Clinical Trial

A Study to Compare the Efficacy and Safety of Entrectinib and Crizotinib in Participants With Advanced or Metastatic ROS1 Non-small Cell Lung Cancer (NSCLC) With and Without Central Nervous System (CNS) Metastases

Active, Not Recruiting Phase 3
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Summary
The study will compare the efficacy and safety of entrectinib with crizotinib in participants with advanced or metastatic ROS1 non-small cell lung cancer (NSCLC). The participants will self-administer oral entrectinib or crizotinib as described in the protocol and local prescribing information. Treatments will continue until progressive disease, unacceptable toxicity, death, or withdrawal from the study, whichever occurs first.
Protocol Amendment History 2 changes
notable Primary completion moved earlier: 2028-06-26 -> 2026-09-30 2026-08-14
minor Completion moved earlier: 2028-06-26 -> 2028-01-29 2026-08-14
Trial Details
NCT Number NCT04603807
Lead Sponsor Hoffmann-La Roche
Conditions Carcinoma, Non-Small-Cell Lung
Enrollment 217 participants
Start Date 2021-09-30
Primary Completion 2026-09-30 (estimated)
Study Completion 2028-01-29 (estimated)
Updated on ClinicalTrials.gov 2026-08-13