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)
Sponsor: Bristol-Myers Squibb
ClinicalTrials ID:NCT06140836
This clinical trial evaluates the efficacy and safety of repotrectinib and crizotinib in participants with locally advanced or metastatic ROS1-positive NSCLC. Eligible participants must have confirmed NSCLC with ROS1 rearrangement, at least one measurable lesion, and no prior TKI exposure. The study involves administering specified doses of repotrectinib or crizotinib.
Patient Parameters
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Program Overview
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 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
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