Survival imProvement in Lung cancEr iNduced by DenOsUmab theRapy

PHASE3TerminatedINTERVENTIONAL
Enrollment

595

Participants

Timeline

Start Date

January 6, 2015

Primary Completion Date

February 29, 2020

Study Completion Date

February 29, 2020

Conditions
Lung Cancer Non-small Cell Stage IV
Interventions
DRUG

Denosumab

Denosumab: 120 mg, s.c. every 3-4 weeks (in cycle 1 additional dose on day 8) until unacceptable toxicity, patient refusal or patient's death (max. 4 years 3 months).

OTHER

None, standard chemotherapy only

"Possible standard chemotherapies (3 weeks cycles, duration: 4 - 6 cycles):~Cisplatin 75 mg/m2 as an infusion on day 1 Gemcitabine 1250 mg/m2 as an infusion days 1 and 8 or Carboplatin AUC 5 as an infusion on day 1 Gemcitabine 1000 mg/m2 as an infusion days 1 and 8 or Cisplatin 75 mg/m2 as an infusion on day 1 Pemetrexed 500 mg/m2 as an infusion on day 1 or Carboplatin AUC 5 as an infusion on day 1 Pemetrexed 500 mg/m2 as an infusion on day 1"

Trial Locations (66)

3600

Onkologiezentrum Berner Oberland, Thun

5000

Clinique et Maternite Sainte Elisabeth, Namur

6016

Kantonsspital Luzern, Lucerne

8401

Kantonsspital Winterthur, Winterthur

14000

Centre Hospitalier Regional De La Citadelle, Liège

20900

Ospedale San Gerardo, Monza

29606

Hôpitale de la Cavale Blanche - CHRU de BREST, Brest

60021

Centre Hospitalier De Beauvais, Beauvais

69655

Hôpital de Villefranche-sur-Saône, Villefranche-sur-Saône

Unknown

Univ. Klinik für Innere Medizin V, Innsbruck

KH der Elisabethinen Linz, Linz

AKH Wien, Vienna

Otto-Wagner-Spital Department 1, Vienna

Otto-Wagner-Spital Department 2, Vienna

Onze Lieve Vrouw Ziekenhuis, Aalst

University Hosptial Ghent, Ghent

Centre hospitalier universitaire d'Angers, Angers

Centre Hospitalier Annecy, Annecy

GHPSO (Sie de Creil), Creil

Centre Hospitalier Intercommunal Creteil, Créteil

Hospital Center Le Mans, Le Mans

Hôpital du Cluzeau, Limoges

CHBS Lorient, Lorient

Hôpital Louis Pradel, Lyon

Assistance Publique-Hôitaux de Marseille, Marseille

Institut Paoli-Calmettes, Marseille

Centre Hospitalier de Meaux, Meaux

Centre Hospitalier Universitaire Rennes, Rennes

Clinique Mutualiste de l'Estuaire, Saint-Nazaire

CHICAS, Sisteron

ASKLEPIOS - Fachkliniken München - Gauting, München

Pius Hospital, Oldenburg

Cork University Hospital, Cork

Beaumont Hospital, Dublin

Mater Miscordia University Hospital, Dublin

Mater Private Hospital, Dublin

St James's Hospital, Dublin

The Adelaide and Meath Hospital, Dublin

University Hospital Galway, Galway

University Hospital Limerick, Limerick

Hospital Waterford, Waterford

S.G Moscati Hospital, Aversa

IRCCS Azienda Ospedaliera Universitaria San Martino, Genova

San Paolo Hospital, Milan

Maria Sklodowska-Curie Memorial Car, Gliwice

University Clinic Golnik, Golnik

Institute of Oncology Ljubljana, Ljubljana

Hospital General de Alicante, Alicante

Institut Català d'Oncologia - L'Hospitalet, Barcelona

Hospital General Castellón, Castelló

Hospital Universitario Reina Sofia, Córdoba

Complejo Hospitalario de Jaén, Jaén

H. U. Insular Gran Canaria, Las Palmas

Regional Universitario Carlos Haya, Málaga

H Morales Meseguer, Murcia

Hospital Son Espases, Palma de Mallorca

Hospital Arnau Vilanova Valencia, Valencia

Hospital Universitario Miguel Servet, Zaragoza

Kantonsspital Graubünden, Chur

HFR Fribourg, Fribourg

Centre Hospitalier Universitaire Vaudois, Lausanne

Universitätsspital Zürich, Zurich

Aberdeen Royal Infirmary, Aberdeen

Oxford University Hospitals Trust, Oxford

Weston Park Hospital, Sheffield

08025

Hospital De La Santa Creu I Sant Pau, Barcelona

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

European Organisation for Research and Treatment of Cancer - EORTC

NETWORK

collaborator

Amgen

INDUSTRY

lead

ETOP IBCSG Partners Foundation

NETWORK