A Post Approval Commitment Study on Tabrecta® (Capmatinib) in South Korea
NCT05703516 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 250
Last updated 2025-01-14
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).
Conditions
- Non-Small-Cell Lung Carcinoma
Interventions
- 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
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Novartis Pharmaceuticals · Novartis Pharmaceuticals
Eligibility
- Min Age
- 18 Years
- Max Age
- 100 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-06-12
- Primary Completion
- 2026-10-31
- Completion
- 2026-10-31
Countries
- South Korea
Study Locations
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