[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100606388":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":39,"locations":48,"responsibleParty":205,"collaborators":26,"id":207,"slug":208,"hasResults":209,"nctId":210,"briefTitle":211,"officialTitle":212,"acronym":26,"eligibilityCriteria":213,"healthyVolunteers":209,"sex":214,"minAge":215,"maxAge":216,"enrollmentInfo":217,"targetDuration":26,"studyType":220,"phases":221,"briefSummary":223,"conditions":224,"keywords":26,"overallStatus":51,"whyStopped":26,"lastUpdateSubmitDate":226,"lastUpdatePostDateStruct":227,"startDateStruct":230,"completionDateStruct":232,"leadSponsor":234,"locationsCount":235},{"fullName":5,"class":6},"InxMed (Shanghai) Co., Ltd.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"IN10018 plus D-1553","EXPERIMENTAL","Subjects receive IN10018 100mg orally once daily (QD) and D-1553 600mg orally twice daily (BID) on Days 1-21 of each 21-day cycle, until disease progression or unacceptable toxicity.",[13],"Drug: IN10018 in combination with D-1553",{"label":15,"type":16,"description":17,"interventionNames":18},"Tislelizumab plus Platinum and Pemetrexed","ACTIVE_COMPARATOR","Subjects receive Tislelizumab 200mg intravenously (IV) once every 3 weeks (Q3W) until disease progression, plus Carboplatin (AUC = 5 mg\u002FmL\u002Fmin, Q3W, IV) or Cisplatin (75 mg\u002Fm², Q3W, IV) for up to 4 cycles, in combination with Pemetrexed (500 mg\u002Fm², Q3W, IV) until disease progression.",[19],"Drug: anti-PD-1 monoclonal antibody in combination with platinum and pemetrexed",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","IN10018 in combination with D-1553","IN10018 100mg QD PO and D-1553 600mg BID PO, 21days per cycle",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"anti-PD-1 monoclonal antibody in combination with platinum and pemetrexed","Tislelizumab 200mg Q3W IV + Carboplatin AUC 5 mg\u002FmL\u002Fmin or Cisplatin 75mg\u002Fm² Q3W IV+ Pemetrexed 500mg\u002Fm² Q3W IV",[15],[32,36],{"name":33,"affiliation":34,"role":35},"Zhengbo Song Professor, Doctor","Zhejiang Cancer Hospital","PRINCIPAL_INVESTIGATOR",{"name":37,"affiliation":38,"role":35},"Shun Lu Professor, Doctor","Shanghai Chest Hospital",[40,45],{"name":41,"role":42,"phone":43,"phoneExt":26,"email":44},"Shu Fang Project Manager, bachelor","CONTACT","86-15933968623","shu.fang@inxmed.com",{"name":46,"role":42,"phone":26,"phoneExt":26,"email":47},"Jack Zhang Clinical Trial Manager, bachelor","jack.zhang@inxmed.com",[49,67,81,95,105,121,136,150,164,177,192],{"facility":50,"status":51,"city":52,"state":53,"zip":26,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"Beijing Cancer Hospital","RECRUITING","Beijing","Beijing Municipality","China","CN",{"type":57,"coordinates":58},"Point",[59,60],116.39723,39.9075,{"lat":60,"lon":59},[63],{"name":64,"role":42,"phone":65,"phoneExt":26,"email":66},"Jun Zhao Chief Physician, MD","86-13521469355","ohJerry@163.com",{"facility":68,"status":51,"city":69,"state":70,"zip":26,"country":54,"countryCode":55,"cosmosGeoPoint":71,"geoPoint":75,"contacts":76},"The First Affiliated Hospital, Sun Yat-sen University","Guangzhou","Guangdong",{"type":57,"coordinates":72},[73,74],113.25,23.11667,{"lat":74,"lon":73},[77],{"name":78,"role":42,"phone":79,"phoneExt":26,"email":80},"Kejing Tang Chief Physician, MD","86-13802946566","tangkj@mail.sysu.edu.cn",{"facility":82,"status":51,"city":83,"state":84,"zip":26,"country":54,"countryCode":55,"cosmosGeoPoint":85,"geoPoint":89,"contacts":90},"Henan