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)

Running, not enrolling · Phase 3

Conditions studied: Carcinoma, Non-Small-Cell Lung

In brief

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).

Key facts

Study ID

NCT06140836

Run by

Bristol-Myers Squibb

People needed

190

Starts

2023-12-21

Expected to finish

2027-03-15

Last updated by the study team

2025-11-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 it is running

• Local Institution - 0075 — Boston, Massachusetts, United States
• Local Institution - 0201 — Boston, Massachusetts, United States
• Local Institution - 0210 — Mineola, New York, United States
• Local Institution - 0134 — New York, New York, United States
• Local Institution - 0214 — Tacoma, Washington, United States
• Local Institution - 0092 — Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
• Instituto Alexander Fleming — Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
• Local Institution - 0091 — ABB, Buenos Aires F.D., Argentina
• Local Institution - 0106 — Buenos Aires, Argentina
• Local Institution - 0207 — Buenos Aires, Argentina
• Local Institution - 0093 — Córdoba, Argentina
• Local Institution - 0041 — Vienna, Austria
• Local Institution - 0073 — Belo Horizonte, Minas Gerais, Brazil
• Local Institution - 0033 — Porto Alegre, Rio Grande do Sul, Brazil
• Local Institution - 0034 — Porto Alegre, Rio Grande do Sul, Brazil
• Local Institution - 0029 — Barretos, São Paulo, Brazil
• Local Institution - 0037 — São José do Rio Preto, São Paulo, Brazil
• Local Institution - 0209 — São Paulo, São Paulo, Brazil
• Local Institution - 0147 — São Paulo, São Paulo, Brazil
• Local Institution - 0098 — Rio de Janeiro, Brazil
• Local Institution - 0108 — Rio de Janeiro, Brazil
• Local Institution - 0032 — São Paulo, Brazil
• Local Institution - 0114 — São Paulo, Brazil
• Local Institution - 0002 — Toronto, Ontario, Canada
• Local Institution - 0221 — Des Moines, Iowa, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.