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Recruiting

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) - CA127-1030

Opdateret: 13 maj, 2024   |   ClinicalTrials.gov

Udskriftsvenligt sammendrag

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Forsøgsdetaljer

  • Phase 3

    Fase

  • Køn

  • 18+

    Aldersinterval

  • 64

    Beliggenhed(er)

  • Recruiting

Behandlingsmuligheder

Forsøgsgrene
TILDELT INTERVENTION
Experimental: Arm A
Drug: Repotrectinib
Active Comparator: Arm B
Drug: Crizotinib

Primære egnethedskriterier

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

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