Osimertinib in resected EGFR-mutated non–small-cell lung cancer: New England Journal of Medicine

Y.-L. Wu, M. Tsuboi, J. He, T. John, C. Grohe, M. Majem, J.W. Goldman, K. Laktionov, S.-W. Kim, T. Kato, H.-V. Vu, S. Lu, K.-Y. Lee, C. Akewanlop, C.-J. Yu, F. de Marinis, L. Bonanno, M. Domine, F.A. Shepherd, L. ZengR. Hodge, A. Atasoy, Y. Rukazenkov, R.S. Herbst

Research output: Contribution to journalArticlepeer-review


BACKGROUND Osimertinib is standard-of-care therapy for previously untreated epidermal growth factor receptor (EGFR) mutation–positive advanced non–small-cell lung cancer (NSCLC). The efficacy and safety of osimertinib as adjuvant therapy are unknown. METHODS In this double-blind, phase 3 trial, we randomly assigned patients with completely resected EGFR mutation–positive NSCLC in a 1:1 ratio to receive either osimertinib (80 mg once daily) or placebo for 3 years. The primary end point was disease-free survival among patients with stage II to IIIA disease (according to investigator assessment). The secondary end points included disease-free survival in the overall population of patients with stage IB to IIIA disease, overall survival, and safety. RESULTS A total of 682 patients underwent randomization (339 to the osimertinib group and 343 to the placebo group). At 24 months, 90% of the patients with stage II to IIIA disease in the osimertinib group (95% confidence interval [CI], 84 to 93) and 44% of those in the placebo group (95% CI, 37 to 51) were alive and disease-free (overall hazard ratio for disease recurrence or death, 0.17; 99.06% CI, 0.11 to 0.26; P
Original languageEnglish
Pages (from-to)1711-1723
Number of pages13
JournalNew Engl. J. Med.
Issue number18
Publication statusPublished - 2020


  • epidermal growth factor receptor
  • osimertinib
  • placebo
  • acrylamide derivative
  • aniline derivative
  • antineoplastic agent
  • protein kinase inhibitor
  • acne
  • adult
  • aged
  • Article
  • cancer adjuvant therapy
  • cancer free survival
  • cancer prognosis
  • cancer recurrence
  • cancer staging
  • controlled study
  • coughing
  • decreased appetite
  • dermatitis
  • diarrhea
  • double blind procedure
  • drug dose reduction
  • drug efficacy
  • dry skin
  • EGFR gene
  • female
  • gene mutation
  • human
  • interstitial lung disease
  • lung embolism
  • lung lobectomy
  • lung resection
  • major clinical study
  • male
  • median survival time
  • mouth ulcer
  • non small cell lung cancer
  • overall survival
  • paronychia
  • phase 3 clinical trial
  • postoperative care
  • priority journal
  • pruritus
  • quality of life
  • randomized controlled trial
  • recurrence risk
  • rhinopharyngitis
  • risk reduction
  • stomatitis
  • treatment duration
  • upper respiratory tract infection
  • adjuvant chemotherapy
  • clinical trial
  • disease free survival
  • genetics
  • lung tumor
  • lymph node metastasis
  • middle aged
  • mortality
  • multicenter study
  • mutation
  • tumor recurrence
  • very elderly
  • Acrylamides
  • Adult
  • Aged
  • Aged, 80 and over
  • Aniline Compounds
  • Antineoplastic Agents
  • Carcinoma, Non-Small-Cell Lung
  • Chemotherapy, Adjuvant
  • Disease-Free Survival
  • Double-Blind Method
  • ErbB Receptors
  • Female
  • Humans
  • Lung Neoplasms
  • Lymphatic Metastasis
  • Male
  • Middle Aged
  • Mutation
  • Neoplasm Recurrence, Local
  • Neoplasm Staging
  • Pneumonectomy
  • Protein Kinase Inhibitors


Dive into the research topics of 'Osimertinib in resected EGFR-mutated non–small-cell lung cancer: New England Journal of Medicine'. Together they form a unique fingerprint.

Cite this