Phase III Lucanix™ Vaccine Therapy in Advanced Non-small Cell Lung Cancer (NSCLC) Following Front-line Chemotherapy

PHASE3CompletedINTERVENTIONAL
Enrollment

532

Participants

Timeline

Start Date

July 31, 2008

Primary Completion Date

January 31, 2013

Study Completion Date

January 31, 2013

Conditions
Lung NeoplasmCarcinoma Non-small Cell Lung Cancer Stage IIIACarcinoma Non-small Cell Lung Cancer Stage IIIBCarcinoma Non-small Cell Lung Cancer Stage IV
Interventions
BIOLOGICAL

Lucanix™

Treatment Arm: Subjects receive Lucanix™ (belagenpumatucel-L) intradermally (ID) once monthly for 18 months and then once at 21 and 24 months in the absence of disease progression or unacceptable toxicity.

OTHER

Placebo Comparator

Control Arm: Subjects receive placebo ID once monthly for 18 months and then once at 21 and 24 months in the absence of disease progression or unacceptable toxicity.

Trial Locations (82)

1121

Orszagos Koranyi TBC es Pulmonologiai Intezet, Budapest

1125

Semmelweis Egyetem Pulmonológiai Klinika, Budapest

1529

Országos Korányi TBC és Pulmonológiai Intézet, Budapest

2045

Pest Megyei Tüdőgyógyintézet, Törökbálint

4412

Szabolcs-Szatmár-Bereg Megyei Önkormányzat Jósa András Oktató Kórháza, Nyíregyháza

6772

Csongrád Megyei Önkormányzat Mellkasi Betegségek Szakkórháza, Deszk

8000

Fejér Megyei Szent György Kórház, Székesfehérvár

10310

Richmond University Medical Center, Staten Island

10469

Eastchester Center for Cancer Care, The Bronx

11000

Klinicko-bolnicki centar Bezanijska kosa, Belgrade

18000

Klinicki Centar Nis, Niš

21204

Institute for pulmonary disease Sremska Kamenica, Kamenitz

26241

Davis Memorial Cancer Care Center, Elkins

28801

Allergy Partners of West North Carolina, Asheville

Cancer Care of WNC, Asheville

29605

Cancer Center of the Carolinas, Greenville

30076

Atlanta Cancer Care, Roswell

32796

Space Coast Medical Center, Titusville

33467

Medical Specialist of Palm Beaches, Lake Worth

34471

Ocala Oncology, Ocala

34613

Pasco Hernando Oncology Associates, P.A., Brooksville

36608

Southern Cancer Center, Mobile

38104

University of Tennessee Cancer Institute, Memphis

38133

University of Tennessee Cancer Institute, Bartlett

38138

University of Tennessee Cancer Institute, Germantown

38671

University of Tennessee Cancer Institute, Southaven

40202

James Graham Brown Cancer Center, Louisville

44718

Gabrail Cancer Center Research LLC, Canton

46237

St. Francis Medical Group Oncology and Hematology Specialists, Indianapolis

48202

Henry Ford Health System, Detroit

52402

Iowa Blood and Cancer Center, Cedar Rapids

54476

Marshfield Clinic Weston Center, Weston

55455

University of Minnesota Medical Center, Minneapolis

55905

Mayo Clinic Cancer Center, Rochester

71301

Hematology Oncology Life Center, Alexandria

72401

Clopton Clinic Hematology/Oncology, Jonesboro

73110

Optim Oncology, Midwest City

75230

Mary Crowley Cancer Research Centers, Dallas

75702

Tyler Cancer Center, Texas Oncology, Tyler

79606

Texas Cancer Center Abilene, Texas Oncology P.A., Abilene

79701

Allison Cancer Center, Texas Oncology, P.A., Midland

80045

University of Colorado Health Science Center, Aurora

85259

Mayo Clinic Cancer Center, Scottsdale

89052

Comprehensive Cancer Centers of Nevada, Henderson

89074

Comprehensive Cancer Centers of Nevada, Henderson

89128

Comprehensive Cancer Centers of Nevada, Las Vegas

89169

Comprehensive Cancer Centers of Nevada, Las Vegas

90277

Cancer Care Associates, Redondo

90404

UCLA Cancer Center, Santa Monica

91105

UCLA Pasadena Oncology, Pasadena

91355

UCLA Cancer Center-Valencia, Valencia

91361

UCLA Cancer Center, Westlake Village

92093

University of California, San Diego, La Jolla

92103

Innovative Research Center of California, San Diego

93105

Sansum Clinic, Santa Barbara

Santa Barbara Hematology Oncology Medical Group, Inc., Santa Barbara

93309

Comprehensive Blood and Cancer Center, Bakersfield

93454

Central Coast Medical Oncology Corporation, Santa Maria

98109

Seattle Cancer Care Alliance/Fred Hutchinson Cancer Res Ctr/Univ. of Washington Med Ctr, Seattle

99508

Alaska Regional Hospital, Anchorage

302013

SEAROC Cancer Center, S.K., Jaipur

380016

Gujarat Cancer Hospital and Research Institute, Ahmedabad

400012

Tata Memorial Hospital, Mumbai

83814q

Kootenai Cancer Center, Coeur d'Alene

20892-1182

National Cancer Institute Center for Cancer Research, Medical Oncology Branch, Bethesda

07601

Cancer Center at Hackensack University Medical Center, Hackensack

T6G 1Z2

University of Alberta Cross Cancer Institute, Edmonton

M5G 2M9

Princess Margaret Hospital, Toronto

Unknown

Noble Hospital, Pune

Antoni van Leeuwenhoek Ziekenhuis, Amsterdam

Universitair Medisch Centrum Maastricht, Maastricht

7609 PP

Ziekenhuis Groep Twente - locatie Twenteborg Ziekenhuis, Almelo

1105 AZ

Academisch Medisch Centrum, Amsterdam

80-952

Akademickie Centrum Kliniczne Szpital Akademii Medycznej w Gdansku, Gdansk

20-954

Samodzielny Publiczny Szpital Kliniczny nr 4, Lublin

60-569

Wielkopolskie Centrum Pulmunologii i Torakochirurgii, Poznan

02-784

Centrum Onkologii - Instytut im.Marii Sklodowskiej-Curie, Warsaw

53-439

Dolnoslaskie Centrum Chorob Pluc, Wroclaw

G12 0YN

The Beatson West of Scotland Cancer Centre, Glasgow

CH63 4JY

Clatterbridge Centre for Oncology, Bebington, Wirral

DD1 9SY

Ninewells Hospital and Medical School, Dundee

SE1 9RT

Guy's Hospital, London

Sponsors

Lead Sponsor

All Listed Sponsors
lead

NovaRx Corporation

INDUSTRY

NCT00676507 - Phase III Lucanix™ Vaccine Therapy in Advanced Non-small Cell Lung Cancer (NSCLC) Following Front-line Chemotherapy | Biotech Hunter | Biotech Hunter