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

Novartis

Status: Enrolling

Conditions: Non-Small-Cell Lung Carcinoma

Treatments: Other: Capmatinib

Study type: Observational

Funder types: Industry

Identifiers

NCT05703516

CINC280AKR01

Details and patient eligibility

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).

Full 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.

Enrollment: 250 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

250 participants in 1 patient group

Capmatinib

Description:

Participants will be treated with capmatinib as per locally approved label

Treatment:

Other: Capmatinib