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

Recruiting now

Conditions studied: Non-Small-Cell Lung Carcinoma

In brief

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).

Key facts

Study ID

NCT05703516

Run by

Novartis Pharmaceuticals

People needed

44

Starts

2023-06-12

Expected to finish

2026-10-31

Last updated by the study team

2026-06-01

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Signed informed consent must be obtained prior to participation in the study.
• Subject who are diagnosed as exon 14 skipping mutated NSCLC from tissue or plasma(ctDNA) sample analysis by treating physician (i.e. Any kind of diagnostic methods the institution currently has. Diagnostic modalities for research purpose would be also allowable.)
• Subject who plan to receive Tabrecta® (Capmatinib) as per locally approved label

You may not qualify if…

• Subject with contraindication according to the locally approved label
• Subject whose medical record is not accessible
• Subject who are not willing to provide informed consent

Where it is running

• Novartis Investigative Site — Daegu, Dalseo gu, South Korea (enrolling)
• Novartis Investigative Site — Suwon, Gyeonggi-do, South Korea (enrolling)
• Novartis Investigative Site — Incheon, Korea, South Korea (enrolling)
• Novartis Investigative Site — Seoul, Korea, South Korea (enrolling)
• Novartis Investigative Site — Seoul, Seoul, South Korea (enrolling)
• Novartis Investigative Site — Busan, South Korea (enrolling)
• Novartis Investigative Site — Daejeon, South Korea (enrolling)
• Novartis Investigative Site — Jeollanam, South Korea (enrolling)
• Novartis Investigative Site — Seoul, South Korea (enrolling)
• Novartis Investigative Site — Seoul, South Korea (enrolling)

Full record on ClinicalTrials.gov

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