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BELIEF (Bevacizumab and ErLotinib In EGFR Mut+ NSCLC)
Sponsor: ETOP IBCSG Partners Foundation
Summary
Rationale: Advanced non-small-cell lung cancer (NSCLC) patients harbouring epidermal growth factor receptor (EGFR) mutations (del19 or L858R) show an impressive progression-free survival between 9 and 14 months when treated with erlotinib. However, the presence of EGFR mutations can only imperfectly predict outcome. The investigators hypothesize that progression-free survival could be influenced both by the pretreatment EGFR T790M mutation and by components of DNA repair pathways. The investigators propose a model of treatment whereby patients with EGFR mutations (single or with T790M) can attain a benefit with longer overall PFS when treated with erlotinib plus bevacizumab. When the patients are grouped by BRCA1 mRNA levels and T790M the hypothesis is that the combination of erlotinib plus bevacizumab can improve the PFS in all subgroups.
Official title: An Open-label Phase II Trial of Erlotinib and Bevacizumab in Patients With Advanced Non-small Cell Lung Cancer and Activating EGFR Mutations
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
109
Start Date
2012-06
Completion Date
2018-10-31
Last Updated
2026-08-26
Healthy Volunteers
No
Conditions
Interventions
Erlotinib
Patients will be treated with erlotinib, 150 mg p.o., daily
Bevacizumab
Patients will be treated with bevacizumab 15 mg/kg i.v. on day 1 of each 3-week cycle (+/- 3 days)
Locations (48)
Centre Francois Baclesse
Caen, France
Hôpital de Marseille
Marseille, France
Hospital Grosshansdorf
Großhansdorf, Germany
Thoraxklinik Heidelberg GmbH
Heidelberg, Germany
Lungenklinik Hemer
Hemer, Germany
Universitätsklinikum Ulm
Ulm, Germany
University General Hospital of Heraklion
Heraklion, Greece
Papageorgias Hospital
Thessaloniki, Greece
St Vincent's University Hospital
Dublin, Ireland
St. James's Hospital
Dublin, Ireland
University Hospital Galway
Galway, Ireland
Mid-Western Regional Hospital
Limerick, Ireland
AMCCH
Tallaght, Ireland
Ospedale San Gerardo
Monza, Italy
Istituto Oncologico Veneto IRCCS
Padova, Italy
Casa di Cura Maddalena
Palermo, Italy
Policlinico Tor Vergata Roma
Roma, Italy
San Camillo Hospital
Roma, Italy
Policlinico Umberto
Roma, Italy
Hospital General Universitario Alicante
Alicante, Spain
ICO - Hospital Universitari Germans Trias i Pujol
Badalona, Spain
Hospital De La Santa Creu I Sant Pau
Barcelona, Spain
Vall d'Hebron University Hospital
Barcelona, Spain
Hospital Clínic Barcelona
Barcelona, Spain
ICO - Girona
Girona, Spain
ICO - Hospital Duran i Reynals
L'Hospitalet de Llobregat, Spain
Hospital Clinico Universitario San Carlos
Madrid, Spain
Hospital 12 de Octubre
Madrid, Spain
Hospital General de Valencia
Valencia, Spain
Hospital La Fe
Valencia, Spain
University Hospital Basel
Basel, Switzerland
Istituto Oncologica della Svizzera Italiana
Bellinzona, Switzerland
Inselspital Bern
Bern, Switzerland
Geneva University Hospital
Geneva, Switzerland
Fondation du centre Pluridisciplinaire d'Oncologie (CePO)
Lausanne, Switzerland
Kantonsspital Luzern
Lucerne, Switzerland
Kantonsspital St. Gallen
Sankt Gallen, Switzerland
Onkologiezentrum Berner Oberland
Thun, Switzerland
Kantonsspital Winterthur
Winterthur, Switzerland
University Hospital Zurich
Zurich, Switzerland
Mid Essex Hospital Services NHS Trust
Chelmsford, Essex, United Kingdom
Queen's Hospital
Burton-on-Trent, United Kingdom
University Hospitals of Leicester
Leicester, United Kingdom
Royal Marsden Hospital
London, United Kingdom
Kent Oncology Centre
Maidstone, United Kingdom
Christie Hospital Manchester
Manchester, United Kingdom
Wythenshawe Hospital Manchester
Manchester, United Kingdom
Wrexham Maelor Hospital
Wrexham, United Kingdom