A Global Study to Assess the Effects of MEDI4736 (Durvalumab), Given as Monotherapy or in Combination With Tremelimumab Determined by PD-L1 Expression Versus Standard of Care in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer

PHASE3CompletedINTERVENTIONAL
Enrollment

597

Participants

Timeline

Start Date

January 13, 2015

Primary Completion Date

February 9, 2018

Study Completion Date

August 30, 2023

Conditions
Non - Small Cell Lung Cancer NSCLC
Interventions
DRUG

MEDI4736 (durvalumab)

MEDI4736 (durvalumab) treatment by intravenous infusion

DRUG

Vinorelbine

Vinorelbine by intravenous infusion. Administered at a dose of 30 mg/m2 iv on Days 1, 8, 15 and 22 of a 28-day cycle.

DRUG

Gemcitabine

Gemcitabine by intravenous infusion. Administered at a dose of 1000 mg/m2 iv over 30 minutes on Days 1, 8, and 15 of a 28-day cycle.

DRUG

Erlotinib

Erlotinib administered at a dose of 150 mg once daily as a tablet for oral administration

DRUG

MEDI4736 (durvalumab) in combination with tremelimumab (anti-CTLA4)

MEDI4736 (durvalumab) in combination with tremelimumab (anti-CTLA4) treatment by intravenous infusion

DRUG

tremelimumab (anti-CTLA4)

tremelimumab (anti-CTLA4) treatment by intravenous infusion

Trial Locations (201)

110

Research Site, Taipei

112

Research Site, Taipei

116

Research Site, Taipei

235

Research Site, Taipei

704

Research Site, Tainan City

1330

Research Site, Sofia

1407

Research Site, Sofia

2045

Research Site, Törökbálint

2444

Research Site, Port Macquarie

3529

Research Site, Miskolc

5530

Research Site, Yvoir

5800

Research Site, Pleven

6000

Research Site, Charleroi

6150

Research Site, Murdoch

6800

Research Site, Libramont-Chevigny

7000

Research Site, Mons

8000

Research Site, Zalaegerszeg

8800

Research Site, Roeselare

8900

Research Site, Zalaegerszeg

9000

Research Site, Ghent

9010

Research Site, Varna

10002

Research Site, Taipei

10011

Research Site, New York

10029

Research Site, New York

10043

Research Site, Orbassano

10060

Research Site, Candiolo

10117

Research Site, Berlin

10330

Research Site, Bangkok

10967

Research Site, Berlin

11000

Research Site, Belgrade

11501

Research Site, Mineola

11527

Research Site, Athens

12351

Research Site, Berlin

13620

Research Site, Seongnam-si

13915

Research Site, Marseille

15006

Research Site, A Coruña

16100

Research Site, Genova

17007

Research Site, Girona

18204

Research Site, Gornji Matejevac

20014

Research Site, Donostia / San Sebastian

20132

Research Site, Milan

20133

Research Site, Milan

20141

Research Site, Milan

20850

Research Site, Rockville

20900

Research Site, Monza

21204

Research Site, Kamenitz

22081

Research Site, Hamburg

23007

Research Site, Jaén

25198

Research Site, Lleida

26100

Research Site, Cremona

28005

Research Site, Madrid

28007

Research Site, Madrid

28033

Research Site, Madrid

28046

Research Site, Madrid

28050

Research Site, Madrid

28204

Research Site, Charlotte

28374

Research Site, Pinehurst

28644

Research Site, Cheongju-si

29609

Research Site, Brest

30046

Research Site, Lawrenceville

30322

Research Site, Atlanta

30607

Research Site, Athens

30625

Research Site, Hanover

32804

Research Site, Orlando

33081

Research Site, Aviano

33705

Research Site, St. Petersburg

33901

Research Site, Fort Myers

34000

Research Site, Kragujevac

34295

Research Site, Montpellier

34952

Research Site, Port Saint Lucie

37203

Research Site, Nashville

37404

Research Site, Chattanooga

38138

Research Site, Germantown

40447

Research Site, Taichung

40705

Research Site, Taichung

41013

Research Site, Seville

41071

Research Site, Seville

41101

Research Site, Ashland

43100

Research Site, Parma

44805

Research Site, Saint-Herblain

45069

Research Site, West Chester

45242

Research Site, Cincinnati

46014

Research Site, Valencia

46026

Research Site, Valencia

47900

Research Site, Rimini

49017

Research Site, Battle Creek

49201

Research Site, Busan

50200

Research Site, Muang

50701

Research Site, Waterloo

51109

Research Site, Cologne

52621

Research Site, Tel Litwinsky

54290

Research Site, Trier

54645

Research Site, Thessaloniki

55100

Research Site, Lucca

56124

Research Site, Pisa

57010

Research Site, Thessaloniki

58128

Research Site, Jeonnam

60612

Research Site, Chicago

63156

Research Site, St Louis

64046

Research Site, Pau

64100

Research Site, Bayonne

65000

Research Site, Phitsanulok

66421

Research Site, Homburg

68506

Research Site, Lincoln

72000

Research Site, Le Mans

74245

Research Site, Löwenstein

78052

Research Site, Villingen-Schwenningen

80045

Research Site, Aurora

80131

Research Site, Napoli

82131

Research Site, Gauting

83100

Research Site, Toulon

84106

Research Site, Salt Lake City

84918

Research Site, Avignon

85224

Research Site, Chandler

89081

Research Site, Ulm

90110

Research Site, Songkhla

91010

Research Site, Duarte

92093

Research Site, La Jolla

92123

Research Site, San Diego

92801

Research Site, Anaheim

93053

Research Site, Regensburg

94010

Research Site, Créteil

94800

Research Site, Villejuif

95123

Research Site, Catania

99208

Research Site, Spokane

119074

Research Site, Singapore

163045

Research Site, Arkhangelsk

169610

Research Site, Singapore

197002

Research Site, Saint Petersburg

197022

Research Site, Saint Petersburg

197758

Research Site, Saint Petersburg

300210

Research Site, Timișoara

308433

Research Site, Singapore

400132

Research Site, Cluj-Napoca

400349

Research Site, Cluj-Napoca

410469

Research Site, Oradea

430031

Research Site, Baia Mare

510077

Research Site, Alba Iulia

601048

Research Site, Onești

644013

Research Site, Omsk

4810469

Research Site, Temuco

7500000

Research Site, Santiago

8420383

Research Site, Santiago

10461-2375

Research Site, The Bronx

E1C 6Z8

Research Site, Moncton

E2L 4L2

Research Site, Saint John

262 04

Research Site, Nová Ves pod Pleší

128 08

Research Site, Prague

150 06

Research Site, Prague

06100

Research Site, Nice

01307

Research Site, Dresden

06120

Research Site, Halle

Unknown

Research Site, Hong Kong

05100

Research Site, Terni

812-8582

Research Site, Fukuoka

583-8588

Research Site, Habikino-shi

350-1298

Research Site, Hidaka-shi

573-1191

Research Site, Hirakata-shi

036-8545

Research Site, Hirosaki-shi

730-8518

Research Site, Hiroshima

920-8641

Research Site, Kanazawa

650-0047

Research Site, Kobe

830-0011

Research Site, Kurume-shi

791-0280

Research Site, Matsuyama

460-0001

Research Site, Nagoya

464-8681

Research Site, Nagoya

466-8560

Research Site, Nagoya

981-1293

Research Site, Natori-shi

700-8558

Research Site, Okayama

541-8567

Research Site, Osaka

591-8555

Research Site, Sakaishi

003-0804

Research Site, Sapporo

060-8648

Research Site, Sapporo

589-8511

Research Site, Sayama

980-0873

Research Site, Sendai

160-0023

Research Site, Shinjuku-ku

162-8655

Research Site, Shinjuku-ku

411-8777

Research Site, Sunto-gun

569-8686

Research Site, Takatsuki-shi

641-8510

Research Site, Wakayama

221-0855

Research Site, Yokohama

236-0024

Research Site, Yokohama

1081 HV

Research Site, Amsterdam

20-362

Research Site, Lublin

60-569

Research Site, Poznan

02-781

Research Site, Warsaw

405-760

Research Site, Incheon

02841

Research Site, Seoul

05505

Research Site, Seoul

06351

Research Site, Seoul

03010

Research Site, Alicante

08003

Research Site, Barcelona

08025

Research Site, Barcelona

08035

Research Site, Madrid

B15 2WB

Research Site, Birmingham

EC1A 7BE

Research Site, London

W1G 6AD

Research Site, London

SO16 6YD

Research Site, Southampton

SG1 4AB

Research Site, Stevenage

TR1 3LJ

Research Site, Truro

WV10 0QP

Research Site, Wolverhampton

Sponsors

Lead Sponsor

All Listed Sponsors
lead

AstraZeneca

INDUSTRY

NCT02352948 - A Global Study to Assess the Effects of MEDI4736 (Durvalumab), Given as Monotherapy or in Combination With Tremelimumab Determined by PD-L1 Expression Versus Standard of Care in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer | Biotech Hunter | Biotech Hunter