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

RECRUITINGSponsored by Novartis Pharmaceuticals
Actively Recruiting
SponsorNovartis Pharmaceuticals
Started2023-06-12
Est. completion2026-10-31
Eligibility
Age18 Years – 100 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT05703516

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

Age: 18 Years – 100 YearsHealthy volunteers accepted
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

Conditions3

CancerLung CancerNon-Small Cell Lung Carcinoma

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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