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

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

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 220 (estimated)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Carcinoma, Non-Small-Cell Lung

Interventions

Type	Name	Description
DRUG	Entrectinib	Entrectinib will be self-administered orally at a dose of 600 mg (three 200 mg capsules per day) once daily with or without food.
DRUG	Crizotinib	Crizotinib will be self-administered orally at a dose of 250 mg twice daily with or without food.

Timeline

• Start date: 2021-09-30
• Primary completion: 2028-06-26
• Completion: 2028-06-26
• First posted: 2020-10-27
• Last updated: 2026-02-27

Locations

63 sites across 18 countries: Brazil, China, Croatia, France, Germany, Greece, India, Italy, Jordan, Lebanon, Mexico, Netherlands, Romania, Slovakia, Spain, Sweden, Thailand, Turkey (Türkiye)

Regulatory

• FDA-regulated drug study