IBI351 Plus Cetuximab β in Untreated Advanced Non-small Cell Lung Cancer With KRAS G12C Mutation

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 safety.

NCT Number	NCT07198841
Lead Sponsor	Guangdong Association of Clinical Trials Collaborators: Innovent Biologics (Suzhou) Co. Ltd., Mabpharm Limitied
Conditions	Lung Cancer (Non-Small Cell)
Enrollment	48 participants
Start Date	2025-11-03
Primary Completion	2027-09 (estimated)
Study Completion	2028-09 (estimated)
Updated on ClinicalTrials.gov	2026-03-11