Trial of Ipilimumab Versus Placebo in Subjects with Lung Cancer
Research type
Research Study
Full title
Randomized, Multicenter, Double-Blind, Phase 3 Trial Comparing the Efficacy of Ipilimumab in Addition to Paclitaxel and Carboplatin versus Placebo in Addition to Paclitaxel and Carboplatin in Subjects with Stage IV/Recurrent Non-Small Cell Lung Cancer (NSCLC)
IRAS ID
75332
Contact name
Christian Ottensmeier
Sponsor organisation
Bristol-Myers Squibb International Corporation
Eudract number
2009-017396-19
Clinicaltrials.gov Identifier
Research summary
This is a multicenter, Phase 3 study involving an investigational drug called ipilimumab, in patients with recurrent or Stage IV (per the 7th IASCLC classification) Non-small Cell Lung Cancer (squamous cell type). The purpose of the study is to evaluate the safety and efficacy of ipilimumab in addition to a well established combination chemotherapy, carboplatin and paclitaxel in treating patients with lung cancer. Approximately 700 patients will take part from centres all around the world, approximately 26 of these participants coming from the UK. The study will be done in the following 5 phases: Screening, Lead-In, Induction, Maintenance and Follow-up. Eligible patients will receive two lead-in doses of chemotherapy (paclitaxel carboplatin) and then if eligible, the patients will be randomised to receive either ipilimumab plus paclitaxel and carboplatin or placebo (dummy) plus paclitaxel and carboplatin via intravenous infusion. During their participation in the study patients will undergo the following study procedures: CT/MRI scans, physical examinations, vital signs recorded, ECOG assessment, weight and body area measurement, ECGs, and blood and urine samples taken for routine safety testing and study specific analyses. All these procedures are standard in the management of NSCLC patients outside a clinical study. Participants will also be required to complete a questionnaire about their lung cancer symptoms at regular intervals throughout the study. If the study treatment works for the participant, and the participant's tolerating the treatment, they will be able to remain in the study until their lung cancer gets worse. At the conclusion of the study patients who continue to gain clinical benefit will be eligible to continue to receive study drug via an extension to the study.
REC name
South Central - Hampshire A Research Ethics Committee
REC reference
11/SC/0169
Date of REC Opinion
24 Jun 2011
REC opinion
Further Information Favourable Opinion