[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100606388":3},{"organization":4,"outcomesModule":7,"designInfo":56,"detailedDescription":63,"studyPopulation":59,"armGroups":64,"interventions":77,"overallOfficials":87,"centralContacts":95,"locations":104,"responsibleParty":261,"collaborators":59,"id":263,"slug":59,"hasResults":264,"nctId":265,"briefTitle":266,"officialTitle":267,"acronym":59,"eligibilityCriteria":268,"healthyVolunteers":264,"sex":269,"minAge":270,"maxAge":271,"enrollmentInfo":272,"targetDuration":59,"studyType":275,"phases":276,"briefSummary":278,"conditions":279,"keywords":59,"overallStatus":107,"whyStopped":59,"lastUpdateSubmitDate":281,"lastUpdatePostDateStruct":282,"startDateStruct":285,"completionDateStruct":287,"leadSponsor":289,"locationsCount":290},{"fullName":5,"class":6},"InxMed (Shanghai) Co., Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":43},[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).","up to 36 months",[14,17,21,25,28,31,34,37,40],{"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":24},"Disease Control Rate (DCR)","Defined as ORR + stable disease (SD) assessed per RECIST v1.1 by BICR","Up to 36 months",{"measure":26,"description":27,"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":29,"description":30,"timeFrame":12},"PFS","Defined as time from randomization until disease progression or death from any cause, whichever occurs first assessed per RECIST v1.1 by investigator assessment.",{"measure":32,"description":33,"timeFrame":12},"ORR","defined as CR+PR assessed per RECIST v1.1 by investigators",{"measure":35,"description":36,"timeFrame":12},"DCR","Defined as ORR + stable disease (SD) assessed per RECIST v1.1 by investigators",{"measure":38,"description":39,"timeFrame":24},"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 investigators",{"measure":41,"description":42,"timeFrame":12},"Number of subjects with adverse event","The number of subjects who experienced AEs is presented",[44,47,50,53],{"measure":45,"description":46,"timeFrame":12},"PK: Cmax of IN10018 and D-1553","Maximum concentration (Cmax)",{"measure":48,"description":49,"timeFrame":12},"PK: Cmin of IN10018 and D-1553","Minimum concentration (Cmin)",{"measure":51,"description":52,"timeFrame":12},"PK: AUC of IN10018 and D-1553","Area under the concentration-time curve (AUC)",{"measure":54,"description":55,"timeFrame":12},"Patient-reported outcome (PRO) questionnaire","Reports of health status directly from patients",{"allocation":57,"interventionModel":58,"interventionModelDescription":59,"primaryPurpose":60,"observationalModel":59,"timePerspective":59,"maskingInfo":61},"RANDOMIZED","PARALLEL",null,"TREATMENT",{"masking":62,"maskingDescription":59,"whoMasked":59},"NONE","Preclinical studies indicate that IN10018 synergizes with D-1553 to enhance antitumor activity and delay resistance through multiple mechanisms, including suppression of FAK-YAP signaling pathway activation, reduction of tumor stromal fibrosis, and induction of immunogenic cell death (ICD). IN10018-602\u002FD1553-106 is an ongoing Phase Ib\u002FII clinical study evaluating the synergistic antitumor activity and safety of IN10018 combined with D-1553 in patients with KRAS G12C-mutant solid tumors. Preliminary results have demonstrated notable antitumor activity and a favorable safety and tolerability profile in patients with advanced KRAS G12C-mutant NSCLC and metastatic colorectal cancer. Based on the