Cancer Hospital","Zhengzhou","Henan",{"type":57,"coordinates":86},[87,88],113.64861,34.75778,{"lat":88,"lon":87},[91],{"name":92,"role":42,"phone":93,"phoneExt":26,"email":94},"Huijuan Wang Chief Physician, MD","86-18638561588","18638561588@163.com",{"facility":96,"status":51,"city":83,"state":84,"zip":26,"country":54,"countryCode":55,"cosmosGeoPoint":97,"geoPoint":99,"contacts":100},"The First Affiliated Hospital of Zhengzhou University",{"type":57,"coordinates":98},[87,88],{"lat":88,"lon":87},[101],{"name":102,"role":42,"phone":103,"phoneExt":26,"email":104},"Sanxing Guo Chief Physician, MD","86-18337128112","sanxing134@hotmail.com",{"facility":106,"status":51,"city":107,"state":108,"zip":26,"country":54,"countryCode":55,"cosmosGeoPoint":109,"geoPoint":113,"contacts":114},"Union Hospital Tongji Medidcal College Huazhong University of Science and Technology","Wuhan","Hubei",{"type":57,"coordinates":110},[111,112],114.26667,30.58333,{"lat":112,"lon":111},[115,119],{"name":116,"role":42,"phone":117,"phoneExt":26,"email":118},"Ruiguang Zhang Associate Chief Physician, MD","86-15071116896","zrg27@163.com",{"name":120,"role":42,"phone":26,"phoneExt":26,"email":26},"Xiaorong Dong Chief Physician, MD",{"facility":122,"status":123,"city":124,"state":125,"zip":26,"country":54,"countryCode":55,"cosmosGeoPoint":126,"geoPoint":130,"contacts":131},"Hunan Cancer Hospital","NOT_YET_RECRUITING","Changsha","Hunan",{"type":57,"coordinates":127},[128,129],112.97087,28.19874,{"lat":129,"lon":128},[132],{"name":133,"role":42,"phone":134,"phoneExt":26,"email":135},"Yongzhong Luo Chief Physician, MD","86-13607443876","luoyongzhong@hnca.org.cn",{"facility":137,"status":51,"city":138,"state":139,"zip":26,"country":54,"countryCode":55,"cosmosGeoPoint":140,"geoPoint":144,"contacts":145},"Jiangsu Cancer Hospital","Nanjing","Jiangsu",{"type":57,"coordinates":141},[142,143],118.77778,32.06167,{"lat":143,"lon":142},[146],{"name":147,"role":42,"phone":148,"phoneExt":26,"email":149},"Bo Shen Chief Physician, MD","86-13913910555","shenbo987@126.com",{"facility":151,"status":123,"city":152,"state":153,"zip":26,"country":54,"countryCode":55,"cosmosGeoPoint":154,"geoPoint":158,"contacts":159},"First Affiliated Hospital of Gannan Medical University","Gannan","Jiangxi",{"type":57,"coordinates":155},[156,157],114.99776,26.78132,{"lat":157,"lon":156},[160],{"name":161,"role":42,"phone":162,"phoneExt":26,"email":163},"Huaqiu Shi Chief Physician, BS","86-13576666365","shq3677274@163.com",{"facility":165,"status":123,"city":166,"state":153,"zip":26,"country":54,"countryCode":55,"cosmosGeoPoint":167,"geoPoint":171,"contacts":172},"The First Affiliated Hospital of Nanchang University","Nanchang",{"type":57,"coordinates":168},[169,170],115.85306,28.68396,{"lat":170,"lon":169},[173],{"name":174,"role":42,"phone":175,"phoneExt":26,"email":176},"Longhua Sun Chief Physician, MD","86-18279110112","sunlonghua012024@163.com",{"facility":38,"status":51,"city":178,"state":179,"zip":26,"country":54,"countryCode":55,"cosmosGeoPoint":180,"geoPoint":184,"contacts":185},"Shanghai","Shanghai Municipality",{"type":57,"coordinates":181},[182,183],121.45806,31.22222,{"lat":183,"lon":182},[186,190],{"name":187,"role":42,"phone":188,"phoneExt":26,"email":189},"Shun Lu Chief Physician, MD","86-13857153345","shun_lu@hotmail.com",{"name":191,"role":42,"phone":26,"phoneExt":26,"email":26},"Yongfeng Yu Chief