当前位置： SCI文献检索 > Clinical Lung Cancer期刊下所有文献 > ADAURA: Phase III, Double-blind, Randomized Study of Osimertinib Versus Placebo in EGFR Mutation-positive Early-stage NSCLC After Complete Surgical Resection.

ADAURA: Phase III, Double-blind, Randomized Study of Osimertinib Versus Placebo in EGFR Mutation-positive Early-stage NSCLC After Complete Surgical Resection.

Abstract：

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.gov identifier, 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).

journal_name

Clin Lung Cancer

journal_title

Clinical lung cancer

authors

Wu YL,Herbst RS,Mann H,Rukazenkov Y,Marotti M,Tsuboi M

doi

10.1016/j.cllc.2018.04.004

subject

Has Abstract

pub_date

2018-07-01 00:00:00

pages

e533-e536

issue

4

eissn

1525-7304

issn

1938-0690

pii

S1525-7304(18)30086-X

journal_volume

19

pub_type

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