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)

Bristol-Myers Squibb (BMS)

Status and phase

Enrolling

Phase 3

Conditions

Carcinoma, Non-Small-Cell Lung

Treatments

Drug: Crizotinib

Drug: Repotrectinib

Study type

Interventional

Funder types

Industry

Identifiers

NCT06140836

U1111-1292-0487 (Registry Identifier)

CA127-1030

Details and patient eligibility

About

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).

Enrollment

230 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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