ADAURA — Osimertinib Versus Placebo in Patients With Stage IB-IIIA EGFR-Mutated NSCLC After Complete Tumour Resection

Phase 3 · 2020 · Non-Small Cell Lung Cancer

Design

Randomized double-blind adjuvant osimertinib vs placebo for 3 years after complete resection +/- adjuvant chemotherapy.

Population

Completely resected stage IB-IIIA NSCLC with EGFR exon 19 deletion or L858R mutation.

Primary Endpoint

disease-free survival (DFS) in stage II-IIIA

Key Result

DFS HR 0.17 in stage II-IIIA; overall HR 0.20; 5-yr OS benefit HR 0.49.

Guideline Impact

NCCN category 1 adjuvant osimertinib for resected EGFR-mutant stage IB-IIIA NSCLC