Physician, MD",{"facility":34,"status":51,"city":193,"state":194,"zip":195,"country":54,"countryCode":55,"cosmosGeoPoint":196,"geoPoint":200,"contacts":201},"Hangzhou","Zhejiang","310005",{"type":57,"coordinates":197},[198,199],120.16142,30.29365,{"lat":199,"lon":198},[202],{"name":203,"role":42,"phone":188,"phoneExt":26,"email":204},"Zhengbo Song Chief Physician, MD","songzb@zjcc.org.cn",{"type":206,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100606388","phase-3-a-phase-3-study-of-in10018-in-combination-with-d-1553-versus-standard-therapy-for-first-line-non-squamous-non-small-cell-lung-cancer-with-kras-g12c-mutation-100606388",false,"NCT07174908","A Phase 3 Study of IN10018 in Combination With D-1553 Versus Standard Therapy for First Line Non-squamous Non-small Cell Lung Cancer With KRAS G12C Mutation","A Phase 3 Multicenter, Randomized, Controlled, and Open-Label Study of IN10018 in Combination With D-1553 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\n* Able and willing to provide informed consent and comply with study requirements\n* Has histologically confirmed locally advanced (Stage IIIB\u002FC) or metastatic (Stage IV) non-squamous NSCLC\n* Aged 18-80 years at the time of consent\n* Has KRAS G12C mutation confirmed by central laboratory\n* Has not received prior systemic therapy for advanced or metastatic NSCLC\n* Has at least one measurable lesion per RECIST v1.1\n* ECOG performance status of 0-1\n* Has adequate organ function\n* Life expectancy ≥3 months in the opinion of the Investigator\n* Male and female subjects of reproductive potential must agree to use effective contraception during and for 6 months after treatment\n\nExclusion Criteria:\n\n* Has other histological subtypes of NSCLC (e.g., small cell or neuroendocrine)\n* Has active or untreated CNS metastases or carcinomatous meningitis\n* Prior treatment with KRAS G12C inhibitors, FAK inhibitors, or immune checkpoint inhibitors\n* Has another known driver mutation with approved targeted therapy (e.g., EGFR, ALK, ROS1)\n* Has uncontrolled cardiovascular disease, active severe infection, interstitial lung disease, or autoimmune disease requiring systemic therapy\n* Has history of another malignancy within 5 years, except those curatively treated and considered low risk (e.g., basal cell carcinoma, cervical carcinoma in situ)\n* Has gastrointestinal conditions that may interfere with absorption of oral drugs (if applicable)\n* Has known active hepatitis B, hepatitis C, or HIV infection\n* Has received a live vaccine within 30 days before first dose of study drug\n* Pregnant or breastfeeding women\n* Has psychiatric or substance abuse disorders that would interfere with study compliance\n* Is participating in another interventional clinical study\n* Any condition that, in the opinion of the Investigator, would interfere with participation or study results","ALL","18 Years","80 Years",{"count":218,"type":219},400,"ESTIMATED","INTERVENTIONAL",[222],"PHASE3","This is a multicenter, randomized, open-label, phase III clinical study, to evaluate the efficacy and safety of IN10018 in combination with D-1553 as compared to anti-PD-1 monoclonal antibody (mAb) in combination with platinum and pemetrexed as the first-line treatment for the locally advanced or metastatic KRASG12C mutation-positive non-squamous non-small cell lung cancer (NSCLC).",[225],"Non-Small Cell Lung Cancer","2026-02-27",{"date":228,"type":229},"2026-03-03","ACTUAL",{"date":231,"type":229},"2025-09-10",{"date":233,"type":219},"2030-09",{"name":5,"class":6},11]