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)

NCT06140836 · tracked via the Priya Life Science Turkey tracker

Sponsor

Bristol-Myers Squibb

Phase

Phase 3

Started

2023-12-21

Last updated

2025-11-21

Condition(s) studied

Carcinoma, Non-Small-Cell Lung

Investigational drug(s) / intervention(s)

Repotrectinib →Crizotinib →

Repotrectinib: Specified dose on specified days

Crizotinib: Specified dose on specified days

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).

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Progression-free Survival (PFS) as per Blinded Independent Central Review (BICR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 — Up to approximately 41 months

Trial sites (122)

Facility	City	Region
Local Institution - 0221	Des Moines	Iowa
Local Institution - 0075	Boston	Massachusetts
Local Institution - 0201	Boston	Massachusetts
Local Institution - 0210	Mineola	New York
Local Institution - 0134	New York	New York
Local Institution - 0214	Tacoma	Washington
Local Institution - 0092	Ciudad Autónoma de Buenos Aires	Buenos Aires
Instituto Alexander Fleming	Ciudad Autónoma de Buenos Aires	Buenos Aires
Local Institution - 0091	ABB	Buenos Aires F.D.
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
Local Institution - 0033	Porto Alegre	Rio Grande do Sul
Local Institution - 0034	Porto Alegre	Rio Grande do Sul
Local Institution - 0029	Barretos	São Paulo
Local Institution - 0037	São José do Rio Preto	São Paulo
Local Institution - 0209	São Paulo	São Paulo
Local Institution - 0147	São Paulo	São Paulo
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
Local Institution - 0123	Trois-Rivières	Quebec
Fundacion Arturo Lopez Perez (FALP)	Santiago	Santiago Metropolitan
Local Institution - 0096	Viña del Mar	Valparaiso
Local Institution - 0168	Beijing	Beijing Municipality
Local Institution - 0185	Chongqing	Chongqing Municipality
Local Institution - 0169	Xiamen	Fujian
Local Institution - 0180	Guangzhou	Guangdong
Local Institution - 0194	Nanning	Guangxi
Local Institution - 0171	Harbin	Heilongjiang
Local Institution - 0166	Zhengzhou	Henan
Local Institution - 0181	Wuhan	Hubei
Local Institution - 0184	Changsha	Hunan
Local Institution - 0193	Nanjing	Jiangsu
Local Institution - 0202	Nanchang	Jiangxi
Local Institution - 0178	Changchun	Jilin

+ 82 more sites — see the full list on the official registry below.

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06140836 on ClinicalTrials.gov ↗ ← All trials in Turkey