[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657110":3},{"organization":4,"outcomesModule":7,"designInfo":40,"detailedDescription":39,"studyPopulation":39,"armGroups":46,"interventions":59,"overallOfficials":39,"centralContacts":68,"locations":74,"responsibleParty":94,"collaborators":39,"id":96,"slug":97,"hasResults":98,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":39,"eligibilityCriteria":102,"healthyVolunteers":98,"sex":103,"minAge":104,"maxAge":105,"enrollmentInfo":106,"targetDuration":39,"studyType":109,"phases":110,"briefSummary":112,"conditions":113,"keywords":39,"overallStatus":115,"whyStopped":39,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":125},{"fullName":5,"class":6},"Shanghai Jeyou Pharmaceutical Co., Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":39},[9],{"measure":10,"description":11,"timeFrame":12},"Progression-Free Survival (PFS)","Defined as time from randomization until disease progression or death from any cause, whichever occurs first assessed per RECIST v1.1 by blinded independent central review (BICR).","30 months",[14,17,21,24,27,31,34,37],{"measure":15,"description":16,"timeFrame":12},"Objective Response Rate (ORR)","Defined as complete response (PR) + partial response (PR) assessed per RECIST v1.1 by BICR",{"measure":18,"description":19,"timeFrame":20},"Overall Survival (OS)","Defined as time from randomization to death by any cause","up to 60 months",{"measure":22,"description":23,"timeFrame":12},"Disease Control Rate (DCR)","Defined as ORR + stable disease (SD) assessed per RECIST v1.1 by BICR",{"measure":25,"description":26,"timeFrame":12},"Duration of Response (DoR)","Defined as time from first evidence of PR or CR to disease progression or death due to any cause, whichever occurs first, assessed per RECIST v1.1 by BICR",{"measure":28,"description":29,"timeFrame":30},"PFS by investigator assessment","Defined as time from randomization until disease progression or death from any cause, whichever occurs first assessed per RECIST v1.1 by investigator assessment.","up to 30 months",{"measure":32,"description":33,"timeFrame":12},"Number of participants with adverse event","Number of participants with treatment-related adverse events as assessed by CTCAE v6.0",{"measure":35,"description":36,"timeFrame":30},"Patient-reported outcome (PRO) questionnaire including EORTC QLQ-C30","Reports of health status directly from participants",{"measure":38,"description":36,"timeFrame":30},"Patient-reported outcome (PRO) questionnaire including EORTC QLQ-LC13.",null,{"allocation":41,"interventionModel":42,"interventionModelDescription":39,"primaryPurpose":43,"observationalModel":39,"timePerspective":39,"maskingInfo":44},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":45,"maskingDescription":39,"whoMasked":39},"NONE",[47,53],{"label":48,"type":49,"description":50,"interventionNames":51},"Study Arm","EXPERIMENTAL","Sosimerasib in combination with IN10018",[52],"Drug: Sosimerasib in combination with IN10018",{"label":54,"type":55,"description":56,"interventionNames":57},"Control Arm","ACTIVE_COMPARATOR","anti-PD-1 monoclonal antibody in combination with chemotherapy",[58],"Drug: Tislelizumab + Carboplatin + Pemetrexed",[60,64],{"type":61,"name":50,"description":62,"armGroupLabels":63,"otherNames":39},"DRUG","Participants receive Sosimerasib in combination with IN10018 orally once daily (QD) in a 21-day cycle, until disease progression or unacceptable toxicity",[48],{"type":61,"name":65,"description":66,"armGroupLabels":67,"otherNames":39},"Tislelizumab + Carboplatin + Pemetrexed","Participants receive Tislelizumab Q3W IV until disease progression or up to 2 years, plus Carboplatin Q3W IV for up to 4 cycles, plus Pemetrexed Q3W IV until disease progression.",[54],[69],{"name":70,"role":71,"phone":72,"phoneExt":39,"email":73},"Jieting Zhao","CONTACT","021-60198525","zhaojieting@jeyoupharma.com",[75],{"facility":76,"status":39,"city":77,"state":78,"zip":39,"country":79,"countryCode":80,"cosmosGeoPoint":81,"geoPoint":86,"contacts":87},"The Second Affiliated Hospital of Nanchang University","Nanchang","Jiangxi","China","CN",{"type":82,"coordinates":83},"Point",[84,85],115.85306,28.68396,{"lat":85,"lon":84},[88,92],{"name":89,"role":71,"phone":90,"phoneExt":39,"email":91},"Anwen Liu","0791-86260752","awliu666@163.com",{"name":89,"role":93,"phone":39,"phoneExt":39,"email":39},"PRINCIPAL_INVESTIGATOR",{"type":95,"investigatorFullName":39,"investigatorTitle":39,"investigatorAffiliation":39,"oldNameTitle":39,"oldOrganization":39},"SPONSOR","100657110","phase-3-a-phase-3-study-of-sosimerasib-in-combination-with-in10018-versus-standard-therapy-for-first-line-non-squamous-non-small-cell-lung-cancer-with-kras-g12c-mutation-100657110",false,"NCT07833202","A Phase 3 Study of Sosimerasib in Combination With IN10018 Versus Standard Therapy for First Line Non-squamous Non-small Cell Lung Cancer With KRAS G12C Mutation","A Phase 3, Randomized, Positive Controlled, Open-Label and Multicenter Study of Sosimerasib in Combination With IN10018 Versus Standard Therapy for the Treatment of First Line Locally-advanced or Metastatic Non-squamous Non-small Cell Lung Cancer With KRAS G12C Mutation","Inclusion Criteria:\n\n1. Histologically or cytologically documented Stage IIIB or IIIC NSCLC disease not amenable for surgical resection or definitive chemoradiation or Stage IV Non-squamous NSCLC disease.\n2. Has KRAS G12C mutation confirmed by central laboratory.\n3. Measurable disease according to RECIST 1.1.\n4. An Eastern Cooperative Group (ECOG) performance status of 0 or 1.\n5. Adequate organ function.\n6. Life expectancy ≥3 months in the opinion of the Investigator\n7. Male and female participants of reproductive potential must agree to use effective contraception during and for 6 months after treatment\n\nExclusion Criteria:\n\n1. Has another known driver mutation with approved first-line targeted therapy.\n2. Participants with carcinomatous meningitis or spinal cord compression; or with other evidence indicating that central nervous system (CNS) metastases or leptomeningeal metastases are not yet controlled.\n3. Prior treatment with KRAS G12C inhibitors, FAK inhibitors, or pan-RAS inhibitors.\n4. History of prior malignancy in the past 3 years, with the exception of curatively treated malignancies.\n5. Gastrointestinal (GI) tract disease causing the inability to take oral medication or affect drug absorption.\n6. Has uncontrolled cardiovascular disease, active severe infection, interstitial lung disease, or autoimmune disease.\n7. Any condition that, in the opinion of the Investigator, would interfere with participation or study results","ALL","18 Years","75 Years",{"count":107,"type":108},416,"ESTIMATED","INTERVENTIONAL",[111],"PHASE3","This is a randomized, positive controlled, open-Label and multicenter phase III study, to evaluate the efficacy and safety of Sosimerasib in combination with IN10018 versus anti-PD-1 monoclonal antibody in combination with carboplatin and pemetrexed as the first-line treatment for the locally advanced or metastatic non-squamous non-small cell lung cancer with KRAS G12C mutation.",[114],"NSCLC","NOT_YET_RECRUITING","2026-09-22",{"date":118,"type":119},"2026-09-24","ACTUAL",{"date":121,"type":108},"2026-10",{"date":123,"type":108},"2030-09",{"name":5,"class":6},1]