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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)

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Summary

  • Phase 3
  • Male and Female Gender icon
  • 18+
    Age Range
  • BMS Active Not Yet Recruiting Study icon
    Active, Not 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

Inclusion Criteria Icon img
:
  • Participant has histologically or cytologically confirmed diagnosis of locally advanced or metastatic NSCLC
    1. Participant has a ROS1 gene rearrangement/fusion as detected by a local test.
      1. At least 1 measurable lesion according to RECIST v1.1, as assessed by the investigator.
        1. Participants must not be exposed previously with TKIs that demonstrated activities in ROS1-positive NSCLC
          1. Up to 1 prior line of systemic treatment for NSCLC is permitted
            1. ECOG Performance Status ≤ 2

              Exclusion Criteria

              Exclusion Criteria Icon
              :
              • Symptomatic brain metastases or symptomatic leptomeningeal involvement.
                1. 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.
                  1. Known tumor targetable co-mutations or rearrangements
                    1. Clinically significant cardiovascular disease (either active or within 6 months prior to enrollment) Note: Other protocol-defined inclusion/exclusion criteria apply
                      Additional Information *

                      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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