drugset / Trial / NCT04603807

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

NCT04603807

Phase 3 Active not recruiting 220 enrolled Hoffmann-La Roche
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2021-09-30
Primary completion
2028-06-26
Completion
2028-06-26

Drugs

EvaluationDrugModalityDoseRoute
Comparator Crizotinib Small molecule 250 mg Oral
Subject Entrectinib Small molecule 600 mg Oral