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

AUGTYRO™ (Repotrectinib) Post-Marketing Surveillance in Korean Patients With Locally Advanced or Metastatic Ros1-Positive NSCLC or Solid Tumors Harboring a NTRK Gene Fusion

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07599007

Enrollment

Registered

2026-05-20

Start date

2026-05-24

Completion date

2028-01-31

Last updated

2026-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-Small Cell Lung Cancer

Keywords

Non-Small Cell Lung Cancer, NSCLC

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.

Interventions

DRUGRepotrectinib

As per product label

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

12 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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)

Secondary

Measure	Time frame
Number of participants achieving objective tumor response according to RECIST version 1.1	Up to 12 months

Countries

South Korea

Contacts

CONTACTBMS Clinical Trials Contact Center www.BMSClinicalTrials.com

Clinical.Trials@bms.com855-907-3286

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

STUDY_DIRECTORBristol-Myers Squibb

Bristol-Myers Squibb

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 21, 2026