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
- Sponsor
- Bristol-Myers Squibb
- Study ID
- NCT07599007
- Status
- Not Yet Recruiting
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Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 12 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Repotrectinib — DRUGAs per product label
Study Details
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.
Key Dates
- First listed
- May 20, 2026
- Start date
- May 24, 2026
- Status verified
- Apr 2026
- Primary completion
- Dec 30, 2027
- Completion
- Jan 31, 2028
Study Design
- Enrollment
- 10 participants (estimated)
Arms
- Arm: ROS1-Positive NSCLC CohortParticipants ≥19 years with histologically or cytologically confirmed locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC)
- Arm: NTRK Gene Fusion Solid Tumor CohortParticipants ≥12 years with solid tumors harboring NTRK gene fusions that are locally advanced, metastatic, or likely to cause severe morbidity if surgically resected
Primary Outcome Measure
Number of participants experiencing adverse events [ Time Frame: Up to 12 months ]
Central Contacts
- BMS Clinical Trials Contact Center www.BMSClinicalTrials.com855-907-3286
- First line of the email MUST contain NCT # and Site #.
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