← The Absolute Effect
Non-Small Cell Lung Cancer · Medical · Adjuvant / Postoperative

ADAURA

In completely resected EGFR-mutated stage IB–IIIA NSCLC, does adjuvant osimertinib improve disease-free and overall survival versus placebo?

Trial design and population

Population / eligibility
682 patients with completely resected EGFR exon 19 deletion or L858R stage IB–IIIA NSCLC; adjuvant chemotherapy was permitted.
Intervention vs comparator
Osimertinib 80 mg orally daily for 3 years vs placebo.
Sample size
682
Primary endpoint
Disease-free survival; overall survival key secondary endpoint

Key results

At 5 years, OS was 88% with osimertinib vs 78% with placebo (HR 0.49, 95.03% CI 0.33–0.73; P<.001). Four-year DFS was 73% vs 38% (HR 0.23, 95% CI 0.18–0.30).

Source-reported outcome visualization

5-year overall survival · 5 years

Osimertinib
88 %
Placebo
78 %

Bars are scaled to the larger reported group value; endpoint, unit and horizon are labelled. Values are source-reported, not estimated from medians.

Absolute Effect

Absolute 5-year OS gain 10 percentage points; NNT 10 based on 5-year OS. Four-year DFS gain 35 points; NNT 3 based on 4-year DFS.

NNT: 10 (5-year OS); 3 (5-year DFS). Use only at the stated endpoint/time horizon; median survival differences are not converted into NNT.

NNH: Not quantifiable. Common effects include diarrhoea, paronychia and rash; uncommon but important risks include interstitial lung disease, QT prolongation and cardiomyopathy. NNH not quantifiable from a single selected fixed-time excess-harm endpoint.

Time-to-event hazard ratios and median survival are not treated as absolute risk differences. Where no defensible fixed-time NNT/NNH is available, the source-reported endpoint is visualized instead.

Safety and treatment burden

Common effects include diarrhoea, paronychia and rash; uncommon but important risks include interstitial lung disease, QT prolongation and cardiomyopathy. NNH not quantifiable from a single selected fixed-time excess-harm endpoint.

Follow-up, maturity and limitations

Follow-up: Updated 5-year analysis.

Applies to EGFR exon 19 deletion/L858R tumours after complete resection; do not extrapolate to uncommon EGFR variants. DFS and OS reflect the adjuvant strategy with chemotherapy permitted.

Clinical interpretation

Three years of adjuvant osimertinib substantially improves DFS and OS after resection of EGFR-mutated stage IB–IIIA NSCLC.

Current-practice context · reviewed 20 October 2026

This page separates the original trial findings from contemporary treatment sequencing. Confirm current guidelines, local regulatory status, biomarker requirements, prior treatment exposure and patient-specific contraindications before applying the evidence. Historical comparators may no longer represent the current standard; subgroup findings and immature endpoints are labelled rather than generalized.

Primary and authoritative sources

Tsuboi M, et al. Overall Survival with Osimertinib in Resected EGFR-Mutated NSCLC. NEJM. 2023. Source ↗
ClinicalTrials.gov NCT02511106 Source ↗