drugset / Trial / NCT07087223
Phase Ib/II Study of Vebreltinib With Furmonertinib in NSCLC Patients With c-Met Amplification After EGFR-TKI Failure
Non-randomizedSequentialOpen-labelTreatment
Summary
The goal of phase Ib study was to evaluate efficacy and tolerability of the combination of vebreltinib and furmonertinib in patients with locally advanced or metastatic non-small cell lung cancer with c-met amplification after failure of EGFR-TKI treatment; to determine the maximum tolerated dose (MTD), and to evaluate the dose-limiting toxicity (DLT) and (recommended Phase 2 dose) RP2D of vebreltinib with furmonertinib. The goal of phase II study was to evaluate efficacy \[overall response rate (ORR), progression-free survival (PFS), and so on\] of vebreltinib and furmonertinib in patients with locally advanced or metastatic non-small cell lung cancer with c-met amplification after failure of EGFR-TKI treatment.
Timeline
- Start
- 2025-04-08
- Primary completion
- 2027-04
- Completion
- 2028-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Firmonertinib | Small molecule | 80 mg | Oral |
| Subject | Vebreltinib | Small molecule | 100 mg | Oral |
| Subject | Vebreltinib | Small molecule | 150 mg | Oral |
| Subject | Vebreltinib | Small molecule | 200 mg | Oral |