocol or study procedures;\n* Any unstable systemic disease (including active infection, active tuberculosis uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous year, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease);\n* A serious concomitant systemic disorder that, in the opinion of the investigator, would compromise the patient's ability to complete the study and may confuse the study results;\n* Women who are pregnant or nursing.\n* Ingredients mixed with small cell lung cancer patients.", "briefSummary": "This umbrella trial directed by next generation sequencing (NGS) includes patients with treatment-naive unresectable stage III non-small-cell lung cancer (NSCLC). The aim of the umbrella study is to evaluate the efficacy of induction NGS-directed targeted therapies followed by surgery for stage III NSCLC patients whose tumor harbors a rare mutation.", "locationsCount": 1, "countries": [ "China" ], "contactCount": 2, "centralContacts": [ { "name": "S*** W*** M***", "role": "C***", "phone": "+** ** ******39", "phoneDisplay": "+** ** ******39", "email": "w***@sysucc.org.cn" } ], "overallOfficials": [ { "name": "S*** W*** M***", "role": "P***", "affiliation": "S*** Y*** U*** C***" } ], "siteContacts": [ { "facility": "S*** Y*** U*** C***", "city": "G***", "state": "G***", "country": "C***", "status": "R***", "contacts": [ { "name": "S*** W*** D***", "role": "C***", "phone": "+** ** ******39", "phoneDisplay": "+** ** ******39", "email": "w***@163.net" } ] } ], "isNew": null, "statusChanged": null, "previousStatus": null, "scrapedAt": "2026-09-27T15:40:00.255532+00:00" }, { "nctId": "NCT07778940", "url": "https://clinicaltrials.gov/study/NCT07778940", "briefTitle": "Thiotepa Administration Via Ommaya Reservoir for Leptomeningeal Metastases in Non-Small Cell Lung Cancer Resistant to EGFR-TKI.", "officialTitle": "A Single-Arm Phase II Study of Intrathecal Thiotepa Via Ommaya Reservoir for Leptomeningeal Metastases in Non-Small Cell Lung Cancer Resistant to EGFR-TKI", "acronym": "LEP-THP-2026", "overallStatus": "NOT_YET_RECRUITING", "statusVerifiedDate": "2026-08", "whyStopped": null, "studyType": "INTERVENTIONAL", "phases": [ "PHASE2" ], "conditions": [ "Leptomeningeal Metastasis" ], "keywords": [], "interventions": [ { "type": "DRUG", "name": "Thiotepa" } ], "leadSponsor": "Tianjin Medical University Cancer Institute and Hospital", "leadSponsorClass": "OTHER", "collaborators": [], "enrollmentCount": 50, "enrollmentType": "ESTIMATED", "startDate": "2026-09", "primaryCompletionDate": "2027-09", "completionDate": "2028-03", "firstPostDate": "2026-08-21", "lastUpdatePostDate": "2026-08-21", "sex": "ALL", "minimumAge": "18 Years", "maximumAge": "75 Years", "healthyVolunteers": false, "eligibilityCriteria": "Inclusion Criteria:\n\n1. Age between 18 and 75 years.\n2. Male or female of non-childbearing potential, or female of childbearing potential who is not pregnant or lactating.\n3. ECOG performance status of 0 to 2, with no deterioration within the past 7 days.\n4. Radiological and/or cerebrospinal fluid (CSF) cytological evidence of leptomeningeal metastases (LM). The diagnosis of non-small cell lung cancer (NSCLC) must be confirmed by histological and/or cytological examination.\n5. Patients must meet at least one of the following criteria: failure of first- or second-generation TKI therapy with T790M mutation negative; failure of third-generation TKI therapy; or EGFR mutation negative with failure of first-line therapy.\n6. If concurrent brain parenchymal metastases are present, they must have received appropriate treatment or been evaluated as stable over the past three months. Additionally, extracranial lesions must be evaluated as stable under the current treatment regimen.\n7. Adequate organ and bone marrow function, as evidenced by the following laboratory parameters: HGB ≥ 90 g/L; NEUT ≥ 1.5 × 10⁹/L; PLT ≥ 80 × 10⁹/L; TBIL ≤ 1.5 × upper limit of normal (ULN); ALT and AST ≤ 2.5 × ULN (if liver metastases are present, ALT and AST ≤ 5 × ULN); creatinine clearance ≥ 50 mL/min (calculated by the Cockcroft-Gault formula); urine protein < (++) or 24-hour urine protein < 1.0 g; normal coagulation function without active bleeding; INR ≤ 1.5; APTT ≤ 1.5 × ULN.