Best standard of care with/without sorafenib in NSC lung cancer
Research type
Research Study
Full title
A Phase III, multi-center, placebo–controlled trial of Sorafenib (BAY 43-9006) in patients with relapsed or refractory advanced predominantly non squamous Non-Small Cell Lung Cancer (NSCLC) after 2 or 3 previous treatment regimens
IRAS ID
17154
Sponsor organisation
Bayer HealthCare AG
Eudract number
2008-006914-62
Clinicaltrials.gov Identifier
Research summary
Background-Lung cancer is the leading cause of cancer death in North America and worldwide. In UK as well, lung cancer is the most common cause of cancer death, accounting for more than 1 in 5 of all cancer deaths Importance-Patients whose disease relapses after receiving two previous chemo regimes and who are receiving best supportive care (BSC) have an average survival time of only 4.5-5 months. Improved treatment options for patients with advanced Non Small Cell Lung Cancer are therefore urgently neededQuestions it will answer- Will third or fourth line therapy with sorafenib in combination with best supportive care (BSC) improve overall survival in patients with advanced relapsed or refractory NSCLC?Study Design-Phase III, randomised, double blind, placebo controlled trial.Potential Benefits-There is good rationale to support the belief that patients may experience clinical benefit from taking the study drug, but this cannot be guaranteed. By participating in the study, important information about the safety and efficacy of the study drug can be gained. Patients are contributing new information that may benefit other patients in the future.The study is now closed to recruitment.
REC name
London - Brent Research Ethics Committee
REC reference
09/H0717/35
Date of REC Opinion
3 Jul 2009
REC opinion
Further Information Favourable Opinion