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)

Inclusion Criteria:

• Participant has histologically or cytologically confirmed diagnosis of locallyadvanced 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 theinvestigator.

• Participants must not be exposed previously with TKIs that demonstrated activitiesin 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 forNSCLC under study, squamous cell or basal-cell carcinoma of the skin, or any in situcarcinoma that has been completely resected.

• Known tumor targetable co-mutations or rearrangements

• Clinically significant cardiovascular disease (either active or within 6 monthsprior to enrollment)

Note: Other protocol-defined inclusion/exclusion criteria apply