ACTIVE_NOT_RECRUITING

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)

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Conditions

Carcinoma, Non-Small-Cell LungTKI-naïveROS1NSCLCROS1-positive non-small cell lung cancer

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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).

Official Title

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)

Quick Facts

Study Start:2023-12-21
Study Completion:2027-06-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06140836

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Participant has histologically or cytologically confirmed diagnosis of locally advanced or metastatic NSCLC
  2. * Participant has a ROS1 gene rearrangement/fusion as detected by a local test.
  3. * At least 1 measurable lesion according to RECIST v1.1, as assessed by the investigator.
  4. * Participants must not be exposed previously with TKIs that demonstrated activities in ROS1-positive NSCLC
  5. * Up to 1 prior line of systemic treatment for NSCLC is permitted
  6. * ECOG Performance Status ≤ 2
  1. * Symptomatic brain metastases or symptomatic leptomeningeal involvement.
  2. * 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.
  3. * Known tumor targetable co-mutations or rearrangements
  4. * Clinically significant cardiovascular disease (either active or within 6 months prior to enrollment)

Contacts and Locations

Principal Investigator

Bristol-Myers Squibb
STUDY_DIRECTOR
Bristol-Myers Squibb

Study Locations (Sites)

Local Institution - 0221
Des Moines, Iowa, 50309
United States
Local Institution - 0075
Boston, Massachusetts, 02114
United States
Local Institution - 0201
Boston, Massachusetts, 02215
United States
Local Institution - 0210
Mineola, New York, 11501
United States
Local Institution - 0134
New York, New York, 10016
United States
Local Institution - 0214
Tacoma, Washington, 98405
United States

Collaborators and Investigators

Sponsor: Bristol-Myers Squibb

  • Bristol-Myers Squibb, STUDY_DIRECTOR, Bristol-Myers Squibb

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-21
Study Completion Date2027-06-03

Study Record Updates

Study Start Date2023-12-21
Study Completion Date2027-06-03

Terms related to this study

Keywords Provided by Researchers

  • TKI-naïve
  • ROS1
  • NSCLC
  • ROS1-positive non-small cell lung cancer

Additional Relevant MeSH Terms

  • Carcinoma, Non-Small-Cell Lung