An open-label phase II trial of erlotinib and bevacizumab in patients with advanced non-small cell lung cancer and activating EGFR mutations

BELIEF: Bevacizumab and ErLotinib In EGFR mut+ NSCLC 

The BELIEF trial was designed to assess the long-term outcome of patients with advanced non-squamous NSCLC with activating EGFR mutations (L858R and exon 19 deletion) with or without T790M resistance mutation at diagnosis and treated with the combination of erlotinib and bevacizumab.

The final accrual goal of 109 was reached in October 2014 and the results of the primary analysis were published in Lancet Respiratory Medicine 2017; 5 (5): 435-444.

Trial Scheme

 

Trial Information

Primary Endpoint:
Progression free survival
Secondary Endpoints:
Overall survival
Time to treatment failure
Objective response rate
Disease control rate
Duration of response
Sample Size:
102 Patients 
Final Accrual:
109 Patients
Protocol Release Date:
January 2012 / AMD1 November 2013
Trial Activation Date:
27 April 2012
First Patient In:
11 June 2012
Accrual Closure Date:
28 January 2015
Global Trial Completion Date:
19 October 2018

Trial Organisation

Trial Chair:
Rafael Rosell
Trial Co-Chair:
Rolf Stahel
Sponsor:
ETOP
Coordinating Groups:
ETOP in collaboration with Spanish Lung Cancer Group (SLCG)
Participating Groups:
Hellenic Oncology Research Group (HORG), All-Ireland Cooperative Oncology Research Group (ICORG), Swiss Group for Clinical Cancer Research (SAKK) and Spanish Lung Cancer Group (SLCG)
Participating Countries:
France, Greece, Ireland, Italy, Spain, Switzerland, United Kingdom
Registrations:
EudraCT number: 2011-004481-15 
ClinicalTrials.gov:  NCT01562028

Contact

ETOP IBCSG Partners Foundation
Effingerstrasse 33
3008 Bern, Switzerland
contact@etop.ibcsg.org