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

Novartis Pharmaceuticals250 enrolled

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).

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.

Study Type

OBSERVATIONAL

Enrollment

250

Conditions

Non-Small-Cell Lung Carcinoma

Interventions

CapmatinibOTHER

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

Sex: ALLMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

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

Locations (12)

Novartis Investigative Site

Daegu, Dalseo Gu, South Korea

RECRUITING

Novartis Investigative Site

Suwon, Gyeonggi-do, South Korea

RECRUITING

Outcomes

Primary Outcomes

Number of participants with adverse events (AEs) and serious adverse events (SAEs).

The number of participants with AEs and SAEs will be assessed

Time frame: From date of first study dose to end of study, assessed up to approximately 28 weeks

Secondary Outcomes

Objective response rates (ORRs) assessed by investigator

ORR is defined as the percentage of subjects with evidence of a confirmed complete response (CR) or partial response (PR) as per Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1 and as assessed by the investigator.

Time frame: Up to 24 weeks

Progression Free Survival (PFS)

PFS defined as the time from first dose of study treatment until the first date of either objective disease progression or death due to any cause.

Time frame: Up to 24 weeks

Central Contacts

Novartis Pharmaceuticals

CONTACT

+41613241111 novartis.email@novartis.com

Novartis Pharmaceuticals

CONTACT

Data from ClinicalTrials.gov

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