Safety and Efficacy of Carboplatin/Paclitaxel and Carboplatin/Paclitaxel/Bevacizumab With and Without Pictilisib in Previously Untreated Advanced or Recurrent Non-small Cell Lung Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

501

Participants

Timeline

Start Date

January 20, 2012

Primary Completion Date

March 30, 2016

Study Completion Date

March 30, 2016

Conditions
Non-Small Cell Lung Cancer
Interventions
DRUG

pictilisib

Pictilisib, 260 milligrams (mg) or 340 mg, will be taken orally once daily on Days 1-14 of a 21-day cycle for four cycles. Starting with Cycle 5, pictilisib will be taken once daily continuously.

DRUG

Placebo

Placebo corresponding to 260 mg or 340 mg pictilisib will be taken orally once daily on Days 1-14 of a 21-day cycle for four cycles. Starting with Cycle 5, placebo will be taken once daily continuously.

DRUG

bevacizumab

Bevacizumab, 15 milligrams per kilogram (mg/kg) will be administered intravenously (IV) at Day 1 of each 21-day cycle for a maximum of 34 cycles.

DRUG

carboplatin

Carboplatin will be administered IV to achieve an initial target area under the concentration curve (AUC) of 6 milligrams per milliliter per minute (mg/mL per min) on Day 1 of each 21-day cycle for a maximum of four cycles.

DRUG

paclitaxel

Paclitaxel will be administered at 200 milligrams per square meter (mg/m\^2) IV on Day 1 of each 21-day cycle for a maximum of four cycles.

Trial Locations (120)

0

Clinica Santa Maria, Santiago

1121

Orszagos Koranyi TBC es Pulmonologiai Intezet, Budapest

2010

St Vincent'S Hospital, Darlinghurst

2045

Tudogyogyintezet Torokbalint, Törökbálint

2050

Royal Prince Alfred Hospital; Sydney Cancer Centre, Camperdown

2298

Calvary Mater Newcastle; Medical Oncology, Waratah

3011

Footscray Hospital, Footscray

3052

Royal Melbourne Hospital; Hematology and Medical Oncology, Parkville

3780

Koch Robert Korhaz, Edelény

5042

Flinders Medical Centre; Medical Oncology, Bedford Park

7000

Royal Hobart Hospital; Medical Oncology, Hobart

8582

Veszprem Megyei Onkormanyzat Tudogyogyintezet, Farkasgyepű

8900

Zala Megyei Korhaz; Dept of Pulmonary Medicine, Zalaegerszeg

9700

Vas Megyei Markusovszky Korhaz ; Pulmonology, Szombathely

10043

Az. Osp. S. Luigi Gonzaga; Malattie Apparato Respiratorio 5 Ad Indirizzo Oncologico, Orbassano

14263

Roswell Park Cancer Inst., Buffalo

20900

ASST DI MONZA; Oncologia Medica, Monza

21237

Franklin Square Hospital, Baltimore

22927

Krankenhaus Grosshansdorf;Pneumologie & Thoraxchirurgie, Großhansdorf

24014

Blue Ridge Cancer Care - Roanoke, Roanoke

24201

Wellmonth Physician Services, Bristol

27103

Piedmont Hematology Oncology Associates, Winston-Salem

28041

Hospital Universitario 12 de Octubre; Servicio de Oncologia, Madrid

28222

Hospital Universitario Puerta de Hierro; Servicio de Oncologia, Madrid

29200

Hopital Morvan, Brest

30318

Peachtree Hematology & Oncology Consultants, Pc, Atlanta

30341

Georgia Cancer Specialists, Atlanta

30607

University Cancer & Blood Center, LLC, Athens

32256

Cancer Specialists; North Florida ;Jacksonville (AC Skinner Pkwy), Jacksonville

33081

Irccs Centro Di Riferimento Oncologico (CRO); Dipartimento Di Oncologia Medica, Aviano

33176

Advanced Medical Specialties, Miami

33486

Lynn Regional Cancer Center West, Boca Raton

33705

Florida Cancer Specialists (St. Petersburg - St. Anthony's Professional Building), St. Petersburg

33905

Florida Cancer Specialists - Fort Myers (Colonial Center Dr), Fort Myers

35211

Alabama Oncology, Birmingham

37134

A.O.U.I. VERONA-OSPEDALE POLICLINICO G.B. ROSSI BORGO ROMA;ONCOLOGIA MEDICA-d.U., Verona

37203

The Sarah Cannon Research Inst, Nashville

37232

Vanderbilt, Nashville

37909

Center for Biomedical Research LLC, Knoxville

40005

Sumy Reg. Clin. Oncological Dispensary; Thoracall Department, Sumy

40139

Ausl Di Bologna-Ospedale Bellaria;U.O. Oncologia Medica, Bologna

43018

Volyn Regional Oncology Dispensary, Lutsk

44106

Univ Hosp Case Medical Center, Cleveland

44202

Clinique Catherine de Sienne; Service de cancérologie, Nantes

44718

Gabrail Cancer Center, Canton

44805

Ico Rene Gauducheau; Oncologie, Saint-Herblain

45219

The Christ Hospital, Cincinnati

46260

Hematology-Oncology of Indiana, Pc, Indianapolis

48201

Wayne State University; Hemat/Onc, 4HW CRC, Detroit

55131

Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Medizinische Klinik, Pneumologie, Mainz

