Post Approval Study of Tabrecta (Capmatinib) in Non-Small-Cell Lung Carcinoma Open Label, Prospective, Multicenter Surveillance Evaluating Safety and Effectiveness in Real-World Practice

What this Trial Is About

This research investigates the safety and effectiveness of Tabrecta4 (Capmatinib) in a real-world setting for patients diagnosed with non-small-cell lung carcinoma (NSCLC) having an exon 14 skipping mutation. The study is an open-label, prospective, multicenter, non-comparative post-approval surveillance designed to meet regulatory requirements requested by the Korea Health Authority (MFDS) as part of the Risk Management Plan for Tabrecta4. Participants will receive Capmatinib prescribed by their physician following the locally approved label. Dosage and treatment duration will be determined by the treating physician based on routine clinical practice, without any intervention or drug supply from Novartis. The study does not include a comparator group or blinding. During the study, participants will be monitored for adverse events and serious adverse events from the first dose until the end of the study, which includes a follow-up period of up to 24 weeks after enrollment or until early discontinuation as judged by the physician. Data collection will continue until the last subject completes the follow-up. The study aims to gather safety data under real-world conditions without altering standard treatment management.

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