Status:
NOT_YET_RECRUITING
Glumetinib Combined With Osimertinib Treatment for Non-Small Cell Lung Cancer Patients
Lead Sponsor:
Shanghai JMT-Bio Inc.
Conditions:
Recurrent or Metastatic NSCLC Patients With Classical EGFR Mutations Accompanied by MET Amplification or Overexpression
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
PHASE3
Brief 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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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;
- Presence of active infection (e.g., subjects are receiving anti-infection therapy);
- Severe or uncontrolled cardiovascular disorder requiring treatment;
- Refractory nausea, vomiting, chronic gastrointestinal disease, inability to swallow drugs orally;
- Women who are pregnant or breastfeeding;
Key Trial Info
Start Date :
April 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2030
Estimated Enrollment :
390 Patients enrolled
Trial Details
Trial ID
NCT06908772
Start Date
April 1 2025
End Date
January 31 2030
Last Update
April 3 2025
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