available clinical data, the sponsor plans to initiate a Phase III study in previously untreated patients with advanced KRAS G12C-mutant NSCLC to further evaluate the efficacy and safety of IN10018 in combination with D-1553 compared with first-line standard treatment.",[65,71],{"label":66,"type":67,"description":68,"interventionNames":69},"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.",[70],"Drug: IN10018 in combination with D-1553",{"label":72,"type":73,"description":74,"interventionNames":75},"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.",[76],"Drug: anti-PD-1 monoclonal antibody in combination with platinum and pemetrexed",[78,83],{"type":79,"name":80,"description":81,"armGroupLabels":82,"otherNames":59},"DRUG","IN10018 in combination with D-1553","IN10018 100mg QD PO and D-1553 600mg BID PO, 21days per cycle",[66],{"type":79,"name":84,"description":85,"armGroupLabels":86,"otherNames":59},"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",[72],[88,92],{"name":89,"affiliation":90,"role":91},"Zhengbo Song Professor, Doctor","Zhejiang Cancer Hospital","PRINCIPAL_INVESTIGATOR",{"name":93,"affiliation":94,"role":91},"Shun Lu Professor, Doctor","Shanghai Chest Hospital",[96,101],{"name":97,"role":98,"phone":99,"phoneExt":59,"email":100},"Shu Fang Project Manager, bachelor","CONTACT","86-15933968623","shu.fang@inxmed.com",{"name":102,"role":98,"phone":59,"phoneExt":59,"email":103},"Jack Zhang Clinical Trial Manager, bachelor","jack.zhang@inxmed.com",[105,123,137,151,161,177,192,206,220,233,248],{"facility":106,"status":107,"city":108,"state":109,"zip":59,"country":110,"countryCode":111,"cosmosGeoPoint":112,"geoPoint":117,"contacts":118},"Beijing Cancer Hospital","RECRUITING","Beijing","Beijing Municipality","China","CN",{"type":113,"coordinates":114},"Point",[115,116],116.39723,39.9075,{"lat":116,"lon":115},[119],{"name":120,"role":98,"phone":121,"phoneExt":59,"email":122},"Jun Zhao Chief Physician, MD","86-13521469355","ohJerry@163.com",{"facility":124,"status":107,"city":125,"state":126,"zip":59,"country":110,"countryCode":111,"cosmosGeoPoint":127,"geoPoint":131,"contacts":132},"The First Affiliated Hospital, Sun Yat-sen University","Guangzhou","Guangdong",{"type":113,"coordinates":128},[129,130],113.25,23.11667,{"lat":130,"lon":129},[133],{"name":134,"role":98,"phone":135,"phoneExt":59,"email":136},"Kejing Tang Chief Physician, MD","86-13802946566","tangkj@mail.sysu.edu.cn",{"facility":138,"status":107,"city":139,"state":140,"zip":59,"country":110,"countryCode":111,"cosmosGeoPoint":141,"geoPoint":145,"contacts":146},"Henan Cancer Hospital","Zhengzhou","Henan",{"type":113,"coordinates":142},[143,144],113.64861,34.75778,{"lat":144,"lon":143},[147],{"name":148,"role":98,"phone":149,"phoneExt":59,"email":150},"Huijuan Wang Chief Physician, MD","86-18638561588","18638561588@163.com",{"facility":152,"status":107,"city":139,"state":140,"zip":59,"country":110,"countryCode":111,"cosmosGeoPoint":153,"geoPoint":155,"contacts":156},"The First Affiliated Hospital of Zhengzhou University",{"type":113,"coordinates":154},[143,144],{"lat":144,"lon":143},[157],{"name":158,"role":98,"phone":159,"phoneExt":59,"email":160},"Sanxing Guo Chief Physician, MD","86-18337128112","sanxing134@hotmail.com",{"facility":162,"status":107,"city":163,"state":164,"zip":59,"country":110,"countryCode":111,"cosmosGeoPoint":165,"geoPoint":169,"contacts":170},"Union Hospital Tongji Medidcal College Huazhong University of