New Indication: Neoadjuvant Osimertinib with/without Chemo for NSCLC


  • Study

    Randomized, controlled, phase III study [NeoADAURA] NCT04351555
    Resectable, EGFR-mutated, stage II-IIIB NSCLC
    Osimertinib+chemotherapy (n=121) vs Osimertinib (n=117) vs Placebo+chemotherapy (n=120)



  • Efficacy

    MPR: 26% vs 25% vs 2%
    EFS at 12mos: 93% vs 95% vs 83%



  • Safety

    Grade >=3 AEs: 36% vs 13% vs 33%
    Serious AEs: 20% vs 11% vs 20%
    Discontinuations: 2% vs 2% vs 2%



  • J Clin Oncol Published online June 2, 2025

    He J,Tsuboi M,Weder W Neoadjuvant Osimertinib for Resectable EGFR-Mutated Non Small Cell Lung Cancer

    http://doi.org/10.1200/JCO-25-00883

    Reviewed by Elvin Chalabiyev, MD on Sep 3, 2025

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