\n8. Women of childbearing potential must have a negative pregnancy test (serum or urine) within 14 days prior to enrollment and must voluntarily use adequate contraception during the study period and for 8 weeks after the last dose of the study drug. Males must be surgically sterilized or agree to use adequate contraception during the study period and for 8 weeks after the last dose of the study drug.\n9. Prior Ommaya reservoir implantation.\n10. Estimated life expectancy of ≥ 12 weeks.\n11. No history of severe neurological diseases or severe hematological abnormalities.\n12. Patients who have received prior brain and/or spinal cord radiotherapy, including stereotactic radiosurgery (SRS) or stereotactic body radiation therapy (SBRT), are eligible, provided that radiotherapy was completed at least 7 days prior to the initiation of study treatment.\n13. Concurrent intrathecal therapy with other agents is prohibited. For patients who have received other systemic therapies, the minimum washout periods are as follows: patients who have received prior intrathecal therapy must complete the last treatment at least 7 days before initiating study treatment; patients who have received systemic chemotherapy must complete the last treatment at least 14 days before initiating study treatment; patients who have received approved systemic immunotherapy (e.g., anti-PD-1, anti-CTLA-4) must complete the last treatment at least 14 days before initiating study treatment; patients who have received any other investigational drugs must complete the last treatment at least 14 days before initiating study treatment.\n14. Ability to provide written informed consent, including compliance with the requirements and restrictions listed in the informed consent form. Patients must have good compliance, voluntarily agree to participate in the clinical study, sign the informed consent form, and be willing to cooperate with follow-up visits.\n\nExclusion Criteria:\n\n1. Patients requiring ventriculoperitoneal (VP) shunt placement due to elevated intracranial pressure.\n2. History of epilepsy unrelated to leptomeningeal metastases.\n3. Evidence of any neurological functional failure, including severe encephalopathy, grade 3 or 4 leukoencephalopathy as shown on imaging, or a Glasgow Coma Scale (GCS) score < 11.\n4. Evidence of any extensive and fatal progressive systemic disease with no effective treatment available.\n5. Prior allogeneic bone marrow transplantation or solid organ transplantation. Uncontrolled hypertension prior to enrollment, defined as: systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 90 mmHg.\n6. Surgical procedures involving vital organs within 3 months prior to enrollment.\n7. Any disease or condition prior to enrollment that affects drug absorption. Clinically significant cardiovascular diseases, including but not limited to acute myocardial infarction, severe/unstable angina, or coronary artery bypass grafting within 6 months prior to enrollment; congestive heart failure with New York Heart Association (NYHA) classification > Grade 2; ventricular arrhythmias requiring medication; left ventricular ejection fraction (LVEF) < 50%; or other related diseases such as severe pulmonary, hepatic, or renal dysfunction, severe gastrointestinal ulcers, or coagulation dysfunction.\n8. Active or uncontrolled severe infections (≥ Grade 2 infections per CTCAE v5.0).\n9. Known human immunodeficiency virus (HIV) infection. Known history of clinically significant liver disease, including viral hepatitis [Known hepatitis B virus (HBV) carriers must be excluded if they have active HBV infection, defined as HBV DNA positive (>1×10⁴ copies/mL or >2000 IU/mL); known hepatitis C virus (HCV) infection with HCV RNA positive (>1×10³ copies/mL)].\n10. Any other disease, clinically significant metabolic abnormalities, physical examination abnormalities, or laboratory abnormalities that, in the investigator's judgment, provide reason to suspect a disease or condition that makes the patient unsuitable for the study drug (e.g., seizures requiring treatment), will affect the interpretation of study results, or place the patient at high risk.\n11. Patients with a prior history of basal cell or squamous cell skin cancer, cervical carcinoma in situ, or other cancers may be considered for enrollment if there is evidence of being disease-free for more than 5 years after treatment.\n12. Severe neurological or psychiatric history; active disseminated intravascular coagulation (DIC); or other concomitant diseases that, in the investigator's judgment, seriously jeopardize patient safety or affect the patient's ability to complete the study.\n13. Participation in other clinical trials, receipt of investigational drugs, or any concomitant treatments containing investigational drugs within 14 days prior to enrollment.\n14. Patients deemed unsuitable for this study by the investigator.", "briefSummary": "The goal of this clinical trial is to learn if the Thiotepa administration via Ommaya Reservoir works to treat non-small cell lung cancer with leptomeningeal metastases resistant to EGFR TKI. The main questions to answer are:\n\nIs Thiotepa administration via Ommaya Reservoir safe to inject? How effective is thiotepa via Ommaya Reservoir in intracranial-disease control? Participants will：\n\nStage 1: Intrathecal injection of 10 mg thiotepa via Ommaya reservoir, twice every week, for 4 consecutive weeks; Stage 2: Intrathecal injection of 10 mg thiotepa via Ommaya reservoir, once every week, for 4 consecutive weeks; Stage 3: Intrathecal injection of 10 mg thiotepa via Ommaya reservoir, once a month, for 4 consecutive months; Before each intrathecal administration, a preliminary intrathecal injection of dexamethasone, 2.5 mg/dose, is given.", "locationsCount": 1, "countries": [ "China" ], "contactCount": 2, "centralContacts": [ { "name": "C*** S***", "role": "C***", "phone": "***-******23", "phoneExt": "1***", "phoneDisplay": "***-******** ext. **41", "email": "s***@tmu.edu.cn" } ], "overallOfficials": [], "siteContacts": [ { "facility": "T*** M*** U*** C***", "city": "T***", "state": null, "country": "C***", "status": null, "contacts": [ { "name": "C*** S***", "role": "C***", "phone": "***-******23", "phoneExt": "1***", "phoneDisplay": "***-******** ext. **41", "email": "s***@tmu.edu.cn" } ] } ], "isNew": null, "statusChanged": null, "previousStatus": null, "scrapedAt": "2026-09-27T15:40:00.248993+00:00" }, { "nctId": "NCT00690963", "url": "https://clinicaltrials.gov/study/NCT00690963", "briefTitle": "Individual Boosting in Non-Small Cell Lung Cancer Using Hypofractionation, Intensity-modulated Radiation Therapy and Respiratory Gating", "officialTitle": "A Phase I/II Dose Escalation Trial Using Hypofractionation With Individualized Differential Boosting With Respiratory Gated Intensity-modulated Radiation Therapy (IMRT) in the Treatment of Non-small Cell Lung Cancer.", "acronym": null, "overallStatus": "UNKNOWN", "statusVerifiedDate": "2016-04", "whyStopped": null, "studyType": "INTERVENTIONAL", "phases": [ "PHASE1", "PHASE2" ], "conditions": [ "Carcinoma, Non-Small-Cell Lung" ], "keywords": [ "Radiotherapy", "Intensity-Modulated", "Dose Fractionation" ], "interventions": [ { "type": "PROCEDURE", "name": "Radiotherapy" } ], "leadSponsor": "AHS Cancer Control Alberta", "leadSponsorClass": "OTHER", "collaborators": [], "enrollmentCount": 12, "enrollmentType": "ACTUAL", "startDate": "2008-09", "primaryCompletionDate": "2016-09", "completionDate": "2016-10", "firstPostDate": "2008-06-05", "lastUpdatePostDate": "2016-04-06", "sex": "ALL", "minimumAge": "18 Years", "maximumAge": "75 Years", "healthyVolunteers": false, "eligibilityCriteria": "Inclusion Criteria:\n\n* Patients with histologically-proven, by biopsy or cytology, unresected lung cancer of the following histologic types: Squamous cell carcinoma, Adenocarcinoma, Undifferentiated large cell carcinoma, Non-Small cee; not otherwise specified (NOS, diagnosis on cytology alone)\n* Patients with AJCC Stage II, IIIA or IIIB if all detectable tumour can be encompassed by radiation therapy fields, including both the primary tumor and the involved regional lymph nodes\n* Patient must be deemed to be suitable to undergo definitive chemo-radiotherapy by the treating Physician.