A Study of GFH925 in Combination With Cetuximab in Previously Untreated Advanced NSCLC Harboring KRAS G12C Mutation

Inclusion criteria

• Patient has provided informed consent form (ICF).
• Males or females aged ≥ 18 years.
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0~1.
• Life expectancy > 3 months judged by the investigator.
• Have histologically or cytologically confirmed advanced KRAS G12C-mutated NSCLC.
• Have at least one measurable lesion per RECIST 1.1.
• Have sufficient organ functions.
• With toxicities left from prior anti-tumor therapy resolved to baseline or CTCAE Grade 1 (neurotoxicity or alopecia ≤ Grade 2).
• Women of childbearing potential (WOCBP) and male patients with WOCBP partners must agree to use effective contraception method during the study specified period.

Exclusion criteria

• With clinically significant cardiovascular diseases.
• With active central nervous system (CNS) metastases and/or carcinomatous meningitis.
• With clinically significant gastrointestinal diseases.
• With active infections.
• With uncontrollable or symptomatic pleural effusion, ascites, or pericardial effusion.
• With uncontrolled systemic diseases, such as hypertension or diabetes.
• Prior treatment with an inhibitor specific to KRAS G12C.
• Major surgery within 4 weeks prior to initiation of study treatment.
• With known allergies to the study drugs or components.
• Pregnant or lactating females, or female patients intend to become pregnant during participation.