Phase 2 Study of Maintenance OSI-906 Plus Erlotinib (Tarceva®), or Placebo Plus Erlotinib in Patients With Nonprogression Following 4 Cycles of Platinum-based Chemotherapy

PHASE2CompletedINTERVENTIONAL
Enrollment

205

Participants

Timeline

Start Date

March 4, 2011

Primary Completion Date

July 1, 2013

Study Completion Date

March 11, 2015

Conditions
Non-Small Cell Lung Cancer (NSCLC) With Nonprogression Following 4 Cycles of Platinum-based Chemotherapy
Interventions
DRUG

OSI-906

Tablet administered with food and with up to 200 mL of water

DRUG

erlotinib

Tablet administered at least 2 hours after food with up to 200 mL of water

DRUG

placebo

Tablet administered at least 2 hours after food with up to 200 mL of water

Trial Locations (69)

10117

Site DE49014, Berlin

22977

Site DE49003, Großhansdorf

23538

Site DE49010, Lübeck

27103

Site US10010, Winston-Salem

27403

Site US10004, Greensboro

31701

Site US10002, Albany

32207

Site US10007, Jacksonville

32429

Site DE49005, Minden

34125

Site DE49015, Kassel

34376

Site DE49006, Immenhausen

34952

Site US10001, Port Saint Lucie

44145

Site DE49011, Dortmund

51109

Site DE49008, Cologne

55131

Site DE49013, Mainz

58675

Site DE49002, Hemer

60612

Site US10008, Chicago

66421

Site DE49009, Homburg/Saar

69126

Site DE49001, Heidelberg

76137

Site DE49012, Karlsruhe

194291

Site RU70007, Saint Petersburg

197089

Site RU70009, Saint Petersburg

Site RU70011, Saint Petersburg

200535

Site RO40006, Craiova

331057

Site RO40004, Hunedoara

400015

Site RO40002, Cluj-Napoca

Site RO40003, Cluj-Napoca

420029

Site RU70010, Kazan'

454087

Site RU70002, Chelaybinsk

490110

Site RO40001, Baia Mare

500366

Site RO40007, Brasov

510077

Site RO40005, Alba Iulia

04074

Site US10011, Scarborough

14784-400

Site BR55005, Barretos

70840-050

Site BR55004, Brasília

29308-014

Site BR55015, Cachoeiro de Itapemirim

88034-000

Site BR55011, Florianópolis

60336-550

Site BR55003, Fortaleza

74605-030

Site BR55016, Goiânia

98700-000

Site BR55006, Ijuí

88301-220

Site BR55001, Itajaí

13419-155

Site BR55008, Piracicaba

90430-090

Site BR55013, Porto Alegre

90610-000

Site BR55014, Porto Alegre

14515-130

Site BR55012, Ribeirão Preto

20231-050

Site BR55002, Rio de Janeiro

01323-920

Site BR55007, São Paulo

L1G 2B9

Site CA11001, Oshawa

K1H 8L6

Site CA11004, Ottawa

M5G 1X5

Site CA11006, Toronto

M6R 1B5

Site CA11002, Toronto

82-300

Site PL48002, Elblag

70-891

Site PL48005, Szczecin

87-100

Site PL48008, Torun

53-439

Site PL48006, Wroclaw

602-715

Site KR82007, Busan

519-809

Site KR82006, Hwasun

400-711

Site KR82008, Incheon

463-707

Site KR82004, Seongnam-si

120-752

Site KR82003, Seoul

135-710

Site KR82005, Seoul

137-701

Site KR82002, Seoul

Unknown

Site KR82001, Suwon

BS2 8ED

Site GB44007, Bristol

DD1 9SY

Site GB44006, Dundee

LS9 7TF

Site GB44003, Leeds

LE1 5WW

Site GB44002, Leicester

NW1 2PQ

Site GB44005, London

M20 4BX

Site GB44001, Manchester

SO16 6YD

Site GB44004, Southampton

Sponsors
All Listed Sponsors
lead

Astellas Pharma Inc

INDUSTRY