Advanced non-small cell lung cancer with MET14 skipping
Conditions
Interventions
Carboplatin, nab paclitaxel, and capmmatinib
Sponsors
Yamamoto Nobuyuki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Written consent has been obtained from the patient. 2) Patients are at least 18 years of age. 3) The patient is able to provide the necessary blood samples for this study. 4) Patients with histologically or cytologically confirmed non-small cell lung cancer. Mixed small cell carcinoma is ineligible. 5) MET exon 14 skipping has been detected by tumor tissue/cells or peripheral blood. 6) Patients with stage III and stage IV tumors who are not amenable to radical treatment (surgical resection or irradiation) or recurrence after surgery or radical radiotherapy. 7) Patients with measurable lesion by RECIST version 1.1. 8) No history of cytotoxic anticancer agents for advanced lung cancer. 9) At the time of enrollment, the following time periods have passed since the prior treatment or procedure was completed. Surgery: 4 weeks Thoracoscopic pleural biopsy, exploratory thoracoscopy, surgical exploratory chest opening, exploratory chest opening: 2 weeks Palliative radiotherapy: 2 weeks Stereotactic radiotherapy for metastases: 1 week Thoracic drainage: 2 weeks Pleurodesis and pericardial adhesion: 2 weeks Immune checkpoint inhibitors: 4 weeks Blood transfusion and hematopoietic factor administration: 1 week. 10) Patients with ECOG PS 0 or 1. 11) Patients without symptomatic brain metastases. 12) Patients without meningeal carcinomatosis. 13) No Grade 3 or higher superior vena cava syndrome, pericardial effusion, pleural effusion, or ascites. For pleural effusions, patients may be enrolled if they have no Grade 3 effusions at 2 weeks after cessation of drainage following intrapleural infusion of talc, antibacterial agents, or OK432. Patients with pericardial effusion or ascites may be enrolled if no Grade 3 effusion is seen 2 weeks after cessation of drainage. 14) Patients with no severe damage to major organs.
Exclusion criteria
Exclusion criteria: 1) Patients with active overlapping cancers 2) Patients with localized or systemically active infections requiring drainage or other surgical procedures. 3) Patients with hepatitis B surface antigen (HBsAg) positive or hepatitis C virus antibody positive; if HBsAg negative or HBs antibody positive, patients may be enrolled if their HBV viral load is less than sensitive or if antiviral drugs are started before registration even if HBV viral load is detected. 4) Interstitial lung disease evident on CT. 5) Patients other than those with endocrine or autoimmune diseases who require continuous systemic administration (oral or intravenous) of steroids at doses higher than 10 mg/day prednisolone equivalent, and patients on immunosuppressive drugs. 6) Significant cardiovascular disease, including New York Heart Association Class II or higher heart disease, myocardial infarction within 6 months prior to enrollment, unstable arrhythmia or unstable angina. 7) Significant gastrointestinal disorders that cause significant malabsorption, require intravenous nutritional supplementation, or cause difficulty taking oral medications. 8) Patients with known genetic abnormalities (e.g., EGFR, ALK, etc.) other than MET exon 14 skipping that are eligible for approved molecular targeted agents. 9) Patients previously treated with capmatinib or other MET inhibitors. 10) Currently receiving treatment with another investigational drug or device or have completed treatment with another investigational drug or device within 4 weeks prior to enrollment. 11) Patients with hypersensitivity to any component or additive of carboplatin, nab-paclitaxel and capmatinib. 12) Pregnant women, lactating women, women who may be currently pregnant, or patients who are unwilling to use contraception. 13) Patients with clinically problematic psychiatric disorders that would preclude enrollment in this study. 14) Other patients who were considered as ineligible by the principal investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall response rate, duration of response, time to response, disease control rate, time to treatment failure, PFS2, overall survival, and safety. | — |
Contacts
Public ContactTakeda Koji
West Japan Oncology Group
Outcome results
None listed