LDK378 Versus Chemotherapy in ALK Rearranged (ALK Positive) Patients Previously Treated With Chemotherapy (Platinum Doublet) and Crizotinib

PHASE3CompletedINTERVENTIONAL
Enrollment

231

Participants

Timeline

Start Date

June 28, 2013

Primary Completion Date

January 26, 2016

Study Completion Date

November 10, 2023

Conditions
Non-Small Cell Lung Cancer
Interventions
DRUG

Ceritinib

Ceritinib was the investigational treatment and was provided as 150 mg hard gelatin capsules for oral use. The dose was 750 mg once daily.

DRUG

Pemetrexed

Pemetrexed was one of the chemotherapy treatments. Pemetrexed, a reconstituted solution, was intravenously administered over 10 minutes at 500 mg/m\^2 every 21 days.

DRUG

Docetaxel

Docetaxel was one of the chemotherapy treatments. Docetaxel, a reconstituted solution, was intravenously administered over 1 hour, at 75 mg/m\^2 every 21 days.

Trial Locations (97)

1000

Novartis Investigative Site, Brussels

1200

Novartis Investigative Site, Brussels

2650

Novartis Investigative Site, Edegem

3000

Novartis Investigative Site, Leuven

6000

Novartis Investigative Site, Lucerne

9007

Novartis Investigative Site, Sankt Gallen

10043

Novartis Investigative Site, Orbassano

13915

Novartis Investigative Site, Marseille

14021

Novartis Investigative Site, Caen

15006

Novartis Investigative Site, A Coruña

15706

Novartis Investigative Site, Santiago de Compostela

20132

Novartis Investigative Site, Milan

20900

Novartis Investigative Site, Monza

22031

Virginia Cancer Specialists, Fairfax

25030

Novartis Investigative Site, Besançon

28034

Novartis Investigative Site, Madrid

28041

Novartis Investigative Site, Madrid

28046

Novartis Investigative Site, Madrid

28222

Novartis Investigative Site, Madrid

29609

Novartis Investigative Site, Brest

32256

Cancer Specialists of North Florida, Jacksonville

33021

Memorial Cancer Institute, Hollywood

33081

Novartis Investigative Site, Aviano

33136

University Of Miami, Miami

34098

Novartis Investigative Site, Istanbul

34899

Novartis Investigative Site, Pendik Istanbul

37126

Novartis Investigative Site, Verona

37203

Sarah Cannon Research Institute, Nashville

41009

Novartis Investigative Site, Seville

41013

Novartis Investigative Site, Seville

42123

Novartis Investigative Site, Reggio Emilia

44281

Novartis Investigative Site, Kfar Saba

45147

Novartis Investigative Site, Essen

46010

Novartis Investigative Site, Valencia

51109

Novartis Investigative Site, Cologne

52242

Uni Of Iowa Hospitals And Clinics, Iowa City

52621

Novartis Investigative Site, Ramat Gan

56124

Novartis Investigative Site, Pisa

60153

Loyola University Medical Center, Marywood

60590

Novartis Investigative Site, Frankfurt

68070

Novartis Investigative Site, Mulhouse

69120

Novartis Investigative Site, Heidelberg

72000

Novartis Investigative Site, Le Mans

72076

Novartis Investigative Site, Tübingen

72703

Highlands Oncology Group, Fayetteville

73730

Novartis Investigative Site, Esslingen am Neckar

74136

Oklahoma Cancer Specialists and Research Institute, Tulsa

75970

Novartis Investigative Site, Paris

76712

Texas Oncology Cancer Care and Research Center, Waco

77479

Texas Oncology-Sugarland, Sugar Land

83100

Novartis Investigative Site, Avellino

89081

Novartis Investigative Site, Ulm

92150

Novartis Investigative Site, Suresnes

98104

Swedish Cancer Institute, Seattle

99438

Novartis Investigative Site, Bad Berka

115478

Novartis Investigative Site, Moscow

119074

Novartis Investigative Site, Singapore

143423

Novartis Investigative Site, Moscow Region Istra Village

166830

Novartis Investigative Site, El Achrafiyé

168583

Novartis Investigative Site, Singapore

197022

Novartis Investigative Site, Saint Petersburg

02114

Massachusetts General Hospital, Boston

M5G 2M9

Novartis Investigative Site, Toronto

F 67085

Novartis Investigative Site, Strasbourg

Unknown

Novartis Investigative Site, Hong Kong

Novartis Investigative Site, Pokfulam

V94 YX29

Novartis Investigative Site, Limerick

DO4

Novartis Investigative Site, Dublin

06129

Novartis Investigative Site, Perugia

00189

Novartis Investigative Site, Roma

464 8681

Novartis Investigative Site, Nagoya

277 8577

Novartis Investigative Site, Kashiwa

811-1395

Novartis Investigative Site, Fukuoka

812-8582

Novartis Investigative Site, Fukuoka

673-8558

Novartis Investigative Site, Akashi

700-8558

Novartis Investigative Site, Okayama

573-1191

Novartis Investigative Site, Hirakata

541-8567

Novartis Investigative Site, Osaka

589 8511

Novartis Investigative Site, Ōsaka-sayama

569-8686

Novartis Investigative Site, Takatsuki

135 8550

Novartis Investigative Site, Koto Ku

951 8520

Novartis Investigative Site, Niigata

9713 GZ

Novartis Investigative Site, Groningen

1649 035

Novartis Investigative Site, Lisbon

06591

Novartis Investigative Site, Seoul

03080

Novartis Investigative Site, Seoul

03722

Novartis Investigative Site, Seoul

05505

Novartis Investigative Site, Seoul

06351

Novartis Investigative Site, Seoul

08028

Novartis Investigative Site, Barcelona

08035

Novartis Investigative Site, Barcelona

06230

Novartis Investigative Site, Ankara

GL53 7AN

Novartis Investigative Site, Cheltenham

AB25 2ZN

Novartis Investigative Site, Aberdeen

LE1 5WW

Novartis Investigative Site, Leicester

SE1 9RT

Novartis Investigative Site, London

SO30 3JB

Novartis Investigative Site, Southampton

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY