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

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 Cohort
    Participants ≥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 Cohort
    Participants ≥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.com
    855-907-3286
  • First line of the email MUST contain NCT # and Site #.

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