Study of Cisplatin/Vinorelbine +/- Cetuximab as First-line Treatment of Advanced Non Small Cell Lung Cancer (FLEX)

PHASE3CompletedINTERVENTIONAL
Enrollment

1,861

Participants

Timeline

Start Date

October 31, 2004

Primary Completion Date

July 31, 2007

Study Completion Date

May 31, 2012

Conditions
Non Small Cell Lung Cancer (NSCLC)
Interventions
DRUG

cetuximab + cisplatin + vinorelbine

cetuximab given as an intravenous (i.v.) infusion every week (400mg/m\^2 initial dose and 250mg/m\^2 subsequent doses) until progressive disease (PD) + cisplatin 80mg/m\^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m\^2 i.v. infusion on days 1 and 8 of each 3-week cycle.

DRUG

cisplatin + vinorelbine

cisplatin 80mg/m\^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m\^2 i.v. infusion on days 1 and 8 of each 3-week cycle.

Trial Locations (118)

Unknown

Research Site, Buenos Aires

Research Site, Córdoba

Research Site, Adelaide

Research Site, Melbourne

Research Site, Randwick

Research Site, Sydney

Research Site, Wodonga

Research Site, Vienna

Research Site, Brussels

Research Site, Charleroi

Research Site, Liège

Research Site, Porto Alegre

Research Site, São Paulo

Research Site, Pleven

Research Site, Sofia

Research Site, Stara Zagora

Research Site, Veliko Tarnovo

Research Site, Antofagasta

Research Site, Santiago

Research Site, Brno

Research Site, Ostrava

Research Site, Pilsen

Research Site, Prague

Research Site, Brest

Research Site, Caen

Research Site, Grenoble

Research Site, Marseille

Research Site, Paris

Research Site, Poitiers

Research Site, Rennes

Research Site, Rouen

Research Site, Strasbourg

Research Site, Augsburg

Research Site, Berlin

Research Site, Cologne

Research Site, Essen

Research Site, Freiburg im Breisgau

Research Site, Gauting

Research Site, Göttingen

Research Site, Großhansdorf

Research Site, Halle-Dölau

Research Site, Hamburg

Research Site, Heidelberg

Research Site, Löwenstein

Research Site, Magdeburg

Research Site, Mainz

Research Site, München

Research Site, Stralsund

Research Site, Wuppertal

Research Site, Honh Kong

Research Site, Budapest

Research Site, Nyiregyháza

Research Site, Székesfehérvár

Research Site, Szombathely

Research Site, Törökbálint

Research Site, Zalegerzeg-Pózva

Research Site, Dublin

Research Site, Bologna

Research Site, Carpi

Research Site, Milan

Research Site, Rome

Research Site, Rozzano-Milano

Research Site, Treviglio

Research Site, Mexico City

Research Site, Monterrey

Research Site, Amsterdam

Research Site, Nieuwegeln

Research Site, Zwolle

Research Site, Bydgoszcz

Research Site, Olsztyn

Research Site, Otwock

Research Site, Posnan

Research Site, Warsaw

Research Site, Wroclaw

Research Site, Moscow

Research Site, Saint Petersburg

Research Site, Singapore

Research Site, Banská Bystrica

Research Site, Bratislava

Research Site, Nitra-Zobor

Research Site, Poprad

Research Site, Seoul

Research Site, Barakaldo (Bilbao)

Research Site, Barcelona

Research Site, Donostia / San Sebastian

Research Site, Elche Alicante

Research Site, Granollers

Research Site, Madrid

Research Site, Pamplona

Research Site, Pontevedra

Research Site, Santander

Research Site, Terrassa

Research Site, Valencia

Research Site, Stockholm

Research Site, Uppsala

Research Site, Bern

Research Site, Thun

Research Site, Zurich

Research Site, Taipei

Research Site, Taipei

Research Site, Ankara

Research Site, Dnipropetrovsk

Research Site, Kharkiv

Research Site, Kyiv

Research Site, Lviv

Research Site, Poltava

Research Site, Sumy

Research Site, Ternopil

Research Site, Uzhhorod

Research Site, Aberdeen

Research Site, Bristol

Research Site, Edinburgh

Research Site, Leicester

Research Site, London

Research Site, Newcastle upon Tyne

Research Site, Poole

Research Site, Sutton

Research Site, Wolverhampton

All Listed Sponsors
lead

Merck KGaA, Darmstadt, Germany

INDUSTRY

NCT00148798 - Study of Cisplatin/Vinorelbine +/- Cetuximab as First-line Treatment of Advanced Non Small Cell Lung Cancer (FLEX) | Biotech Hunter | Biotech Hunter