A Study of Neoadjuvant/Adjuvant Durvalumab for the Treatment of Patients With Resectable Non-small Cell Lung Cancer

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

825

Participants

Timeline

Start Date

December 6, 2018

Primary Completion Date

November 10, 2022

Study Completion Date

September 11, 2028

Conditions
Non-Small Cell Lung Cancer
Interventions
DRUG

Durvalumab

1500mg on Day 1 of each 3-week cycle for 4 cycles during the neoadjuvant period and 1500mg on Day 1 of each 4-week cycle for 12 cycles during the adjuvant period

OTHER

Placebo

Day 1 of each 3-week cycle for 4 cycles during the neoadjuvant period and Day 1 of each 4-week cycle for 12 cycles during the adjuvant period

DRUG

Carboplatin

Area under the curve of 5/6 on Day 1 of each 3-week cycle for 4 cycles

DRUG

Cisplatin

75 mg/m2 on Day 1 of each 3-week cycle, for 4 cycles

DRUG

Pemetrexed

500 mg/m2 on Day 1 of each 3-week cycle for 4 cycles.

DRUG

Paclitaxel

200mg/m2 on Day 1 of each 3-week cycle for 4 cycles.

DRUG

Gemcitabine

1250 mg/m2 on Day 1 and Day 8 of each 3-week cycle, for 4 cycles.

PROCEDURE

Surgery

Expected within 40 days from the last dose of Investigational Product following the completion of neoadjuvant treatment.

Trial Locations (231)

110

Research Site, Taipei

235

Research Site, Taipei

402

Research Site, Taichung

500

Research Site, Changhua

1000

Research Site, San José

1090

Research Site, Vienna

1100

Research Site, Quezon City

1121

Research Site, Budapest

1210

Research Site, Vienna

1229

Research Site, Makati

1330

Research Site, Sofia

1400

Research Site, México

1407

Research Site, Sofia

1797

Research Site, Sofia

1900

Research Site, La Plata

2045

Research Site, Törökbálint

3200

Research Site, Gyöngyös - Mátraháza

4000

Research Site, Liège

4004

Research Site, Plovdiv

4600

Research Site, San Salvador de Jujuy

5000

Research Site, Iloilo City

6020

Research Site, Innsbruck

6830

Research Site, Rankweil

7000

Research Site, Mons

8000

Research Site, Székesfehérvár

Research Site, Davao City

8036

Research Site, Graz

9000

Research Site, Ghent

9024

Research Site, Győr

10000

Research Site, Ho Chi Minh City

10002

Research Site, Taipei

10028

Research Site, New York

10065

Research Site, New York

10108

Research Site, San José

10300

Research Site, Bangkok

10330

Research Site, Bangkok

11967

Research Site, Shirley

13620

Research Site, Seongnam-si

14050

Research Site, México

15212

Research Site, Pittsburgh

15706

Research Site, Santiago de Compostela (A Coruña)

