BELIEF (Bevacizumab and ErLotinib In EGFR mut+ NSCLC)
Research type
Research Study
Full title
An open-label phase II trial of erlotinib and bevacizumab in patients with advanced non-small cell lung cancer and activating EGFR mutations
IRAS ID
101596
Contact name
Sanjay Popat
Sponsor organisation
ETOP (European Thoracic Oncology Platform)
Eudract number
2011-004481-15
Clinicaltrials.gov Identifier
Research summary
This is a multinational, multi-center phase II trial of Erlotinib, an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) plus Bevacizumab, a humanised antibody targeting vascular endothelial growth factor (VEGF), in 102 patients with advanced non-squamous non-small cell lung cancer (NSCLC) harbouring EGFR mutations. Its primary objective is to determine long-term outcome of these patients treated with this combination of treatment (progression free survival, PFS). EGFR TKIs such as Erlotinib have been shown to be superior to chemotherapy in the treatment of patients with advanced NSCLC with activating EGFR mutations. However, a proportion of patients with activating mutations in EGFR acquire other mutations which confer resistance to these EGFR TKIs. The aim of this study is to determine whether this combination of an EGFR TKI and Bevacizumab, is superior to an EGFR TKI alone. Secondary objectives include evaluation of overall survival (OS), time to treatment failure (TTF), objective response rate (ORR), disease control rate and duration of response. Safety and tolerability of the combination of Erlotinib and Bevacizumab will be assessed. Serum will be taken to monitor EGFR mutations longitudinally and to assess biomarkers related to EGFR TKI and Bevacizumab treatment and its pathways of resistance. Tumour specimens will be assessed for EGFR mutations. Information from this study will potentially allow for recommendations to be made on future therapy for patients in this setting based on tumour and serum biomarker characteristics at the time of disease progression.
REC name
London - South East Research Ethics Committee
REC reference
12/LO/1295
Date of REC Opinion
17 Jan 2013
REC opinion
Further Information Favourable Opinion