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Clinical Trials in South Korea / NCT05703516
Recruiting Observational

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

NCT05703516 · tracked via the Priya Life Science South Korea tracker
Sponsor
Novartis Pharmaceuticals
Phase
Observational
Started
2023-06-12
Last updated
2026-06-01

Condition(s) studied

Non-Small-Cell Lung Carcinoma

Investigational drug(s) / intervention(s)

Capmatinib

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

Study 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

Sex
ALL
Min age
18 Years
Max age
100 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Number of participants with adverse events (AEs) and serious adverse events (SAEs). — From date of first study dose to end of study, assessed up to approximately 28 weeks
    The number of participants with AEs and SAEs will be assessed

Trial sites (10)

FacilityCityRegionStatus
Novartis Investigative Site Daegu Dalseo gu Recruiting
Novartis Investigative Site Suwon Gyeonggi-do Recruiting
Novartis Investigative Site Incheon Korea Recruiting
Novartis Investigative Site Seoul Korea Recruiting
Novartis Investigative Site Seoul Seoul Recruiting
Novartis Investigative Site Busan South Korea Recruiting
Novartis Investigative Site Daejeon South Korea Recruiting
Novartis Investigative Site Jeollanam South Korea Recruiting
Novartis Investigative Site Seoul South Korea Recruiting
Novartis Investigative Site Seoul South Korea Recruiting

More Novartis Pharmaceuticals trials in South Korea

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A Phase I/II, Dose Finding and Optimization Study of [177Lu]Lu-NeoB in Combination With Capecitabine in Patients With GRPR+, ER+, HER2- Metastatic Breast Cancer After Progression on Previous Endocrine Therapy in Combination With a CDK4/6 Inhibitor. Active, not recruiting
An International Prospective Open-label, Randomized, Phase III Study Comparing 177Lu-PSMA-617 in Combination With Standard of Care (SoC), Versus SoC Alone, in Adult Male Patients With Metastatic Hormone Sensitive Prostate Cancer (mHSPC) Active, not recruiting
A Clinical Trial to Learn About the Effects of VHB937 in People With Amyotrophic Lateral Sclerosis (ALS) Active, not recruiting
Study of JDQ443 in Comparison With Docetaxel in Participants With Locally Advanced or Metastatic KRAS G12C Mutant Non-small Cell Lung Cancer Active, not recruiting

Other trials for the same condition

A Study of AZD2936 Anti-TIGIT/Anti-PD-1 Bispecific Antibody in Participants With Advanced or Metastatic NSCLC Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05703516 on ClinicalTrials.gov ↗ ← All trials in South Korea