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

Clin Lung Cancer. 2018 Jul;19(4):e533-e536. doi: 10.1016/j.cllc.2018.04.004. Epub 2018 May 1.

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).

Keywords: Adjuvant therapy; EGFR-TKI; Non–small-cell lung cancer; Surgery; Tyrosine kinase inhibitor.

Publication types

  • Clinical Trial, Phase III
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Acrylamides
  • Aniline Compounds
  • Antineoplastic Agents / therapeutic use*
  • Carcinoma, Non-Small-Cell Lung / drug therapy*
  • Carcinoma, Non-Small-Cell Lung / genetics
  • Carcinoma, Non-Small-Cell Lung / surgery
  • Chemotherapy, Adjuvant / methods
  • Double-Blind Method
  • ErbB Receptors / antagonists & inhibitors
  • ErbB Receptors / genetics
  • Humans
  • Lung Neoplasms / drug therapy*
  • Lung Neoplasms / genetics
  • Lung Neoplasms / surgery
  • Mutation
  • Piperazines / therapeutic use*
  • Research Design

Substances

  • Acrylamides
  • Aniline Compounds
  • Antineoplastic Agents
  • Piperazines
  • osimertinib
  • EGFR protein, human
  • ErbB Receptors

Associated data

  • ClinicalTrials.gov/NCT02511106