\n* Age > = 18\n* ECOG/Zubrod status 0-1\n* Patients must have measurable disease on CT imaging\n* Satisfactory granulocytes, platelets, bilirubin, AST and calculated creatinine clearance\n* Dose volume constraints must be met\n* Patient must be able to use the breath-held technique\n\nExclusion Criteria:\n\n* Patients who have undergone complete or subtotal tumour resection\n* Patients with post-resection intrathoracic tumour recurrence\n* Patients eligible for definitive surgery\n* Evidence of any small cell histology\n* Prior or concurrent malignancy except non-melanomatous skin cancer unless disease-free for at least 5 years\n* Exudative pleural effusion, or pleural effusions with positive cytology. Minimal pleural effusions which are too small to safely tap (i.e. not visible on chest x-ray) are eligible.\n* Patients with myocardial infarction within the preceding 6 months or symptomatic heart disease, including angina, congestive heart failure and uncontrolled arrhythmias\n* Pregnant women are ineligible. Patients with childbearing potential must practice appropriate contraception\n* Patients with FEV1 <= 0.8. Patients with FEV1 >0.8 and <1.0 to be discussed with a Respiratory Physician", "briefSummary": "Patients who have inoperable non-small cell lung cancer are presently treated with chemotherapy and radiation therapy. Despite this combined approach, the vast majority of patients will have their cancer recur after treatment. A recurrence is not curable at this time. Because of the sensitivity of surrounding structures to chest irradiation, it has not been possible to give radiation doses that can cure many of these tumors. Intensity-modulated radiation therapy is a special form of radiotherapy delivery that allows doctors to reduce the amount of radiation dose to normal tissues and therefore reduce side effects. The reduction of radiation side effects may allow more radiation to be delivered to tumors, therefore improving tumor control and possibly longevity of patients. The purpose of this study is to determine whether the combination of custom designed intensity-modulated radiotherapy (based on individual tumor anatomy) with regular chemotherapy, will be safe enough to allow further intensification of radiation treatment.", "locationsCount": 1, "countries": [ "Canada" ], "contactCount": 0, "centralContacts": [], "overallOfficials": [ { "name": "W*** R*** M*** M***", "role": "S***", "affiliation": "C*** C*** I*** A***" } ], "siteContacts": [], "isNew": null, "statusChanged": null, "previousStatus": null, "scrapedAt": "2026-09-27T15:40:00.232895+00:00" }, { "nctId": "NCT00738452", "url": "https://clinicaltrials.gov/study/NCT00738452", "briefTitle": "Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Stage I-IIIB Non-Small Cell Lung Cancer After Completion of Radiation Therapy Alone or Combined Radiation Therapy and Chemotherapy", "officialTitle": "A Phase I Trial of Radioimmunotherapy (Y-90-Mx-DTPA-cT84.66) After Completion of Radiation Therapy Alone, or Radiation Therapy Plus Systemic Therapy in Unresectable or Medically Inoperable, Non-metastatic CEA-Producing Stage I-IIIB Non-Small Cell Lung Cancer", "acronym": null, "overallStatus": "COMPLETED", "statusVerifiedDate": "2018-02", "whyStopped": null, "studyType": "INTERVENTIONAL", "phases": [ "PHASE1" ], "conditions": [ "Lung Cancer" ], "keywords": [ "recurrent non-small cell lung cancer", "stage II non-small cell lung cancer", "stage IIIA non-small cell lung cancer", "stage IIIB non-small cell lung cancer" ], "interventions": [ { "type": "OTHER", "name": "high performance liquid chromatography" }, { "type": "OTHER", "name": "pharmacological study" }, { "type": "PROCEDURE", "name": "radionuclide imaging" }, { "type": "PROCEDURE", "name": "single photon emission computed tomography" }, { "type": "RADIATION", "name": "radiation therapy" }, { "type": "RADIATION", "name": "yttrium Y 90 anti-CEA monoclonal antibody cT84.66" } ], "leadSponsor": "City of Hope Medical Center", "leadSponsorClass": "OTHER", "collaborators": [ "National Cancer Institute (NCI)" ], "enrollmentCount": 10, "enrollmentType": "ACTUAL", "startDate": "2008-08-06", "primaryCompletionDate": "2018-02-07", "completionDate": "2018-02-07", "firstPostDate": "2008-08-20", "lastUpdatePostDate": "2018-02-13", "sex": "ALL", "minimumAge": "18 Years", "maximumAge": null, "healthyVolunteers": false, "eligibilityCriteria": "Inclusion criteria:\n\n* Patients must be >= 18 years of age.