# ALINA

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

## TL;DR

Showed that giving an ALK pill after surgery, instead of chemotherapy, sharply reduces recurrence, including in the brain.

## Summary

ALINA, trial NCT03456076 sponsored by Roche and reported in 2023, showed that two years of the ALK inhibitor alectinib after surgery, instead of platinum chemotherapy, sharply reduces recurrence in resected stage IB to IIIA ALK-positive non-small-cell lung cancer, including recurrence in the brain. It enrolled 257 patients, met its primary disease-free survival endpoint in stage II to IIIA disease with a large reduction in the risk of recurrence, also reduced central nervous system recurrence, and led to FDA approval in April 2024. OnCo links it to ALK as a target, to alectinib and to ADAURA, whose adjuvant osimertinib template it follows for a second oncogene. Overall survival data are immature, so whether delaying recurrence translates into more cures is the open question. Alectinib has its own page.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-06
- Registry id: NCT03456076
- Phase: 3
- Setting: Adjuvant alectinib 2 years vs platinum chemotherapy after resection of stage IB (≥4 cm)-IIIA ALK-positive NSCLC
- Sponsor: Roche
- Enrolled: 257
- Result: DFS HR 0.24.
- Outcomes: Disease-free survival, stage II to IIIA: Alectinib vs Platinum chemotherapy 44.4 months, HR 0.24
- Replication: Mirrors ADAURA (adjuvant osimertinib) for a second oncogene; OS immature.

## Sources

- ClinicalTrials.gov NCT03456076: https://clinicaltrials.gov/study/NCT03456076

## Connected records

- cancers: [ALK-positive non-small-cell lung cancer](https://onco.cc/cancers/alk-positive-nsclc/), [Lung cancer (all types)](https://onco.cc/cancers/lung-cancer/), [Non-small-cell lung cancer](https://onco.cc/cancers/nsclc/), [Resectable stage I to III non-small-cell lung cancer](https://onco.cc/cancers/resectable-nsclc/)
- technologies: [Small-molecule kinase inhibitors](https://onco.cc/technologies/kinase-inhibitors/)
- targets: [ALK](https://onco.cc/targets/alk/)
- drugs: [Alectinib](https://onco.cc/drugs/alectinib/)
- companies: [Roche / Genentech](https://onco.cc/companies/roche-genentech/)
- trials: [ADAURA](https://onco.cc/trials/adaura/), [Study to Assess Safety and Efficacy of Atezolizumab (MPDL3280A) Compared to Best Supportive Care Following Chemotherapy in Patients With Lung Cancer [](https://onco.cc/trials/nct02486718/)
- key papers: [Alectinib in resected ALK-positive non-small-cell lung cancer](https://onco.cc/key-papers/paper-wu-alina-adjuvant-alectinib-nejm-2024/)
- ideas: [Prevention trials aimed only at brain metastasis](https://onco.cc/ideas/idea-bio2-brain-met-prevention-trials/), [Stop excluding brain metastases from cancer trials](https://onco.cc/ideas/idea-bio2-cns-cohort-mandate/)
- roadmaps: [Targeted therapy roadmap: imatinib → designed for resistance → the undruggable drivers fall](https://onco.cc/roadmaps/targeted-therapy-roadmap/)

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