[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"locally-advanced-or-metastatic-nsclc\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:locally-advanced-or-metastatic-nsclc":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,44,67],{"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":27,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100551520","phase-1-a-study-of-hs-10504-in-patients-with-advanced-or-metastatic-non-small-cell-lung-cancernsclc-100551520",false,"NCT06461156","A Study of HS-10504 in Patients With Advanced or Metastatic Non-Small-Cell Lung Cancer(NSCLC)","A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of HS-10504 in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC）","Inclusion Criteria:\n\n* Males or females, aged ≥ 18 years.\n* Subjects with histologically or cytologically confirmed locally advanced or metastatic NSCLC\n* Progressive disease on or after prior treatment with EGFR-TKIs.\n* Enrollment will be restricted to participants with evidence of EGFR-positive in tumor as determined by local or central testing.\n* At least 1 target lesion according to RECIST 1.1.\n* ECOG PS score: 0-1.\n* Estimated life expectancy\\> 12 weeks.\n* Men or women should be using adequate contraceptive measures throughout the study.\n* Women must have the evidence of non-childbearing potential.\n* Signed and dated Informed Consent Form.\n\nExclusion Criteria:\n\n* Subjects with known oncogenic driver genes other than EGFR.\n* Subjects with mixed cell histologic or with phenotypic transformation.\n* Treatment with any of the following:\n\n  1. Prior or concurrent treatment with fourth-generation EGFR tyrosine kinase inhibitors.\n  2. Cytotoxic chemotherapy, any other investigational drugs, traditional Chinese medicine with anti-tumor indications, or other anti-tumor drugs within 14 days prior to the first dose of HS-10504 or require continued treatment with these drugs during the study.\n  3. Any local radiotherapy 2 weeks prior to the first dose of study treatment; have received irradiation of more than 30% of bone marrow prior to the first dose\n  4. Uncontrolled pleural effusion or ascites or pericardial effusion.\n  5. Major surgery within 4 weeks before the first dose.\n  6. CNS metastases with symptomatic or active progression.\n* Subjects who have any grade ≥2 residual toxicities from prior therapies.\n* Subjects who have history of other primary malignancies.\n* Inadequate bone marrow reserve or hepatic and renal functions.\n* Subjects with severe or poorly controlled diabetes, cardiovascular diseases or hypertension; subjects with severe arteriovenous thrombotic events, severe infection, clinically significant bleeding symptoms or clinically significant gastrointestinal dysfunction.\n* Hypersensitivity to any ingredient of HS-10504.\n* Moderate to severe pulmonary diseases.\n* Prior history of significant neurological or mental disorders.\n* Women who are breastfeeding or pregnant or planned to be pregnant during the study period.\n* Unlikely to comply with study procedures, restrictions, and requirements in the opinion of the investigator.\n* Any disease or condition that, in the opinion of the investigator, would compromise subject safety or interfere with study assessments.","ALL","18 Years",{"count":19,"type":20},230,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","HS-10504 is a fourth-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor targeting EGFR C797S mutation. This study will evaluate the safety, tolerability, pharmacokinetics and efficacy of HS-10504 in Chinese locally advanced or metastatic NSCLC.",[26],"Locally Advanced or Metastatic NSCLC",[28,29,30],"locally advanced or metastatic NSCLC","EGFR C797S","HS-10504","RECRUITING","2025-09-11",{"date":34,"type":35},"2025-09-17","ACTUAL",{"date":37,"type":35},"2025-07-22",{"date":39,"type":20},"2027-03-31",{"name":41,"class":42},"Jiangsu Hansoh Pharmaceutical Co., Ltd.","INDUSTRY",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":21,"phases":53,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":43},"100601364","phase-3-askc202-combined-with-limertinib-versus-platinum-based-chemotherapy-in-treatment-of-locally-advanced-or-metastatic-nsclc-with-met-amplificationoverexpression-after-failure-of-egfr-tki-therapy-100601364","NCT07109531","ASKC202 Combined With Limertinib Versus Platinum-based Chemotherapy in Treatment of Locally Advanced or Metastatic NSCLC With MET Amplification\u002FOverexpression After Failure of EGFR-TKI Therapy","A Randomized, Controlled, Open-Label, Multicenter, Phase 3 Study to Evaluate the Efficacy and Safety of ASKC202 in Combination With Limertinib Versus Platinum-based Chemotherapy in Participants With MET Amplification\u002FOverexpression Locally Advanced or Metastatic NSCLC Who Have Failed After Prior EGFR-TKI Therapy.","Inclusion Criteria:\n\n1. Willing and able to provide signed and dated informed consent;\n2. Patients at least 18 years of age;\n3. Locally advanced or metastatic non-small cell lung cancer (NSCLC);\n4. Objective disease progression following prior EGFR-TKI therapy;\n5. EGFR mutation with MET amplification\u002FOverexpression by a central laboratory;\n6. Measurable lesions based on RECIST 1. 1;\n7. ECOG performance status 0 or 1;\n8. Expected survival \\>12 weeks;\n9. Adequate bone marrow reserve or organ function.