A Study 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)
The purpose of this study is to evaluate the efficacy and safety of repotrectinib and crizotinib in participants with locally advanced or metastatic TKI-naïve ROS1-positive non-small cell lung cancer (NSCLC).
Checked against the public recordLast updated Nov 21, 2025 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 3
- Sponsor
- Bristol-Myers Squibb
- Interventions being studied
- Drug: Repotrectinib; Drug: Crizotinib
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Local Institution - 0221Des Moines, Iowa
- Local Institution - 0075Boston, Massachusetts
- Local Institution - 0201Boston, Massachusetts
- Local Institution - 0210Mineola, New York
- Local Institution - 0134New York, New York
- Local Institution - 0214Tacoma, Washington
- Local Institution - 0092Ciudad Autónoma de Buenos Aires, Buenos Aires
- Instituto Alexander FlemingCiudad Autónoma de Buenos Aires, Buenos Aires
- Local Institution - 0091ABB, Buenos Aires F.D.
- Local Institution - 0106Buenos Aires
- Local Institution - 0207Buenos Aires
- Local Institution - 0093Córdoba
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Nov 21, 2025. Always confirm current availability with the study team.