[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100619070":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":11,"centralContacts":29,"locations":11,"responsibleParty":35,"collaborators":11,"id":39,"slug":40,"hasResults":41,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":11,"eligibilityCriteria":45,"healthyVolunteers":41,"sex":46,"minAge":47,"maxAge":11,"enrollmentInfo":48,"targetDuration":11,"studyType":51,"phases":52,"briefSummary":55,"conditions":56,"keywords":11,"overallStatus":59,"whyStopped":11,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":11},{"fullName":5,"class":6},"Cancer Institute and Hospital, Chinese Academy of Medical Sciences","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Glecirasib Combined With Ivonescimab","EXPERIMENTAL",null,[13,14],"Drug: Glecirasib","Drug: Ivonescimab",[16,23],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"DRUG","Glecirasib","For Phase I Dose Escalation, Glecirasib includes 2 dose cohorts: 600 mg QD and 800 mg QD, respectively, to determine the Glecirasib PR2D dose for the Phase II study.",[9],[22],"JAB-21822",{"type":17,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"Ivonescimab","Administered intravenously at 20 mg\u002Fkg, every 3 weeks (Q3W).",[9],[28],"AK112",[30],{"name":31,"role":32,"phone":33,"phoneExt":11,"email":34},"Zhijie Wang, MD","CONTACT","010-67781331","wangzj@cicams.ac.cn",{"type":36,"investigatorFullName":37,"investigatorTitle":38,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","Zhijie Wang","Professor","100619070","phase-1-glecirasib-combined-with-ivonescimab-for-first-line-treatment-of-kras-g12c-mutated-nsclc-100619070",false,"NCT07339839","Glecirasib Combined With Ivonescimab for First-line Treatment of KRAS G12C-mutated NSCLC","Glecirasib Combined With Ivonescimab for First-line Treatment of KRAS G12C-mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer: A Prospective, Multi-center, Phase I\u002FII Clinical Study","Inclusion Criteria:\n\n* Signed written informed consent.\n* Age ≥18 years.\n* Newly diagnosed, unresectable, locally advanced (ineligible for curative concurrent - chemoradiotherapy) or metastatic NSCLC per AJCC 9th edition.\n* KRAS G12C mutation confirmed by validated testing.\n* PD-L1 TPS ≥1%.\n* ≥1 measurable lesion per RECIST v1.1.\n* No prior systemic therapy for advanced\u002Fmetastatic NSCLC; prior adjuvant therapy allowed if completed \\>6 months before dosing and toxicities recovered to ≤Grade 1.\n* ECOG PS 0-2.\n* Life expectancy \\>3 months\n* Adequate organ function (hematologic, hepatic, renal, coagulation per protocol thresholds)\n* Negative pregnancy test for women of childbearing potential; adequate contraception for men and women through 3 months post-treatment\n* Willing and able to comply with study procedures and follow-up.\n\nExclusion Criteria:\n\n* History of other malignancies (exceptions: cured basal cell carcinoma, cervical carcinoma in situ)\n* Predominant squamous NSCLC, small cell carcinoma, or neuroendocrine carcinoma.\n* Other actionable drivers (EGFR, ALK, ROS1, RET, BRAF, NTRK, MET, etc.).\n* Known hypersensitivity to study drugs.\n* Prior PD-1\u002FPD-L1 inhibitors or KRAS inhibitors.\n* Active autoimmune disease or autoimmune disease history requiring systemic therapy.\n* Systemic immunosuppressive therapy within 14 days prior to first dose.\n* Symptomatic ascites\u002Fpleural effusion needing recurrent drainage.\n* Significant cardiovascular disease (NYHA ≥2, MI within 1 year, uncontrolled arrhythmias).\n* Active infection, unexplained fever \\>38.5°C.\n* Interstitial lung disease or pneumonitis.\n* HIV infection or other immunodeficiency.\n* Live vaccines within 4 weeks.\n* Substance abuse, alcoholism, or psychiatric disorders impairing compliance.\n* Unable to swallow oral medication.\n* Any condition that may interfere with study participation or interpretation as judged by investigator.","ALL","18 Years",{"count":49,"type":50},42,"ESTIMATED","INTERVENTIONAL",[53,54],"PHASE1","PHASE2","This study evaluates the safety, tolerability, maximum tolerated dose (MTD), dose-limiting toxicities (DLTs), and recommended phase II dose (RP2D) of Glecirasib in combination with Ivonescimab in patients with previously untreated, KRAS G12C-mutated, locally advanced or metastatic non-small cell lung cancer (NSCLC) with PD-L1 TPS ≥1%. The study includes a Phase I 3+3 dose-escalation stage followed by a Phase II Simon two-stage design to assess preliminary antitumor efficacy.",[57,58],"NSCLC Stage IV","KRAS G12C","NOT_YET_RECRUITING","2026-01-05",{"date":62,"type":63},"2026-01-14","ACTUAL",{"date":65,"type":50},"2026-03-01",{"date":67,"type":50},"2029-09-30",{"name":5,"class":6}]