NCT06908772

Glumetinib Combined With Osimertinib Treatment for Non-Small Cell Lung Cancer Patients

A Multicenter Phase II/III Clinical Study on the Efficacy and Safety of Glumetinib Combined With Osimertinib as First-Line Treatment in Non-Small Cell Lung Cancer Patients With Classical EGFR Mutations Accompanied by MET Amplification or Overexpression

• Status: Not Yet Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 390 (estimated)
• Sponsor: Shanghai JMT-Bio Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the efficacy and safety of glumetinib combined with osimertinib as the first-line treatment for locally advanced or metastatic NSCLC.

Detailed description

In the Phase II stage, eligible subjects who have passed screening will be randomly assigned in a 1:1:1 ratio into the Group 1, Group 2, and Group 3 to receive study treatment: In the Phase III stage, eligible subjects who have passed screening will be randomly assigned in a 1:1 ratio into the test group and the control group to receive the study treatments, and the RP3D obtained from Phase II will be used as the dose of glumetinib for the test group. Randomization stratification factors include: c-MET status (≥2+, ≥75% and 3+, \<50% vs 3+, ≥50% or FISH positive), and EGFR-sensitive mutation type (19Del vs L858R). In both the Phase II and Phase III stages, each treatment cycle is every 3 weeks, with continuous treatment until progressive disease (PD) confirmed by the investigator, intolerable toxicity, withdrawal of informed consent by the subject, loss to follow-up, death, or other criteria for terminating treatment as specified in the protocol, whichever occurs first.

Conditions

• Recurrent or Metastatic NSCLC Patients With Classical EGFR Mutations Accompanied by MET Amplification or Overexpression

Interventions

Type	Name	Description
DRUG	Glumetinib Tablets	An ATP competitive, highly selective MET receptor tyrosine kinase inhibitor
DRUG	Osimertinib Mesylate Tablets	3rd EGFR-TKI
DRUG	Glumetinib Tablets Placebo	Placebo

Timeline

• Start date: 2025-04-01
• Primary completion: 2028-12-31
• Completion: 2030-01-31
• First posted: 2025-04-03
• Last updated: 2025-04-03