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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)

NCT06140836 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 190

Last updated 2025-11-21

No results posted yet for this study

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

DRUG

Crizotinib

Specified dose on specified days

DRUG

Repotrectinib

Specified dose on specified days

Sponsors & Collaborators

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-21
Primary Completion
2026-03-13
Completion
2027-03-15
FDA Drug
Yes

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)

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06140836 on ClinicalTrials.gov