Phase Ib/II Study of Vebreltinib With Furmonertinib in NSCLC Patients With c-Met Amplification After EGFR-TKI Failure

Sponsor
Peking University Cancer Hospital & Institute
Study ID
NCT07087223
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Non Small Cell Lung Cancer NSCLC

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Vebreltinib combined with Furmonertinib — DRUG
    Vebreltinib 100mg/1500mg/200mg oral twice daily combined with Furmonertinib 80mg oral once daily
  • Vebreltinib combined with Furmonertinib — DRUG
    Vebreltinib 100mg/1500mg/200mg oral twice daily combined with Furmonertinib 80mg oral once daily. Based on the safety data from the completed dose cohorts, the investigators will involve the selection of 1-2 dose cohorts for further study. Approximately 10 additional subjects will be enrolled in the selected dose expansion cohort to determine the recommended dose for Phase II clinical trials.
  • Vebreltinib combined with Furmonertinib — DRUG
    RP2D of Vebreltinib as determined during Phase Ib oral twice daily combined with Furmonertinib 80mg oral once daily

Study Details

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.

Key Dates

Start date
Apr 8, 2025
Status verified
Jul 2025
Primary completion
Apr 30, 2027
Completion
Apr 30, 2028

Study Design

Enrollment
42 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: phase Ib Dose Escalation
  • Experimental: phase Ib Dose Expansion
  • Experimental: phase II

Primary Outcome Measure

phase Ib: Incidence of dose-limiting toxicities (DLT) as defined in the protocol [ Time Frame: 12 months ]

Central Contacts