Studieoverzicht

Study name: TRIDENT-3 / protocol CA127-1030: Randomized, Open-label, Multicenter, Phase 3 Trial of Repotrectinib Versus Crizotinib in Participants With Locally Advanced or Metastatic Tyrosine Kinase Inhibitor (TKI)-naive ROS1-positive Non-Small Cell Lung Cancer (NSCLC)

Histology	NSCLC, all subtypes
Tumor stage	Stage III - IV
Host / recruiting site 1	Amsterdam UMC	Enrollment	Closed
Therapy line	First line (1L)
Design	Randomized, Open-label, Multicenter, Phase 3 Trial
Intervention	Experimental - Arm A: Drug: repotrectinib (BMS-986472) Active comparator - Arm B: Drug crizotinib
Key outcome parameters	Progression-free Survival (PFS) Overall Survival (OS)
Key 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
Key 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)
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