Durvalumab With Stereotactic Body Radiation Therapy (SBRT) vs Placebo With SBRT in Early Stage Unresected Non-small Cell Lung Cancer (NSCLC) Patients/ Osimertinib Following SBRT in Patients With Early Stage Unresected NSCLC Harboring an EGFR Mutation

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

724

Participants

Timeline

Start Date

March 6, 2019

Primary Completion Date

April 16, 2027

Study Completion Date

April 4, 2028

Conditions
Carcinoma, Non-Small-Cell Lung
Interventions
DRUG

Durvalumab

Durvalumab 1500 mg every 4 weeks \[q4w\] intravenously \[iv\] for up to 26 cycles or until progression or other discontinuation criteria are met.

OTHER

Placebo

Matching placebo for infusion every 4 weeks iv for up to 26 cycles or until progression or other discontinuation criteria are met.

DRUG

(Osimertinib cohort, single-arm, open-label separate cohort)

Osimertinib 80 mg every day \[qd\] orally for up to 36 months or until progression or other discontinuation criteria are met. Osimertinib treatment should start from 7 to 14 days after completion of SBRT

Trial Locations (209)

2650

Research Site, Edegem

3000

Research Site, Leuven

3168

Research Site, Clayton

6000

Research Site, Charleroi

6006

Research Site, Badajoz

9000

Research Site, Ghent

9300

Research Site, Aalst

10016

Research Site, New York

10043

Research Site, Orbassano

10408

Research Site, Goyang-si

10461

Research Site, The Bronx

10467

Research Site, The Bronx

10709

Research Site, Newark

11042

Research Site, New Hyde Park

11526

Research Site, Athens

11527

Research Site, Athens

11794

Research Site, Stony Brook

12206

Research Site, Albany

13057

Research Site, East Syracuse

13210

Research Site, Syracuse

13620

Research Site, Gyeonggi-do

14642

Research Site, Rochester

15212

Research Site, Pittsburgh

15706

Research Site, Santiago de Compostela

16132

Research Site, Genova

19107

Research Site, Philadelphia

20010

Research Site, Washington D.C.

