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Spots Global Cancer Trial Database for BELIEF (Bevacizumab and ErLotinib In EGFR Mut+ NSCLC)

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Trial Identification

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

Conditions

Lung Cancer

Study Description

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

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

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

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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