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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
  • 66
    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

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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