A Post Approval Commitment Study on Tabrecta® (Capmatinib) in South Korea
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Capmatinib.
- Who it may be relevant to
- Registry conditions: Non-Small-Cell Lung Carcinoma. Basic parameters: 18 years — 100 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Post Approval Commitment Study on Tabrecta® (Capmatinib) in South Korea; Open Label, Prospective, Multicenter, Post Approval Surveillance
Overview
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.
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
Primary outcome measures
- Number of participants with adverse events (AEs) and serious adverse events (SAEs). [Time frame: From date of first study dose to end of study, assessed up to approximately 28 weeks]
Secondary outcome measures (2)
- Objective response rates (ORRs) assessed by investigator [Time frame: Up to 24 weeks]
- Progression Free Survival (PFS) [Time frame: Up to 24 weeks]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
South Korea · 10 centers
- Novartis Investigative Site — Daegu
- Novartis Investigative Site — Suwon
- Novartis Investigative Site — Incheon
- Novartis Investigative Site — Seoul
- Novartis Investigative Site — Seoul
- Novartis Investigative Site — Busan
- Novartis Investigative Site — Daejeon
- Novartis Investigative Site — Jeollanam
- … and 2 more centers
Identifiers
NCT: NCT05703516 · CINC280AKR01