Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Repotrectinib | Drug | Repotrectinib | ALIAS |
Design
Arms and outcomes
Arms (2)
- label
- ROS1-Positive NSCLC Cohort
- description
- Participants ≥19 years with histologically or cytologically confirmed locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC)
- interventionNames
- Drug: Repotrectinib
- label
- NTRK Gene Fusion Solid Tumor Cohort
- description
- Participants ≥12 years with solid tumors harboring NTRK gene fusions that are locally advanced, metastatic, or likely to cause severe morbidity if surgically resected
- interventionNames
- Drug: Repotrectinib
Primary outcomes (1)
- measure
- Number of participants experiencing adverse events
- timeFrame
- Up to 12 months
- description
- 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)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 12 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available