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Comparing repotrectinib and crizotinib for treating advanced ROS1-positive lung cancer

Randomized, Open-label, Multicenter, Phase 3 Trial of Repotrectinib Versus Crizotinib in Participants With Locally Advanced or Metastatic Tyrosine Kinase Inhibitor (TKI)-naïve ROS1-positive Non-Small Cell Lung Cancer (NSCLC) (TRIDENT-3)

Phase 3 Interventional Bristol-Myers Squibb · NCT06140836

This study tests which medication, repotrectinib or crizotinib, works better for people with advanced ROS1-positive lung cancer who haven't had treatment with certain targeted therapies before.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment190 (estimated)
Ages18 Years and up
SexAll
SponsorBristol-Myers Squibb Industry-sponsored
Drugs / interventionsrepotrectinib, crizotinib
Locations144 sites (Augusta, Georgia and 143 other locations)
Trial IDNCT06140836 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness and safety of two medications, repotrectinib and crizotinib, in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have not previously received tyrosine kinase inhibitors (TKIs). Participants must have a confirmed ROS1 gene rearrangement and at least one measurable lesion. The study aims to determine which treatment provides better outcomes for these patients.

Who should consider this trial

Good fit: Ideal candidates are adults with locally advanced or metastatic ROS1-positive NSCLC who have not been treated with TKIs.

Not a fit: Patients with symptomatic brain metastases or those with known tumor targetable co-mutations may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective treatment option for patients with ROS1-positive NSCLC.

How similar studies have performed: Previous studies have shown promising results with similar approaches in treating ROS1-positive NSCLC, indicating potential for success.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Participant has histologically or cytologically confirmed diagnosis of locally advanced or metastatic NSCLC
* Participant has a ROS1 gene rearrangement/fusion as detected by a local test.
* At least 1 measurable lesion according to RECIST v1.1, as assessed by the investigator.
* Participants must not be exposed previously with TKIs that demonstrated activities in ROS1-positive NSCLC
* Up to 1 prior line of systemic treatment for NSCLC is permitted
* ECOG Performance Status ≤ 2

Exclusion Criteria:

* Symptomatic brain metastases or symptomatic leptomeningeal involvement.
* History of previous cancer requiring therapy within the previous 2 years, except for NSCLC under study, squamous cell or basal-cell carcinoma of the skin, or any in situ carcinoma that has been completely resected.
* Known tumor targetable co-mutations or rearrangements
* Clinically significant cardiovascular disease (either active or within 6 months prior to enrollment)

Note: Other protocol-defined inclusion/exclusion criteria apply

Where this trial is running

Augusta, Georgia and 143 other locations

+94 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Carcinoma, Non-Small-Cell LungTKI-naïveROS1NSCLCROS1-positive non-small cell lung cancer
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.