Study

EORTC-08111-LCG

A randomised, open-label phase III trial evaluating the addition of denosumab to standard first-line anticancer treatment in advanced NSCLC

Study documentation Back to result

Trial Status

LT-FU ongoing

Dates

Date of activation: 11-Dec-2014
Date Step1 close: 31-Jan-2018
Date Step2 close: 31-Jan-2018

Data management at EORTC

Yes

Design

Phase 3
Randomized open label

Targeted Sample size

EORTC Groups: 500 - All Groups: 1000

Treatment

Drug
Pemetrexed, Carboplatin, Cisplatin, Gemcitabine, Denosumab

Study Staff

  • Sarah Danson (Study Coordinator), Sheffield Teaching Hospitals NHS Foundation Trust - Weston Park Hospital, Sheffield
  • Beatrice Fournier (Clinical Scientist), EORTC Headquarters, Brussels
  • Herve Azobou (Statistical Analyst), EORTC Headquarters, Brussels
  • Ellen Peeters (Clinical Operations Manager), EORTC Headquarters, Brussels
  • Yuliya Vostrikova (Data Manager), EORTC Headquarters, Brussels
  • Hadi Almidani (Pharmacovigilance Manager), EORTC Headquarters, Brussels
  • Sandrine Rivrain (Pharmacovigilance Manager), EORTC Headquarters, Brussels
  • Leslie Herman (Regulatory Affairs Manager), EORTC Headquarters, Brussels

Type of cancer

  • Lung

Participating groups

  • EORTC Lung Cancer Group
  • ETOP IBCSG Partners Foundation

Recruiting centers

  • A.O Landeskrankenhaus - Innsbruck Universitaetsklinik (Innsbruck, Austria)
  • AZ Delta - Campus Rumbeke (Roeselare, Belgium)
  • AZORG (previous Onze Lieve Vrouw ZK) (Aalst, Belgium)
  • Asklepios Fachkliniken Muenchen-Gauting (Gauting, Germany)
  • Azienda Sociosanitaria Territoriale Santi Paolo E Carlo (Milano, Italy)
  • Beaumont Hospital (Dublin, Ireland)
  • CHU Site Sainte-Elisabeth-UCL Namur (Namur, Belgium)
  • CHU d'Angers (ANGERS CEDEX 9, France)
  • CHU de Limoges - Hopital Universitaire Du Cluzeau (LIMOGES CEDEX 1, France)
  • CHU de Lyon - Hopital Louis Pradel (BRON, France)
  • CHU de Rennes - Hôpital de Pontchaillou (RENNES CEDEX 9, France)
  • Centre Hopitalier Intercommunal De Creteil (Creteil, France)
  • Centre Hospitalier Bretagne Sud - Site du Scorff (LORIENT CEDEX, France)
  • Centre Hospitalier General le Mans (Le Mans, France)
  • Centre Hospitalier Intercommunal des Alpes du Sud - Gap (GAP CEDEX, France)
  • Centre Hospitalier Regional De La Citadelle (Liege, Belgium)
  • Centre Hospitalier Simone Veil De Beauvais (Beauvais, France)
  • Centre Hospitalier Universitaire Vaudois - Lausanne (Lausanne, Switzerland)
  • Complejo Hospitalario Universitario Insular Materno Infantil (Las Palmas de Gran Canaria, Spain)
  • Grand Hopital De L Est Francilien (MEAUX CEDEX, France)
  • HFR Fribourg – Hôpital cantonal (Fribourg / Freiburg, Switzerland)
  • Hopital Nord (APHM) (Marseille, France)
  • Hospi Grand Ouest - Clinique Mutualiste de l’Estuaire (Saint Nazaire, France)
  • Hospital Arnau de Vilanova (Valencia, Spain)
  • Hospital De La Santa Creu I Sant Pau (Barcelona, Spain)
  • Hospital General Universitario Doctor Balmis (Alicante, Spain)
  • Hospital General Universitario Dr Morales Meseguer (Murcia, Spain)
  • Hospital Provincial De Castellon (Castellon, Spain)
  • Hospital Universitari Son Espases (Palma De Mallorca, Spain)
  • Hospital Universitario Regional de Malaga (Malaga, Spain)
  • Hospital Universitario Reina Sofia (Cordoba, Spain)
  • Hospital Universitario de Jaen (Jaen, Spain)
  • Hospital Unviersitario Miguel Servet (Zaragoza, Spain)
  • ICO Badalona - Hospital Germans Trias i Pujol (Institut Catala D'Oncologia) (Badalona - (Barcelona), Spain)
  • IRCCS Ospedale San Martino (Genova, Italy)
  • Inselspital (Bern, Switzerland)
  • Institut Paoli-Calmettes (MARSEILLE CEDEX 09, France)
  • Kantonsspital Graubuenden (Chur, Switzerland)
  • Kantonsspital Winterthur (Winterthur, Switzerland)
  • Les Hopitaux Nord-Ouest (VILLEFRANCHE SUR SAONE CEDEX, France)
  • Luzerner Kantonsspital (Luzern, Switzerland)
  • Maria Sklodowska-Curie National Research Institute of Oncology (Warsaw, Poland)
  • Mater Misericordia University Hospital (Dublin, Ireland)
  • Meir Hospital (Kfar Saba, Israel)
  • NHS Grampian - Aberdeen Royal Infirmary (Aberdeen, United Kingdom)
  • Ordensklinikum Linz-Elisabethinen (Linz, Austria)
  • PIUS Hospital Oldenburg (Oldenburg, Germany)
  • Rabin Medical Center - Tel Aviv (Petah Tikva, Israel)
  • Rambam Health Care Campus, Oncology Institute (Haifa, Israel)
  • Sheffield Teaching Hospitals NHS Foundation Trust - Weston Park Hospital (Sheffield, United Kingdom)
  • St. James'S Hospital (Dublin, Ireland)
  • St. Vincent'S University Hospital (Dublin 4, Ireland)
  • Tallaght University Hospital (Dublin, Ireland)
  • Tel Aviv Sourasky Medical Center (Tel Aviv, Israel)
  • The Institute Of Oncology (Ljubljana, Slovenia)
  • UniversitaetsSpital Zurich (Zurich, Switzerland)
  • Universitaetsklinikum Wien - AKH unikliniken (Vienna, Austria)
  • Universitair Ziekenhuis Gent (Gent, Belgium)
  • University Clinic Golnik (Golnik, Slovenia)
  • University Hospital Galway (Galway, Ireland)
  • University Hospital Limerick (Limerick, Ireland)
  • University Hospital Waterford (Waterford, Ireland)
  • Wiener Gesundheidsverbund - Klinik Penzing (Vienna, Austria)

Centers to be activated

  • Cork University Hospital (Cork, Ireland)
  • Spital STS AG Thun (Thun, Switzerland)

Protocol summary

http://clinicaltrials.gov/study/NCT02129699

NCT number

NCT02129699

EudraCT

2013-003156-21