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)

Study summary

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).

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedRepotrectinib and Crizotinib

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · ROS1 · Locally advanced

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Sep 22, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Active Not Recruiting

The study is underway but is not accepting new participants.

What kind of study?Phase 3

Interventional

Where is it offered?122 U.S. locations

Locations may change over time.

Who runs it?Bristol-Myers Squibb

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 3
Sponsor: Bristol-Myers Squibb
Interventions being studied: Drug: Repotrectinib; Drug: Crizotinib

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type

Non-small cell lung cancer (NSCLC)→

Disease setting

Locally advanced→Metastatic or stage IV→

Biomarkers

ROS1→

Treatment approach

Targeted therapy→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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

Reasons someone may not be able to joinExclusion 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/

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

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: Sep 22, 2026. Always confirm current availability with the study team.

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