Post Approval Safety and Effectiveness Study of Tabrecta Capmatinib for Non-Small-Cell Lung Cancer in South Korea Open Label, Prospective, Multicenter Post Approval Surveillance

What this Trial Is About

This research aims to evaluate the safety and effectiveness of Tabrecta4 Capmatinib in patients with non-small-cell lung carcinoma NSCLC who have an exon 14 skipping mutation. The study is observational and open-label, conducted across multiple centers in South Korea to fulfill regulatory requirements set by the Ministry of Food and Drug Safety. It focuses on real-world use of the medication without comparison to other treatments or placebo. Participants will receive Capmatinib prescribed by their treating physician according to the locally approved label. The dose and treatment duration will be determined by the physician under routine clinical practice, with no intervention from the study sponsor regarding these decisions. This post-approval surveillance study does not involve blinding or comparator arms. During the study, participants will be monitored for adverse and serious adverse events from the first dose until up to 28 weeks. Follow-up is recommended for up to 24 weeks or until treatment discontinuation based on clinical judgment. Researchers will assess objective response rates and progression-free survival within 24 weeks. Data collection will continue until the last participant completes the follow-up period.

A Post Approval Commitment Study on Tabrecta® (Capmatinib) in South Korea