drugset / Trial / NCT07554859
GFH375 Monotherapy and Combination Therapy as First-Line Treatment for Advanced KRAS G12D-Mutant Non-Small Cell Lung Cancer
RandomizedParallel-groupOpen-labelTreatment
Summary
This study is a multicenter, open-label, randomized clinical trial aimed at exploring the efficacy and safety of three treatment regimens for treatment-naive advanced NSCLC patients with KRAS G12D mutation: GFH375 monotherapy (Cohort 1), GFH375 combined with cetuximab (Cohort 2), and GFH375 combined with pemetrexed (Cohort 3).Every cohort will recruit 30 participants.
Timeline
- Start
- 2026-05-20
- Primary completion
- 2027-04-30
- Completion
- 2028-04-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cetuximab | Monoclonal antibody | 500 mg/m2 | Intravenous |
| Subject | GFH375 | Small molecule | 600 mg | Oral |
| Subject | Pemetrexed | Small molecule | 500 mg/m2 | Intravenous |