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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

StatusRecruiting
PhasePhase 3
Started2025-04-03
View on ClinicalTrials.gov ↗

Amendment history

2025-04-06
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2025-02-15→confirmed 2025-04-03
Study sites0→1
2025-02-11
minor
Original filing
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).
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