# 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

Source: https://onco.cc/trials/nct04603807/  
OnCo record `nct04603807` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A phase 3 trial of Entrectinib and Crizotinib in non-small-cell lung cancer, run by Hoffmann-La Roche, active and no longer recruiting.

## Summary

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 is a phase 3 interventional study registered as NCT04603807 by Hoffmann-La Roche, with 217 participants enrolled, started 2021-09-30 and due to reach its primary completion in 2026-09-30. Interventions recorded: Entrectinib and Crizotinib.

## Fields

- Kind: Trial
- Status: active
- Last checked: 2026-09-16
- Tags: pipeline; ctgov-ingest
- Registry id: NCT04603807
- Phase: 3
- Setting: 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
- Sponsor: Hoffmann-La Roche
- Enrolled: 217

## Sources

- ClinicalTrials.gov NCT04603807: https://clinicaltrials.gov/study/NCT04603807

## Connected records

- cancers: [Non-small-cell lung cancer](https://onco.cc/cancers/nsclc/)
- drugs: [Crizotinib](https://onco.cc/drugs/crizotinib/), [Entrectinib](https://onco.cc/drugs/entrectinib/)
- companies: [Flatiron Health (Roche)](https://onco.cc/companies/flatiron-health/)

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JSON: https://onco.cc/api/v1/entities/nct04603807.json