Clinical Trial

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

Recruiting Phase 3
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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).
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-02-11.
Status change: Not Yet Recruiting → Recruiting 2025-04-06
Trial Details
NCT Number NCT06829459
Lead Sponsor Shanghai JMT-Bio Inc.
Conditions Non-Small Cell Lung Cancer
Enrollment 350 participants
Start Date 2025-04-03
Primary Completion 2028-02-15 (estimated)
Study Completion 2029-02-15 (estimated)
Updated on ClinicalTrials.gov 2025-04-08