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)
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Interventions
- Registration Number
- NCT06140836
- Lead Sponsor
- Bristol-Myers Squibb
- Brief 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 190
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm B Crizotinib - Arm A Repotrectinib -
- Primary Outcome Measures
Name Time Method Progression-free Survival (PFS) as per Blinded Independent Central Review (BICR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 Up to approximately 41 months
- Secondary Outcome Measures
Name Time Method Overall Survival (OS) Up to approximately 41 months Overall Response Rate (ORR) as per BICR according to RECIST v1.1 Up to approximately 41 months ORR as per Investigator according to RECIST v1.1 Up to approximately 41 months Duration of Response (DOR) as per BICR according to RECIST v1.1 Up to approximately 41 months DOR as per Investigator according to RECIST v1.1 Up to approximately 41 months Time to Response (TTR) as per BICR according to RECIST v1.1 Up to approximately 41 months TTR as per Investigator according to RECIST v1.1 Up to approximately 41 months PFS as per Investigator according to RECIST v1.1 Up to approximately 41 months Time to intracranial progressions as per BICR according to RECIST v1.1 Up to approximately 41 months Number of participants with Adverse Events (AEs), Serious AEs (SAEs), AEs leading to study intervention discontinuation, and drug-related AEs Up to 30 days after last dose Number of deaths Up to 30 days after last dose Number of participants without at least a 3-point change in the Non-Small Cell Lung Cancer-Symptom Assessment Questionnaire (NSCLC-SAQ) total score Up to 30 days after last dose
Trial Locations
- Locations (144)
Local Institution - 0136
🇺🇸Augusta, Georgia, United States
Local Institution - 0221
🇺🇸Des Moines, Iowa, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Local Institution - 0217
🇺🇸Brooklyn, New York, United States
Perlmutter Cancer Center at NYU Langone Hospital - Long Island
🇺🇸Mineola, New York, United States
Laura and Isaac Perlmutter Cancer Center
🇺🇸New York, New York, United States
SUNY Upstate Medical University
🇺🇸Syracuse, New York, United States
Local Institution - 0214
🇺🇸Tacoma, Washington, United States
Local Institution - 0061
🇺🇸Milwaukee, Wisconsin, United States
Scroll for more (134 remaining)Local Institution - 0136🇺🇸Augusta, Georgia, United States