68114

Nebraska Methodist Hospital, Omaha

69040

Zaporizhzhia Regional Clinical Oncology Dispensary; Zaporizhzhya State Medical University, Zaporizhzhya

69655

Centre Hospitalier de Villefranche sur Saone, Villefranche-sur-Saône

72015

Clinique Victor Hugo; Radiotherapie, Le Mans

72758

Highlands Oncology Group, Rogers

76137

St. Vincentius Kliniken Karlsruhe; Abteilung Hämatologie / Onkologie, Karlsruhe

77030

University of Texas M.D. Anderson Cancer Center, Houston

78052

Schwarzwald-Baar Klinikum/VS GmbH; Onkologie/Hämatologie/Infektologie, Villingen-Schwenningen

79031

State Oncology Regional Treatment-Diagnostic Center; Chemotherapy Department, Lviv

82131

Asklepios-Fachkliniken Muenchen-Gauting; Onkologie, Gauting

87401

San Juan Oncology Associates, Farmington

89081

Universitätsklinikum Ulm; Medizinische Uni-Klinik III Abt. Innere Medizin III Hämatologie u. Onkolo., Ulm

89502

Va Sierra Nevada Health Care System, Reno

91031

Shaare Zedek Medical Center; Oncology Dept, Jerusalem

92024

cCare, Encinitas

92120

Southern CA Permanente Med Grp, San Diego

92270

Desert Hematology Oncology Group, Rancho Mirage

93053

Universitätsklinikum Regensburg; Klinik und Poliklinik für Innere Medizin II, Pneumologie, Regensburg

94115

Kaiser Permanente, San Francisco

94589

Kaiser Permanente - Vallejo, Vallejo

94596

K. Permanente - Walnut Creek, Walnut Creek

94611

Kaiser Permanente - Oakland, Oakland

94805

Institut Gustave Roussy; Departement Oncologie Medicale, Villejuif

95023

Crimean Republican Institute; Oncology Clin Dispensary; Chemotherapy Dept, Simferopol

95051

K. Permanente - Santa Clara, Santa Clara

95204

Stockton Hema Onc Med Grp Inc, Stockton

95661

Kaiser Permanente - Roseville, Roseville

95825

Kaiser Permanente Sacramento Medical Center, Sacramento

98108

VA Puget Sound Health Care Sys, Seattle

98405

Northwest Medical Specialties, Tacoma

99437

Zentralklinik Bad Berka GmbH; Abteilung Onkologie und Hämatologie, Bad Berka

143423

Moscow city oncology hospital #62 of Moscow Healthcare Department, Moscow

189646

Rsrch Onc Inst of Rosmed Tech; n.a. prof. N.N. Petrov; Dept of Surgery, Saint Petersburg

194291

Leningrad Regional Clinical Hospital, Saint Petersburg

454087

Regional Oncology Center, Chelyabinsk

603000

City Oncology Hospital; Chemotherapy Dept, Nizhny Novgorod

2520612

Hospital Clinico Vina del Mar, Viña del Mar

4428164

Meir Medical Center; Oncology, Kfar Saba

4810469

Instituto Oncologico del sur, Temuco

5262100

Chaim Sheba Medical Center; Oncology Dept, Ramat Gan

7500921

Fundacion Arturo Lopez Perez, Santiago

59040150

Liga Norte Riograndense Contra O Câncer, Natal

06902

Hematology Oncology PC; Bennett Cancer Center, Stamford

02114

Massachusetts General Hospital., Boston

02115

Dana Farber Cancer Inst., Boston

02215

Beth Israel Deaconess Medical Center, Boston

X5004FHP

Clinica Universitaria Reina Fabiola, Córdoba

B1900BAJ

Instituto FIDES, La Plata

03000

Isis Centro Especializado de Luces; Oncology, Santa Fe

41820-021

Centro de Oncologia da Bahia - CENOB, Salvador

70390-055

Clinica de Tratamento e Pesquisa Oncologica - Oncotek, Brasília

20560-120

Instituto Nacional de Cancer - INCa; Oncologia, Rio de Janeiro

90020-090

Santa Casa de Misericordia de Porto Alegre, Porto Alegre

90110-270

Hospital Mae de Deus, Porto Alegre

88034-000

Centro de Pesquisas Oncologicas - CEPON, Florianópolis

17210-080

Hospital Amaral Carvalho, Jaú

01246-000

Instituto do Cancer do Estado de Sao Paulo - ICESP, São Paulo

18030-245

Instituto de Oncologia de Sorocaba - CEPOS, Sorocaba

H3A 1A1

Mcgill University - Royal Victoria Hospital; Oncology, Montreal

J4B 5Z7

Hopital du Sacre-Coeur, Montreal

4818 CK

Amphia Ziekenhuis, Breda

5623 EJ

Catharina-ziekenhuis; Longgeneeskunde en Tuberculose, Eindhoven

9700 RB

Universitair Medisch Centrum Groningen, Groningen

05071

Hospital Nuestra Señora de Sonsoles; servicio de Oncologia, Ávila

08035

Hospital Univ Vall d'Hebron; Servicio de Oncologia, Barcelona

08916

Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia, Barcelona

03115

Kiev City Clinical Oncology Center, Kiev

GU2 7XX

Royal Surrey County Hospital; St. Lukes Cancer Centre, Guildford

LE1 5WW

Leicester Royal Infirmary; Dept. of Medical Oncology, Leicester

M2O 4BX

Christie Hospital Nhs Trust; Medical Oncology, Manchester

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Genentech, Inc.

INDUSTRY