RecruitingPhase 3NCT06829459

A Study to Evaluate the Efficacy and Safety of Glumetinib Combined With Osimertinib Mesylate Versus Platinum-based Doublet Chemotherapy in Non-Small Cell Lung Cancer Patients After Resistance to EGFR-TKIs

A Randomized, Controlled, Open-label Phase III Clinical Study to Evaluate the Efficacy and Safety of Glumetinib Combined With Osimertinib Mesylate Versus Platinum-based Doublet Chemotherapy in Non-Small Cell Lung Cancer Patients With MET Amplification and/or Overexpression After Resistance to EGFR-TKIs

Sponsor

Shanghai JMT-Bio Inc.

Enrollment

350 participants

Start Date

Apr 3, 2025

Study Type

INTERVENTIONAL

Summary

The is a randomized, controlled, open-label Phase III clinical study to evaluate the efficacy and safety of glumetinib combined with osimertinib mesylate versus platinum-based doublet chemotherapy in non-small cell lung cancer( NSCLC) patients with MET amplification and/or overexpression after resistance to EGFR-TKIs.. Approximately 350 NSCLC patients with MET amplification and/or overexpression after previous treatment with EGFR-TKIs are planned to be enrolled. After patients sign the informed consent form (ICF), those who are eligible for enrollment after screening examinations will be randomized to the investigational group or the control group in a 1:1 ratio by the central randomization system (IWRS).

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two treatments for people with advanced non-small cell lung cancer (NSCLC) that has stopped responding to a class of targeted drugs called EGFR inhibitors (TKIs). One option is a combination of two targeted drugs (glumetinib plus osimertinib), and the other is standard platinum-based chemotherapy. **You may be eligible if...** - You are 18 years or older - You have advanced or metastatic NSCLC confirmed by biopsy - Your tumor was previously treated with EGFR-targeting drugs (TKIs) and is no longer responding - You are in reasonably good health (adequate organ function and performance status) - You have not received prior treatment with the specific drug combinations being studied **You may NOT be eligible if...** - Your cancer contains small cell or neuroendocrine components - You have active brain metastases that are symptomatic and untreated - You have significant liver, kidney, or blood problems - You are pregnant or breastfeeding - You have previously received one of the study drugs 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

DRUGGlumetinib

Patients will be administered glumetinib 300 mg/dose once daily once daily under fasting conditions in each 21-day treatment cycle.

DRUGOsimertinib mesylate

Patients will be administered osimertinib mesylate 80 mg/dose once daily under fasting conditions in each 21-day treatment cycle.

DRUGPemetrexed

Patients will be administered pemetrexed 500 mg/m\^2 via intravenous infusion on the first day of each 3-week cycle.

DRUGCisplatin or carboplatin

Patients will be administered cisplatin 75 mg/m\^2 or carboplatin AUC=5 via intravenous infusion on the first day of each 3-week cycle

Locations(1)

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

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NCT06829459