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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)

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ClinicalTrials.gov Identifier: NCT06140836
Recruitment Status : Recruiting
First Posted : November 20, 2023
Last Update Posted : May 21, 2024
Sponsor:
Collaborator:
Zai Lab (Shanghai) Co., Ltd.
Information provided by (Responsible Party):
Bristol-Myers Squibb

Tracking Information
First Submitted Date  ICMJE November 15, 2023
First Posted Date  ICMJE November 20, 2023
Last Update Posted Date May 21, 2024
Actual Study Start Date  ICMJE December 21, 2023
Estimated Primary Completion Date February 26, 2029   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 15, 2023)		 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 15, 2023)
  • Overall Survival (OS) [ Time Frame: Up to 87 months ]
  • Overall Response Rate (ORR) as per BICR according to RECIST v1.1 [ Time Frame: Up to 64 months ]
  • ORR as per Investigator according to RECIST v1.1 [ Time Frame: Up to 64 months ]
  • Duration of Response (DOR) as per BICR according to RECIST v1.1 [ Time Frame: Up to 64 months ]
  • DOR as per Investigator according to RECIST v1.1 [ Time Frame: Up to 64 months ]
  • Time to Response (TTR) as per BICR according to RECIST v1.1 [ Time Frame: Up to 64 months ]
  • TTR as per Investigator according to RECIST v1.1 [ Time Frame: Up to 64 months ]
  • PFS as per Investigator according to RECIST v1.1 [ Time Frame: Up to 64 months ]
  • Time to intracranial progressions as per BICR according to RECIST v1.1 [ Time Frame: Up to 64 months ]
  • 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 ]
  • Number of deaths [ Time Frame: Up to 30 days after last dose ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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)
Official Title  ICMJE 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)
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Carcinoma, Non-Small-Cell Lung
Intervention  ICMJE
  • Drug: Repotrectinib
    Specified dose on specified days
    Other Name: BMS-986472
  • Drug: Crizotinib
    Specified dose on specified days
    Other Name: Xalkori
Study Arms  ICMJE
  • Experimental: Arm A
    Intervention: Drug: Repotrectinib
  • Active Comparator: Arm B
    Intervention: Drug: Crizotinib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 15, 2023)		 230
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 27, 2031
Estimated Primary Completion Date February 26, 2029   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
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 #.
Listed Location Countries  ICMJE Argentina,   Austria,   Brazil,   Canada,   Chile,   China,   France,   Germany,   Greece,   Hungary,   India,   Italy,   Japan,   Korea, Republic of,   Netherlands,   Poland,   Romania,   Spain,   Switzerland,   Turkey,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT06140836
Other Study ID Numbers  ICMJE CA127-1030
U1111-1292-0487 ( Registry Identifier: WHO )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Bristol-Myers Squibb
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Bristol-Myers Squibb
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Zai Lab (Shanghai) Co., Ltd.
Investigators  ICMJE
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
PRS Account Bristol-Myers Squibb
Verification Date May 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP