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Trial ID CA127-1030  |   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)

Summary

  • Phase 3
  • Male and Female Gender icon
  • 18+
    Age Range
  • 64
    Locations
  • BMS Recruiting Study icon
    Recruiting

Overview

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).

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Key Eligibility 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

Treatment Options

Study Arms

ASSIGNED INTERVENTION

Study Arms

Experimental: Arm A

ASSIGNED INTERVENTION
  • Drug: Repotrectinib

Study Arms

Active Comparator: Arm B

ASSIGNED INTERVENTION
  • Drug: Crizotinib
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