Phase III Study Evaluating Efficacy and Safety of Canakinumab in Combination With Docetaxel in Adult Subjects With Non-small Cell Lung Cancers as a Second or Third Line Therapy

PHASE3TerminatedINTERVENTIONAL
Enrollment

245

Participants

Timeline

Start Date

January 23, 2019

Primary Completion Date

January 8, 2021

Study Completion Date

December 20, 2021

Conditions
Non-Small-Cell Lung
Interventions
DRUG

Canakinumab

Canakinumab, 200 mg, subcutaneous. The initial dose regimen was once every 3 weeks (on Day 1 of each 21-day cycle)

DRUG

Docetaxel

Docetaxel 75mg/m\^2, intravenous, administered on Day 1 of each 21-day cycle

OTHER

Placebo

Placebo, sub-cutaneous, admnistered at the RP3R defined in Part 1-safety run-in.

Trial Locations (78)

1200

Novartis Investigative Site, Brussels

2045

Novartis Investigative Site, Törökbálint

3630

Novartis Investigative Site, Shepparton

4120

Novartis Investigative Site, Greenslopes

4200

Novartis Investigative Site, Santiago del Estero

5300

Novartis Investigative Site, La Rioja

6000

Novartis Investigative Site, Charleroi

8800

Novartis Investigative Site, Roeselare

9000

Novartis Investigative Site, Ghent

9100

Novartis Investigative Site, Sint-Niklaas

10461

Montefiore Medical Center Albert Einstein College of Med, The Bronx

11941

Novartis Investigative Site, Amman

13125

Novartis Investigative Site, Berlin

15006

Novartis Investigative Site, A Coruña

20089

Novartis Investigative Site, Rozzano

22947

Novartis Investigative Site, Großhansdorf

25030

Novartis Investigative Site, Besançon

28034

Novartis Investigative Site, Madrid

28040

Novartis Investigative Site, Madrid

28041

Novartis Investigative Site, Madrid

28222

Novartis Investigative Site, Madrid

29010

Novartis Investigative Site, Málaga

30322

Emory Winship Cancer Institute, Atlanta

33000

Novartis Investigative Site, Bordeaux

33081

Novartis Investigative Site, Aviano

45267

University of Cincinnati Cancer Institute, Cincinnati

46014

Novartis Investigative Site, Valencia

51109

Novartis Investigative Site, Cologne

52621

Novartis Investigative Site, Ramat Gan

55100

Novartis Investigative Site, Lucca

57001

Novartis Investigative Site, Thessaloniki

60488

Novartis Investigative Site, Frankfurt

64111

Saint Luke's Hospital/Marion Bloch Neuroscience Institute Dept of Regulatory, Kansas City

67091

Novartis Investigative Site, Strasbourg

69677

Novartis Investigative Site, Bron

70403

Novartis Investigative Site, Tainan City

70839

Novartis Investigative Site, Gerlingen

72037

Novartis Investigative Site, Le Mans

77030

MD Anderson, Houston

89081

Novartis Investigative Site, Ulm

103616

Novartis Investigative Site, Taipei

166830

Novartis Investigative Site, El Achrafiyé

168583

Novartis Investigative Site, Singapore

196603

Novartis Investigative Site, Pushkin Saint Petersburg

197758

Novartis Investigative Site, Saint Petersburg

200433

Novartis Investigative Site, Shanghai

610041

Novartis Investigative Site, Chengdu

7500006

Novartis Investigative Site, Santiago

84112 0550

Huntsman Cancer Institute Univ of Utah ., Salt Lake City

B1884BBF

Novartis Investigative Site, Berazategui

C1426ANZ

Novartis Investigative Site, CABA

B7600FZN

Novartis Investigative Site, Mar del Plata

40170-110

Novartis Investigative Site, Salvador

90880-480

Novartis Investigative Site, Porto Alegre

88301-229

Novartis Investigative Site, Itajaí

V5Z 4E6

Novartis Investigative Site, Vancouver

H4A 3J1

Novartis Investigative Site, Montreal

625 00

Novartis Investigative Site, Brno - Bohunice

703 84

Novartis Investigative Site, Ostrava Vitkovice

DK 2730

Novartis Investigative Site, Herlev

DK 5000

Novartis Investigative Site, Odense C

01307

Novartis Investigative Site, Dresden

711 10

Novartis Investigative Site, Heraklion Crete

464 8681

Novartis Investigative Site, Nagoya

670-8520

Novartis Investigative Site, Himeji

241-8515

Novartis Investigative Site, Yokohama

104 0045

Novartis Investigative Site, Chuo Ku

545-8586

Novartis Investigative Site, Osaka

1081 HV

Novartis Investigative Site, Amsterdam

9713 GZ

Novartis Investigative Site, Groningen

6229 HX

Novartis Investigative Site, Maastricht

80 952

Novartis Investigative Site, Gdansk

35-021

Novartis Investigative Site, Rzeszów

02 781

Novartis Investigative Site, Warsaw

06591

Novartis Investigative Site, Seoul

03722

Novartis Investigative Site, Seoul

05505

Novartis Investigative Site, Seoul

08916

Novartis Investigative Site, Badalona

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY