NCT06140836

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)

Randomized, Open-label, Multicenter, Phase 3 Trial 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: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 190 (estimated)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Carcinoma, Non-Small-Cell Lung

Interventions

Type	Name	Description
DRUG	Repotrectinib	Specified dose on specified days
DRUG	Crizotinib	Specified dose on specified days

Timeline

• Start date: 2023-12-21
• Primary completion: 2026-03-13
• Completion: 2027-03-15
• First posted: 2023-11-20
• Last updated: 2025-11-21

Locations

122 sites across 21 countries: United States, Argentina, Austria, Brazil, Canada, Chile, China, France, Germany, Greece, Hungary, India, Italy, Japan, Netherlands, Poland, Romania, South Korea, Spain, Switzerland, Turkey (Türkiye)

Regulatory

• FDA-regulated drug study