\n\nExclusion Criteria:\n\n1. Prior or ongoing treatment with any c-Met target;\n2. Previously received systemic chemotherapy;\n3. Patients requiring continuous use of systemic immunosuppressants or systemic corticosteroids within 2 weeks prior to the first dose.\n4. Patients who underwent other major surgical procedures other than diagnosis or biopsy within 4 weeks prior to the first dose, or who were expected to undergo major surgeries during the study period;\n5. Prior to the first administration, there are unhealed toxic reactions of ≥ grade 2 (CTCAE 5.0 standard) associated with any previous treatment, any level of hair loss, and platinum drugs Except for grade 2 neuropathy caused;\n6. Patients with leptomeningeal metastasis, brainstem metastasis, or spinal cord compression;\n7. Presence of dysphagia or gastrointestinal disorders that may interfere with oral medication absorption;\n8. Previous history includes interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis requiring steroid therapy, or evidence of clinically active ILD；\n9. Have previously received hematopoietic stem cell transplants or solid organ transplants, or plan to receive hematopoietic stem cell transplants or solid organ transplants during the current period of study;\n10. There are serious or active infections that required intravenous antibiotics or hospitalization, such as HBV (HBsAg-positive and peripheral HBV-DNA titer test≥1×104 copies\u002FmL or 2000 IU\u002FmL), HCV, HIV, and syphilis;\n11. Serious or uncontrolled cardiovascular disease;\n12. Pregnant or lactating females;\n13. Other primary malignancies have been diagnosed within the last 5 years, and the following conditions can be enrolled: non-melanoma skin cancer, superficial bladder cancer, cervical carcinoma in situ that has undergone surgery and has been cured;",{"count":52,"type":20},286,[54],"PHASE3","This study is designed to compare the safety and efficacy of ASKC202 combined with Limertinib Versus platinum-based chemotherapy in locally advanced or metastatic NSCLC With MET Amplification\u002FOverexpression after disease progression on EGFR tyrosine kinase inhibitor.",[26],"NOT_YET_RECRUITING","2025-07-31",{"date":60,"type":35},"2025-08-07",{"date":62,"type":20},"2025-08-31",{"date":64,"type":20},"2028-12-31",{"name":66,"class":42},"Jiangsu Aosaikang Pharmaceutical Co., Ltd.",{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":4,"eligibilityCriteria":73,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":74,"targetDuration":4,"studyType":21,"phases":76,"briefSummary":77,"conditions":78,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":88},"100515332","phase-3-a-study-of-ak104tislelizumab-with-chemotherapy-as-first-line-treatment-in-pd-l1-tps--1-non-small-cell-lung-cancer-100515332","NCT05990127","A Study of AK104\u002FTislelizumab With Chemotherapy as First-line Treatment in PD-L1 TPS \u003C 1% Non-small Cell Lung Cancer","A Randomized, Double-blind, Phase III Trial to Compare the Efficacy and Safety of AK104 Combined With Chemotherapy to Tislelizumab Combined With Chemotherapy as First-line Treatment in PD-L1 TPS \u003C 1% Non-small Cell Lung Cancer (NSCLC)","Inclusion Criteria:\n\n1. The subjects voluntarily participated in the study with full informed consent and signed written informed consent form.\n2. Aged ≥18 years when the subject signed the informed consent.\n3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n4. Life expectancy ≥ 3 months.\n5. Histologically or cytologically confirmed locally advanced (Stage IIIB\u002FIIIC) that not amenable to complete surgical resection and not amenable to radical concurrent\u002Fsequential chemoradiation or metastatic (Stage IV) NSCLC (American Joint Committee on Cancer \\[AJCC\\] 8th edition).\n6. No prior systemic therapy for advanced or metastatic NSCLC was received.\n7. PD-L1 TPS \\\u003C 1%.\n8. No EGFR sensitive mutations or ALK gene translocation alterations.\n\nExclusion Criteria:\n\n1. Histologically confirmed small cell lung cancer (SCLC).\n2. NSCLC with driver gene mutations for approved targeted drug indications.\n3. Active central nervous system (CNS) metastases were present.\n4. Pulmonary radiation therapy \\> 30 Gy within 6 months prior to first dose.\n5. Active malignant tumors within the past 5 years, except for tumors in this study and scured local tumors.\n6. Pregnant or lactating women.\n7. Clinically significant cardiovascular or cerebrovascular disease.\n8. Subjects with a known history of severe hypersensitivity to other monoclonal antibodies. A known history of allergy or hypersensitivity to all investigational drugs or any of their components.\n9. Active autoimmune disease requiring systemic treatment within 2 years prior to the start of study treatment, or autoimmune diseases that may relapse or require scheduled treatment as judged by the Investigator.\n10. Known active pulmonary tuberculosis.\n11. Patients with active hepatitis B or active hepatitis C.\n12. Known medical history of immunodeficiency or positive HIV test.",{"count":75,"type":20},642,[54],"This is a randomized, double-blind, phase III clinical study to compare the efficacy and safety of AK104 combined chemotherapy versus Tislelizumab combined chemotherapy in first-line treatment of Locally advanced or metastatic NSCLC with PD-L1 TPS \\\u003C 1%.",[26],"2023-08-10",{"date":81,"type":35},"2023-08-14",{"date":83,"type":20},"2023-11-14",{"date":85,"type":20},"2026-11-28",{"name":87,"class":42},"Akeso",62]