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 | Not Yet Recruiting FDA Drug

• 1 other identifier: CA127-1085
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Non-Small Cell Lung Cancer

Keywords

Non-Small Cell Lung Cancer; NSCLC

Outcome Measures

Primary Outcomes (1)

• Number of participants experiencing adverse events

  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)

  Up to 12 months

Secondary Outcomes (1)

• Number of participants achieving objective tumor response according to RECIST version 1.1

  Up to 12 months

Study Arms (2)

ROS1-Positive NSCLC Cohort

Participants ≥19 years with histologically or cytologically confirmed locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC)

Drug: Repotrectinib

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

Drug: Repotrectinib

Interventions

Repotrectinib DRUG

As per product label

NTRK Gene Fusion Solid Tumor Cohort; ROS1-Positive NSCLC Cohort

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Korean participants with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) or solid tumors harboring Neurotrophic Tyrosine Receptor Kinase (NTRK) gene fusions who are prescribed repotrectinib in routine clinical practice.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

Bristol Myers Squibb Pharmaceutical Korea Ltd

Seoul, South Korea

Location

Related Links

• BMS Clinical Trial Information
• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

repotrectinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Central Study Contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

855-907-3286; Clinical.Trials@bms.com

First line of the email MUST contain NCT # and Site #.

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2026
• First Posted: May 20, 2026
• Study Start (Estimated): May 24, 2026
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): January 31, 2028
• Last Updated: May 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)