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Not yet recruitingNCT07599007Updated Sep 30, 2026

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

An observational study in Non-Small Cell Lung Cancer, sponsored by Bristol-Myers Squibb. Not yet recruiting at 1 site in South Korea. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2026-09-30.

Sponsored by Bristol-Myers Squibb · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
10
Ages
12 Years and older
Sex
All
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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.

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Conditions studied

  • Non-Small Cell Lung Cancer

Keywords

  • Non-Small Cell Lung Cancer
  • NSCLC
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Who can participate

Ages eligible
12 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

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

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
10 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • DrugRepotrectinib

    As per product label

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What researchers measure

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)

    Time frame: Up to 12 months

Secondary outcomes

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

    Time frame: Up to 12 months

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Study locations

1 site
  • Bristol Myers Squibb Pharmaceutical Korea Ltd
    Seoul, South Korea
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References and documents

Individual participant data

Plan to share: No

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Registry details

Key details

Study ID
NCT07599007
Lead sponsor
Bristol-Myers Squibb
Responsible party
Sponsor
First posted
May 20, 2026
Start date
Oct 31, 2026 (estimated)
Primary completion
Dec 30, 2027 (estimated)
Completion
Jan 31, 2028 (estimated)
Last update
Sep 30, 2026

Study contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
Contact
Clinical.Trials@bms.com
855-907-3286
First line of the email MUST contain NCT # and Site #.
Contact
Bristol-Myers Squibb
study director · Bristol-Myers Squibb

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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