Last Update: Jan 24, 2024
A Post Approval Commitment Study on Tabrecta® (Capmatinib) in South Korea; Open Label, Prospective, Multicenter, Post Approval Surveillance
ClinicalTrials.gov Identifier:
Novartis Reference Number:CINC280AKR01
All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Study Description

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). 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.

Non-Small-Cell Lung Carcinoma
Recruiting
250
Jun 12, 2023
Oct 31, 2024
All
18 Years - (Adult, Older Adult)

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

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

Worldwide Contacts

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Novartis Pharmaceuticals