Repotrectinib Post-Marketing Surveillance in Korean Patients With ROS1-Positive Non-Small Cell Lung Cancer (NSCLC) or Solid Tumors Harboring a Neurotrophic Tyrosine Receptor Kinase (NTRK) Gene Fusion

NCT07599007 · tracked via the Priya Life Science South Korea tracker

Sponsor

Bristol-Myers Squibb

Phase

Observational

Started

2026-10-31

Last updated

2026-09-30

Condition(s) studied

Non-Small Cell Lung Cancer

Investigational drug(s) / intervention(s)

Repotrectinib →

Repotrectinib: As per product label

Study summary

This observational study evaluates the real-world safety and effectiveness of repotrectinib in Korean participants with locally advanced or metastatic ROS1-positive non-small cell lung cancer or solid tumors harboring neurotrophic tyrosine receptor kinase (NTRK) gene fusions. Participants receiving repotrectinib in routine clinical practice will be followed for up to 12 months or until the end of the 2-year surveillance period, whichever occurs first.

Eligibility

Sex

ALL

Min age

12 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Participants aged ≥19 years with histologically OR cytologically confirmed locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) * Participants aged ≥12 years with solid tumors harboring Neurotrophic Tyrosine Receptor Kinase (NTRK) gene fusions * Documented ROS1 or NTRK 1-3 gene fusion by validated local testing * Written informed consent Exclusion Criteria: * Treatment with repotrectinib for indications not approved in Korea * Treatment with repotrectinib at dosages not approved in Korea * Contraindication to repotrectinib according to MFDS prescribing information

Primary outcome measure(s)

Number of participants experiencing adverse events — Up to 12 months
Adverse events include: adverse drug reaction (ADR), serious adverse event (SAE), serious adverse drug reaction (SADR), unexpected adverse event (AE), unexpected ADR, unexpected SAE or SADR and adverse events of special interest (AESI)

Trial sites (1)

Facility	City	Region	Status
Bristol Myers Squibb Pharmaceutical Korea Ltd	Seoul	South Korea

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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 NCT07599007 on ClinicalTrials.gov ↗ ← All trials in South Korea