Science and Technology","Wuhan","Hubei",{"type":113,"coordinates":166},[167,168],114.26667,30.58333,{"lat":168,"lon":167},[171,175],{"name":172,"role":98,"phone":173,"phoneExt":59,"email":174},"Ruiguang Zhang Associate Chief Physician, MD","86-15071116896","zrg27@163.com",{"name":176,"role":98,"phone":59,"phoneExt":59,"email":59},"Xiaorong Dong Chief Physician, MD",{"facility":178,"status":179,"city":180,"state":181,"zip":59,"country":110,"countryCode":111,"cosmosGeoPoint":182,"geoPoint":186,"contacts":187},"Hunan Cancer Hospital","NOT_YET_RECRUITING","Changsha","Hunan",{"type":113,"coordinates":183},[184,185],112.97087,28.19874,{"lat":185,"lon":184},[188],{"name":189,"role":98,"phone":190,"phoneExt":59,"email":191},"Yongzhong Luo Chief Physician, MD","86-13607443876","luoyongzhong@hnca.org.cn",{"facility":193,"status":107,"city":194,"state":195,"zip":59,"country":110,"countryCode":111,"cosmosGeoPoint":196,"geoPoint":200,"contacts":201},"Jiangsu Cancer Hospital","Nanjing","Jiangsu",{"type":113,"coordinates":197},[198,199],118.77778,32.06167,{"lat":199,"lon":198},[202],{"name":203,"role":98,"phone":204,"phoneExt":59,"email":205},"Bo Shen Chief Physician, MD","86-13913910555","shenbo987@126.com",{"facility":207,"status":179,"city":208,"state":209,"zip":59,"country":110,"countryCode":111,"cosmosGeoPoint":210,"geoPoint":214,"contacts":215},"First Affiliated Hospital of Gannan Medical University","Gannan","Jiangxi",{"type":113,"coordinates":211},[212,213],114.99776,26.78132,{"lat":213,"lon":212},[216],{"name":217,"role":98,"phone":218,"phoneExt":59,"email":219},"Huaqiu Shi Chief Physician, BS","86-13576666365","shq3677274@163.com",{"facility":221,"status":179,"city":222,"state":209,"zip":59,"country":110,"countryCode":111,"cosmosGeoPoint":223,"geoPoint":227,"contacts":228},"The First Affiliated Hospital of Nanchang University","Nanchang",{"type":113,"coordinates":224},[225,226],115.85306,28.68396,{"lat":226,"lon":225},[229],{"name":230,"role":98,"phone":231,"phoneExt":59,"email":232},"Longhua Sun Chief Physician, MD","86-18279110112","sunlonghua012024@163.com",{"facility":94,"status":107,"city":234,"state":235,"zip":59,"country":110,"countryCode":111,"cosmosGeoPoint":236,"geoPoint":240,"contacts":241},"Shanghai","Shanghai Municipality",{"type":113,"coordinates":237},[238,239],121.45806,31.22222,{"lat":239,"lon":238},[242,246],{"name":243,"role":98,"phone":244,"phoneExt":59,"email":245},"Shun Lu Chief Physician, MD","86-13857153345","shun_lu@hotmail.com",{"name":247,"role":98,"phone":59,"phoneExt":59,"email":59},"Yongfeng Yu Chief Physician, MD",{"facility":90,"status":107,"city":249,"state":250,"zip":251,"country":110,"countryCode":111,"cosmosGeoPoint":252,"geoPoint":256,"contacts":257},"Hangzhou","Zhejiang","310005",{"type":113,"coordinates":253},[254,255],120.16142,30.29365,{"lat":255,"lon":254},[258],{"name":259,"role":98,"phone":244,"phoneExt":59,"email":260},"Zhengbo Song Chief Physician, MD","songzb@zjcc.org.cn",{"type":262,"investigatorFullName":59,"investigatorTitle":59,"investigatorAffiliation":59,"oldNameTitle":59,"oldOrganization":59},"SPONSOR","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":273,"type":274},400,"ESTIMATED","INTERVENTIONAL",[277],"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).",[280],"Non-Small Cell Lung Cancer","2026-02-27",{"date":283,"type":284},"2026-03-03","ACTUAL",{"date":286,"type":284},"2025-09-10",{"date":288,"type":274},"2030-09",{"name":5,"class":6},11]