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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)

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT06140836
Collaborator
Zai Lab (Shanghai) Co., Ltd. (Industry)
230
Enrollment
41
Locations
2
Arms
84.4
Anticipated Duration (Months)
5.6
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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
Phase 3

Study Design

Study Type:
Interventional
Anticipated 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)
Anticipated Study Start Date :
Jan 15, 2024
Anticipated Primary Completion Date :
Feb 26, 2029
Anticipated Study Completion Date :
Jan 27, 2031

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm A

Drug: Repotrectinib
Specified dose on specified days
Other Names:
  • BMS-986472

    		•
    Active Comparator: Arm B

    Drug: Crizotinib
    Specified dose on specified days
    Other Names:
  • Xalkori

    		•

    Outcome Measures

    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 [Up to 64 months]

    Secondary Outcome Measures

    1. Overall Survival (OS) [Up to 87 months]

    2. Overall Response Rate (ORR) as per BICR according to RECIST v1.1 [Up to 64 months]

    3. ORR as per Investigator according to RECIST v1.1 [Up to 64 months]

    4. Duration of Response (DOR) as per BICR according to RECIST v1.1 [Up to 64 months]

    5. DOR as per Investigator according to RECIST v1.1 [Up to 64 months]

    6. Time to Response (TTR) as per BICR according to RECIST v1.1 [Up to 64 months]

    7. TTR as per Investigator according to RECIST v1.1 [Up to 64 months]

    8. PFS as per Investigator according to RECIST v1.1 [Up to 64 months]

    9. Time to intracranial progressions as per BICR according to RECIST v1.1 [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 [Up to 30 days after last dose]

    11. Number of deaths [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 [Up to 30 days after last dose]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Augusta University Augusta Georgia United States 30912
    2 Laura and Isaac Perlmutter Cancer Center New York New York United States 10016
    3 Memorial Sloan Kettering Cancer Center New York New York United States 10065
    4 Local Institution - 0207 Buenos Aires Argentina C1417DTB
    5 Local Institution - 0037 São José do Rio Preto São Paulo Brazil 15090000
    6 Local Institution - 0032 São Paulo Brazil 01401-002
    7 Local Institution - 0001 Montréal Quebec Canada H4A 3J1
    8 Local Institution - 0191 Santiago Región Metropolitana De Santiago Chile 7500653
    9 Local Institution - 0094 Santiago Región Metropolitana De Santiago Chile 7500921
    10 Local Institution - 0182 Zhengzhou Henan China 450052
    11 Local Institution - 0203 Wuhan Hubei China 430022
    12 Local Institution - 0202 Nanchang Jiangxi China 330006
    13 Local Institution - 0176 Jinan Shandong China 250013
    14 Local Institution - 0205 Linyi Shandong China 276027
    15 Local Institution - 0204 Kunming Shanghai China 650106
    16 Local Institution - 0206 Hangzhou Zhejiang China 310003
    17 Local Institution - 0079 Köln Germany 50937
    18 Local Institution - 0199 Mainz Germany 55131
    19 Local Institution - 0135 Budapest Hungary 1121
    20 Local Institution - 0151 Aviano Italy 33081
    21 Local Institution - 0190 Nagoya Aichi Japan 466-8560
    22 Local Institution - 0132 Kashiwa Chiba Japan 277-8577
    23 Local Institution - 0174 Matsuyama Ehime Japan 791-0280
    24 Local Institution - 0163 Sapporo Hokkaido Japan 060-8648
    25 Local Institution - 0173 Yokohama Kanagawa Japan 2418515
    26 Local Institution - 0172 Sendai Miyagi Japan 9800873
    27 Local Institution - 0198 Bunkyo ku Tokyo Japan 113-8677
    28 Local Institution - 0159 Yonago Tottori Japan 683-8504
    29 Local Institution - 0195 Fukuoka Japan 811-1395
    30 Local Institution - 0160 Osaka Japan 534-0021
    31 Local Institution - 0208 Tokyo Japan 164-8541
    32 Local Institution - 0066 Bucharest București Romania 022328
    33 Local Institution - 0031 Craiova Dolj Romania 200542
    34 Local Institution - 0067 Iași Romania 700106
    35 Local Institution - 0086 Yenimahalle Ankara Turkey 06200
    36 Local Institution - 0087 Stanbul İstanbul Turkey 34214
    37 Local Institution - 0088 Adana Turkey 01140
    38 Local Institution - 0084 Ankara Turkey 06010
    39 Local Institution - 0097 Istanbul Turkey 34440
    40 Local Institution - 0083 Istanbul Turkey 34899
    41 Local Institution - 0085 Sakarya Turkey 0

    Sponsors and Collaborators

    • Bristol-Myers Squibb
    • Zai Lab (Shanghai) Co., Ltd.

    Investigators

    • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Bristol-Myers Squibb
    ClinicalTrials.gov Identifier:
    NCT06140836
    Other Study ID Numbers:
    • CA127-1030
    • U1111-1292-0487
    First Posted:
    Nov 20, 2023
    Last Update Posted:
    Nov 30, 2023
    Last Verified:
    Nov 1, 2023
    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:
    Lung Neoplasms
    Carcinoma, Non-Small-Cell Lung
    Crizotinib

    Study Results

    No Results Posted as of Nov 30, 2023