GFH375 Monotherapy and Combination Therapy as First-Line Treatment for Advanced KRAS G12D-Mutant Non-Small Cell Lung Cancer

This study is a multicenter, open-label, randomized clinical trial designed to evaluate the efficacy and safety of three treatment regimens in patients with previously untreated advanced NSCLC harboring KRAS G12D mutations: GFH375 monotherapy (Cohort 1), GFH375 combined with cetuximab (Cohort 2), and GFH375 combined with pemetrexed (Cohort 3). The study population consists of participants with advanced, previously untreated NSCLC carrying KRAS G12D mutations. Participants must not have received any prior systemic anti-tumor therapy. After enrollment, participants will be randomized to one of the following cohorts: Cohort 1: GFH375 monotherapy (600 mg, QD, oral), approximately 30 participants. Cohort 2: GFH375 (600 mg, QD, oral) combined with cetuximab (500 mg/m², Q2W, intravenous), approximately 30 participants. Cohort 3: GFH375 (600 mg, QD, oral) combined with pemetrexed (500 mg/m², Q3W, intravenous), approximately 30 participants. A total of approximately 90 participants will be enrolled in this study, and each participant will be randomized to only one cohort.