[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100656255":3},{"organization":4,"outcomesModule":7,"designInfo":31,"detailedDescription":30,"studyPopulation":30,"armGroups":37,"interventions":56,"overallOfficials":30,"centralContacts":30,"locations":30,"responsibleParty":78,"collaborators":30,"id":80,"slug":81,"hasResults":82,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":30,"eligibilityCriteria":86,"healthyVolunteers":82,"sex":87,"minAge":88,"maxAge":30,"enrollmentInfo":89,"targetDuration":30,"studyType":92,"phases":93,"briefSummary":95,"conditions":96,"keywords":30,"overallStatus":98,"whyStopped":30,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":30},{"fullName":5,"class":6},"Jiangsu Hansoh Pharmaceutical Co., Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":30},[9],{"measure":10,"description":11,"timeFrame":12},"Progression-Free Survival (PFS)","Progression-Free Survival (PFS) PFS per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by blinded independent central review (BICR)","Randomization to first documented progression of disease or death from any cause. (Estimated as approximately 1 year)",[14,16,20,24,27],{"measure":10,"description":15,"timeFrame":12},"Progression-Free Survival (PFS) PFS per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Investigator",{"measure":17,"description":18,"timeFrame":19},"Overall Survival (OS)","OS","Randomization to date of death from any cause. (Estimated as up to 3 years)",{"measure":21,"description":22,"timeFrame":23},"Overall Response Rate (ORR)","ORR per RECIST v1.1 by BICR and Investigator","Randomization to disease progression or death. (Estimated as approximately 1 year)",{"measure":25,"description":26,"timeFrame":23},"Duration of Response (DOR)","DOR per RECIST v1.1 by BICR and Investigator",{"measure":28,"description":29,"timeFrame":12},"Number of Participants with a Treatment Emergent Adverse Event(s) (TEAE)","Number of Participants with a TEAE",null,{"allocation":32,"interventionModel":33,"interventionModelDescription":30,"primaryPurpose":34,"observationalModel":30,"timePerspective":30,"maskingInfo":35},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":36,"maskingDescription":30,"whoMasked":30},"NONE",[38,47,52],{"label":39,"type":40,"description":30,"interventionNames":41},"Arm A: HS-10370 plus Adebrelimab plus chemotherapy","EXPERIMENTAL",[42,43,44,45,46],"Drug: HS-10370","Drug: Adebrelimab","Drug: Cisplatin","Drug: Carboplatin","Drug: Pemetrexed",{"label":48,"type":49,"description":30,"interventionNames":50},"Arm B: Tislelizumab plus chemotherapy","ACTIVE_COMPARATOR",[44,45,46,51],"Drug: Tislelizumab",{"label":53,"type":54,"description":30,"interventionNames":55},"Arm C: HS-10370 plus chemotherapy","OTHER",[42,44,45],[57,62,66,69,72,75],{"type":58,"name":59,"description":60,"armGroupLabels":61,"otherNames":30},"DRUG","HS-10370","Administered orally.",[39,53],{"type":58,"name":63,"description":64,"armGroupLabels":65,"otherNames":30},"Adebrelimab","Administered intravenously",[39],{"type":58,"name":67,"description":64,"armGroupLabels":68,"otherNames":30},"Cisplatin",[39,48,53],{"type":58,"name":70,"description":64,"armGroupLabels":71,"otherNames":30},"Carboplatin",[39,48,53],{"type":58,"name":73,"description":64,"armGroupLabels":74,"otherNames":30},"Pemetrexed",[39,48],{"type":58,"name":76,"description":64,"armGroupLabels":77,"otherNames":30},"Tislelizumab",[48],{"type":79,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100656255","phase-3-a-study-evaluating-hs-10370-plus-platinum-based-doublet-chemotherapy-with-or-without-adebrelimab-vs-tislelizumab-plus-chemotherapy-as-first-line-therapy-in-patients-with-advanced-kras-g12c-mutant-non-small-cell-lung-cancer-100656255",false,"NCT07822542","A Study Evaluating HS-10370 Plus Platinum-based Doublet Chemotherapy With or Without Adebrelimab vs. Tislelizumab Plus Chemotherapy as First-Line Therapy in Patients With Advanced KRAS G12C-Mutant Non-small Cell Lung Cancer","A Randomized, Open-label, Controlled, Multicenter Phase 3 Trial of HS-10370 Plus Platinum-based Doublet Chemotherapy With or Without Adebrelimab vs. Tislelizumab Plus Chemotherapy as First-Line Therapy in Patients With Locally Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer With KRAS G12C Mutation.","Inclusion Criteria:\n\n* Participants are able to comply with the process of the protocol.\n* Men or women greater than or equal to 18 years\n* At least one measurable lesion in accordance with RECIST 1.1\n* Must have an ECOG performance status of 0 or 1.\n* Must have adequate laboratory parameters.\n* Patients with advanced solid tumors who have failed after adequate standard treatment, are intolerant to standard treatment, or have no standard treatment available.\n* Documentation of the presence of a KRAS G12C mutation\n* Reproductive-age women agree to use adequate contraception and cannot breastfeed while participating in this study and for a period of 6 months after the last dose.Men also consent to use adequate contraceptive method within the same time limit.\n\nExclusion Criteria:\n\n* Participants with tumors known to harbor molecular alterations for which targeted therapy is locally approved, except for KRAS G12C.\n* Treatment with any of the following: Previous or current treatment with other KRAS G12C inhibitors.\n* Active brain metastases.\n* Participants with uncontrolled pleural, ascites or pericardial effusion\n* History of other primary malignancies.\n* Abnormal cardiac examination results.\n* Severe, uncontrolled or active cardiovascular disorders.\n* Uncontrolled hypertension.\n* Severe bleeding symptoms or bleeding tendencies.\n* Severe arteriovenous thrombosis occurred\n* Serious infection.\n* Continuous use of glucocorticoids\n* Active infectious diseases.\n* Refractory nausea, vomiting, or chronic gastrointestinal diseases, or inability to swallow oral medications\n* Interstitial lung disease (ILD).\n* Serious neurological or mental disorders.\n* Active autoimmune diseases.","ALL","18 Years",{"count":90,"type":91},448,"ESTIMATED","INTERVENTIONAL",[94],"PHASE3","This is a trial to evaluate the efficacy, safety, and tolerability of HS-10370 in combination with Platinum-based Doublet Chemotherapy With or Without Adebrelimab Versus Tislelizumab Plus Platinum-based Doublet Chemotherapy as first-line treatment in participants with previously untreated, locally advanced or metastatic NSCLC with KRAS G12C mutation",[97],"Carcinoma, Non-Small-Cell Lung","NOT_YET_RECRUITING","2026-09-11",{"date":101,"type":102},"2026-09-16","ACTUAL",{"date":104,"type":91},"2026-10-31",{"date":106,"type":91},"2031-12-31",{"name":5,"class":6}]