# Crizotinib in ROS1-rearranged non-small-cell lung cancer

Source: https://onco.cc/key-papers/paper-shaw-crizotinib-ros1-nejm-2014/  
OnCo record `paper-shaw-crizotinib-ros1-nejm-2014` (Key paper). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Crizotinib shrank tumours in almost three quarters of patients with ROS1-rearranged lung cancer and controlled the disease for a median of 19 months, establishing ROS1 as a targetable driver and leading to the first approval.

## Summary

Expansion cohort of a phase 1 study treating 50 patients with advanced ROS1-rearranged non-small-cell lung cancer with crizotinib 250 mg twice daily.

Objective response was 72 percent with median duration of response 17.6 months and median progression-free survival 19.2 months; the safety profile matched that seen in ALK-positive disease.

## Fields

- Kind: Key paper
- Last checked: 2026-09-17
- Journal: New England Journal of Medicine
- Year: 2014
- DOI: 10.1056/NEJMoa1406766
- Authors: Shaw AT, Ou SH, Bang YJ, et al.
- Findings: Objective response 72 percent.; Median progression-free survival 19.2 months.
- What it means: ROS1 testing became standard in lung adenocarcinoma; crizotinib was the first approved ROS1 inhibitor and remains an option, though entrectinib, repotrectinib and taletrectinib now offer brain penetration and resistance coverage.
- Caveats: Single-arm study of 50 patients.; Poor brain penetration and the G2032R resistance mutation limit crizotinib.

## Sources

- N Engl J Med 2014: https://doi.org/10.1056/NEJMoa1406766
- PubMed: https://pubmed.ncbi.nlm.nih.gov/25264305/

## Connected records

- cancers: [ROS1-positive non-small-cell lung cancer](https://onco.cc/cancers/ros1-positive-nsclc/)
- drugs: [Crizotinib](https://onco.cc/drugs/crizotinib/)
- journals: [New England Journal of Medicine](https://onco.cc/journals/nejm/)

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