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

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

Trial statusNot yet recruiting

Trial phasePhase 2, Phase 3

Trial typeInterventional

Biological sexAll

Age18-75

SponsorShanghai JMT-Bio Inc.

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

1. Able to understand and voluntarily sign the written informed consent form (ICF); 2. Male or female subjects aged 18 to 75 years (inclusive). 3. Patients with NSCLC who have unresectable locally advanced or metastatic disease; 4. At least one measurable lesion, as defined by RECIST 1.1 criteria; 5. ECOG performance status of 0 or 1; 6. Expected survival ≥ 3 months; 7. Adequate function of major organs and bone marrow; 8. Women or man of childbearing potential must use highly effective contraception.

Disqualifiers

Prior treatment with an EGFR inhibitor or MET inhibitor;

Patients with metastases to meninges; with spinal cord compression; symptomatic and unstable brain metastasis;

Patients who have taken strong inducers or inhibitors of CYP3A4 within 2 weeks prior to the first dose of the study drug, or who cannot discontinue the use of strong CYP3A4 inducers and inhibitors during the study;

Patients with a history of autoimmune diseases, a history of immunodeficiency, including positive for HIV, or other acquired or congenital immunodeficiency diseases, or a history of organ transplant;

Trial design

Design model

Parallel

Treatments tested in this trial

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

Treatment groups

390 Participants

are divided into 3 treatment groups

Group A: Glumetinib（200 mg） + OsimertinibExperimental treatment 2 interventions

Group B: Glumetinib（300mg） + OsimertinibExperimental treatment 2 interventions

Group C: OsimertinibExperimental treatment 2 interventions