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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age12+
SponsorBristol-Myers Squibb

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Repotrectinib

    Drug

    As per product label

Treatment groups

10 Participants
are divided into 2 treatment groups
Group A: ROS1-Positive NSCLC Cohort1 intervention
Group B: NTRK Gene Fusion Solid Tumor Cohort1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: