A Study of Repotrectinib Versus Crizotinib in Participant... | NCT06140836

Studies
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

Sponsor

Bristol-Myers Squibb

Status

Active, not recruiting

Last Update Posted

Nov 21, 2025Actual

Enrollment

190Estimated

Phase

Phase 3

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Repotrectinib
Crizotinib

Countries

United States
Argentina
Austria
Brazil
Canada
Chile
China
France
Germany
Greece
Hungary
India
Italy
Japan
Netherlands
Poland
Romania
South Korea
Spain
Switzerland
Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

ID	Type	Description	Link
U1111-1292-0487	Registry Identifier	WHO

Status Module

Record Verification Date

Nov 2025

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

YesNCT05926232Available

Start Date

Dec 21, 2023Actual

Primary Completion Date

Mar 13, 2026Estimated

Completion Date

Mar 15, 2027Estimated

First Submitted Date

Nov 15, 2023

First Submission Date that Met QC Criteria

Nov 15, 2023

First Posted Date

Nov 20, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 18, 2025

Last Update Posted Date

Nov 21, 2025Actual

Name	Class
Zai Lab (Shanghai) Co., Ltd.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

190Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm A	Experimental		Drug: Repotrectinib
Arm B	Active Comparator		Drug: Crizotinib

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Repotrectinib	Drug	Specified dose on specified days	Arm A	BMS-986472

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Measure	Description	Time Frame
Overall Survival (OS)		Up to approximately 41 months
Overall Response Rate (ORR) as per BICR according to RECIST v1.1		Up to approximately 41 months
ORR as per Investigator according to RECIST v1.1

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bristol-Myers Squibb	Bristol-Myers Squibb	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Local Institution - 0221		Des Moines	Iowa	50309	United States
Local Institution - 0075

Label	URL
BMS Clinical Trial Information	View source
BMS Clinical Trial Patient Recruiting	View source

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D008175	Lung Neoplasms
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

ID	Term
D010880	Piperidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D000631	Aminopyridines
D011725	Pyridines