clinical 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
Hoffmann-La Roche·phase3·active not recruiting·n = 220
Carcinoma, Non-Small-Cell LungEntrectinibCrizotinib
brief 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.
started
Sep 30, 2021
primary completion
Jun 26, 2028
completion
Jun 26, 2028
last updated
Feb 27, 2026
official title
Randomized, Open Label, Multicenter, Phase III Study of Entrectinib Versus Crizotinib in Patients With Locally-Advanced or Metastatic Non-Small Cell Lung Cancer Harboring ROS1 Gene Rearrangements With and Without Central Nervous System Metastases
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol