RecruitingPhase 1Phase 2NCT07087223

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

The Open-Label, Multicenter Phase Ib/II Clinical Study Evaluating the Safety and Efficacy of Vebreltinib Combined With Furmonertinib in Locally Advanced or Metastatic NSCLC Patients With c-Met Amplification After EGFR-TKI Failure


Sponsor

Peking University Cancer Hospital & Institute

Enrollment

42 participants

Start Date

Apr 8, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination of two targeted cancer drugs — vebreltinib and furmonertinib — in people with advanced lung cancer (non-small cell lung cancer, NSCLC) whose tumors have specific gene mutations. These patients have already tried standard targeted therapy that stopped working. **You may be eligible if...** - You are 18 or older - You have been diagnosed with advanced or metastatic NSCLC (stage IIIB, IIIC, or IV) - Your tumor has a specific EGFR mutation (exon 19 deletion or L858R) - Your cancer progressed after treatment with an EGFR-targeting drug (like osimertinib) - Your tumor shows c-Met amplification confirmed by testing - You have at least one measurable tumor lesion **You may NOT be eligible if...** - You have received certain prior treatments (e.g., c-Met inhibitors) - You have uncontrolled brain metastases - You have significant heart, liver, or kidney problems - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGVebreltinib combined with Furmonertinib

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

DRUGVebreltinib 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.

DRUGVebreltinib combined with Furmonertinib

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


Locations(12)

Ordos Central Hospital

Neimeng, Neimeng, China

Peking University Cancer Hospital (Inner Mongolia Campus)

Neimeng, Neimeng, China

Affiliated Hospital of Hebei University

Baoding, China

Baotou Cancer Hospital

Baotou, China

Peking University Cancer Hospital & Institute

Beijing, China

Beijing Chest Hospital, Capital Medical University

Beijing, China

Beijing Daxing District People's Hospital

Beijing, China

Peking Union Medical College Hospital

Beijing, China

Peking University People's Hospital

Beijing, China

Peking University Third Hospital

Beijing, China

The Second Hospital of Dalian Medical University

Dalian, China

Tianjin Medical University Cancer Institute & Hospital

Tianjin, China

View Full Details on ClinicalTrials.gov

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NCT07087223


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