Osimertinib in Resected EGFR-Mutated Non-Small-Cell Lung Cancer.
Yi-Long Wu, Masahiro Tsuboi, Jie He, Thomas John, Christian Grohe, Margarita Majem, Jonathan W Goldman, Konstantin Laktionov, Sang-We Kim, Terufumi Kato, Huu-Vinh Vu, Shun Lu, Kye-Young Lee, Charuwan Akewanlop, Chong-Jen Yu, Filippo de Marinis, Laura Bonanno, Manuel Domine, Frances A Shepherd, Lingmin Zeng Show all
New England Journal of Medicine | Published : 2020
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 wit..View full abstract