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

Launched by SHANGHAI JMT-BIO INC. · Mar 27, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for patients with a type of lung cancer called non-small cell lung cancer (NSCLC) who have specific genetic changes known as EGFR mutations along with MET amplification or overexpression. The aim is to see how well a combination of two drugs, glumetinib and osimertinib, works as a first-line treatment for patients whose cancer has spread or cannot be surgically removed. The trial is currently not recruiting participants, but it will eventually look for patients aged 18 to 75 who can understand the study and its requirements.

To be eligible for this trial, potential participants should have advanced NSCLC that has not been treated with certain previous medications, and they must have at least one measurable tumor. They should also be in fairly good health, with the ability to perform daily activities. Participants can expect close monitoring during the trial to ensure their safety while receiving the new treatment. It's important to note that certain health conditions, like severe heart issues or recent infections, may exclude someone from joining the study. If you or a loved one is interested, discussing this option with a healthcare provider would be a great next step.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 1. Prior treatment with an EGFR inhibitor or MET inhibitor;
• • 2. Patients with metastases to meninges; with spinal cord compression; symptomatic and unstable brain metastasis;
• • 3. 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;
• • 4. 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;
• • 5. Presence of active infection (e.g., subjects are receiving anti-infection therapy);
• • 6. Severe or uncontrolled cardiovascular disorder requiring treatment;
• • 7. Refractory nausea, vomiting, chronic gastrointestinal disease, inability to swallow drugs orally;
• • 8. Women who are pregnant or breastfeeding;