IBI351 Plus Cetuximab β in Untreated Advanced Non-small Cell Lung Cancer With KRAS G12C Mu
Study Design: a Phase II, single-arm, multicenter, prospective, interventional study. Target Population: Subjects with previously untreated, locally advanced or metastatic non-small cell lung cancer (NSCLC) confirmed to harbor the KRAS G12C mutation. Treatment Regimen: All enrolled subjects will receive IBI351 combined
| Condition(s) | Lung Cancer (Non-Small Cell) |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | Study Design: a Phase II, single-arm, multicenter, prospective, interventional study. Target Population: Subjects with previously untreated, locally advanced or metastatic non-small cell lung cancer (NSCLC) confirmed to harbor the KRAS G12C mutation. Treatment Regimen: All enrolled subjects will receive IBI351 combined with cetuximab β injection. Treatment will continue until disease progression (as assessed by the investigator per RECIST 1.1 criteria) or the occurrence of intolerable toxicity. Primary Endpoint: Objective Response Rate (ORR) as assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Secondary Endpoints: Disease Control Rate (DCR), Time to Response (TTR), Progression-Free Survival (PFS), and Overall Survival (OS) , and sa |
| Who can participate | Inclusion Criteria 1. Voluntarily participate in the study and sign the informed consent form (ICF). 2. Male or female subjects aged ≥18 years and ≤75 years at the time of signing the ICF. 3. Life expectancy ≥ 3 months. 4. Histologically or cytologically confirmed unresectable locally advanced (Stage IIIB/IIIC), metastatic, or recurrent (Stage IV) non-small cell lung cancer (NSCLC), per the International Association for the Study of Lung Cancer (IASLC) and American Joint Committee on Cancer (AJCC) 8th edition TNM staging, and not candidates for curative concurrent chemoradiotherapy. 5. Documented KRAS G12C mutation confirmed by a written report from a certified laboratory. 6. Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1. 7. No prior systemic anti-tumor |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Lead sponsor | Guangdong Association of Clinical Trials |
| Locations | Guangzhou, Guangdong, China; Beijing, China; Foshan, China; Nanchang, China; Nanchang, China; Nanning, China (+1 more sites) |
| Start date | 2025-11-03 |
| NCT ID | NCT07198841 |
| Official listing | https://clinicaltrials.gov/study/NCT07198841 |