AZD9291 (Osimertinib) Versus Platinum-Based Doublet-Chemotherapy in Locally Advanced or Metastatic Non-Small Cell Lung Cancer

PHASE3CompletedINTERVENTIONAL
Enrollment

421

Participants

Timeline

Start Date

August 4, 2014

Primary Completion Date

April 15, 2016

Study Completion Date

December 15, 2023

Conditions
Anticancer Treatment
Interventions
DRUG

Chemotherapy

Randomization to either Osimertinib or platinum-based doublet-chemotherapy on Day 1 of every 21d cycle in a 2:1 (Osimertinib:platinum-based doublet-chemotherapy) ratio

DRUG

Cross-over to Osimertinib

"Once subjects on the platinum-based doublet chemotherapy arm are determined to have objective radiological progression according to RECIST 1.1 by the investigator and confirmed by independent central imaging review, they will be given the opportunity to begin treatment with Osimertinib 80mg, once daily. These subjects may continue treatment with Osimertinib even after disease progression, as long as they are continuing to show clinical benefit, as judged by the investigator.~Subjects who stop platinum-based doublet chemotherapy for reasons other than objective disease progression according to RECIST 1.1 will not be eligible to cross-over to Osimertinib."

Trial Locations (150)

112

Research Site, Taipei

300

Research Site, Hsinchu

333

Research Site, Taoyuan District

500

Research Site, Changhua

704

Research Site, Tainan City

1121

Research Site, Budapest

2010

Research Site, Darlinghurst

2217

Research Site, Kogarah

3084

Research Site, Heidelberg

4102

Research Site, Woolloongabba

6009

Research Site, Nedlands

6351

Research Site, Seoul

10002

Research Site, Taipei

10032

Research Site, New York

10043

Research Site, Orbassano

10408

Research Site, Goyang-si

13620

Research Site, Seongnam-si

13915

Research Site, Marseille

16499

Research Site, Suwon

20133

Research Site, Milan

20815

Research Site, Chevy Chase

21079

Research Site, Dijon

21565

Research Site, Incheon

26121

Research Site, Oldenburg

28034

Research Site, Madrid

28041

Research Site, Madrid

28644

Research Site, Cheongju-si

29010

Research Site, Málaga

29425

Research Site, Charleston

30322

Research Site, Atlanta

31059

Research Site, Toulouse

32610

Research Site, Gainesville

32804

Research Site, Orlando

33028

Research Site, Pembroke Pines

40447

Research Site, Taichung

40705

Research Site, Taichung

41013

Research Site, Seville

44033

Research Site, Ulsan

45122

Research Site, Essen

46202

Research Site, Indianapolis

47014

Research Site, Meldola

47392

Research Site, Busan

50009

Research Site, Zaragoza

52763

Research Site, México

53226

Research Site, Milwaukee

59000

Research Site, Lille

60068

Research Site, Park Ridge

60590

Research Site, Frankfurt

63003

Research Site, Clermont-Ferrand

67091

Research Site, Strasbourg

68000

Research Site, Oaxaca City

70072

Research Site, Marrero

70839

Research Site, Gerlingen

75020

Research Site, Paris

77030

Research Site, Houston

81362

Research Site, Kaohsiung City

82445

Research Site, Kaohsiung City

83100

Research Site, Avellino

83301

Research Site, Kaohsiung City

92801

Research Site, Anaheim

92868

Research Site, Orange

93053

Research Site, Regensburg

94800

Research Site, Villejuif

95403

Research Site, Santa Rosa

97080

Research Site, Würzburg

98405

Research Site, Tacoma

98503

Research Site, Lacey

100021

Research Site, Beijing

100142

Research Site, Beijing

115478

Research Site, Moscow

130000

Research Site, Changchun

150049

Research Site, Harbin

197183

Research Site, Saint Petersburg

197342

Research Site, Saint Petersburg

197758

Research Site, Saint Petersburg

200030

Research Site, Shanghai

300060

Research Site, Tianjin

310003

Research Site, Hangzhou

330006

Research Site, Nanchang

350014

Research Site, Fuzhou

400038

Research Site, Chongqing

400042

Research Site, Chongqing

450008

Research Site, Zhengzhou

510060

Research Site, Guangzhou

510100

Research Site, Guangzhou

620905

Research Site, Yekaterinburg

644013

Research Site, Omsk

830000

Research Site, Ürümqi

06856

Research Site, Norwalk

03756

Research Site, Lebanon

08724

Research Site, Brick

17033-0850

Research Site, Hershey

T6G 1Z2

Research Site, Edmonton

V5Z 4E6

Research Site, Vancouver

B3H 1V7

Research Site, Halifax

K1H 8L6

Research Site, Ottawa

M5G 2M9

Research Site, Toronto

H2L 4M1

Research Site, Montreal

CN-200433

Research Site, Shanghai

Unknown

Research Site, Hong Kong

00000

Research Site, Shatin

00128

Research Site, Roma

673-8558

Research Site, Akashi-shi

113-8431

Research Site, Bunkyō City

812-8582

Research Site, Fukuoka

573-1191

Research Site, Hirakata-shi

920-8641

Research Site, Kanazawa

362-0806

Research Site, Kitaadachi-gun

650-0047

Research Site, Kobe

710-8602

Research Site, Kurashiki-shi

606-8507

Research Site, Kyoto

791-0280

Research Site, Matsuyama

464-8681

Research Site, Nagoya

981-1293

Research Site, Natori-shi

951-8566

Research Site, Niigata

700-8558

Research Site, Okayama

534-0021

Research Site, Osaka

541-8567

Research Site, Osaka

591-8555

Research Site, Sakaishi

589-8511

Research Site, Sayama

160-0023

Research Site, Shinjuku-ku

411-8777

Research Site, Sunto-gun

569-8686

Research Site, Takatsuki-shi

641-8510

Research Site, Wakayama

236-0024

Research Site, Yokohama

236-0051

Research Site, Yokohama

241-8515

Research Site, Yokohama

1066 CX

Research Site, Amsterdam

1081 HV

Research Site, Amsterdam

9713 GZ

Research Site, Groningen

660-702

Research Site, Jinju

03722

Research Site, Seoul

05505

Research Site, Seoul

06591

Research Site, Seoul

156-707

Research Site, Seoul

08035

Research Site, Madrid

413 45

Research Site, Gothenburg

221 85

Research Site, Lund

171 76

Research Site, Stockholm

AB2 2ZB

Research Site, Aberdeen

BS2 8ED

Research Site, Bristol

EH4 2XU

Research Site, Edinburgh

G12 0YN

Research Site, Glasgow

HD3 3EA

Research Site, Huddersfield

SW10 9NH

Research Site, London

W1G 6AD

Research Site, London

M20 4BX

Research Site, Manchester

NE7 7DN

Research Site, Newcastle upon Tyne

NG5 1PB

Research Site, Nottingham

WV10 0QP

Research Site, Wolverhampton

Sponsors

Lead Sponsor

All Listed Sponsors
lead

AstraZeneca

INDUSTRY