期刊
CLINICAL LUNG CANCER
卷 19, 期 4, 页码 E533-E536出版社
CIG MEDIA GROUP, LP
DOI: 10.1016/j.cllc.2018.04.004
关键词
Adjuvant therapy; EGFR-TKI; Non-small-cell lung cancer; Surgery; Tyrosine kinase inhibitor
类别
资金
- AstraZeneca, the manufacturer of osimertinib
- AstraZeneca
- Good Publications Practice (GPP3)
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.
作者
我是这篇论文的作者
点击您的名字以认领此论文并将其添加到您的个人资料中。
推荐
暂无数据