Non small cell lung cancer with MET overexpression non small cell lung cancer, MET
Conditions
Interventions
Glumetinib will be administered orally once daily continuously in a 3-week (21-day) treatment cycle.
Docetaxel will be administered by intravenous drip at a recommended dose of 75 mg/m2 over 1 hour on
Sponsors
Sunagawa Yoshihiro
Eligibility
Inclusion criteria
Inclusion criteria: Locally advanced or metastatic non-small cell lung cancer (NSCLC) with driver gene negative defined as no known EGFR mutations, ALK fusions, ROS1 fusions, METex14 skipping mutations, BRF, NTRK, RET, KRAS, ERBB2 (HER2) mutations that show sensitivity to target therapy and MET overexpression defined as IHC 3+
Exclusion criteria
Exclusion criteria: 1. Prior treatment with MET inhibitor. 2. Docetaxel was included in the prior treatment regimen. 5. Patients with active leptomeningeal disease or uncontrolled, untreated brain metastasis. 7. Having central squamous cell lung cancer with cavitation or hemoptysis (> 50 mL/day). 8. Patients with a history of gastrointestinal disease or surgery, gastrointestinal disorders, or other diseases that may affect the absorption of the study drug (e.g., inability to swallow medication, severe ulcers, uncontrolled nausea, vomiting and diarrhea, malabsorption syndrome, colitis ulcerative, extensive resection of the stomach and small bowel) within 6 months prior to randomization. 9. Receiving major surgery or having significant traumatic injury within 28 days prior to randomization or having not recovered from major side effects. 10. Having interstitial lung disease (ILD) or drug-induced interstitial pneumonia, noninfectious pneumonitis, including radiation pneumonitis, pulmonary fibrosis, or acute lung disease requiring steroid treatment. 11. Patients with clinically significant pericardial effusion 13. Presence of >= Grade 2 edema and lymphoid tissue edema that cannot be resolved with clinical intervention. 14. Any active malignancy == NYHA Class III within 6 months prior to the first dose; - Left ventricular ejection fraction (LVEF) 460 ms (corrected by Fridricias formula) - Presence of congenital long QT syndrome, a history of Torsades de Pointe or a family history of unexplained sudden death; - Uncontrolled hypertension (defined as systolic blood pressure >= 140 mmHg and/or diastolic blood pressure >= 90 mmHg after standard antihypertensive treatment). 20. Known history of human immunodeficiency virus (HIV) infection or known history of acquired immunodeficiency syndrome (AIDS); 21. Active hepatitis B and hepatitis C. Patients will be excluded if they meet any of the following criteria: a) Serum HBsAg positive and HBV DNA > 200 IU/mL or > 1000 copies/mL; b) Serum HBsAg negative, or if HBcAb results are positive with HBV DNA > 200 IU/mL or 1000 copies/mL; c) Serum HCV antibody and HCV RNA positive.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation on comparing the OS of glumetinib with docetaxel. | — |
Secondary
| Measure | Time frame |
|---|---|
| Key secondary objective: Evaluation on comparing the PFS ofglumetinib with docetaxel. Secondary objectives: To evaluate other efficacy variables of glumetinib and docetaxel. To evaluate the safety and tolerability of glumetinib and docetaxel. To evaluate the effect of glumetinib and docetaxel on patients' quality of life (QoL). | — |
Countries
China, Japan, US
Contacts
Public ContactYoshihiro Sunagawa
Haihe Biopharma K. K.
Outcome results
None listed