Gemcitabine/Carboplatin with/without Iniparib in patients with NSCLC
Research type
Research Study
Full title
Randomized Phase 3 Trial of Gemcitabine/Carboplatin With or Without Iniparib (SAR240550) (a PARP1 Inhibitor) in Subjects with Previously Untreated Stage IV Squamous Non-Small-Cell Lung Cancer (NSCLC)
IRAS ID
53981
Contact name
Fiona Blackhall
Sponsor organisation
One Onslow Street
Eudract number
2010-019255-22
Clinicaltrials.gov Identifier
Research summary
RANDOMISED PHASE 3 TRIAL OF GEMCITABINE/CARBOPLATIN WITH OR WITHOUT INIPARIB (A PARP1 INHIBITOR) IN PATIENTS WITH PREVIOUSLY UNTREATED STAGE IV SQUAMOUS NON-SMALL-CELL LUNG CANCER (NSCLC)Non-Small Cell Lung Cancer (NSCLC) is a leading cause of cancer mortality with a dismal prognosis in advanced disease and new therapies that may improve outcome for these patients are urgently needed. The majority of these cases are inoperable due to the advanced stage of the disease at diagnosis. Patients with advanced disease rarely survive 5 years, and over half die within the first year of diagnosis. Patients with squamous histology comprise approximately 20-30% of the NSCLC population. Several agents that have recently improved treatment for other NSCLC patients are not used in patients with squamous lung cancer, either due to lack of efficacy (pemetrexed) or increased toxicity (bevacizumab). Therefore, the need for improved treatment for squamous lung cancer is particularly urgent.The study drug being tested ?? Iniparib ?? blocks the PARP enzyme, an important DNA repair enzyme in cancer cells. When the PARP enzyme is blocked (or inactivated), DNA repair cannot occur, and the cell usually dies. Many cytotoxic cancer treatments, including carboplatin, induce DNA damage as their mechanism of action against cancer cells. Therefore, the use of an agent that inhibits DNA repair plus an agent that damages DNA is expected to increase the efficacy of both agents.Nine countries are participating in this study, with sites from Europe and Canada. 825 patients are planned to be enrolled across 100 sites globally. Patients will be randomised to 1 of 2 arms ?? (1) gemcitabine/carboplatin with the study drug OR (2) gemcitabine/carboplatin without the study drug.In the UK, the study will be conducted by specialist oncologists at NHS hospitals in England, and Scotland at the hospital Oncology Units and specialised cancer care centres.The study is expected to last for up to 2 years.
REC name
London - Riverside Research Ethics Committee
REC reference
10/H0706/81
Date of REC Opinion
14 Jan 2011
REC opinion
Further Information Favourable Opinion