Study of TH-302 or Placebo in Combination With Pemetrexed in Patients With Non-squamous Non-small Cell Lung Cancer

PHASE2TerminatedINTERVENTIONAL
Enrollment

265

Participants

Timeline

Start Date

June 30, 2014

Primary Completion Date

April 30, 2016

Study Completion Date

May 31, 2016

Conditions
Non-small Cell Lung Cancer
Interventions
DRUG

TH-302 combination with pemetrexed

"400 mg/m2 of TH-302 will be administered by IV infusion over 30 - 60 minutes on Day 1 and Day 8 of a 21-day cycle.~Pemetrexed (500 mg/m2) will be administered as an IV infusion on Day 1 two - four hours after TH-302 administration."

DRUG

Matched placebo in combination with pemetrexed

"Matched placebo will be administered by IV infusion over 30 - 60 minutes on Day 1 and Day 8 of a 21-day cycle.~Pemetrexed (500 mg/m2) will be administered as an IV infusion on Day 1 two - four hours after placebo administration."

Trial Locations (80)

1121

Koranyi National Institute of TBC and Pulmonology, 14th Dept of Pulmonology, Budapest

Koranyi National Institute of TBC and Pulmonology, 6th Department of Pulmonology, Budapest

Koranyi National Institute of TBC and Pulmonology, 8th Department of Pulmonology, Budapest

4032

University of Debrecen, Medical and Health Science Center, Department of Pulmonology, Debrecen

5004

Hetenyi Geza Hospital, Department of Oncology, Szolnok

6772

Csongrad County Hospital of Chest Diseases, Deszk

10021

Clinical Research Alliance, New York

10043

A.O.U.S. Luigi GonzagaUniversity Hospital, Orbassano

10461

Montefire-Einstein Center for Cancer Care, The Bronx

12200

Charité Universitätsmedizin Berlin;, Berlin

12800

General Univesity Hospital in Prague, Clinic of Oncology, Prague

15478

Blokhin Russian Oncology Research Center, Moscow

15562

IASO General, Oncology Unit, Athens

17033

Penn State Milton S. Hershey Medical Center, Hershey

18081

Hospital Na Bulovce, Department of Pneumology and Thoracic Surgery, Libeň

19713

Christiana Care Health Services, Newark

20141

European Institute of Oncology (IEO) - Medical Care Unit, Milan

20889

Walter Reed National Military Medical Center, Bethesda

20900

S. Gerardo Hospital - Complex Structure of Medical Oncology, Monza

22060

Fpr Belvoir Community Hospital, Fort Belvoir

22927

Lungen Clinic Grosshandsdorf GmbH, Großhansdorf

23538

Universitatsklinikum Schleswig-Holstein, Lübeck

26500

University General Hospital of Patras, Oncology Unit, Pátrai

27705

Durham VA Medical Center, Durham

28007

General University Hospital Gregorio Maranon, Dept. of Oncology, Madrid

28040

Jimenez Diaz Foundation, Madrid

28144

W.G. (Bill) Hefner VA Medical Center, Salisbury

28222

Hospital Universitario Puerta de Hierro, Madrid

29209

DORN VA Medical Center, Columbia

32256

Cancer Specialists of North Florida - CBO, Jacksonville Beach

33133

AMPM Research, Miami

33170

"Santa Maria degli Angeli - Hospital - Complex Operative Unit of Oncology", Pordenone

35294

UAB Cancer Center, Birmingham

37045

"Mater Salutis Hospital - Operative Unit of Oncology", Verona

37421

Associates in Oncology & Hematology, Chattanooga

40139

"Hospital Bellaria Carlo Alberto Pizzardi - Operative Unit of Oncology", Bologna

41014

University Hospital Virgen de Valme, Seville

44718

Gabrail Cancer Center Research, Canton

46017

Dr. Peset University Hospital, Dept. of Oncology, Valencia

46026

Hospital Universitario La Fe, Servicio de Oncologia, Valencia

48106

St. Joseph Mercy Ann Arbor Cancer Center, Ann Arbor

55905

Mayo Clinic in Rochester, Rochester

56124

University Hospital of Pisa, Department of Cardothoracic Surgery, Operative unit of Pneumology, Pisa

57701

Regional Cancer Care Institute at Regional Health, Rapid City

60693

Med-Polonia Sp. z o.o., Poznan

64132

Research Medical Center, Kansas City

65929

Klinikum Frankfurt Höchst GmbH, Frankfurt

70121

Ochsner Clinical Foundation, New Orleans

71110

Department of Medical Oncology, Heraklion

76275

Regional Hospital T. Bta, Department of Pneumology, Zlín

77024

Oncology Consultants, Houston

77090

Millennium Oncology, Houston

78234

San Antonio Military Medical Center, Fort Sam Houston

80220

VA Eastern Colorado Healthcare System, Denver

81925

Städtisches Klinikum München - Klinikum Bogenhausen, München

82131

Asklepios Fachkliniken Munchen-Gaunting, Gauting

85224

Ironwood Cancer and Research Centers, Chandler

89081

Universitätsklinikum Ulm; Zentrum für Innere Medizin, Ulm

90095

UCLA-Department of Medicine a Division of Hem/Onc, Los Angeles

90403

Sarcoma Oncology Research Center, Santa Monica

92024

California Cancer Center, Encinitas

93720

California Cancer Center Associates, Fresno

98101

Virginia Mason Medical Center, Seattle

115478

Russian Oncology Research Center n.a. N.N. Blokhin under the Russian Academy of Medical Sciences, Moscow

194044

St. Petersburg Clinical Center for Applied Special Medical Services (Oncology), Saint Petersburg

197101

St. Petersburg 1st State Medical University n.a.I.P. Pavlov under the Ministry of Healthcare of the Russian Federation, Saint Petersburg

198255

City Clinical Oncology Center, Oncology Department (Thoracic Oncology), Saint Petersburg

400015

Prof. Dr. Ioan Chiricuta Institute of Oncology, Cluj-Napoca

420029

Republican Clinical Oncology Center under the Ministry of Healthcare of Tatarstan Republic, Kazan'

603081

State Healthcare Institution: Nizhny Novgorod Regional Oncology Center, Nizhny Novgorod

140 59

Thomayer Hospital, Clinic of Pneumology, Prague

Unknown

Marien Hospital Herne, Herne

Attikon University General Hospital, Athens

IRCCS Azienda Ospedallera Universitaria San Martino-IST-Istituto Nazionale per la Ricerca sul Cancro, Genova

Azienda Ospedaliera Universitaria Policlinico della Seconda Universita di Napoli, Napoli

"Oncology Centre Sf. Nectarie", Craiova

00152

San Camillo-Forlanini Hospital - U.O.C. Pneumologia Oncologica 1, Rome

87-100

L. Rydygier Provencial Hospitals in Torun, Dept. of Tumors Chemotherapy, Torun

02781

Maria Sklodowska-Curie Institute of Oncology in Warsaw, Warsaw

022328

Pro. Dr. Alex Trestioreanu Institute of Oncology, Bucharest

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

EMD Serono

INDUSTRY

lead

ImmunoGenesis

INDUSTRY