16499

Research Site, Suwon

20014

Research Site, Donostia / San Sebastian

20132

Research Site, Milan

20230

Research Site, Aguascalientes

20900

Research Site, Monza

20910

Research Site, Silver Spring

21204

Research Site, Towson

22031

Research Site, Fairfax

24127

Research Site, Bergamo

27710

Research Site, Durham

28040

Research Site, Madrid

28644

Research Site, Cheongju-si

29010

Research Site, Málaga

29414

Research Site, Charleston

29424

Research Site, Charleston

31000

Research Site, Chihuahua City

31008

Research Site, Pamplona

32256

Research Site, Jacksonville

33011

Research Site, Oviedo

33486

Research Site, Boca Raton

33611

Research Site, Bielefeld

35128

Research Site, Padua

37126

Research Site, Verona

40002

Research Site, Khon Kaen

40513

Research Site, Lexington

40705

Research Site, Taichung

41101

Research Site, Ashland

42090

Research Site, Pachuca

44680

Research Site, Guadalajara

48108

Research Site, Busan

50134

Research Site, Florence

50200

Research Site, Chiang Mai

51109

Research Site, Cologne

52000

Research Site, Lampang

54031

Research Site, Xintai

55404

Research Site, Minneapolis

55805

Research Site, Duluth

57000

Research Site, Chiang Rai

57070

Research Site, Vantoux

60126

Research Site, Ancona

60431

Research Site, Frankfurt am Main

60612

Research Site, Chicago

64000

Research Site, Monterrey

64710

Research Site, Monterrey

67214

Research Site, Wichita

69373

Research Site, Lyon

70000

Research Site, Ho Chi Minh City

70124

Research Site, Bari

70403

Research Site, Tainan City

73657

Research Site, Tainan City

76104

Research Site, Fort Worth

77030

Research Site, Houston

77090

Research Site, Houston

78745

Research Site, Austin

80012

Research Site, Aurora

83800

Research Site, Toulon

84902

Research Site, Avignon

85054

Research Site, Phoenix

87509

Research Site, Immenstadt im Allgäu

91010

Research Site, Duarte

92868

Research Site, Orange

97504

Research Site, Medford

97701

Research Site, Bend

98034

Research Site, Kirkland

98109

Research Site, Seattle

100000

Research Site, Hanoi

100021

Research Site, Beijing

100029

Research Site, Beijing

100191

Research Site, Beijing

101149

Research Site, Beijing

105229

Research Site, Moscow

110042

Research Site, Shenyang

110044

Research Site, Shenyang

110076

Research Site, New Delhi

110085

Research Site, New Delhi

115008

Research Site, Moscow

115280

Research Site, Moscow

121205

Research Site, Moscow

122001

Research Site, Gūrgaon

122002

Research Site, Gūrgaon

150054

Research Site, Yaroslavl

197022

Research Site, Saint Petersburg

200052

Research Site, Shanghai

200433

Research Site, Shanghai

213000

Research Site, Changzhou

225001

Research Site, Yangzhou

230001

Research Site, Hefei

249036

Research Site, Obninsk

300060

Research Site, Tianjin

310003

Research Site, Hangzhou

310022

Research Site, Hangzhou

310030

Research Site, Hangzhou

310052

Research Site, Hangzhou

315000

Research Site, Ningbo

317000

Research Site, Linhai

330006

Research Site, Nanchang

344037

Research Site, Rostov-on-Don

361004

Research Site, Xiamen

380060

Research Site, Ahmedabad

400012

Research Site, Mumbai

400053

Research Site, Mumbai

401107

Research Site, Thāne

410008

Research Site, Changsha

410013

Research Site, Changsha

420029

Research Site, Kazan'

422002

Research Site, Nashik

430060

Research Site, Wuhan

430079

Research Site, Wuhan

450008

Research Site, Zhengzhou

510095

Research Site, Guangzhou

510515

Research Site, Guangzhou

518035

Research Site, Shenzhen

518036

Research Site, Shenzhen

530017

Research Site, Visakhapatnam

550002

Research Site, Guiyang

570017

Research Site, Mysuru

576104

Research Site, Manipal

603081

Research Site, Nizhny Novgorod

610041

Research Site, Chengdu

634063

Research Site, Tomsk

637001

Research Site, Namakkal

650118

Research Site, Kunming

660133

Research Site, Krasnoyarsk

700000

Research Site, Ho Chi Minh City

700160

Research Site, Kolkata

720237

Research Site, Suceava

830000

Research Site, Ürümqi

2540488

Research Site, Viña del Mar

4810469

Research Site, Temuco

7500713

Research Site, Santiago

7500921

Research Site, Santiago

07962

Research Site, Morristown

C1118AAT

Research Site, Buenos Aires

C1012AAR

Research Site, CABA

C1280AEB

Research Site, CABA

B2700CPM

Research Site, Pergamino

S2000DEJ

Research Site, Rosario

R8500ACE

Research Site, Viedma

14784-400

Research Site, Barretos

30380-090

Research Site, Belo Horizonte

13060-904

Research Site, Campinas

81520-060

Research Site, Curitiba

88034-000

Research Site, Florianópolis

59075-740

Research Site, Natal

90610-000

Research Site, Porto Alegre

97015-450

Research Site, Santa Maria

15090-000

Research Site, São José do Rio Preto

01246-000

Research Site, São Paulo

01323-903

Research Site, São Paulo

64049-200

Research Site, Teresina

29043-260

Research Site, Vitória

T6G 1Z2

Research Site, Edmonton

N2G 1G3

Research Site, Kitchener

G6V 3Z1

Research Site, Lévis

H1T 2M4

Research Site, Montreal

H4J 1C5

Research Site, Montreal

G1V 4G5

Research Site, Québec

S7N 4H4

Research Site, Saskatoon

06100

Research Site, Nice

00100

Research Site, Roma

583-8588

Research Site, Habikino-shi

670-8520

Research Site, Himeji-shi

730-8518

Research Site, Hiroshima

734-8551

Research Site, Hiroshima

740-8510

Research Site, Iwakuni-shi

362-0806

Research Site, Kitaadachi-gun

807-8555

Research Site, Kitakyushu-shi

701 0192

Research Site, Kurashiki Shi

464-8681

Research Site, Nagoya

951-8566

Research Site, Niigata

700-8558

Research Site, Okayama

589-8511

Research Site, Osakasayama-shi

470-1192

Research Site, Toyoake-shi

641-8510

Research Site, Wakayama

6815 AD

Research Site, Arnhem

6525 GA

Research Site, Nijmegen

CALLAO 2

Research Site, Bellavista

LIMA 11

Research Site, Lima

LIMA 31

Research Site, Lima

Lima 32

Research Site, Lima

LIMA 34

Research Site, Lima

15-276

Research Site, Bialystok

10-357

Research Site, Olsztyn

02-781

Research Site, Warsaw

04-141

Research Site, Warsaw

05505

Research Site, Seoul

06591

Research Site, Seoul

442-723

Research Site, Suwon

03010

Research Site, Alicante

08036

Research Site, Barcelona

Sponsors

Lead Sponsor

All Listed Sponsors
lead

AstraZeneca

INDUSTRY