NCT05703516Recruiting
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
Source: ClinicalTrials.gov · Last updated 1 Jun 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 44 (estimated)
- First submitted
- 19 Jan 2023
- Start date
- 12 Jun 2023
- Primary completion date
- 31 Oct 2026
- Lead sponsor
- Novartis Pharmaceuticals
- Diseases
- Lung cancer
- NCT number
- NCT05703516
What you commit to
- Study type: Observational
- Planned participants: 44
- From 12 Jun 2023 to the primary completion date, 31 Oct 2026
- 7 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to 100 years · Sex: All · Does not accept healthy volunteers
Sites (7)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | Busan | South Korea | Recruiting |
| - Coordinator of this site? Confirm its status | Daegu | South Korea | Recruiting |
| - Coordinator of this site? Confirm its status | Daejeon | South Korea | Recruiting |
| - Coordinator of this site? Confirm its status | Incheon | South Korea | Recruiting |
| - Coordinator of this site? Confirm its status | Jeollanam | South Korea | Recruiting |
| - Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| - Coordinator of this site? Confirm its status | Suwon | South Korea | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.