RecruitingPhase 3NCT06930794

A Study of Vebreltinib and Platinum-Containing Double Agents in Subjects With MET-Positive

An Open-label, Randomized, Controlled, Multicenter Phase IIIb Clinical Study to Evaluate the Efficacy and Safety of Vebreltinib Enteric Capsule Combined With Platinum-based Doublet Chemotherapy Compared With Platinum-based Doublet Chemotherapy in Subjects With Locally Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer Who Have Not Received Previous Systemic Treatment and MET-Positive

Sponsor

Beijing Pearl Biotechnology Limited Liability Company

Enrollment

300 participants

Start Date

Jul 7, 2025

Study Type

INTERVENTIONAL

Summary

This study is an open-label, randomized, controlled, multicenter Phase IIIb clinical study, aiming to evaluate the efficacy, safety, and tolerability of Vebreltinib Enteric Capsule combined with platinum-based doublet chemotherapy compared with platinum-based doublet chemotherapy in treating subjects with locally advanced or metastatic non-squamous NSCLC who have not received previous systemic treatment and MET-positive. The target population of this study is subjects with histologically confirmed locally advanced or metastatic non-squamous NSCLC who have not received previous systemic anti-tumor treatment and MET-positive( MET Amplification or Overexpression). This study adopts an enrichment design. The enriched population is those with MET GCN ≥ 6, and the overall population is those with MET GCN ≥ 4. This study consists of two parts: the lead-in period (Part 1) and the randomized controlled period (Part 2). Both the lead-in period (Part 1) and the randomized controlled period (Part 2) will include a screening period (from Day -28 to Day -1), a treatment period (until the termination of treatment), and a follow-up period (including safety follow-up and survival follow-up).

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether combining a targeted drug called vebreltinib with standard platinum-based chemotherapy works better for people with advanced non-small cell lung cancer (NSCLC) that has a specific change in the MET gene. MET alterations can drive cancer growth. **You may be eligible if...** - You are 18 years or older - You have locally advanced or metastatic non-squamous NSCLC - Your tumor has been tested and found to have a MET gene amplification or overexpression - You can provide a tumor tissue sample **You may NOT be eligible if...** - Your cancer is squamous cell type NSCLC - You have not had your tumor tested for MET status - You do not meet required organ function criteria - 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 platinum-based doublet chemotherapy.

Vebreltinib: Each cycle is 3 weeks (21 days). It is administered orally twice a day (BID), and the dosage level depends on the cohort assignment. Platinum-based doublet chemotherapy: Each cycle is 3 weeks (21 days), and it is administered once on the first day (D1) of each cycle. Pemetrexed at a dose of 500 mg/m² plus a platinum agent (carboplatin with an area under the curve (AUC) of 5 or cisplatin at a dose of 75 mg/m²) is given by intravenous infusion for 4 to 6 cycles as the initial treatment. After that, it is switched to pemetrexed (500 mg/m²) given by intravenous infusion as the maintenance treatment.

DRUGplatinum-based doublet chemotherapy.

Platinum-based doublet chemotherapy: Each cycle is 3 weeks (21 days), and it is administered once on the first day (D1) of each cycle. Pemetrexed at a dose of 500 mg/m² plus a platinum agent (carboplatin with an area under the curve (AUC) of 5 or cisplatin at a dose of 75 mg/m²) is given by intravenous infusion for 4 to 6 cycles as the initial treatment. After that, it is switched to pemetrexed (500 mg/m²) given by intravenous infusion as the maintenance treatment.

Locations(2)

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

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NCT06930794