BMS-936558 vs Docetaxel in metastic Non Small Cell Lung Cancer
Research type
Research Study
Full title
An Open-label Randomised Phase III Trial of BMS-936558 versus Docetaxel in Previously Treated Metastatic squamous Non-small Cell Lung Cancer (NSCLC)
IRAS ID
99029
Contact name
Christian Ottensmeier
Sponsor organisation
Bristol Myers Squibb International Corporation
Eudract number
2011-004792-36
Clinicaltrials.gov Identifier
Research summary
This is a multicentre, phase 3 study involving an investigational drug called BMS-936558, in patients with squamous non-small cell lung cancer (NSCLC). The purpose of this study is to find out if patients with advanced NSCLC, who have been previously treated, survive for longer on BMS-936558 when compared to the well established chemotherapy agent, docetaxel. Lung cancer is the commonest cause of cancer death. Worldwide nearly 1.2 million people die from lung cancer each year. A significant number of patients have advanced or metastatic (cancer which has spread to other parts of the body) cancer at diagnosis and unfortunately the survival rate remains quite poor. Approximately 264 patients will take part from centres all around the world, approximately 15 coming from the UK. The study is sponsored by Bristol-Myers Squibb. Following a screening period, eligible patients will receive either BMS-936558 or docetaxel. Patients and doctors will know what medication they have been assigned to. Both medications are given intravenously (through your vein) via an infusion. Patients will undergo the following study procedures: CT/MRI scans, physical exams, vital signs such as blood pressure checks, height, weight, body temperature, blood samples taken for routine safety testing and study specific testing and oxygen levels. All these procedures are common in the management of NSCLC. Participants will also be required to complete a questionnaire about their lung cancer symptoms at regular intervals throughout the study. Patients can remain in the study for as long as they are tolerating the treatment or until it has been confirmed that their cancer has worsened. The expected duration of your participation may be up to 24 months.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
12/SC/0472
Date of REC Opinion
24 Oct 2012
REC opinion
Further Information Favourable Opinion