A Post Approval Commitment Study on Tabrecta® (Capmatinib) in South Korea
Recruiting · NCT05703516 · Observational (researchers observe without assigning treatment)
View the official record on ClinicalTrials.gov →Interventions studied
Capmatinib
What this trial is about
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).
Who can take part
Age range
18 Years to 100 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- 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
Exclusion criteria
- 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
10 locations listed.
- Novartis Investigative Site - Busan, South Korea
- Novartis Investigative Site - Daejeon, South Korea
- Novartis Investigative Site - Jeollanam, South Korea
- Novartis Investigative Site - Seoul, South Korea
- Novartis Investigative Site - Seoul, South Korea
- Novartis Investigative Site - Daegu, Dalseo gu, South Korea
- Novartis Investigative Site - Suwon, Gyeonggi-do, South Korea
- Novartis Investigative Site - Incheon, Korea, South Korea
- Novartis Investigative Site - Seoul, Korea, South Korea
- Novartis Investigative Site - Seoul, Seoul, South Korea