NCT00449033 - A Phase III Randomized, Double-blind, Placebo Controlled Trial Comparing the Efficacy of Gemcitabine, Cisplatin and Sorafenib to Gemcitabine, Cisplatin and Placebo in First-Line Treatment of Patients With Stage IIIb With Effusion and Stage IV Non-Small Cell Lung Cancer (NSCLC) | Biotech Hunter

Enrollment

904

Participants

Timeline

Start Date

February 28, 2007

Primary Completion Date

April 30, 2010

Study Completion Date

June 30, 2011

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

DRUG

Sorafenib (Nexavar, BAY43-9006)

Multikinase inhibitor, Sorafenib 400 mg po bid; applied in combination with chemotherapy components: Gemcitabine 1250 mg/m\^2 IV, Cisplatin 75 mg/m\^2 IV

DRUG

Placebo

Placebo 2 tablets po bid; applied in combination with chemotherapy components: Gemcitabine 1250 mg/m\^2 IV, Cisplatin 75 mg/m\^2 IV

DRUG

Gemcitabine

Chemotherapy component; Gemcitabine 1250 mg/m\^2 IV

DRUG

Cisplatin

Chemotherapy component; Cisplatin 75 mg/m\^2 IV

Trial Locations (122)

1121

Budapest

1125

Budapest

1130

Vienna

1140

Vienna

1200

Bruxelles - Brussel

1205

Genéve

2006

Nicosia

2045

Törökbálint

2650

Edegem

2930

Brasschaat

3000

Leuven

3010

Bern

3233

Mátraháza

4000

Liège

4010

Linz

4031

Basel

5000

Namur

6020

Innsbruck

6772

Deszk

8000

Székesfehérvár

11527

Athens

13275

Marseille

14080

Mexico City

15006

A Coruña

20052

Monza

20089

Rozzano

20132

Milan

21075

Hamburg

21540

Preitilä

22927

Großhansdorf

28040

Madrid

28041

Madrid

29010

Málaga

30122

Venezia

30907

Nîmes

33081

Aviano

37044

Tours

37134

Verona

38043

Grenoble

38100

Grenoble

40138

Bologna

41013

Seville

44280

Guadalajara

44805

Nantes

45122

Essen

46010

Valencia

46014

Valencia

46015

Valencia

48903

Cruces/Barakaldo

50134

Florence

51109

Cologne

57124

Livorno

58100

Holon

60431

Frankfurt am Main

64100

Bayonne

64460

Monterrey

65719

Hofheim

66000

Perpignan

67901

Strasbourg

69126

Heidelberg

69495

Pierre-Bénite

72015

Le Mans

74245

Löwenstein

75908

Paris

76137

Karlsruhe

82131

Gauting

83400

Hyères

95122

Catania

99437

Bad Berka

100021

Beijing

200030

Shanghai

200433

Shanghai

210002

Nanjing

310016

Hangzhou

310022

Hangzhou

430030

Wuhan

510060

Guangzhou

4428164

Kfar Saba

5262000

Tel Litwinsky

7610001

Rehovot

7830604

Ashkelon

40050410

Salvador

74075040

Goiânia

40170-070

Salvador

41820 021

Salvador

70840 901

Brasília

74605-070

Goiânia

30110-090

Belo Horizonte

20231 050

Rio de Janeiro

90050 170

Porto Alegre

90610-000

Porto Alegre

17210-120

Jaú

09060-870

Santo André

09090-780

Santo André

01221020

São Paulo

01331020

São Paulo

05403-010

São Paulo

05651-901

São Paulo

18030-510

Sorocaba

H3A 1A1

Montreal

00029

HUS

FIN-33521

Tampere

04207

Leipzig

711 10

Heraklion

00152

Roma

07100

Sassari

5211 RW

's-Hertogenbosch

6716 RP

Ede

3844 DG

Harderwijk

6419 PC

Heerlen

3435 CM

Nieuwegein

08025

Barcelona

08227

Terrassa

CB2 0QQ

Cambridge

AB25 2ZN

Aberdeen

LE1 5WW

Leicester

SE1 9RT

London

SW3 6JJ

London

SM2 5PT

Sutton

WV10 0QP

Wolverhampton

B15 2TH

Birmingham