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)

Part of paid clinical trials in Des Moines, Iowa.

Sponsor
Bristol-Myers Squibb
Study ID
NCT06140836
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Carcinoma, Non-Small-Cell Lung

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Repotrectinib — DRUG
    Specified dose on specified days
  • Crizotinib — DRUG
    Specified dose on specified days

Study Details

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).

Key Dates

Start date
Dec 21, 2023
Status verified
Nov 2025
Primary completion
Mar 13, 2026
Completion
Mar 15, 2027

Study Design

Enrollment
190 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A
  • Active Comparator: Arm B

Primary Outcome Measure

Progression-free Survival (PFS) as per Blinded Independent Central Review (BICR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 [ Time Frame: Up to approximately 41 months ]

Locations (6)

FacilityCityStateZIPSite coordinators
Local Institution - 0221Des MoinesIowa50309-
Local Institution - 0075BostonMassachusetts02114-
Local Institution - 0201BostonMassachusetts02215-
Local Institution - 0210MineolaNew York11501-
Local Institution - 0134New YorkNew York10016-
Local Institution - 0214TacomaWashington98405-

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Local Institution - 0221· Des Moines, IALocal Institution - 0075· Boston, MALocal Institution - 0201· Boston, MALocal Institution - 0210· Mineola, NYLocal Institution - 0134· New York, NYLocal Institution - 0214· Tacoma, WA

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