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)

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

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