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

NCT07087223 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2025-07-25

No results posted yet for this study

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.

Conditions

  • Non Small Cell Lung Cancer NSCLC

Interventions

DRUG

Vebreltinib combined with Furmonertinib

Vebreltinib 100mg/1500mg/200mg oral twice daily combined with Furmonertinib 80mg oral once daily

DRUG

Vebreltinib combined with Furmonertinib

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.

DRUG

Vebreltinib combined with Furmonertinib

RP2D of Vebreltinib as determined during Phase Ib oral twice daily combined with Furmonertinib 80mg oral once daily

Sponsors & Collaborators

  • Peking University Cancer Hospital & Institute

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-08
Primary Completion
2027-04-30
Completion
2028-04-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07087223 on ClinicalTrials.gov