\n* Patients must have a Karnofsky performance status of >= 60%.\n* Patients must have histological confirmation non-small cell lung cancer and must have tumors that produce CEA as documented by either immunohistochemistry or by an elevated serum CEA level.\n* Patients must have American Joint Committee on Cancer (AJCC) Version 7 Stage I-IIIB non small cell lung cancer (NSCLC) who are not a surgical candidate due to unresectability or medical inoperability.\n* Patients must have undergone radiation therapy alone, or radiation therapy plus systemic therapy (which includes chemotherapy or tyrosine kinase inhibitors) as treatment for their lung cancer; patients may receive up to two cycles of consolidative chemotherapy after radiation therapy +/- chemotherapy; this therapy must be completed within 6-12 weeks prior to starting treatment on this trial.\n* Patients must have had measurable or evaluable disease prior to receiving standard radiation therapy alone, or radiation therapy plus systemic therapy.\n* Patients must have no evidence of progressive disease (therefore, must have stable disease, partial response or complete response) to the therapy given prior to enrollment on this study.\n* No radiotherapy, immunotherapy, or chemotherapy within the last 5 years prior to the diagnosis of locally advanced NSCLC; prior adjuvant chemotherapy or tyrosine kinase inhibitor therapy for early stage, resected NSCLC is allowed as long as it was given > 12 months prior to the current diagnosis of locally advanced NSCLC.\n* Patients must demonstrate an forced expiratory volume in one second (FEV1) >= 0.9.\n* Adequate bone marrow function as evidenced by hemoglobin >= 10 gm %, WBC >= 3500/ul, an absolute granulocyte count of >= 1,500/mm3, and platelets >= 140,000/ul. Patients may be transfused to reach a hemoglobin >=10 gm %.\n* Patients must have a total bilirubin <= 1.5 mg/dL and liver transaminases no higher then 2 times the upper limit of normal.\n* Patients must have serum creatinine <= 1.5 x upper limit of normal (ULN) and a creatinine clearance >= 45 cc/min (based on Cockcroft Gault formula).\n* Patients must not have post-obstructive pneumonia or other serious infection.\n* If a patient has previously received murine or chimeric antibody, then serum anti-antibody testing must be negative.\n* Serum HIV testing and hepatitis B surface antigen and hepatitis C antibody testing must be negative.\n* Women of childbearing potential must have a negative serum pregnancy test prior to entry and while on study must be practicing an effective form of contraception.\n\nExclusion Criteria:\n\n* Patients with any nonmalignant intercurrent illness (example cardiovascular, pulmonary, or central nervous system disease) which is either poorly controlled with currently available treatment or which is of such severity that the investigators deem it unwise to enter the patient on protocol shall be ineligible.\n* Metastatic disease.\n* Malignant pleural effusion.\n* Patients that did not receive at least 50 Gy thoracic radiation during the course of radiation +/- systemic therapy.", "briefSummary": "RATIONALE: Radiation therapy uses high energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as carboplatin, paclitaxel, cisplatin, and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiolabeled monoclonal antibodies can find tumor cells and carry tumor-killing substances to them without harming normal cells. Giving radiation therapy and combination chemotherapy together before radiolabeled monoclonal antibody therapy may kill more tumor cells.