drugset / Trial / NCT07174908
A Phase 3 Study of IN10018 in Combination With D-1553 Versus Standard Therapy for First Line Non-squamous Non-small Cell Lung Cancer With KRAS G12C Mutation
RandomizedParallel-groupOpen-labelTreatment
Summary
This is a multicenter, randomized, open-label, phase III clinical study, to evaluate the efficacy and safety of IN10018 in combination with D-1553 as compared to anti-PD-1 monoclonal antibody (mAb) in combination with platinum and pemetrexed as the first-line treatment for the locally advanced or metastatic KRASG12C mutation-positive non-squamous non-small cell lung cancer (NSCLC).
Timeline
- Start
- 2025-09-10
- Primary completion
- 2028-09
- Completion
- 2030-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Carboplatin | Small molecule | 5 unknown | Intravenous |
| Comparator | Cisplatin | Other / unclassified | 75 mg/m2 | Intravenous |
| Subject | D-1553 | Unknown | 600 mg | Oral |
| Subject | Ifebemtinib | Small molecule | 100 mg | Oral |
| Comparator | Pemetrexed | Small molecule | 500 mg/m2 | Intravenous |
| Comparator | Tislelizumab | Monoclonal antibody | 200 mg | Intravenous |