Study to Test a New Drug for Treating Non-small Cell Lung Cancer
Research type
Research Study
Full title
A Phase II study of the selective BRAF kinase inhibitor GSK2118436 in subjects with advanced non-small cell lung cancer and BRAF mutations
IRAS ID
100166
Contact name
Sanjay Popat
Sponsor organisation
GlaxoSmithKline
Eudract number
2011-001161-41
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
105,032, IND Number
Duration of Study in the UK
5 years, 11 months, 28 days
Research summary
For patients diagnosed with advanced non-small cell lung cancer (NSCLC), conventional cytotoxic chemotherapy remains the standard treatment and offers only a modest survival benefit. Therefore, more innovative approaches are needed to improve the therapy of this deadly disease. One approach is to identify specific genetic changes in different lung cancer patients and treat them with agents directed against those genetic changes. One specific genetic change is present in approximately 2% of non small cell lung cancers is a BRAF mutation. BRAF is a cellular protein that regulates cell growth, proliferation and differentiation. Importantly, most cancer cells harboring this V600E BRAF mutation display a an unnatural tendency for increased growth and survival, and are extremely sensitive to selective BRAF and MEK inhibitors. Although relatively uncommon in NSCLC, V600 BRAF mutations may identify a subset of lung cancers sensitive to BRAF inhibition, hopefully resulting in significantly improved outcomes for these patients. This study, sponsored by GlaxoSmithKline of 40 patients in the US, France and the UK will investigate the effects of GSK2118436 administered orally as a single agent to subjects with stage IV or metastatic relapsed NSCLC whose tumours carry a V600E BRAF mutation and have progressed or relapsed after one or more prior chemotherapy regimens.Patients who full fill the study criteria will receive study drug until their disease progresses.
REC name
London - West London & GTAC Research Ethics Committee
REC reference
12/LO/0847
Date of REC Opinion
20 Sep 2012
REC opinion
Further Information Favourable Opinion