[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"local-advanced-or-metastatic-nsclc\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:local-advanced-or-metastatic-nsclc":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,40],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100615565","phase-2-garsorasib-in-kras-g12c-mutant-locally-advanced-and-metastatic-nsclc-100615565",false,"NCT07294261","Garsorasib In KRAS G12C Mutant Locally Advanced and Metastatic NSCLC","A Multicenter, Prospective Clinical Study Evaluating Goselasib Combination Therapy for First-Line Treatment of KRAS G12C Locally Advanced or Metastatic Non-Small Cell Lung Cancer","Inclusion Criteria:\n\n* 1\\. A written informed consent form should be signed prior to any study-related procedures 2. Male or female, aged 18 or above. 3.Histologically confirmed IIIB-IV NSCLC. 4.Subjects have not received systemic treatment for locally advanced or metastatic non-small cell lung cancer. 5.The patients should be confirmed with KRAS G12C mutation and provide PD-L1 test result. 6.At least 1 measurable lesion (RECIST 1.1 criteria). 7.ECOG 0-1. 8. Good organ function includes:\n* Neutrophil count≥1.5×109\u002FL,\n* Platelet count≥90×109\u002FL,\n* Hemoglobin≥90g\u002FL\n* Serum creatinine≤1.5×upper limit of normal (ULN), creatinine clearance≥50 mL\u002Fmin (Cockcroft-Gault formula)\n* Total bilirubin≤1.5×ULN\n* AST and ALT≤2.5×ULN; for patients with liver metastasis, AST and ALT≤5×ULN, the investigator should determine whether they are enrolled\n* Normal coagulation function: INR and PT≤1.5×ULN ,APTT≤1.5×ULN\n* Urinary protein in routine urinalysis is less than 2+, or 24-hour urinary protein quantification is \\\u003C 1 g.\n\n  9\\. Life expectancy is at least 3 months; 10.Negative pregnancy test at enrollment. Male or female subjects should commit to take adequate and effective contraceptive measures or abstain from sexual for the duration of study participation and within 3 months after the last dose of the study drug\n\nExclusion Criteria:\n\n* 1.Patients received anti-tumor drug treatment or investigational drug treatment 3 years ago.2.Non-Small Cell Lung Cancer (NSCLC) with a history of other actionable driver gene mutations for which standard treatment drugs are available (e.g., EGFR, ALK, BRAF(V600E), HER-2, MET(exon14), ROS1, RET, or NTRK1\u002F2\u002F3, etc.) 3.Other active malignant tumors requiring concurrent treatment 4.Patients with active brain metastasis, cancerous meningitis, spinal cord compression, or with brain or pia mater diseases detected by CT or MRI at screening time (patients with stable symptoms and complete treatment 14 days before enrollment may be admitted to the group, but no symptoms of cerebral hemorrhage should be confirmed by craniocerebral MRI, CT or venography evaluation).5.Serious cardiovascular history:\n* NYHA (New York Heart Association) Class 3 and 4 congestive heart failure\n* Arrhythmia requiring therapeutic intervention\n* Thrombotic or embolic event within the past 6 months, e.g., cerebrovascular accident (including transient ischemic attack), and pulmonary embolism\n* LVEF\\\u003C50%\n* Subjects with a prolonged QT interval corrected by the Fridericia formula (QTcF) at rest, where the QTcF measured by electrocardiogram (ECG) is \\> 470 ms in females or \\> 450 ms in males; or subjects with risk factors for torsades de pointes (TdP), such as hypokalemia deemed clinically significant by the investigator, a family history of long QT syndrome, or a family history of arrhythmias (e.g., pre-excitation syndrome).\n* Uncontrollable hypertension (systolic blood pressure ≥ 140 mmHg, or diastolic blood pressure ≥ 90 mmHg, despite using the optimal medical treatment; 6.Subjects with arterial\u002Fvenous thrombotic events occurring within 6 months, such as cerebrovascular accidents (including transient ischemic attacks), deep vein thrombosis, and pulmonary embolism; or subjects with hypertensive crisis or hypertensive encephalopathy.7.Subjects with a previous history of epilepsy.8.Presence of superior vena cava syndrome.9.Active non-infectious pneumonia with interstitial changes such as interstitial lung disease, radiation pneumonitis, or immune-related pneumonitis during the screening period; active pulmonary tuberculosis; pneumoconiosis; other types of pneumonia graded ≥ Grade 2; or severe impairment of pulmonary function confirmed by pulmonary function tests (FEV1, DLCO, or DLCO\u002FVA \\\u003C 40% of the predicted value).10.Presence of severe bone damage caused by bone metastases, or a risk of such damage occurring after enrollment-for example, pathological fractures of weight-bearing bones that have occurred within 6 months or may occur after enrollment, extensive bone metastases, or spinal cord compression; or uncontrolled pain related to bone metastases.11.Active or uncontrolled severe infection (≥ CTCAE Grade 2 infection) or unexplained fever \\> 38.5°C. 12.Third-space fluid accumulation (including pleural effusion, ascites, or pericardial effusion) that is poorly controlled clinically or requires local symptomatic management such as percutaneous drainage. 