\n\nPURPOSE: This phase I trial is studying the side effects and best dose of radiolabeled monoclonal antibody therapy when given after radiation therapy and combination chemotherapy in treating patients with stages I-IIIB non-small cell lung cancer.", "locationsCount": 1, "countries": [ "United States" ], "contactCount": 0, "centralContacts": [], "overallOfficials": [ { "name": "J*** Y*** W*** M***", "role": "P***", "affiliation": "C*** o*** H*** M***" }, { "name": "M*** K*** M***", "role": "P***", "affiliation": "C*** o*** H*** M***" } ], "siteContacts": [], "isNew": null, "statusChanged": null, "previousStatus": null, "scrapedAt": "2026-09-27T15:40:00.238932+00:00" }, { "nctId": "NCT04655976", "url": "https://clinicaltrials.gov/study/NCT04655976", "briefTitle": "Efficacy Comparison of Cobolimab + Dostarlimab + Docetaxel to Dostarlimab + Docetaxel to Docetaxel Alone in Participants With Advanced Non-small Cell Lung Cancer Who Have Progressed on Prior Anti-PD-(L)1 Therapy and Chemotherapy", "officialTitle": "A Randomized, Open Label Phase 2/3 Study Comparing Cobolimab + Dostarlimab + Docetaxel To Dostarlimab + Docetaxel To Docetaxel Alone In Participants With Advanced Non-small Cell Lung Cancer Who Have Progressed On Prior Anti-PD-(L)1 Therapy And Chemotherapy (COSTAR Lung)", "acronym": "COSTAR Lung", "overallStatus": "ACTIVE_NOT_RECRUITING", "statusVerifiedDate": "2026-06", "whyStopped": null, "studyType": "INTERVENTIONAL", "phases": [ "PHASE2", "PHASE3" ], "conditions": [ "Lung Cancer, Non-Small Cell" ], "keywords": [ "GSK4069889A", "GSK4057190A", "Cobolimab", "Dostarlimab", "Docetaxel", "Chemotherapy" ], "interventions": [ { "type": "BIOLOGICAL", "name": "Cobolimab" }, { "type": "BIOLOGICAL", "name": "Dostarlimab" }, { "type": "DRUG", "name": "Docetaxel" } ], "leadSponsor": "GlaxoSmithKline", "leadSponsorClass": "INDUSTRY", "collaborators": [], "enrollmentCount": 758, "enrollmentType": "ACTUAL", "startDate": "2020-12-08", "primaryCompletionDate": "2025-06-05", "completionDate": "2027-03-30", "firstPostDate": "2020-12-07", "lastUpdatePostDate": "2026-07-01", "sex": "ALL", "minimumAge": "18 Years", "maximumAge": null, "healthyVolunteers": false, "eligibilityCriteria": "Inclusion Criteria:\n\n* Participant has histologically or cytologically proven advanced or metastatic NSCLC and only squamous or non-squamous cell carcinoma.\n* Participant has received no more than 2 prior lines of therapy for advanced or metastatic disease, which must only include a platinum based (e.g., cisplatin, carboplatin) doublet chemotherapy regimen and an anti-PD-1 or an anti-PD-(L)1 antibody.\n* Participant has measurable disease.\n* Participant has documented radiographic disease progression on prior platinum based chemotherapy and on or after prior anti-PD-(L)1 therapy.\n* Participant agrees to submit an archival formalin-fixed paraffin-embedded (FFPE) tumor tissue specimen that was collected on or after diagnosis of metastatic disease. If archival tissue is not available, the participant must undergo biopsy prior to study entry.\n* Participant has an ECOG performance status score of 0 or 1.\n* Participant has a life expectancy of at least 3 months.\n* Participant has adequate Baseline organ function.\n* Participant has recovered from any prior treatment related toxicities.\n* Participant agrees to use contraception.\n\nExclusion Criteria:\n\n* Participant has been previously treated with an anti-PD-[L]1 or anti-programmed death-ligand 2 (anti-PD-[L]2) agent that resulted in permanent discontinuation due to an AE.\n* Participant has been previously treated with an anti-T cell immunoglobulin and mucin domain containing 3 (anti-TIM-3) or anti-cytotoxic T lymphocyte associated protein 4 (CTLA 4) agent or docetaxel.\n* Participant has a documented sensitizing epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), or c-ros oncogene 1 (ROS-1) mutation. Participants whose tumors have not been tested for these driver mutations and therefore who have unknown driver mutation status are not eligible. Participants with squamous histology do not need to be tested for these driver mutations.