LDK378 Versus Chemotherapy in Previously Untreated Patients With ALK Rearranged Non-small Cell Lung Cancer

PHASE3CompletedINTERVENTIONAL
Enrollment

376

Participants

Timeline

Start Date

July 9, 2013

Primary Completion Date

June 24, 2016

Study Completion Date

January 7, 2024

Conditions
Non-Small Cell Lung Cancer
Interventions
DRUG

Ceritinib

Ceritinib was administered orally once-daily fasted at a dose of 750 mg capsules on a continuous dosing schedule.

DRUG

Pemetrexed

Pemetrexed was administered at a dose of 500 mg/m\^2 as an intravenous (iv) infusion on Day 1 of each 21-day cycle

DRUG

Cisplatin

Cisplatin was administered by iv infusion at a dose of 75 mg/m\^2 every 21 days for up to 4 cycles.

DRUG

Carboplatin

Carboplatin was administered as iv infusion (AUC 5-6) every 21 days up to 4 cycles

Trial Locations (167)

652

Novartis Investigative Site, Saida

1121

Novartis Investigative Site, Budapest

1210

Novartis Investigative Site, Vienna

3084

Novartis Investigative Site, Heidelberg

4102

Novartis Investigative Site, Woolloongabba

4400

Novartis Investigative Site, Nyíregyháza

5020

Novartis Investigative Site, Salzburg

5300

Novartis Investigative Site, La Rioja

8200

Novartis Investigative Site, Veszprém

8900

Novartis Investigative Site, Zalaegerszeg

10002

Novartis Investigative Site, Taipei

10043

Novartis Investigative Site, Orbassano

10330

Novartis Investigative Site, Bangkok

10400

Novartis Investigative Site, Bangkok

10408

Novartis Investigative Site, Gyeonggi-do

11217

Novartis Investigative Site, Taipei

13620

Novartis Investigative Site, Bundang Gu

14033

Novartis Investigative Site, Caen

15006

Novartis Investigative Site, A Coruña

16132

Novartis Investigative Site, Genova

18014

Novartis Investigative Site, Granada

20089

Novartis Investigative Site, Rozzano

20132

Novartis Investigative Site, Milan

20141

Novartis Investigative Site, Milan

20162

Novartis Investigative Site, Milan

20900

Novartis Investigative Site, Monza

22947

Novartis Investigative Site, Großhansdorf

24125

Novartis Investigative Site, Bergamo

25198

Novartis Investigative Site, Lleida

26121

Novartis Investigative Site, Oldenburg

27003

Novartis Investigative Site, Lugo

28033

Novartis Investigative Site, Madrid

28040

Novartis Investigative Site, Madrid

28041

Novartis Investigative Site, Madrid

28050

Novartis Investigative Site, Madrid

29010

Novartis Investigative Site, Málaga

31008

Novartis Investigative Site, Pamplona

33011

Novartis Investigative Site, Oviedo

33081

Novartis Investigative Site, Aviano

33100

Novartis Investigative Site, Udine

33305

Novartis Investigative Site, Taoyuan District

35043

Novartis Investigative Site, Rennes

35100

Novartis Investigative Site, Istanbul

37075

Novartis Investigative Site, Göttingen

38043

Novartis Investigative Site, Grenoble

38320

Novartis Investigative Site, San Cristóbal de La Laguna

40002

Novartis Investigative Site, Khon Kaen

40447

Novartis Investigative Site, Taichung

41013

Novartis Investigative Site, Seville

41014

Novartis Investigative Site, Seville

42123

Novartis Investigative Site, Reggio Emilia

43100

Novartis Investigative Site, Parma

43201

Novartis Investigative Site, Reus

44280

Novartis Investigative Site, Guadalajara

45147

Novartis Investigative Site, Essen

46014

Novartis Investigative Site, Valencia

50937

Novartis Investigative Site, Cologne

56124

Novartis Investigative Site, Pisa

59037

Novartis Investigative Site, Lille

60126

Novartis Investigative Site, Ancona

67091

Novartis Investigative Site, Strasbourg

69120

Novartis Investigative Site, Heidelberg

69495

Novartis Investigative Site, Pierre-Bénite

71110

Novartis Investigative Site, Heraklion Crete

72076

Novartis Investigative Site, Tübingen

75475

Novartis Investigative Site, Paris

80131

Novartis Investigative Site, Napoli

83301

Novartis Investigative Site, Kaohsiung City

83800

Novartis Investigative Site, Toulon

87000

Novartis Investigative Site, Limoges

89081

Novartis Investigative Site, Ulm

90110

Novartis Investigative Site, Songkhla

92024

Novartis Investigative Site, Auckland

94800

Novartis Investigative Site, Villejuif

100730

Novartis Investigative Site, Beijing

101149

Novartis Investigative Site, Beijing

110076

Novartis Investigative Site, New Delhi

