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Active, not recruiting

NCT Number: NCT06140836

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 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).

Active, not recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Carcinoma, Non-Small-Cell Lung Bronchial Neoplasms Carcinoma, Bronchogenic Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Instituto Alexander Fleming, Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Repotrectinib

Drug

Specified dose on specified days

Other names: BMS-986472

Crizotinib

Drug

Specified dose on specified days

Other names: Xalkori

Primary outcomes

  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 approximately 41 months

Secondary outcomes

  1. Overall Survival (OS)

    Time frame: Up to approximately 41 months

  2. Overall Response Rate (ORR) as per BICR according to RECIST v1.1

    Time frame: Up to approximately 41 months

  3. ORR as per Investigator according to RECIST v1.1

    Time frame: Up to approximately 41 months

  4. Duration of Response (DOR) as per BICR according to RECIST v1.1

    Time frame: Up to approximately 41 months

  5. DOR as per Investigator according to RECIST v1.1

    Time frame: Up to approximately 41 months

  6. Time to Response (TTR) as per BICR according to RECIST v1.1

    Time frame: Up to approximately 41 months

  7. TTR as per Investigator according to RECIST v1.1

    Time frame: Up to approximately 41 months

  8. PFS as per Investigator according to RECIST v1.1

    Time frame: Up to approximately 41 months

  9. Time to intracranial progressions as per BICR according to RECIST v1.1

    Time frame: Up to approximately 41 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

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Collaborators

  • Zai Lab (Shanghai) Co., Ltd.

Registry information

Official study 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)

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Nov 20, 2023
Registry last updated
Nov 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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