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Brief Title: BELIEF (Bevacizumab and ErLotinib In EGFR Mut+ NSCLC)
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
Study ID: NCT01562028
Brief 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.
Detailed Description: Objectives: 1. To determine long-term outcome of patients with advanced non-squamous NSCLC harbouring EGFR mutations with or without T790M mutation at diagnosis and treated with the combination of erlotinib and bevacizumab. Primary endpoint: progression-free survival 2. To evaluate the efficacy and tolerability of the combination 3. To evaluate the correlation of BRCA1 mRNA and AEG-1 mRNA expression and T790M with progression-free survival 4. To monitor EGFR mutations (including T790M) in serum and plasma longitudinally 5. To evaluate molecular biomarkers related to EGFR TKI and bevacizumab Design: This is a multinational, multi-center phase II trial of erlotinib plus bevacizumab in patients with advanced non-squamous NSCLC harbouring EGFR mutations confirmed by central re-assessment. Patients will be stratified into two subgroups, with and without EGFR T790M mutation. The stratification will be done after the inclusion of patients. Sample size: 102 patients
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
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, Luzern, , Switzerland
Kantonsspital St. Gallen, St. 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-upon-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
Name: Rafael Rosell, MD
Affiliation: Catalan Institute of Oncology, Hospital Germans Trias i Pujol
Role: STUDY_CHAIR
Name: Stahel Rolf, MD
Affiliation: Laboratory of Molecular Oncology, Clinic of Oncology, University Hospital Zuerich
Role: STUDY_CHAIR
Name: Miquel Taron
Affiliation: Medical Oncology Service-ICO, Hospital Germans Trias i Pujol
Role: STUDY_CHAIR