NCT06908772Not yet recruitingPhase 2/3
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
Source: ClinicalTrials.gov · Last updated 3 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
To evaluate the efficacy and safety of glumetinib combined with osimertinib as the first-line treatment for locally advanced or metastatic NSCLC.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 390 (estimated)
- First submitted
- 27 Mar 2025
- Start date
- 1 Apr 2025
- Primary completion date
- 31 Dec 2028
- Lead sponsor
- Shanghai JMT-Bio Inc.
- Diseases
- Lung cancer
- NCT number
- NCT06908772
What you commit to
- Study type: Interventional · Phase 2/3
- Planned participants: 390
- From 1 Apr 2025 to the primary completion date, 31 Dec 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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;
- Presence of active infection (e.g., subjects are receiving anti-infection therapy);
Other illness
- 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;
- Severe or uncontrolled cardiovascular disorder requiring treatment;
- Refractory nausea, vomiting, chronic gastrointestinal disease, inability to swallow drugs orally;
Lab values
- Prior treatment with an EGFR inhibitor or MET inhibitor;
Other
- Patients with metastases to meninges; with spinal cord compression; symptomatic and unstable brain metastasis;
- Women who are pregnant or breastfeeding;
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.