# Alectinib in resected ALK-positive non-small-cell lung cancer

Source: https://onco.cc/key-papers/paper-wu-alina-adjuvant-alectinib-nejm-2024/  
OnCo record `paper-wu-alina-adjuvant-alectinib-nejm-2024` (Key paper). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

After surgery for ALK-positive lung cancer, two years of alectinib kept 93.8 percent of patients disease-free at two years against 63.0 percent on chemotherapy.

## Summary

The ALINA investigators, reported by Wu, Dziadziuszko, Ahn and colleagues with Solomon as senior author, randomised 257 patients with completely resected ALK-positive non-small-cell lung cancer of stage IB (tumours 4 cm or larger), II or IIIA to oral alectinib 600 mg twice daily for 24 months or four 21-day cycles of intravenous platinum-based chemotherapy. The primary endpoint was disease-free survival, tested hierarchically in stage II or IIIA and then in the intention-to-treat population.

With ADAURA for EGFR, ALINA completes the move of targeted therapy from the metastatic setting into the operating theatre's aftermath. The open question both share is whether an effect on disease-free survival becomes an effect on cure or only postpones recurrence until the drug stops.

## Fields

- Kind: Key paper
- Last checked: 2026-09-25
- Tags: lung-evidence
- Journal: New England Journal of Medicine
- Year: 2024
- DOI: 10.1056/NEJMoa2310532
- Authors: Wu YL, Dziadziuszko R, Ahn JS, et al.
- Findings: Among patients with stage II or IIIA disease, 93.8 percent were alive and disease-free at 2 years with alectinib against 63.0 percent with chemotherapy: hazard ratio for disease recurrence or death 0.24 (95 percent confidence interval 0.13 to 0.45).; 257 patients were randomised, 130 to alectinib and 127 to platinum-based chemotherapy.; Other endpoints included central nervous system disease-free survival, overall survival and safety.
- What it means: Adjuvant treatment for lung cancer is now chosen by genotype. A resected ALK-positive tumour is treated with two years of a tablet instead of four cycles of platinum, which is a different life as well as a different outcome.
- Caveats: Disease-free survival, not overall survival, and follow-up is short for a curative-intent question.; Chemotherapy comparator rather than chemotherapy plus alectinib, and no answer to the duration question: 24 months is a convention, not a result.; 257 patients is small, and an ALK-positive resected population has to be found by testing early-stage tumours, which is not yet universal.

## Sources

- N Engl J Med 2024: https://doi.org/10.1056/NEJMoa2310532
- PubMed: https://pubmed.ncbi.nlm.nih.gov/38598794/
- ClinicalTrials.gov NCT03456076: https://clinicaltrials.gov/study/NCT03456076

## Connected records

- key papers: [ADAURA: three years of osimertinib after surgery for EGFR-mutated lung cancer](https://onco.cc/key-papers/paper-adaura-nejm-2020/), [Alectinib versus crizotinib in untreated ALK-positive non-small-cell lung cancer](https://onco.cc/key-papers/paper-peters-alex-alectinib-crizotinib-nejm-2017/), [Lung adjuvant cisplatin evaluation: a pooled analysis by the LACE Collaborative Group](https://onco.cc/key-papers/paper-lace-adjuvant-cisplatin-pooled-analysis-jco-2008/)
- 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/)
- fronts: [Surgery & Interventional](https://onco.cc/fronts/surgery/), [Targeted Therapy](https://onco.cc/fronts/targeted-therapy/)
- targets: [ALK](https://onco.cc/targets/alk/)
- drugs: [Alectinib](https://onco.cc/drugs/alectinib/), [Carboplatin](https://onco.cc/drugs/carboplatin/), [Cisplatin](https://onco.cc/drugs/cisplatin/)
- companies: [Roche / Genentech](https://onco.cc/companies/roche-genentech/)
- terms: [Brain metastases (intracranial disease)](https://onco.cc/terms/brain-metastases/), [Minimal / molecular residual disease (MRD)](https://onco.cc/terms/mrd/), [Neoadjuvant / adjuvant / perioperative](https://onco.cc/terms/neoadjuvant-adjuvant/)
- trials: [ALINA](https://onco.cc/trials/alina/)
- bottlenecks: [Biomarkers are not validated or standardised](https://onco.cc/bottlenecks/b-biomarker-validation/), [Dormant cells and minimal residual disease](https://onco.cc/bottlenecks/b-dormancy-mrd/)
- journals: [New England Journal of Medicine](https://onco.cc/journals/nejm/)
- roadmaps: [Lung cancer roadmap: from Doll and Hill and the naming of tobacco, through the cytotoxic plateau, computed tomography screening, EGFR and ALK, immunotherapy by PD-L1, the perioperative trials and PACIFIC, to DLL3 in small-cell disease and a 2032 registry watch](https://onco.cc/roadmaps/lung-cancer-evidence-roadmap/)
- ideas: [Measure brain metastasis prevention as a primary endpoint, not as a secondary one](https://onco.cc/ideas/idea-lung-brain-metastasis-prevention-as-a-primary-endpoint/)

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