IBI351 Plus Cetuximab in Untreated Advanced Non-small Cell Lung Cancer With KRAS G12C Mutation
Status:
NOT_YET_RECRUITING
Trial end date:
2028-09-01
Target enrollment:
Participant gender:
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 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.