Non-small cell lung cancer
Conditions
Interventions
Arm A: MET tyrosine kinase inhibitors
Tepotinib or capmatinib (Physician's choice)
Arm B: Immune checkpoint inhibitors with or without platinum-based chemotherapy
- If PD-L1 TPS >= 50%: Pembrolizuma
Sponsors
GOTO Yasushi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Cytologically or histologically confirmed non-small cell lung cancer. (2) Fulfillment of at least one of the following criteria (i)-(iii): (i) Previously untreated clinical stage III disease without an indication for definitive thoracic radiotherapy or stage IV disease. (ii) Postoperative recurrent disease without prior systemic therapy or with perioperative therapy completed at least 168 days before enrollment (adjuvant UFT was permitted regardless of the interval) (iii)Recurrent disease after definitive radiotherapy completed at least 168 days before enrollment. (3) Presence of MET exon 14 skipping mutation. (4) Absence of known driver gene mutations other than MET exon 14 skipping. (5) Age 18 years or older. (6) Eastern Cooperative Group performance status of 0 or 1. (7) No requirement for measurable lesions. (8) No prior treatment with immune checkpoint inhibitors or MET tyrosine kinase inhibitors, including MET-targeted antibodies. (9) Eligibility regardless of PD-L1 expression status. (10) Completion of the protocol-specified washout period following supportive care, such as palliative radiotherapy, whole-brain radiotherapy, or drainage, before enrollment. (11) No symptomatic central nervous system metastases at enrollment. (12) No evidence of interstitial lung disease on chest computed tomography. (13) No active or documented history of autoimmune or inflammatory disorders. (14) Ability to take oral medication. (15) Adequate organ and bone marrow function. (16) Provision of written informed consent.
Exclusion criteria
Exclusion criteria: (1) Synchronous or metachronous malignancy within the previous 2 years, except for intramucosal tumors curatively treated with local therapy. (2) Active infectious disease requiring systemic treatment. (3) Body temperature of 38 degrees Celsius or higher at enrollment. (4) Pregnant or lactating females, females within 28 days postpartum, or males planning conception with their partner. (5) Psychiatric disorders or symptoms that interfere with daily life and preclude participation in the study. (6) Receiving continuous systemic administration (oral or intravenous) of steroids at a dose exceeding 10 mg/day of prednisone equivalent or other immunosuppressive drugs. (7) Uncontrolled diabetes mellitus. (8) History of unstable angina or myocardial infarction within the past 6 months. (9) Uncontrolled valvular heart disease, dilated cardiomyopathy, or hypertrophic cardiomyopathy. (10) Presence of clinically significant arrhythmia on electrocardiography. (11) Positive serology for hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency virus antibody. (12) Known allergy or hypersensitivity to any of the study drugs or their excipients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival, duration of response, objective response rate, adverse events, serious adverse events, the incidence of grade >=3 non-hematologic adverse events, the incidence of grade >= 2 non-hematologic adverse events, quality of life score (EORTC QLQ-C30), post-crossover progression-free survival, post-crossover adverse events. | — |
Contacts
Public ContactEriko SATOMI
National Cancer Center Hospital
Outcome results
None listed