Study of Efficacy and Safety of Pembrolizumab Plus Platinum-based Doublet Chemotherapy With or Without Canakinumab in Previously Untreated Locally Advanced or Metastatic Non-squamous and Squamous NSCLC Subjects

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

673

Participants

Timeline

Start Date

December 21, 2018

Primary Completion Date

August 9, 2021

Study Completion Date

June 7, 2027

Conditions
Non-small Cell Lung Cancer
Interventions
DRUG

canakinumab

canakinumab 200 mg subcutaneous (s.c.) injection every 3 weeks (squamous and non-squamous)

DRUG

canakinumab-matching placebo

canakinumab placebo every 3 weeks (squamous and non-squamous)

DRUG

pembrolizumab

200 mg every 3 weeks (squamous and non-squamous)

DRUG

carboplatin

Area Under the Curve (AUC) 5 mg/mL\*min every 3 weeks (non-squamous) or AUC 6 mg/mL\*min (squamous)

DRUG

cisplatin

75 mg/m\^2 every 3 weeks (non-squamous)

DRUG

paclitaxel

200 mg/m\^2 every 3 weeks (squamous)

DRUG

nab-paclitaxel

100 mg/m\^2 on Days 1, 8, and 15 of every cycle (squamous)

DRUG

pemetrexed

500 mg/m\^2 every 3 weeks (non-squamous)

Trial Locations (153)

333

Novartis Investigative Site, Taoyuan District

652

Novartis Investigative Site, Saida

704

Novartis Investigative Site, Tainan City

1102

Novartis Investigative Site, Quezon

1229

Novartis Investigative Site, Makati City

1500

Novartis Investigative Site, San Juan City

1634

Novartis Investigative Site, City of Taguig

2145

Novartis Investigative Site, Westmead

3000

Novartis Investigative Site, Melbourne

3004

Novartis Investigative Site, Drammen

4031

Novartis Investigative Site, Basel

4102

Novartis Investigative Site, Wooloongabba

5020

Novartis Investigative Site, Salzburg

6150

Novartis Investigative Site, Murdoch

6800

Novartis Investigative Site, Ankara

7400

Novartis Investigative Site, Herning

8200

Novartis Investigative Site, Veszprém

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

10700

Novartis Investigative Site, Bangkok

11217

Novartis Investigative Site, Taipei

13125

Novartis Investigative Site, Berlin

13915

Novartis Investigative Site, Marseille

16132

Novartis Investigative Site, Genova

18014

Novartis Investigative Site, Granada

20080

Novartis Investigative Site, Donostia / San Sebastian

20089

Novartis Investigative Site, Rozzano

20132

Novartis Investigative Site, Milan

20133

Novartis Investigative Site, Milan

20141

Novartis Investigative Site, Milan

22030

Novartis Investigative Site, Edirne

25100

Novartis Investigative Site, Kuantan

28009

Novartis Investigative Site, Madrid

28040

Novartis Investigative Site, Madrid

28041

Novartis Investigative Site, Madrid

28046

Novartis Investigative Site, Madrid

29010

Novartis Investigative Site, Málaga

32804

Advent Health Cancer Institute, Orlando

34070

Novartis Investigative Site, Montpellier

34214

Novartis Investigative Site, Istanbul

35016

Novartis Investigative Site, Las Palmas de Gran Canaria

35100

Novartis Investigative Site, Padua

37075

Novartis Investigative Site, Göttingen

40002

Novartis Investigative Site, Khon Kaen

41124

Novartis Investigative Site, Modena

43126

Novartis Investigative Site, Parma

44093

Novartis Investigative Site, Nantes

45147

Novartis Investigative Site, Essen

46026

Novartis Investigative Site, Valencia

49124

Novartis Investigative Site, Georgsmarienhütte

50009

Novartis Investigative Site, Zaragoza

50586

Novartis Investigative Site, Kuala Lumpur

50937

Novartis Investigative Site, Cologne

51109

Novartis Investigative Site, Cologne

59100

Novartis Investigative Site, Kuala Lumpur

69120

Novartis Investigative Site, Heidelberg

69373

Novartis Investigative Site, Lyon

70839

Novartis Investigative Site, Gerlingen

75231

Novartis Investigative Site, Paris

81377

Novartis Investigative Site, Munich

83100

Novartis Investigative Site, Avellino

83301

Novartis Investigative Site, Kaohsiung City

83310

Novartis Investigative Site, Bratislava

90033

USC Kenneth Norris Comprehensive Cancer Center, Los Angeles

90110

Novartis Investigative Site, Songkhla

90813

Pacific Shores Medical Group, Long Beach

93586

Novartis Investigative Site, Kuching

100000

Novartis Investigative Site, Hanoi

100036

Novartis Investigative Site, Beijing

119228

Novartis Investigative Site, Singapore

130012

Novartis Investigative Site, Changchun

150081

Novartis Investigative Site, Harbin

163045

Novartis Investigative Site, Arkhangelsk

166830

Novartis Investigative Site, Beirut

168583

Novartis Investigative Site, Singapore

192148

Novartis Investigative Site, Saint Petersburg

196603

Novartis Investigative Site, Pushkin Saint Petersburg

197022

Novartis Investigative Site, Saint Petersburg

200347

Novartis Investigative Site, Craiova

302017

Novartis Investigative Site, Jaipur

310022

Novartis Investigative Site, Hangzhou

400124

Novartis Investigative Site, Cluj-Napoca

410013

Novartis Investigative Site, Changsha

411013

Novartis Investigative Site, Pune

430022

Novartis Investigative Site, Wuhan

430030

Novartis Investigative Site, Wuhan

500082

Novartis Investigative Site, Hyderabad

644013

Novartis Investigative Site, Omsk

700160

Novartis Investigative Site, Kolkata

710038

Novartis Investigative Site, Xi’an

999999

Novartis Investigative Site, Kowloon

4810469

Novartis Investigative Site, Temuco

5602310

Novartis Investigative Site, Valledupar

8420383

Novartis Investigative Site, Santiago

02215

Dana Farber Cancer Institute, Boston

C1426ANZ

Novartis Investigative Site, CABA

C1431FWO

Novartis Investigative Site, Caba

A 4020

Novartis Investigative Site, Linz

14784 400

Novartis Investigative Site, Barretos

01246 000

Novartis Investigative Site, São Paulo

04014-002

Novartis Investigative Site, São Paulo

T6G 1Z2

Novartis Investigative Site, Edmonton

L6R 3J7

Novartis Investigative Site, Brampton

M5G 2M9

Novartis Investigative Site, Toronto

703 84

Novartis Investigative Site, Ostrava

625 00

Novartis Investigative Site, Brno

656 53

Novartis Investigative Site, Brno

128 08

Novartis Investigative Site, Prague

FIN-90220

Novartis Investigative Site, Oulu

01307

Novartis Investigative Site, Dresden

04347

Novartis Investigative Site, Leipzig

06120

Novartis Investigative Site, Halle

115 27

Novartis Investigative Site, Athens

185 47

Novartis Investigative Site, Athens

Unknown

Novartis Investigative Site, Kowloon

IS-101

Novartis Investigative Site, Reykjavik

500 034

Novartis Investigative Site, Hyderabad

122 001

Novartis Investigative Site, Gurgaon

06129

Novartis Investigative Site, Perugia

464 8681

Novartis Investigative Site, Nagoya

060 8648

Novartis Investigative Site, Sapporo

670-8520

Novartis Investigative Site, Himeji

241-8515

Novartis Investigative Site, Yokohama

591-8555

Novartis Investigative Site, Sakai

411 8777

Novartis Investigative Site, Sunto Gun

104 0045

Novartis Investigative Site, Chuo Ku

755-0241

Novartis Investigative Site, Ube

545-8586

Novartis Investigative Site, Osaka

9713 GZ

Novartis Investigative Site, Groningen

9728 NZ

Novartis Investigative Site, Groningen

44 101

Novartis Investigative Site, Gliwice

60 569

Novartis Investigative Site, Poznan

97-200

Novartis Investigative Site, Tomaszw Mazowiecki

1769 001

Novartis Investigative Site, Lisbon

4200-072

Novartis Investigative Site, Porto

S308433

Novartis Investigative Site, Singapore

958 01

Novartis Investigative Site, Partizánske

06591

Novartis Investigative Site, Seoul

03080

Novartis Investigative Site, Seoul

03722

Novartis Investigative Site, Seoul

05505

Novartis Investigative Site, Seoul

08916

Novartis Investigative Site, Badalona

08035

Novartis Investigative Site, Barcelona

08036

Novartis Investigative Site, Barcelona

171 76

Novartis Investigative Site, Stockholm

06230

Novartis Investigative Site, Ankara

NE7 7DN

Novartis Investigative Site, High Heaton

NW3 2QG

Novartis Investigative Site, London

M20 2BX

Novartis Investigative Site, Manchester

PL6 8DH

Novartis Investigative Site, Plymouth

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY