# ALTA-1L

Source: https://onco.cc/trials/alta-1l/  
OnCo record `alta-1l` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

ALTA-1L showed that brigatinib more than doubled the time ALK-positive lung cancer stayed under control compared with crizotinib, with strong activity against brain metastases.

## Summary

ALTA-1L randomised 275 patients with untreated advanced ALK-positive non-small-cell lung cancer to brigatinib or crizotinib, allowing up to one prior line of chemotherapy. Brigatinib had been approved in 2017 for patients who had progressed on crizotinib.

In the final analysis median progression-free survival by blinded independent review was 24.0 months with brigatinib against 11.1 months with crizotinib (hazard ratio 0.48); among patients with brain metastases at baseline the intracranial response rate was much higher with brigatinib. Early pulmonary events in the first week, seen in a small minority, are the drug's distinctive toxicity and are managed by a lower starting dose.

The FDA approved brigatinib for first-line use in May 2020, giving a third first-line option alongside alectinib and lorlatinib.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-17
- Registry id: NCT02737501
- Phase: 3
- Setting: Untreated advanced ALK-positive non-small-cell lung cancer: brigatinib versus crizotinib
- Sponsor: Takeda (ARIAD)
- Enrolled: 275
- Result: Median progression-free survival 24.0 vs 11.1 months (hazard ratio 0.48, blinded independent review, final analysis).
- Outcomes: Progression-free survival (blinded independent review, final): Brigatinib 24 months vs Crizotinib 11.1 months, HR 0.48
- Replication: Consistent with ALEX and CROWN; brigatinib is one of three next-generation inhibitors recommended first line.

## Sources

- ClinicalTrials.gov NCT02737501: https://clinicaltrials.gov/study/NCT02737501
- New England Journal of Medicine 2018: https://doi.org/10.1056/NEJMoa1810171
- Journal of Thoracic Oncology 2021 (final analysis): https://doi.org/10.1016/j.jtho.2021.07.035

## Connected records

- cancers: [ALK-positive non-small-cell lung cancer](https://onco.cc/cancers/alk-positive-nsclc/), [Non-small-cell lung cancer](https://onco.cc/cancers/nsclc/)
- technologies: [Small-molecule kinase inhibitors](https://onco.cc/technologies/kinase-inhibitors/)
- targets: [ALK](https://onco.cc/targets/alk/)
- drugs: [Brigatinib](https://onco.cc/drugs/brigatinib/), [Crizotinib](https://onco.cc/drugs/crizotinib/)
- companies: [Takeda](https://onco.cc/companies/takeda/)
- terms: [Brain metastases (intracranial disease)](https://onco.cc/terms/brain-metastases/)
- people: [D. Ross Camidge](https://onco.cc/people/ross-camidge/)

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