# ADAURA: three years of osimertinib after surgery for EGFR-mutated lung cancer

Source: https://onco.cc/key-papers/paper-adaura-nejm-2020/  
OnCo record `paper-adaura-nejm-2020` (Key paper). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

After surgery for early-stage EGFR-mutated lung cancer, three years of osimertinib cut recurrences by about 80% and later reduced deaths by half.

## Summary

Double-blind, placebo-controlled phase 3 trial of 682 patients with completely resected stage IB-IIIA EGFR-mutated NSCLC, with or without adjuvant chemotherapy, randomised to three years of osimertinib or placebo. Primary endpoint was disease-free survival in stage II-IIIA.

The trial was unblinded early: DFS HR 0.17 in stage II-IIIA and 0.20 overall, with 24-month DFS 89% vs 52%. The 2023 overall survival report showed 5-year OS 88% vs 78% (HR 0.49). It made adjuvant osimertinib standard and established EGFR testing of resected tumours.

## Fields

- Kind: Key paper
- Last checked: 2026-09-08
- Journal: New England Journal of Medicine
- Year: 2020
- DOI: 10.1056/NEJMoa2027071
- Authors: Wu YL, Tsuboi M, He J, et al.
- Findings: Stage II-IIIA: 24-month disease-free survival 90% vs 44%; HR 0.17 (99.06% CI 0.11-0.26).; Overall population (IB-IIIA): 24-month DFS 89% vs 52%; HR 0.20.; CNS recurrence or death HR 0.18.; Overall survival (2023): 5-year OS 88% vs 78% overall, HR 0.49; stage II-IIIA 85% vs 73%.; Benefit was seen with or without prior adjuvant chemotherapy.
- What it means: Every resected non-squamous lung cancer should be tested for EGFR mutations, because patients who carry one live longer if they take osimertinib for three years after surgery. The trial does not tell us whether adjuvant chemotherapy can be omitted, nor what happens on relapse after osimertinib, and the three-year duration was chosen empirically.
- Caveats: Early unblinding after a dramatic DFS effect meant the trial was stopped before the planned analysis.; Recurrences resumed after osimertinib stopped, raising the question of whether it delays rather than prevents relapse in some patients; OS benefit argues it does more than delay.; Optimal duration (three years vs indefinite) is untested.; Cost of three years of therapy is very high.

## Sources

- NEJM 2020: https://doi.org/10.1056/NEJMoa2027071
- ClinicalTrials.gov NCT02511106: https://clinicaltrials.gov/study/NCT02511106

## Connected records

- 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/)
- key papers: [Alectinib in resected ALK-positive non-small-cell lung cancer](https://onco.cc/key-papers/paper-wu-alina-adjuvant-alectinib-nejm-2024/), [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/), [Osimertinib after chemoradiotherapy in stage III EGFR-mutated NSCLC](https://onco.cc/key-papers/paper-lu-laura-osimertinib-stage-iii-nejm-2024/)
- cancers: [EGFR-mutated non-small-cell lung cancer](https://onco.cc/cancers/egfr-mutant-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: [EGFR](https://onco.cc/targets/egfr/)
- drugs: [Osimertinib](https://onco.cc/drugs/osimertinib/)
- companies: [AstraZeneca](https://onco.cc/companies/astrazeneca/)
- terms: [Minimal / molecular residual disease (MRD)](https://onco.cc/terms/mrd/), [Neoadjuvant / adjuvant / perioperative](https://onco.cc/terms/neoadjuvant-adjuvant/), [Oncogene addiction](https://onco.cc/terms/oncogene-addiction/)
- trials: [ADAURA](https://onco.cc/trials/adaura/)
- people: [Jie He](https://onco.cc/people/he-jie/), [Roy S. Herbst](https://onco.cc/people/roy-herbst/), [Shun Lu](https://onco.cc/people/lu-shun/), [Yi-Long Wu](https://onco.cc/people/wu-yi-long/)
- bottlenecks: [Dormant cells and minimal residual disease](https://onco.cc/bottlenecks/b-dormancy-mrd/), [Prices and value](https://onco.cc/bottlenecks/b-drug-pricing/)
- journals: [New England Journal of Medicine](https://onco.cc/journals/nejm/)

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