110111

Novartis Investigative Site, Bogota

115478

Novartis Investigative Site, Moscow

119228

Novartis Investigative Site, Singapore

130012

Novartis Investigative Site, Changchun

130021

Novartis Investigative Site, Changchun

166830

Novartis Investigative Site, El Achrafiyé

168583

Novartis Investigative Site, Singapore

197022

Novartis Investigative Site, Saint Petersburg

200433

Novartis Investigative Site, Shanghai

230004

Novartis Investigative Site, Montería

300052

Novartis Investigative Site, Tianjin

302017

Novartis Investigative Site, Jaipur

310003

Novartis Investigative Site, Hangzhou

310022

Novartis Investigative Site, Hangzhou

400037

Novartis Investigative Site, Chongqing

400042

Novartis Investigative Site, Chongqing

407219

Novartis Investigative Site, Taichung

510080

Novartis Investigative Site, Guangzhou

510120

Novartis Investigative Site, Guang Dong Province

610041

Novartis Investigative Site, Chengdu

625107

Novartis Investigative Site, Madurai

700160

Novartis Investigative Site, Kolkata

710038

Novartis Investigative Site, Xi’an

C1050AAK

Novartis Investigative Site, CABA

C1180AAX

Novartis Investigative Site, CABA

60336-045

Novartis Investigative Site, Fortaleza

40170-110

Novartis Investigative Site, Salvador

50070-550

Novartis Investigative Site, Recife

20231-050

Novartis Investigative Site, Rio de Janiero

59075 740

Novartis Investigative Site, Natal

90610-000

Novartis Investigative Site, Porto Alegre

88301-229

Novartis Investigative Site, Itajaí

14784 400

Novartis Investigative Site, Barretos

15090 000

Novartis Investigative Site, São José do Rio Preto

01246-000

Novartis Investigative Site, São Paulo

DK-2730

Novartis Investigative Site, Herlev

DK 5000

Novartis Investigative Site, Odense C

01640

Novartis Investigative Site, Coswig

D-65199

Novartis Investigative Site, Wiesbaden

115 27

Novartis Investigative Site, Athens

500 034

Novartis Investigative Site, Hyderabad

560 095

Novartis Investigative Site, Bangalore

682 041

Novartis Investigative Site, Kochi

422 004

Novartis Investigative Site, Nashik

632 004

Novartis Investigative Site, Vellore

110 085

Novartis Investigative Site, Delhi

400 012

Novartis Investigative Site, Mumbai

DO4

Novartis Investigative Site, Dublin

06129

Novartis Investigative Site, Perugia

00152

Novartis Investigative Site, Roma

00189

Novartis Investigative Site, Roma

464 8681

Novartis Investigative Site, Nagoya

277 8577

Novartis Investigative Site, Kashiwa

673-8558

Novartis Investigative Site, Akashi

573-1191

Novartis Investigative Site, Hirakata

541-8567

Novartis Investigative Site, Osaka

135 8550

Novartis Investigative Site, Koto Ku

951 8520

Novartis Investigative Site, Niigata

2333 ZA

Novartis Investigative Site, Leiden

3818 ES

Novartis Investigative Site, Amersfroort

7512 KZ

Novartis Investigative Site, Enschede

9713 GZ

Novartis Investigative Site, Groningen

9728 NZ

Novartis Investigative Site, Groningen

6229 HX

Novartis Investigative Site, Maastricht

NL-2722 EP

Novartis Investigative Site, Zoetermeer

0310

Novartis Investigative Site, Oslo

70-891

Novartis Investigative Site, Szczecin

02 781

Novartis Investigative Site, Warsaw

03722

Novartis Investigative Site, Seoul

05505

Novartis Investigative Site, Seoul

06351

Novartis Investigative Site, Seoul

07120

Novartis Investigative Site, Palma de Mallorca

08003

Novartis Investigative Site, Barcelona

08035

Novartis Investigative Site, Barcelona

08907

Novartis Investigative Site, L'Hospitalet de Llobregat

08301

Novartis Investigative Site, Mataró

06080

Novartis Investigative Site, Badajoz

03010

Novartis Investigative Site, Alicante

08041

Novartis Investigative Site, Barcelona

SE 581 85

Novartis Investigative Site, Linköping

221 85

Novartis Investigative Site, Lund

171 76

Novartis Investigative Site, Stockholm

751 85

Novartis Investigative Site, Uppsala

06230

Novartis Investigative Site, Ankara

EX2 5DW

Novartis Investigative Site, Exeter

LS9 7TF

Novartis Investigative Site, Leeds

B9 5SS

Novartis Investigative Site, Birmingham

NW1 2BU

Novartis Investigative Site, London

M20 2BX

Novartis Investigative Site, Manchester

NG5 1PB

Novartis Investigative Site, Nottingham

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY