Study to Access the Safety of AZD9291 Vs SoC in Patients with NSCLC
Research type
Research Study
Full title
A phase III, double-blind, randomised study to assess the efficacy and safety of AZD9291 versus a standard of care Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor as first-line treatment in patients with Epidermal Growth Factor Receptor Mutation Positive, locally advanced or Metastatic Non-Small Cell Lung Cancer
IRAS ID
163443
Contact name
Nicola Turvey
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2014-002694-11
Duration of Study in the UK
3 years, 7 months, 0 days
Research summary
Lung cancer has been the most common cancer in the world for several decades. By 2012, there were an estimated 1.8 million new cases, representing 12.9% of all new cancers. Non-small Cell Lung Cancer represents approx. 80% to 85% of all lung cancers.
The purpose of this study is to determine whether AZD9291 (study drug) may be effective than standard therapy in extending the time before the participants lung cancer gets worse. EGFR is a type of gene mutation. Gene mutation helps guide doctors in recommending the best treatment for participants. When a participant with advanced lung cancer is found to have a mutation in EGFR, standard first-line treatment currently involves the use of an oral therapy that targets the mutation. Although these drugs can be effective in controlling and shrinking the tumour initially, patients can develop resistance to these standard drugs.
This study is comparing AZD9291 with standard treatment (gefitinib or eroltinib) in participants with Epidermal Growth Factor Receptor (EGFR) mutated lung cancer. Patients will be randomised (like the tossing of a coin) to receive either AZD9291 or the standard of care treatment once daily. Patients will have 50% chance of receiving either AZD9291 or the standard of care treatment.
Around 650 participants will take part at approximately 150 study centres in North America, South America, Europe, and Asia.REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
14/YH/1237
Date of REC Opinion
9 Jan 2015
REC opinion
Further Information Favourable Opinion