Assess Efficacy & Safety of Selumetinib in Combination With Docetaxel in Patients Receiving 2nd Line Treatment for v-Ki-ras2 Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Positive NSCLC

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

510

Participants

Timeline

Start Date

September 25, 2013

Primary Completion Date

June 7, 2016

Study Completion Date

December 31, 2025

Conditions
Locally Advanced or Metastatic Non Small Cell Lung Cancer Stage IIIb - IV
Interventions
DRUG

Selumetinib

Three 25 mg selumetinib capsules (Hyd-Sulfate) be administered orally, twice daily, (total dose 75 mg dose bd) on an uninterrupted schedule.

DRUG

Docetaxel

Docetaxel 75 mg/m2 will be administered intravenously on day 1 of each 21 day cycle.

DRUG

Placebo

Three placebo capsules will be administered orally uninterrupted twice daily in combination with docetaxel 75 mg/m2 intravenously administered on day 1 of each 21 day cycle.

DRUG

Pegylated G-CSF

All patients will receive pegylated Granulocyte Colony Stimulating Factor (G-CSF) at least 24 hours after administration of every docetaxel dose and not within 14 days prior to the next docetaxel administration.

Trial Locations (197)

1000

Research Site, Brussels

1090

Research Site, Brussels

1100

Research Site, Vienna

1121

Research Site, Budapest

1122

Research Site, Budapest

1160

Research Site, Vienna

1180

Research Site, Ciudad de Buenos Aires

1200

Research Site, Brussels

1233

Research Site, Sofia

1303

Research Site, Sofia

1330

Research Site, Sofia

1426

Research Site, Buenos Aires

2010

Research Site, Darlinghurst

2045

Research Site, Törökbálint

2050

Research Site, Camperdown

2217

Research Site, Kogarah

3000

Research Site, Leuven

Research Site, Vratsa

3065

Research Site, Fitzroy

3144

Research Site, Malvern

3355

Research Site, Wendouree

3529

Research Site, Miskolc

3780

Research Site, Edelény

4000

Research Site, Plovdiv

4020

Research Site, Linz

4032

Research Site, Chermside

4400

Research Site, Nyíregyháza

5000

Research Site, Córdoba

5011

Research Site, Woodville South

5020

Research Site, Salzburg

5037

Research Site, Kurralta Park

6020

Research Site, Innsbruck

7400

Research Site, Kaposvár

8800

Research Site, Roeselare

9000

Research Site, Ghent

9010

Research Site, Varna

9024

Research Site, Győr

10011

Research Site, New York

10032

Research Site, New York

10043

Research Site, Orbassano

13915

Research Site, Marseille

14080

Research Site, México

15033

Research Site, Lima

15046

Research Site, Miraflores

15073

Research Site, Lima

16100

Research Site, Genova

17033

Research Site, Hershey

19107

Research Site, Philadelphia

20132

Research Site, Milan

21079

Research Site, Dijon

22927

Research Site, Großhansdorf

26506

Research Site, Morgantown

27710

Research Site, Durham

28034

Research Site, Madrid

28041

Research Site, Madrid

29010

Research Site, Málaga

29609

Research Site, Brest

30318

Research Site, Atlanta

31059

Research Site, Toulouse

31096

Research Site, Haifa

33028

Research Site, Pembroke Pines

34662

Research Site, Istanbul

34844

Research Site, Istanbul

35033

Research Site, Rennes

35100

Research Site, Izmir

35110

Research Site, Izmir

36204

Research Site, Vigo(Pontevedra)

37203

Research Site, Nashville

37232

Research Site, Nashville

40022

Research Site, Sumy

41013

Research Site, Seville

43126

Research Site, Parma

44309

Research Site, Dortmund

45030

Research Site, Manisa

47441

Research Site, Moers

49100

Research Site, Petah Tikva

49102

Research Site, Dnipro

50009

Research Site, Zaragoza

50048

Research Site, Kryvyi Rih

50937

Research Site, Cologne

52621

Research Site, Tel Litwinsky

57100

Research Site, Livorno

58013

Research Site, Chernivtsі

59000

Research Site, Lille

60637

Research Site, Chicago

61070

Research Site, Kharkiv Region

63003

Research Site, Clermont-Ferrand

64239

Research Site, Tel Aviv

64460

Research Site, Monterrey

65199

Research Site, Wiesbaden

66424

Research Site, Homburg

69040

Research Site, Zaporizhzhia

69126

Research Site, Heidelberg

69310

Research Site, Pierre-Bénite

70006

Research Site, Metairie

70124

Research Site, Bari

70839

Research Site, Gerlingen

74245

Research Site, Löwenstein

75020

Research Site, Paris

80045

Research Site, Aurora

80131

Research Site, Napoli

81925

Research Site, München

86156

Research Site, Augsburg

88000

Research Site, Uzhhorod

89081

Research Site, Ulm

97080

Research Site, Würzburg

98104

Research Site, Seattle

99437

Research Site, Bad Berka

105229

Research Site, Moscow

115478

Research Site, Moscow

194291

Research Site, Saint Petersburg

197342

Research Site, Saint Petersburg

197758

Research Site, Saint Petersburg

400015

Research Site, Cluj-Napoca

400058

Research Site, Cluj-Napoca

400138

Research Site, Volgograd

420012

Research Site, Kazan'

4428164

Research Site, Kfar Saba

7500921

Research Site, Santiago

7520349

Research Site, Santiago

7630370

Research Site, Santiago

8360160

Research Site, Santiago

8380456

Research Site, Santiago

8410101

Research Site, Beersheba

8420383

Research Site, Santiago

02114

Research Site, Boston

02215

Research Site, Boston

01923

Research Site, Danvers

C1025ABI

Research Site, Buenos Aires

S2000KZE

Research Site, Rosario

14784-400

Research Site, Barretos

98700-000

Research Site, Ijuí

096015-280

Research Site, Pelotas

90035-003

Research Site, Porto Alegre

90610-000

Research Site, Porto Alegre

15090-000

Research Site, São José do Rio Preto

01209-000

Research Site, São Paulo

01246-000

Research Site, São Paulo

Unknown

Research Site, São Paulo

T6G 1Z2

Research Site, Edmonton

V1Y 5L3

Research Site, Kelowna

V3V 1Z2

Research Site, Surrey

B3H 1V7

Research Site, Halifax

L1G 2B9

Research Site, Oshawa

M5G 2M9

Research Site, Toronto

H4A 3J1

Research Site, Montreal

G1V 4G5

Research Site, Québec

S4T 7T1

Research Site, Regina

S7N 4H4

Research Site, Saskatoon

F-14033

Research Site, Caen

06120

Research Site, Halle

06132

Research Site, Perugia

00128

Research Site, Roma

00144

Research Site, Roma

5223 GZ

Research Site, 's-Hertogenbosch

1066 CX

Research Site, Amsterdam

1081 HV

Research Site, Amsterdam

4624 VT

Research Site, Bergen op Zoom

6202 AZ

Research Site, Maastricht

L27

Research Site, Lima

LIMA 01

Research Site, Lima

LIMA 11

Research Site, Lima

LIMA 29

Research Site, Lima

LIMA 34

Research Site, Lima

36-200

Research Site, Brzozów

85-796

Research Site, Bydgoszcz

80-219

Research Site, Gdansk

80-952

Research Site, Gdansk

86-300

Research Site, Grudziądz

31-202

Research Site, Krakow

59-301

Research Site, Lubin

10-357

Research Site, Olsztyn

45-061

Research Site, Opole

34-200

Research Site, Sucha Beskidzka

70-891

Research Site, Szczecin

02-781

Research Site, Warsaw

2720-276

Research Site, Amadora

3040-316

Research Site, Coimbra

1099-023

Research Site, Lisbon

1769-001

Research Site, Lisbon

4100-180

Research Site, Porto

4200-319

Research Site, Porto

4434-502

Research Site, Vila Nova de Gaia

08003

Research Site, Barcelona

08035

Research Site, Madrid

581 85

Research Site, Linköping

701 85

Research Site, Örebro

SE-751 85

Research Site, Uppsala

06230

Research Site, Ankara

06280

Research Site, Ankara

03115

Research Site, Kyiv

AB2 2ZB

Research Site, Aberdeen

SW3 6JJ

Research Site, London

M20 4BX

Research Site, Manchester

NG5 1PB

Research Site, Nottingham

SM2 5PT

Research Site, Sutton

WV10 0QP

Research Site, Wolverhampton

Sponsors

Lead Sponsor

All Listed Sponsors
lead

AstraZeneca

INDUSTRY