A Randomized Controlled Trial Comparing Safety and Efficacy of Carboplatin and Paclitaxel Plus or Minus Sorafenib (BAY 43-9006) in Chemonaive Patients With Stage IIIB-IV Non-Small Cell Lung Cancer (NSCLC)

PHASE3TerminatedINTERVENTIONAL
Enrollment

926

Participants

Timeline

Start Date

February 28, 2006

Primary Completion Date

October 31, 2007

Study Completion Date

February 28, 2009

Conditions
Carcinoma, Non-Small Cell Lung
Interventions
DRUG

Nexavar (Sorafenib, BAY43-9006) + carboplatin + paclitaxel

Chemotherapy Phase up to 6 cycles: Sorafenib (Nexavar, BAY43-9006), \[400 mg orally, twice daily\] on Study Days 2-19 and paclitaxel (P) (200 mg/m2, intravenous (IV)) and carboplatin (C) (area under the curve (AUC) =6 mg/ml\*min-1, IV) on Study Day 1. The cycle duration 21 days. Maintenance Phase: Sorafenib 400 mg orally twice daily was administered on Days 1-21 of each 21-day cycle.

DRUG

Carboplatin plus Paclitaxel

Chemotherapy Phase up to 6 cycles: Sorafenib Placebo (2 tablets orally twice daily\] on Study Days 2-19 and paclitaxel (200 mg/m2, intravenous (IV)) and carboplatin (area under the curve (AUC) =6 mg/ml\*min-1, IV) on Study Day 1. The cycle duration 21 days. Maintenance Phase: Sorafenib Placebo 2 tablets orally twice daily was administered on Days 1-21 of each 21-day cycle.

Trial Locations (202)

110

Taipei

333

Taoyuan District

1200

Bruxelles - Brussel

1529

Budapest

1684

El Palomar - Morón

2000

Rosario

2045

Törökbálint

2444

Port Macquarie

2500

Wollongong

3144

Melbourne

3199

Frankston

3233

Mátraháza

4000

Liège

4029

Brisbane

5065

Adelaide

5703

Gyula

6000

Perth

Charleroi

6772

Deszk

7100

La Louvière

10029

New York

10043

Orbassano

10126

Torino

10305

Staten Island

12200

Berlin

14073

Caen

14622

Rochester

16132

Genova

17901

Pottsville

18015

Bethlehem

18103

Allentown

18840

Sayre

19115

Philadelphia

20162

Milan

21075

Hamburg

22031

Fairfax

22927

Großhansdorf

23230

Richmond

24128

Bergamo

24211

Abingdon

24641

Richlands

26121

Oldenburg

26505

Morgantown

27100

Pavia

28006

Madrid

28034

Madrid

28222

Majadahonda

29403

Charleston

29615

Greenville

30060

Marietta

30309

Atlanta

30625

Hanover

31405

Savannah

32804

Orlando

32806

Orlando

32952

Merritt Island

33805

Lakeland

35211

Birmingham

36001

Pontevedra

36608

Mobile

37075

Göttingen

37920

Knoxville

39401

Hattiesburg

40215

Louisville

40705

Taichung

43100

Parma

43213

Columbus

43235

Columbus

44622

Dover

45122

Essen

45136

Essen

45429

Dayton

46202

Indianapolis

46254

Indianapolis

46260

Indianapolis

46815

Fort Wayne

46902

Kokomo

48106

Ann Arbor

48202

Detroit

49021

Zamora

50009

Zaragoza

51101

Sioux City

51375

Leverkusen

53215

Milwaukee

54100

Nancy

55131

Mainz

57000

Metz

58122

Fargo

58501

Bismarck

58675

Hemer

60076

Skokie

60077

Skokie

60637

Chicago

63141

St Louis

64111

Kansas City

64131

Kansas City

65109

Jefferson City

65719

Hofheim

67100

Strasbourg

67214

Wichita

67502

Hutchinson

68167

Mannheim

68510

Lincoln

69126

Heidelberg

70006

Metairie

70808

Baton Rouge

72205

Little Rock

72764

Springdale

73104

Oklahoma City

74136

Tulsa

76262

Trophy Club

80218

Denver

80336

München

82131

Gauting

84112

Salt Lake City

85715

Tucson

89102

Las Vegas

89106

Las Vegas

90057

Los Angeles

91595

Burbank

92024

Encinitas

92140

Clamart

92346

Highland

92801

Anaheim

92829

Corona

92868

Orange

93009

Bobigny

95817

Sacramento

97213

Portland

115478

Moscow

117837

Moscow

135710

Seoul

138736

Seoul

143423

Moscow

198255

Saint Petersburg

14784400

Barretos

30380490

Belo Horizonte

34000000

Nova Lima

40050410

Salvador

70390907

Brasília

90619900

Porto Alegre

90211-1850

Beverly Hills

02130

Boston

01201

Pittsfield

07601

Hackensack

07962-1089

Morristown

37232-6307

Nashville

23298-0037

Richmond

B1900AVG

La Plata

B7602CBM

Mar del Plata

C1405DCS

Buenos Aires

C1426ANZ

Capital Federal-Buenos Aires

S3000FFV

Santa Fé

60336-550

Fortaleza

60430-230

Fortaleza

74605-180

Goiânia

80730-180

Curitiba

91350-200

Porto Alegre

89202-050

Joinville

17210-120

Jaú

14015-140

Ribeirão Preto

09090-780

Santo André

01331010

São Paulo

04024-002

São Paulo

05403-000

São Paulo

Unknown

São Paulo

Santiago

Hong Kong

18030-510

Sorocaba

V7L 2L7

North Vancouver

L4M 6M2

Barrie

L6W 3X4

Brampton

H3T 1E2

Montreal

S4T 7T1

Regina

838-0455

Santiago

760 0448

Santiago

836-0156

Santiago

06102

Nice

06156

Perugia

00152

Roma

5623 EJ

Eindhoven

8011 JW

Zwolle

80-952

Gdansk

31-115

Krakow

10-228

Olsztyn

05-400

Otwock

02-781

Warsaw

04-141

Warsaw

53-439

Wroclaw

00921

San Juan

110-799

Seoul

03010

Alicante

03202

Elche

08036

Barcelona

801 87

Gävle

171 76

Stockholm

751 85

Uppsala

PL6 8DH

Plymouth

BH7 7DW

Bornemouth

LE1 5WW

Leicester

SE1 9RT

London

M23 9LT

Manchester

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Bayer

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