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Clinical Trials

Topic   Non-Small Cell Lung Cancer
Title   A Phase III, Double-blind, Randomized, Placebo-Controlled Multicenter, study to assess the efficacy and safety of AZD9291 versus Placebo, in Patients with Epidermal Growth Factor Receptor Mutation Positive Stage IB-IIIA Non-small Cell Lung Carcinoma,...
Summary   Full Title: A Phase III, Double-blind, Randomized, Placebo-Controlled Multicenter, study to assess the efficacy and safety of AZD9291 versus Placebo, in Patients with Epidermal Growth Factor Receptor Mutation Positive Stage IB-IIIA Non-small Cell Lung Carcinoma, following Complete Tumor Resection With or Without Adjuvant Chemotherapy (ADAURA)

The main purpose of this study is to see if an investigational drug, AZD9291, is safe and effective in treating early stage lung cancer after a complete surgical removal of the tumor and, if so, how it compares with a placebo.
Description   This study is blinded, meaning no one involved (including the doctors and pharmacists) will know who receives the study drug and who recieves the placebo. Patients will be randomized to one of two possible treatment arms. One group of patients will receive 80 mg of the study drug AZD9291 once a day by mouth; the other group of patients will receive a placebo once a day by mouth.
IRB Number   20152493
Inclusion/Notes   To be eligible for this study, patients must meet several criteria, including but not limited to the following: patients must be at least 18 years and have had a complete surgical resection of Stage IB, II or IIA non-small lung cancer (NSCLC) or predominantly non-squamous lung cancer. Patients must confirm one of two common EGFR mutations (Ex19del, L858R), either alone or in combination with other EGFR mutations including T790M.
Status   Open
Start Date   07/29/2015
Principal Name   Jeffery Schneider, MD
Contact Name   Jena Trebendis, RN
Email   Jena.Trebendis@nyulangone.org
Fax   516-663-1871
Current Trial Type   Interventional
Phone   516-663-1811
Alternate Phone   516-663-3115