NCT06829459

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 350 (estimated)
• Sponsor: Shanghai JMT-Bio Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Glumetinib	Patients will be administered glumetinib 300 mg/dose once daily once daily under fasting conditions in each 21-day treatment cycle.
DRUG	Osimertinib mesylate	Patients will be administered osimertinib mesylate 80 mg/dose once daily under fasting conditions in each 21-day treatment cycle.
DRUG	Pemetrexed	Patients will be administered pemetrexed 500 mg/m\^2 via intravenous infusion on the first day of each 3-week cycle.
DRUG	Cisplatin 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

Timeline

• Start date: 2025-04-03
• Primary completion: 2028-02-15
• Completion: 2029-02-15
• First posted: 2025-02-17
• Last updated: 2025-04-08

Locations

1 site across 1 country: China