Phase Ib/II Study of Vebreltinib With Furmonertinib in NSCLC Patients With c-Met Amplification After EGFR-TKI Failure
Trial Parameters
Brief 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.
Eligibility Criteria
Inclusion Criteria: 1. Fully aware this study and voluntary to sign the informed consent form, and willing and able to comply with the study procedure. 2. Aged ≥18 years, male or female. 3. Patients with histologically or cytologically confirmed unresectable and non-suitable for radical surgery, or concurrent chemoradiotherapy , locally advanced or metastatic (stage IIIB, IIIC or IV) NSCLC; 4. Documented EGFR sensitive mutations (exon 19 deletion or exon 21 L858R mutation). 5. Disease progression after prior EGFR-TKI therapy. Participants must meet both of the following 2 criteria: (1) ≤1 prior chemotherapy regimen allowed besides EGFR-TKI. Combination with anti-angiogenic therapy or PD-1/PD-L1 inhibitors are allowed during EGFR-TKI targeted therapy or chemotherapy. （2） Objective clinical benefit documented during previous EGFR-TKI therapy, defined by either partial or complete radiological response, or durable stable disease should be greater than 6 months after initiation of EGFR-TKI