About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial 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.
Trial design
Cohort
Prospective
Treatments tested in this trial
Repotrectinib
DrugAs per product label
Treatment groups
Trial outcomes
Primary outcomes
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)
Secondary outcomes
Number of participants achieving objective tumor response according to RECIST version 1.1
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: