NCT05703516

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

A Post Approval Commitment Study on Tabrecta® (Capmatinib) in South Korea; Open Label, Prospective, Multicenter, Post Approval Surveillance

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 250 (estimated)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

This is an open label, prospective, multicenter, non-comparative study to assess the safety and effectiveness of Tabrecta® (Capmatinib) in real world setting. Also, this study is to fulfill the regulatory requirements as part of the RMP (Risk Management Plan) for Tabrecta® (Capmatinib), as requested by Korea Health Authority, MFDS (Ministry of Food and Drug Safety).

Detailed description

The study is a post approval surveillance so there will be no comparator arm/drug nor blinding process. Dose/regimen should follow locally approved label and it could be adjusted as per the decision from treating physician during treatment period, under their routine clinical practice. Treatment duration is deemed to the decision from treating physician under their routine clinical practice, since this study is a post approval surveillance and to look for safety profiles happening under real world practice. There will be no intervention from Novartis regarding dose/regimen and treatment duration. This study will be completed after data collection of the last subject during the follow up period. The follow up period is recommended for up to 24 weeks after enrollment or up to the time of discontinuation of study drug (in case of early discontinuation) as per linical judgement of treating physician.

Conditions

• Non-Small-Cell Lung Carcinoma

Interventions

Type	Name	Description
OTHER	Capmatinib	There is no treatment allocation. Capmatinib will be prescribed by the physician as per locally approved label. Treatment duration depends on the decision of treating physician. No drug will be dispensed from Novartis

Timeline

• Start date: 2023-06-12
• Primary completion: 2026-10-31
• Completion: 2026-10-31
• First posted: 2023-01-30
• Last updated: 2025-01-14

Locations

12 sites across 1 country: South Korea