First-line Treatment of Patients With Stage IV Nonsquamous Non-Small Cell Lung Cancer With Necitumumab (IMC-11F8) and Pemetrexed-Cisplatin

PHASE3CompletedINTERVENTIONAL
Enrollment

633

Participants

Timeline

Start Date

November 2, 2009

Primary Completion Date

November 14, 2012

Study Completion Date

December 23, 2020

Conditions
Non Small Cell Lung Cancer
Interventions
DRUG

Pemetrexed

500 milligram per square meter (mg/m2) administered Intravenously (I.V.) on Day 1 of every 3-week cycle, for a maximum of six cycles

DRUG

Cisplatin

75 mg/m2 administered I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles

BIOLOGICAL

Necitumumab

800 mg (absolute dose) on Days 1 and 8 of every 3-week cycle, administered as an I.V.

Trial Locations (101)

1090

ImClone Investigational Site, Vienna

1125

ImClone Investigational Site, Budapest

1130

ImClone Investigational Site, Vienna

1145

ImClone Investigational Site, Budapest

2045

ImClone Investigational Site, Törökbálint

2217

ImClone Investigational Site, Kogarah

2570

ImClone Investigational Site, Duffel

3165

ImClone Investigational Site, East Bentleigh

4000

ImClone Investigational Site, Liège

5000

ImClone Investigational Site, Namur

6772

ImClone Investigational Site, Deszk

6830

ImClone Investigational Site, Rankweil

7000

ImClone Investigational Site, Hobart

8000

ImClone Investigational Site, Székesfehérvár

9200

ImClone Investigational Site, Mosonmagyaróvár

9301

ImClone Investigational Site, Bloemfontein

9700

ImClone Investigational Site, Szombathely

10960

ImClone Investigational Site, Nyack

11527

ImClone Investigational Site, Athens

12200

ImClone Investigational Site, Berlin

14076

ImClone Investigational Site, Caen

16132

ImClone Investigational Site, Genova

20133

ImClone Investigational Site, Milan

21075

ImClone Investigational Site, Hamburg

22927

ImClone Investigational Site, Großhansdorf

26500

ImClone Investigational Site, Pátrai

28041

ImClone Investigational Site, Madrid

28050

ImClone Investigational Site, Madrid

28222

ImClone Investigational Site, Majadahonda

33081

ImClone Investigational Site, Aviano

39291

ImClone Investigational Site, Lostau

41013

Imclone Investigational Site, Seville

43100

ImClone Investigational Site, Parma

45136

ImClone Investigational Site, Essen

48149

ImClone Investigational Site, Münster

52100

ImClone Investigational Site, Pula

55041

ImClone Investigational Site, Lido di Camaiore

55131

ImClone Investigational Site, Mainz

58675

ImClone Investigational Site, Hemer

60487

ImClone Investigational Site, Frankfurt

65719

ImClone Investigational Site, Hofheim

69126

ImClone Investigational Site, Heidelberg

71110

ImClone Investigational Site, Heraklion, Crete

74245

ImClone Investigational Site, Löwenstein

75571

ImClone Investigational Site, Paris

76137

ImClone Investigational Site, Karlsruhe

81675

ImClone Investigational Site, München

82131

ImClone Investigational Site, Gauting

89081

ImClone Investigational Site, Ulm

93053

ImClone Investigational Site, Regensburg

150054

ImClone Investigational Site, Yaroslavi

153013

ImClone Investigational Site, Ivanovo

194044

ImClone Investigational Site, Saint Petersburg

197022

ImClone Investigational Site, Saint Petersburg

198255

ImClone Investigational Site, Saint Petersburg

200385

ImClone Investigational Site, Craiova, Dolj

400015

ImClone Investigational Site, Cluj-Napoca

450054

ImClone Investigational Site, Ufa

500366

ImClone Investigational Site, Brasov

550245

ImClone Investigational Site, Sibiu

610021

ImClone Investigational Site, Kirov

644013

ImClone Investigational Site, Omsk

700106

ImClone Investigational Site, Iași

14784-400

ImClone Investigational Site, Barretos - SP

70310-050

ImClone Investigational Site, Brasilia, Distrito Federal

74884-606

ImClone Investigational Site, Goiania - GO

98700-000

ImClone Investigational Site, Ijuí

88301-220

ImClone Investigational Site, Itajaí

95900-000

ImClone Investigational Site, Lajeado

90610-000

ImClone Investigational Site, Porto Alegre/RS

14015-130

ImClone Investigational Site, Ribeirão Preto - SP

40050-410

ImClone Investigational Site, Salvador

09090-780

ImClone Investigational Site, Santo Andre - SP

01246-000

ImClone Investigational Site, São Paulo - SP

H3T 1E2

ImClone Investigational Site, Montreal

06120

ImClone Investigational Site, Halle

03100

ImClone Investigational Site, Frosinone

06126

ImClone Investigational Site, Perugia

10-357

ImClone Investigational Site, Olsztyn

05-400

ImClone Investigational Site, Otwock

60-569

ImClone Investigational Site, Poznan

26-617

ImClone Investigational Site, Radom

70-891

ImClone Investigational Site, Szczecin

53-439

ImClone Investigational Site, Wroclaw

3041-801

ImClone Investigational Site, Coimbra

1649-035

ImClone Investigational Site, Lisbon

022328

ImClone Investigational Site, Bucharest

030171

ImClone Investigational Site, Bucharest

826 06

ImClone Investigational Site, Bratislava

949 88

ImClone Investigational Site, Nitra

0001

ImClone Investigational Site, Pretoria

08035

ImClone Investigational Site, Barcelona

08041

ImClone Investigational Site, Barcelona

08221

ImClone Investigational Site, Terrassa

08908

ImClone Investigational Site, L'Hospitalet de Llobregat

AB25 2ZN

ImClone Investigational Site, Aberdeen

BH7 7DW

ImClone Investigational Site, Bournemouth

EH4 2XU

ImClone Investigational Site, Edinburgh

GU2 7XX

ImClone Investigational Site, Guildford

LS16 6QB

ImClone Investigational Site, Leeds

PR2 9HT

ImClone Investigational Site, Preston

All Listed Sponsors
collaborator

Quintiles, Inc.

INDUSTRY

collaborator

Parexel

INDUSTRY

collaborator

PPD Development, LP

INDUSTRY

collaborator

Medidata Solutions

INDUSTRY

collaborator

Laboratory Corporation of America

INDUSTRY

collaborator

University of Colorado, Denver

OTHER

collaborator

Thermo Fisher Scientific, Inc

INDUSTRY

collaborator

Pacific Biomarkers

OTHER

collaborator

Intertek

INDUSTRY

collaborator

Sysmex Inostics GmbH

INDUSTRY

lead

Eli Lilly and Company

INDUSTRY