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

Sponsor
Shanghai JMT-Bio Inc.
Study ID
NCT06908772
Phase
PHASE2/PHASE3
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • 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

Study Details

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

Key Dates

Start date
Apr 1, 2025
Status verified
Mar 2025
Primary completion
Dec 31, 2028
Completion
Jan 31, 2030

Study Design

Enrollment
390 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Glumetinib（200 mg） + Osimertinib
    Group 1: Glumetinib 200 mg oral QD + Osimertinib 80 mg oral QD.
  • Experimental: Glumetinib（300mg） + Osimertinib
    Group 2: Glumetinib 300 mg oral QD + Osimertinib 80 mg oral QD;
  • Experimental: Osimertinib
    Group 3: Osimertinib 80 mg oral QD.

Primary Outcome Measure

Phase 2：ORR as assessed by IRC [ Time Frame: Up to approximately 30 months after the first participant is enrolled ]

Central Contacts