Journal
CLINICAL LUNG CANCER
Volume 19, Issue 4, Pages E533-E536Publisher
CIG MEDIA GROUP, LP
DOI: 10.1016/j.cllc.2018.04.004
Keywords
Adjuvant therapy; EGFR-TKI; Non-small-cell lung cancer; Surgery; Tyrosine kinase inhibitor
Categories
Funding
- AstraZeneca, the manufacturer of osimertinib
- AstraZeneca
- Good Publications Practice (GPP3)
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Introduction: Currently, the role of epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors as adjuvant therapy for early-stage non-small-cell lung cancer after complete surgical tumor resection remains under investigation. We present the rationale and study design for the ADAURA (ClinicalTrials.govidentifier, NCT02511106) trial, a multicenter, double-blind, randomized, placebo-controlled study. Patients and Methods: Study entry will be limited to adults aged >= 18 years (and in Japan and Taiwan, age >= 20 years) with primary nonsquamous stage IB-IIIA non-small-cell lung cancer with central confirmation of an EGFR exon 19 deletion or L858R mutation. Patients will be randomized 1: 1 to receive osimertinib 80 mg once daily or placebo once daily until disease recurrence, a treatment discontinuation criterion is met, or patients achieve the maximum treatment duration of 3 years. The primary endpoint of this study is disease-free survival. Secondary endpoints include the disease-free survival rate at 2, 3, and 5 years, overall survival, overall survival rate at 5 years, and safety and tolerability. Health-related quality of life and pharmacokinetics will also be evaluated. The exploratory objectives include assessment of osimertinib efficacy in patients with a confirmed baseline T790M mutation status and postrecurrence outcomes, health resource use, and a comparison of plasma-derived circulating tumor DNA EGFR mutation status at baseline and at disease recurrence. Results: Study enrollment began in August 2015, and results are expected in the third quarter of 2021 (depending on the actual event rate). (C) 2018 The Authors. Published by Elsevier Inc.
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