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

Inclusion criteria

• ✓. Voluntarily participate in the study and sign the informed consent form (ICF).
• ✓. Male or female subjects aged ≥18 years and ≤75 years at the time of signing the ICF.
• ✓. Life expectancy ≥ 3 months.
• ✓. 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.
• ✓. Documented KRAS G12C mutation confirmed by a written report from a certified laboratory.
• ✓. Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1.
• ✓. No prior systemic anti-tumor therapy for locally advanced or metastatic non-squamous NSCLC. Subjects who received prior adjuvant therapy are eligible provided disease recurrence occurred ≥6 months after the last dose of adjuvant therapy or the last session of radical radiotherapy.
• ✓. At least one measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Lesions within a prior radiation field or after local therapy can be considered target lesions if documented progression is evident.