6/28/23, 12:03 AM ADAURA Pathway Feedback Search Clinical Topics Home Studies ADAURA ADAURA Disease Non-small cell lung cancer Trial question What is the role of adjuvant osimertinib therapy in patients with completely resected, epidermal growth factor receptor-mutated, stage IB-IIIA non-small cell lung cancer? Study design Multi-center Double blinded RCT Population Characteristics of study participants 70.0% female N = 682 30.0% male 682 patients (477 female, 205 male) Inclusion criteria: adult patients with postsurgical stage IB, II, or IIIA non-small cell lung cancer who had centrally confirmed epidermal growth factor receptor mutation Key exclusion criteria: prior anticancer therapy; history of other malignancies; major surgery within 4 weeks of the first dose of study drug; severe or uncontrolled systemic diseases Interventions N=339 osimertinib (at an oral dose of 80 mg once daily) N=343 placebo (matching placebo once daily) Primary outcome https://web.pathway.md/studies/recTTJtAVwQsJpZIw 1/2 6/28/23, 12:03 AM ADAURA Pathway Overall survival at 5 years, among patients with stage II to IIIA disease 85.0 % 85 73 63.8 % 42.5 % Significant increase 21.3 % NNT = 8 0.0 % Osimertinib Placebo Significant increase in overall survival at 5 years, among patients with stage II to IIIA disease (85% vs. 73%; AD 12%, 95% CI 4.88 to 19.12) Secondary outcomes Significant increase in overall survival at 5 years, among patients with stage IB to IIIA disease (88% vs. 78%; AD 10%, 95% CI 4.07 to 15.93) Safety outcomes No significant difference in adverse events and serious adverse events. Conclusion In adult patients with postsurgical stage IB, II, or IIIA non-small cell lung cancer who had centrally confirmed epidermal growth factor receptor mutation, osimertinib was superior to placebo with respect to overall survival at 5 years, among patients with stage II to IIIA disease. Reference Masahiro Tsuboi, Roy S Herbst, Thomas John et al. Overall Survival with Osimertinib in Resected EGFR-Mutated NSCLC. N Engl J Med. 2023 Jun 4. Online ahead of print. Open reference URL https://web.pathway.md/studies/recTTJtAVwQsJpZIw 2/2