13.Imaging (CT or MRI) shows that the tumor invades large blood vessels or has an unclear boundary with large blood vessels.14.Subjects with evidence of or a history of bleeding tendency within 2 months prior to the first dose, regardless of severity; subjects with a history of hemoptysis (\\> 2.5 ml\u002Fday) within 2 weeks prior to the first dose, or with unhealed wounds, ulcers, or fractures.15.Known gastrointestinal (GI) dysfunction or gastrointestinal (GI) diseases that may significantly affect the absorption or metabolism of oral medications.16.Have received a live-attenuated preventive vaccine within 4 weeks prior to the first dose.17.Subjects who have experienced severe hypersensitivity reactions after receiving other monoclonal antibody drugs.18.Active autoimmune diseases requiring systemic treatment that occurred within 2 years. 19.Immunodeficiency, or ongoing systemic glucocorticoid treatment, or any other form of immunosuppressive therapy. 20.Active viral infections such as HIV, hepatitis B, hepatitis C, etc. 21.Active syphilis.22.Subjects with renal failure requiring hemodialysis or peritoneal dialysis. 23.Uncontrolled diabetes, FBG\\>10mmol\u002FL. 24.Received organ transplantation or planned to undergo organ transplantation. 25.Undergone major surgical treatment or significant traumatic injury within 4 weeks. 26.Received palliative radiotherapy for local lesions within 2 weeks. 27.Toxicity of any previous therapy have not recovered to ≤ CTCAE Grade 1 or baseline 28.Pregnant or breeding women. 29.Severe psychiatric or psychological disorders, a history of substance abuse, or a history of severe alcoholism. 30.Allergy to the investigational medicinal product or any of its excipients. 31. The patient is not appropriate for the study In the opinion of the investigator.","ALL","18 Years",{"count":19,"type":20},69,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This study is aimed to evaluate the efficacy and safety of the Garsorasib combination therapy in KRAS G12C mutant locally advanced and metastatic NSCLC",[26],"Local Advanced or Metastatic NSCLC","NOT_YET_RECRUITING","2025-12-07",{"date":30,"type":31},"2025-12-19","ACTUAL",{"date":33,"type":20},"2025-12-23",{"date":35,"type":20},"2028-12-30",{"name":37,"class":38},"Sun Yat-sen University","OTHER",1,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":47,"enrollmentInfo":48,"targetDuration":4,"studyType":21,"phases":50,"briefSummary":52,"conditions":53,"keywords":54,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":4},"100545318","phase-3-jmt101-in-combination-with-osimertinib-versus-cisplatin-pemetrexed-in-participants-with-locally-advanced-or-metastatic-non-small-cell-lung-cancer-nsclc-characterized-by-epithermal-growth-factor-receptor-egfr-exon-20ins-mutations-100545318","NCT06380348","JMT101 in Combination With Osimertinib, Versus Cisplatin-pemetrexed in Participants With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) Characterized by Epithermal Growth Factor Receptor (EGFR) Exon 20ins Mutations","A Randomized, Open-label, Parallel-controlled Phase 3 Study of Combination JMT101 and Osimertinib Compared With Cisplatin -Pemetrexed in Patients With EGFR Exon 20ins Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer","Inclusion Criteria:\n\n1. Age between 18-75 years old.\n2. Histologically or cytologically confirmed diagnosis of NSCLC, locally advanced (Stage IIIB and IIIC according to the 8th edition of the IASLC TNM staging criteria) or metastatic (Stage IV), not suitable for curative therapy. For central laboratory confirmation of EGFR exon 20 insertion mutation with tumour tissue\u002Fblood sample.\n3. At least 1 measurable lesion per RECIST Version 1.1\n4. Life expectancy ≥ 12 weeks\n5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1\n6. Adequate organ and hematologic function\n\nExclusion Criteria:\n\n1. Prior treatment with any systemic anti-cancer therapy for locally advanced or metastatic NSCLC.\n2. Central nervous system metastasis with associated symptom and signs.\n3. Concurrent EGFR mutations: exon 19 deletion, L858R, T790M, G719X, S768I, or L861Q.\n4. History of interstitial lung disease, or infectious pneumonitis need heavy antibiotics therapy\n5. As judged by the investigator, unsuitable for attending the study.","75 Years",{"count":49,"type":20},398,[51],"PHASE3","This is a multicenter, randomized, open-label, parallel-controlled phase 3 study. This study aims to evaluate the efficacy and safety of JMT101 combined with Osimertinib compared with Cisplatin combined with pemetrexed in participants with local advanced or metastatic non-small-cell lung cancer harboured EGFR 20ins mutation without prior systemic therapy.\n\nPrimary objective of this study is to assess the efficacy of JMT101 combined with Osimertinib versus Cisplatin combined with pemetrexed using by （Independent Review Center）IRC-assessed Progression Free Survival (PFS) per RECIST 1.1 as primary endpoint. Approximately 398 participants are estimated to be randomized into the study. Participants enrolled will be randomized to JMT101 or Cisplatin chemotherapy in a 1:1 manner, stratified by baseline brain metastasis (with\u002Fwithout) and Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) (0 versus 1).",[26],[55,56],"Harboring EGFR 20ins mutation","Without prior systemic therapy","2024-04-18",{"date":59,"type":31},"2024-04-23",{"date":61,"type":20},"2024-04-26",{"date":63,"type":20},"2028-03-26",{"name":65,"class":66},"Shanghai JMT-Bio Inc.","INDUSTRY"]