NCT01328951 - A Study of First-line Maintenance Erlotinib Versus Erlotinib at Disease Progression in Participants With Advanced Non-Small Cell Lung Cancer (NSCLC) Who Have Not Progressed Following Platinum-Based Chemotherapy | Biotech Hunter

Enrollment

643

Participants

Timeline

Start Date

September 30, 2011

Primary Completion Date

December 31, 2015

Study Completion Date

January 31, 2016

Conditions

Non-Squamous Non-Small Cell Lung Cancer

Interventions

DRUG

Placebo

Placebo will be administered PO once daily as first-line maintenance until disease progression, death, or unacceptable toxicity.

DRUG

Erlotinib

Erlotinib will be administered as 150 mg PO once daily until disease progression, death, or unacceptable toxicity, as first-line maintenance or as second-line therapy for those who progress while receiving placebo.

DRUG

Second-Line Chemotherapy

Participants who progress on first-line maintenance erlotinib may receive an approved second-line therapy (but not EGFR targeted therapies) until disease progression, death, or unacceptable toxicity. The selected chemotherapy will be non-investigational and chosen at the discretion of the Investigator.

Trial Locations (155)

100

Taipei

112

Taipei

1121

Budapest

1122

Budapest

1125

Budapest

1145

Budapest

1233

Sofia

1303

Sofia

1527

Sofia

1606

Sofia

1756

Sofia

1784

Sofia

2045

Törökbálint

3233

Mátraháza

3526

Miskolc

4004

Plovdiv

5000

Szolnok

5300

Gabrovo

5417

Daugavpils

5703

Gyula

6045

Port Elizabeth

6300

Haskovo

6530

George

6772

Deszk

7000

Rousse

7570

Cape Town

7700

Cape Town

8000

Székesfehérvár

8582

Farkasgyepű

8900

Zalaegerszeg

9010

Varna

9024

Győr

10700

Bangkok

11490

Taipei

20010

Washington D.C.

21029

Vinnytsia

22027

Saint-Brieuc

24047

Treviglio

25011

Kirovograd

33505

Libourne

37045

Legnago

37134

Verona

37404

Chattanooga

40005

Sumy

40138

Bologna

40447

Taichung

40705

Taichung

43100

Parma

44202

Nantes

45420

Dayton

49102

Dnipropetrovsk

50009

Kaunas

50200

Muang

56100

Pisa

57000

Muang

57124

Livorno

59020

Lille

59802

Missoula

60321

Compiègne

61024

Kharkiv

63000

Lutsk

64109

Bayonne

64132

Kansas City

69040

Zaporizhzhya

69655

Villefranche-sur-Saône

71013

S. Giovanni Rotondo

83092

Donetsk

83100

Avellino

88000

Uzhhorod

90110

Hat Yai

95020

Gilroy

97901

Rimavská Sobota

98405

Tacoma

99218

Spokane

100142

Beijing

100337

Ploieşti

100730

Beijing

110001

Shenyang

130012

Changchun

150081

Harbin

200030

Shanghai

200433

Shanghai

215004

Suzhou

300060

Tianjin

350014

Fuzhou

400015

Cluj-Napoca

400058

Cluj-Napoca

400132

Cluj-Napoca

410167

Oradea

430031

Baia Mare

430071

Wuhan

500091

Brasov

500152

Brasov

510515

Guangzhou

515041

Shantou

540136

Târgu Mureş

710061

Xi'an

810325

Brăila

90470340

Porto Alegre

03756

Lebanon

30150-281

Belo Horizonte

95900-000

Lajeado

90020-090

Porto Alegre

90035-003

Porto Alegre

90430-090

Porto Alegre

98700-000

Ijuí

88034-000

Florianópolis

09060-650

Santo André

N8W 2X3

Windsor

H3T 1E2

Montreal

G1V 4G5

Québec

S4T 7T1

Regina

Unknown

Guangzhou

370 87

České Budějovice

377 01

Jindřichův Hradec

288 01

Nymburk

708 52

Ostrava - Poruba

150 06

Prague

180 81

Prague

390 03

Tábor

05007

Gap

00144

Rome

00151

Rome

00168

Rome

LV-1079

Riga

LV1002

Riga

08660

Vilnius

6800 TA

Arnhem

6419 PC

Heerlen

1625 HV

Hoorn

6162 BG

Sittard-Geleen

7207 AE

Zutphen

36-200

Brzozów

31-115

Krakow

60-569

Poznan

44-300

Wodzisław Śląski

22-400

Zamość

010976

Bucharest

022328

Bucharest

975 17

Banská Bystrica

085 01

Bardejov

04001

Košice

940 02

Nové Zámky

058 01

Poprad

0002

Pretoria

463-707

Gyeonggi-do

03722

Seoul

06351

Seoul

150-713

Seoul

442-723

Suwon

00833

Kaohsiung City

00112

Taipei

03022

Kyiv

03115

Kyiv

04107

Kyiv

All Listed Sponsors

lead

Hoffmann-La Roche

INDUSTRY