\n* Participant had radiological or clinical disease progression (i.e., worsening performance status, clinical symptoms, and laboratory data) <=8 weeks after initiation of prior anti-programmed cell death protein 1 (anti-PD-1) or anti-PD-L1 antibody. The clinical disease progression should have been confirmed by a subsequent radiological scan.\n* Participant has received radiation to the lung that is >30 gray (Gy) within 6 months prior to the first dose of study treatment.\n* Participant has completed palliative radiotherapy within 7 days prior to the first dose of study treatment.\n* Participant is ineligible if any of the following hepatic characteristics are present: a. Alanine aminotransferase (ALT) >2.5 times upper limit normal (ULN) b. ALT and/or aspartate aminotransferase (AST) >1.5 times ULN concomitant with alkaline phosphatase (ALP) >2.5 times ULN; c. Bilirubin >1 times ULN; d. Current active liver or biliary disease (with the exception of Gilbert's syndrome or asymptomatic gallstones, liver metastases, or otherwise stable chronic liver disease per the Investigator's assessment).\n* Participant has known new or progressive brain metastases and/or leptomeningeal metastases. Participants who have received prior therapy for their brain metastases and have radiographically stable central nervous system disease may participate, provided they are neurologically stable for at least 4 weeks before study entry and are off corticosteroids within 3 days prior to the first dose of study treatment.\n* Participant has tested positive for the following at Screening or within 3 months before the first dose of study treatment: a. Presence of hepatitis B surface antigen. b. Presence of hepatitis C antibody in the absence of a ribonucleic acid (RNA) test for hepatitis C virus. If a confirmatory RNA test is available, a positive test result will exclude a participant, while a negative test result (indicating absence of active infection) will allow the participant to enter into the study.\n* Participant has known human immunodeficiency virus (HIV) (positive for HIV 1 or HIV 2 antibodies).\n* Participant has active autoimmune disease that required systemic treatment in the past 2 years, is immunocompromised in the opinion of the Investigator, or is receiving systemic immunosuppressive treatment.\n* Participant has symptomatic ascites or pleural effusion. A participant who is clinically stable following treatment of these conditions (including therapeutic thoracentesis or paracentesis) is eligible.\n* Participant has current interstitial lung disease, current pneumonitis, or a history of pneumonitis that required the use of glucocorticoids to assist with management.\n* Participant has pre-existing peripheral neuropathy that is Grade >=2 by National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 criteria.\n* Participant has received a live vaccine within 30 days of the first dose of study treatment. Seasonal flu vaccines that do not contain live virus and Coronavirus Disease 2019 (COVID-19) vaccines.\n* Participant is unable to interrupt aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs) for undergoing a biopsy procedure (in cases when a participant does not have an archival biopsy), other than an aspirin dose <=1.3 grams (g) per day, for a 5-day period (8-day) period for long-acting agents, such as piroxicam).", "briefSummary": "This is a multi-center, parallel group treatment, Phase 2/3 open label study evaluating cobolimab in combination with dostarlimab and docetaxel in participants with advanced non-small cell Lung Cancer (NSCLC) who have progressed on prior anti-PD-(L)1 therapy and chemotherapy.", "locationsCount": 163, "countries": [ "United States", "Argentina", "Australia", "Belgium", "Brazil", "Canada", "Finland", "France", "Germany", "Greece", "Italy", "Japan", "Mexico", "Netherlands", "Poland", "Romania", "Russia", "South Korea", "Spain", "Sweden", "Taiwan", "Thailand", "Turkey (Türkiye)", "United Kingdom" ], "contactCount": 0, "centralContacts": [], "overallOfficials": [ { "name": "G*** C*** T***", "role": "S***", "affiliation": "G***" } ], "siteContacts": [], "isNew": null, "statusChanged": null, "previousStatus": null, "scrapedAt": "2026-09-27T15:40:00.246483+00:00" } ] }