20014

Research Site, San Sebastián

20089

Research Site, Rozzano

20132

Research Site, Milan

20910

Research Site, Silver Spring

21079

Research Site, Dijon

21201

Research Site, Baltimore

21204

Research Site, Towson

21237

Research Site, Rosedale

21401

Research Site, Annapolis

23249

Research Site, Richmond

27100

Research Site, Pavia

27157

Research Site, Winston-Salem

28034

Research Site, Madrid

28040

Research Site, Madrid

28041

Research Site, Madrid

28046

Research Site, Madrid

28644

Research Site, Cheongju-si

29010

Research Site, Málaga

29425

Research Site, Charleston

30322

Research Site, Atlanta

30342

Research Site, Atlanta

30459

Research Site, Hanover

31000

Research Site, Toulouse

31096

Research Site, Haifa

32256

Research Site, Jacksonville

32804

Research Site, Orlando

33140

Research Site, Miami Beach

33744

Research Site, Bay Pines

34214

Research Site, Istanbul

35128

Research Site, Padua

35340

Research Site, Izmir

35401

Research Site, Tuscaloosa

37075

Research Site, Göttingen

40202

Research Site, Louisville

40503

Research Site, Lexington

41013

Research Site, Seville

41400

Research Site, Kocaeli

42701

Research Site, Elizabethtown

44106

Research Site, Cleveland

44202

Research Site, Nantes

44304

Research Site, Akron

45219

Research Site, Cincinnati

45242

Research Site, Cincinnati

46010

Research Site, Valencia

46845

Research Site, Fort Wayne

48073

Research Site, Royal Oak

48197

Research Site, Ann Arbor

48201

Research Site, Detroit

49100

Research Site, Petah Tikva

50009

Research Site, Zaragoza

50134

Research Site, Florence

52242

Research Site, Iowa City

52403

Research Site, Cedar Rapids

52621

Research Site, Ramat Gan

53226

Research Site, Milwaukee

54292

Research Site, Trier

55236

Research Site, Thessaloniki

55805

Research Site, Duluth

55905

Research Site, Rochester

57105

Research Site, Sioux Falls

57201

Research Site, Watertown

58201

Research Site, Grand Forks

60126

Research Site, Elmhurst

60540

Research Site, Naperville

60611

Research Site, Chicago

60612

Research Site, Chicago

60637

Research Site, Chicago

62526

Research Site, Decatur

63110

Research Site, St Louis

64239

Research Site, Tel Aviv

66424

Research Site, Homburg

68105

Research Site, Omaha

69126

Research Site, Heidelberg

69310

Research Site, Pierre-Bénite

69317

Research Site, Lyon

69677

Research Site, Bron

70006

Research Site, Metairie

70121

Research Site, New Orleans

75090

Research Site, Sherman

75235

Research Site, Dallas

77030

Research Site, Houston

78745

Research Site, Austin

85004

Research Site, Phoenix

85224

Research Site, Chandler

85719

Research Site, Tucson

89135

Research Site, Las Vegas

90095

Research Site, Los Angeles

90806

Research Site, Long Beach

91010

Research Site, Duarte

91120

Research Site, Jerusalem

92123

Research Site, San Diego

93053

Research Site, Regensburg

94805

Research Site, Villejuif

95847

Research Site, Kfar Saba

97210

Research Site, Portland

97213

Research Site, Portland

98195

Research Site, Seattle

98225

Research Site, Bellingham

99216

Research Site, Spokane Valley

100003

Research Site, Shenyang

100021

Research Site, Beijing

100142

Research Site, Beijing

105229

Research Site, Moscow

115478

Research Site, Moscow

119421

Research Site, Moscow

130021

Research Site, Changchun

197758

Research Site, Saint Petersburg

200002

Research Site, Shanghai

200030

Research Site, Shanghai

200032

Research Site, Shanghai

200433

Research Site, Shanghai

210009

Research Site, Nanjing

215006

Research Site, Suzhou

230031

Research Site, Hefei

250117

Research Site, Jinan

310002

Research Site, Hangzhou

310022

Research Site, Hangzhou

325000

Research Site, Wenzhou

350005

Research Site, Fuzhou

410013

Research Site, Changsha

420029

Research Site, Kazan, Tatarstan

430022

Research Site, Wuhan

430030

Research Site, Wuhan

450008

Research Site, Zhengzhou

450054

Research Site, Ufa

610042

Research Site, Chengdu

620905

Research Site, Yekaterinburg

04106

Research Site, South Portland

02215

Research Site, Boston

03756

Research Site, Lebanon

08103

Research Site, Camden

07652

Research Site, Paramus

05401

Research Site, Burlington

14784-400

Research Site, Barretos

90110-270

Research Site, Porto Alegre

52010-075

Research Site, Recife

22271-110

Research Site, Rio de Janeiro

01327-001

Research Site, São Paulo

27258-000

Research Site, Volta Redonda

T6G 1Z2

Research Site, Edmonton

N6A 5W9

Research Site, London

M4N 3M5

Research Site, Toronto

M5G 2M9

Research Site, Toronto

H2X 3E4

Research Site, Montreal

01307

Research Site, Dresden

06120

Research Site, Halle

00128

Research Site, Roma

673-8558

Research Site, Akashi-shi

113-8677

Research Site, Bunkyō City

104-0045

Research Site, Chūōku

812-8582

Research Site, Fukuoka

036-8563

Research Site, Hirosaki-shi

734-8551

Research Site, Hiroshima

650-0047

Research Site, Kobe

951-8566

Research Site, Niigata

541-8567

Research Site, Osaka

591-8555

Research Site, Sakaishi

060-8648

Research Site, Sapporo

411-8777

Research Site, Sunto-gun

470-1192

Research Site, Toyoake-shi

241-8515

Research Site, Yokohama

1081 HV

Research Site, Amsterdam

9713 GZ

Research Site, Groningen

3584 CX

Research Site, Utrecht

85-796

Research Site, Bydgoszcz

02-300

Research Site, Elblag

80-952

Research Site, Gdansk

40-514

Research Site, Katowice

93-513

Research Site, Lodz

02-781

Research Site, Warsaw

00917

Research Site, Hato Rey

03722

Research Site, Seoul

05505

Research Site, Seoul

06351

Research Site, Seoul

08041

Research Site, Barcelona

08907

Research Site, L'Hospitalet de Llobregat

06010

Research Site, Ankara

06520

Research Site, Ankara

B9 5SS

Research Site, Birmingham

LS9 7TF

Research Site, Leeds

EC1A 7BE

Research Site, London

M20 4BX

Research Site, Manchester

Sponsors

Lead Sponsor

All Listed Sponsors
lead

AstraZeneca

INDUSTRY