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)

Description

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

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Study Overview

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Study Details

Study overview

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).

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)

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)

Condition
Carcinoma, Non-Small-Cell Lung
Intervention / Treatment

-

Contacts and Locations

Augusta

Local Institution - 0136, Augusta, Georgia, United States, 30912

Des Moines

Local Institution - 0221, Des Moines, Iowa, United States, 50309

Boston

Massachusetts General Hospital, Boston, Massachusetts, United States, 02114

Boston

Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States, 02215

Brooklyn

Local Institution - 0217, Brooklyn, New York, United States, 11220

Mineola

Perlmutter Cancer Center at NYU Langone Hospital - Long Island, Mineola, New York, United States, 11501

New York

Laura and Isaac Perlmutter Cancer Center, New York, New York, United States, 10016

Syracuse

SUNY Upstate Medical University, Syracuse, New York, United States, 13210

Tacoma

Local Institution - 0214, Tacoma, Washington, United States, 98405

Milwaukee

Local Institution - 0061, Milwaukee, Wisconsin, United States, 53226

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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)

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Bristol-Myers Squibb,

Bristol-Myers Squibb, STUDY_DIRECTOR, Bristol-Myers Squibb

Study Record Dates

2031-01-27