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)

• Status: Recruiting
• Trial end date: 2031-01-27
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Collaborator: Zai Lab (Shanghai) Co., Ltd.
• Treatments: Crizotinib

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