Efficacy comparison of Ipilimumab vs Etoposide in ED-SCLC patients
Research type
Research Study
Full title
Randomized, Multicenter, Double-Blind, Phase 3 Trial Comparing the Efficacy of Ipilimumab plus Etoposide/Platinum versus Etoposide/Platinum in Subjects with Newly Diagnosed Extensive-Stage Disease Small Cell Lung Cancer (ED-SCLC)
IRAS ID
90989
Contact name
Paul Lorigan
Sponsor organisation
Bristol-Myers Squibb International Corporation
Eudract number
2011-000850-48
Clinicaltrials.gov Identifier
Research summary
Despite improvements in diagnosis and therapy the current prognosis for Extensive-stage Disease Small Cell Lung Cancer (ED-SCLC) remains unsatisfactory. Mean survival rates remain below 11 months, while patients in remission typically experience recurrence within 2 years. Since the introduction of etoposide and cisplatin as first-line therapy in the 1980s no systemic therapy has shown an improvement in the overall survival of patients with ED-SCLC. Etoposide/platinum combination therapy (etoposide in combination with cisplatin or carboplatin) remains the global standard treatment for first-line treatment of SCLC to date. The aim of this study is to investigate the use of ipilimumab as a therapy for patients with ED-SCLC. Ipilimumab is a human monoclonal antibody approved for the treatment of metastatic melanoma. Ipilimumab binds to CTLA-4, a molecule that acts to down-regulate the immune systems T-cell responses. Blocking this function using ipilimumab, results in a more effective immune response against cancer cells. This is a Phase 3 study, to be undertaken in newly diagnosed patients with ED-SCLC, where ipilimumab will be administered in combination with the standard etoposide/platinum treatment. Approximately 1100 SCLC patients will be randomised (like flipping a coin) to either ipilimumab or placebo (inactive substance) both in combination with standard treatment. Patients will be assessed every 3 weeks in the induction phase, and every 12 weeks in the maintainence phase. The study assessments will include: - physical examinations - measurement of blood pressure, heart rate, respiration rate and temperature - ECG (heart trace) - blood and urine sample analysis - MRI/CT and bone scans - Lung Cancer Symptom Scale (LCSS) questionnaire The duration of the study is dependent on the overall survival of the study participants. We plan to investigate if using ipilimumab in combination with etoposide/platinum will prolong overall survival rates, and result in a reduced recurrence of the disease.
REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
12/NW/0255
Date of REC Opinion
2 May 2012
REC opinion
Further Information Favourable Opinion