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. Treatment and follow-up are still ongoing.

Trial Scheme

Trial Design

 

 

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
Accrual Closure Date: 28 January 2015
Last Patient Last Visit: 19 October 2018
   

Trial Organisation

Trial Chair: Rafael Rosell
Trial Co-Chair: Rolf Stahel
Sponsor: ETOP
Coordinating Groups: ETOP in collaboration with SLCG
Participating Groups: HORG, ICORG, SAKK and SLCG
Participating Countries:
France, Germany, Greece, Ireland, Italy, Spain, Switzerland and United Kingdom
Registrations:

EudraCT number: 2011-004481-15 

ClinicalTrials.gov: NCT01562028

 

Contact

Virginia Rodriguez Martinez (Trial Manager)

Tel: +41 31 511 94 48

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European Thoracic Oncology Platform
c/o IBCSG
Effingerstrasse 40
3008 Bern, Switzerland
Tel: +41 31 511 94 00