Study of Capmatinib in Indian Patients With MET Exon 14 Skipping Mutation Positive Advanced NSCLC.

This was a Phase IV, prospective, multicenter, open-label, interventional study evaluating the safety and efficacy of capmatinib in Indian patients with metastatic non-small cell lung cancer (NSCLC) harboring a MET exon 14 skipping mutation, in any line of therapy. A total of 50 patients were included, with an overall study duration of approximately 2.5 years. The study consisted of a molecular pre-screening phase of up to 28 days for patients without documented MET exon 14 skipping mutation-positive status, followed by a screening period of up to 28 days, a treatment period of 24 weeks (6 months), an end-of-treatment (EOT) visit, and a follow-up period of 30 days after the last dose of study treatment. Molecular testing was performed centrally using a next-generation sequencing (NGS)-based platform on formalin-fixed, paraffin-embedded (FFPE) tumor samples. Patients with confirmed MET exon 14 skipping mutation, epidermal growth factor receptor (EGFR) wild-type status, and anaplastic lymphoma kinase (ALK)-negative status were eligible for enrollment. Patients negative for MET exon 14 skipping mutation or positive for other biomarkers were excluded and treated according to standard of care. All eligible participants received capmatinib as the investigational therapy. Capmatinib film-coated tablets (strengths of 150 mg and 200 mg) were administered orally at a starting dose of 400 mg twice daily (BID) on a continuous dosing schedule. Treatment was initiated only after prior anticancer therapy, if applicable, had been discontinued for at least 4 weeks or for a minimum of five times the drug half-life, whichever was longer. The treatment period began on Day 1 of Cycle 1, with each treatment cycle defined as 21 days. Cycle 2 began on Day 22 (Cycle 2 Day 22 \[C2D22\]), and subsequent cycles followed accordingly in the absence of temporary treatment discontinuation. Dose interruptions and dose reductions to 300 mg BID and subsequently 200 mg BID were permitted per protocol-defined criteria based on patient tolerability. Tablets were administered with or without food and were swallowed whole without chewing, crushing, or breaking. Treatment was planned for a duration of 24 weeks and continued until disease progression, unacceptable toxicity, withdrawal of consent, or death, or at the discretion of the investigator or the patient. Efficacy assessments were performed every 6 weeks (±7 days) from Cycle 1 Day 1 until disease progression, with radiological assessments conducted using consistent imaging modalities throughout the study. Safety assessments included monitoring of adverse events, laboratory parameters, electrocardiograms (ECGs), and concomitant medications, and patients maintained subject diaries to assess treatment compliance. Patients who discontinued treatment prematurely underwent end-of-study (EOS) assessments 30 days after administration of the last dose of study treatment. Patients who discontinued treatment without documented disease progression were followed for disease progression until EOS. Completion of the 30-day follow-up period marked EOS. Post-trial access (PTA) to capmatinib was provided by Novartis to patients who were ongoing on treatment at the end of the planned study duration and were deriving clinical benefit, to ensure uninterrupted therapy beyond the study period. Patients transitioning to PTA were also required to complete the EOS visit assessments after the last dose of capmatinib administered within the study.