Status:
ACTIVE_NOT_RECRUITING
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)
Lead Sponsor:
Bristol-Myers Squibb
Collaborating Sponsors:
Zai Lab (Shanghai) Co., Ltd.
Conditions:
Carcinoma, Non-Small-Cell Lung
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 21 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 15 2027
Estimated Enrollment :
190 Patients enrolled
Trial Details
Trial ID
NCT06140836
Start Date
December 21 2023
End Date
March 15 2027
Last Update
November 21 2025
Active Locations (122)
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1
Local Institution - 0221
Des Moines, Iowa, United States, 50309
2
Local Institution - 0075
Boston, Massachusetts, United States, 02114
3
Local Institution - 0201
Boston, Massachusetts, United States, 02215
4
Local Institution - 0210
Mineola, New York, United States, 11501