Randomized Phase 3 Trial Comparing Oral Tepotinib to Standard Treatments in Adults with Advanced MET Exon 14 Mutated Non-Small Cell Lung Cancer After Prior Therapy

What this Trial Is About

This trial investigates the effectiveness of tepotinib compared to standard treatments in patients with advanced non-small cell lung cancer NSCLC who have a specific MET exon 14 mutation and have progressed after at least one prior treatment. The study addresses the lack of comparative data for new-generation MET tyrosine kinase inhibitors TKIs in this patient group and aims to generate evidence to support reimbursement and access to tepotinib in France. Tepotinib is seen as a promising oral treatment option for typically elderly and frail patients with limited therapeutic choices. Participants will be randomly assigned to receive either tepotinib orally once daily at 500 mg or an investigator-chosen standard treatment, which may include various chemotherapy drugs, anti-PDL1 agents, or best supportive care for certain patients. Treatments in the control group cannot have been previously received by the patient. This study includes crossover to tepotinib for patients in the control arm who experience disease progression. The trial duration for primary outcome assessment is about 36 months. Throughout the study, patients will undergo regular assessments including scans and laboratory tests to monitor disease progression and treatment safety. Quality of life, objective response rate, duration of response, and treatment adherence are among the measured outcomes. Safety and tolerability of treatments will also be evaluated. This trial is expected to last until mid-2028, with close monitoring to ensure patient well-being and gather comprehensive data on treatment effects.

Tepotinib vs Standard Treatment in Patients With Advanced MET Exon 14 Mutated Non-Small Cell Lung Cancer Previously Treated