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Not Yet Recruiting NCT05703516

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

Conditions: Non-Small-Cell Lung Carcinoma

Sex: All
Ages: 18 Years – N/A
Enrollment: 250
Sponsor: Novartis Pharmaceuticals

Summary

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).

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 labelExclusion Criteria:Subject with contraindication according to the locally approved labelSubject whose medical record is not accessibleSubject who are not willing to provide informed consent

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05703516). StuddyBuddy aggregates publicly available trial information.