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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06140836
Recruitment Status : Recruiting
First Posted : November 20, 2023
Last Update Posted : April 17, 2024
Sponsor:
Collaborator:
Zai Lab (Shanghai) Co., Ltd.
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Description
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Brief 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).

Condition or disease Intervention/treatment Phase
Carcinoma, Non-Small-Cell Lung Drug: Repotrectinib Drug: Crizotinib Phase 3

Expanded Access : An investigational treatment associated with this study is available outside the clinical trial.   More info ...

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 230 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : December 21, 2023
Estimated Primary Completion Date : February 26, 2029
Estimated Study Completion Date : January 27, 2031

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
Drug Information available for: Crizotinib

Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm A Drug: Repotrectinib
Specified dose on specified days
Other Name: BMS-986472
Active Comparator: Arm B Drug: Crizotinib
Specified dose on specified days
Other Name: Xalkori


Outcome Measures
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Primary Outcome Measures :
  1. 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 64 months ]

Secondary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: Up to 87 months ]
  2. Overall Response Rate (ORR) as per BICR according to RECIST v1.1 [ Time Frame: Up to 64 months ]
  3. ORR as per Investigator according to RECIST v1.1 [ Time Frame: Up to 64 months ]
  4. Duration of Response (DOR) as per BICR according to RECIST v1.1 [ Time Frame: Up to 64 months ]
  5. DOR as per Investigator according to RECIST v1.1 [ Time Frame: Up to 64 months ]
  6. Time to Response (TTR) as per BICR according to RECIST v1.1 [ Time Frame: Up to 64 months ]
  7. TTR as per Investigator according to RECIST v1.1 [ Time Frame: Up to 64 months ]
  8. PFS as per Investigator according to RECIST v1.1 [ Time Frame: Up to 64 months ]
  9. Time to intracranial progressions as per BICR according to RECIST v1.1 [ Time Frame: Up to 64 months ]
  10. Number of participants with Adverse Events (AEs), Serious AEs (SAEs), AEs leading to study intervention discontinuation, and drug-related AEs [ Time Frame: Up to 30 days after last dose ]
  11. Number of deaths [ Time Frame: Up to 30 days after last dose ]
  12. Number of participants without at least a 3-point change in the Non-Small Cell Lung Cancer-Symptom Assessment Questionnaire (NSCLC-SAQ) total score [ Time Frame: Up to 30 days after last dose ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion 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

Exclusion Criteria:

  • 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)

Note: Other protocol-defined inclusion/exclusion criteria apply

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06140836


Contacts
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Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com 855-907-3286 Clinical.Trials@bms.com
Contact: First line of the email MUST contain the NCT# and Site #.

Locations
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Sponsors and Collaborators
Bristol-Myers Squibb
Zai Lab (Shanghai) Co., Ltd.
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
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Additional Information:

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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT06140836    
Other Study ID Numbers: CA127-1030
U1111-1292-0487 ( Registry Identifier: WHO )
First Posted: November 20, 2023    Key Record Dates
Last Update Posted: April 17, 2024
Last Verified: April 2024

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bristol-Myers Squibb:
TKI-naïve
ROS1
NSCLC
ROS1-positive non-small cell lung cancer
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
 Carcinoma, Bronchogenic
Bronchial Neoplasms
Crizotinib
Tyrosine Kinase Inhibitors
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents