Phase IIB/III Of TG4010 Immunotherapy In Patients With Stage IV Non-Small Cell Lung Cancer

PHASE2/PHASE3TerminatedINTERVENTIONAL
Enrollment

222

Participants

Timeline

Start Date

April 30, 2012

Primary Completion Date

July 31, 2015

Study Completion Date

July 31, 2016

Conditions
Non-Small-Cell Lung Carcinoma
Interventions
BIOLOGICAL

TG4010

"TG4010 • TG4010 will be administered starting on Day 1 (D1) of Cycle 1 of chemotherapy and will be administered weekly for 6 weeks by subcutaneous (SC) injections and then once every 3 weeks until progression or discontinuation due to any reason.~Chemotherapy (and bevacizumab if prescribed), will be given as 21-day cycles for a minimum of 4 cycles and up to 6 cycles.~First line therapy:~* Non-squamous carcinoma: pemetrexed + cisplatin or paclitaxel + carboplatin +/- bevacizumab~* Squamous carcinoma: gemcitabine + cisplatin or paclitaxel + carboplatin~Maintenance therapy:~• Pemetrexed or erlotinib for eligible patients and according to labeling."

DRUG

placebo

"Placebo will be administered starting on D1 of Cycle 1 of chemotherapy and will be administered weekly for 6 weeks by SC injections and then once every 3 weeks until progression or discontinuation due to any reason.~* First line therapy: as in Arm 1~* Maintenance therapy: as in Arm 1"

Trial Locations (72)

1122

Orszagos Onkologiai Intezet, Budapest

1125

Semmelweis Egyetem AOK, Budapest

1525

Orszagos Koranyi TBC es Pulmonologiai Intezet, Budapest

2020

ZNA Middelheim, Antwerp

2045

Tudogyogyintezet Torokbalint, Törökbálint

2114

Massachusetts General Hospital, Cambridge

2800

Komarom-Esztergom Megyei Onkorm. Szent Borbala Korhaza, Tatabánya

3233

Matrai Gyogyintezet, Mátraháza

4000

C. H. U. Sart-Tilman, Liège

4032

Kenezy Korhaz-Rendelointezet Eu Szolgaltato Nonprofit Kft, Debrecen

5703

Bekes Megyei Kepviselotestulet Pandy Kalman Korhaza, Gyula

6041

Clinique Nôtre-Dame de Grâce, Gosselies

6156

Azienda Ospedaliera di Perugia Ospedale S.Maria della Miseri, Perugia

6800

Centre Hospitalier de l'Ardenne, Libramont

7100

Tolna Megyei Onkormanyzat Balassa Janos Korhaza, Szekszárd

8000

Fejér Megyei Szent György Kórház, Székesfehérvár

8900

Zala Megyei Korhaz, Zalaegerszeg

9024

Petz Aladár Megyei Oktató kórház, Győr

13273

Institut Paoli-Calmettes, Service d'oncologie médicale, Marseille

14004

Hospital Universitario Reina Sofia, Córdoba

14076

Centre François Baclesse, Caen

17007

ICO Girona - Hospital Dr Josep Trueta, Girona

19090

Abington Hematology Oncology Associates Inc, Willow Grove

20141

IEO Istituto Europeo di Oncologia, Milan

20246

Universitaetsklinikum Hamburg-Eppendorf, Hamburg

20850

Oncology/Hematology P.C., Rockville

23000

Centre Médical Alfred Leune, Sainte-Feyre

25000

CHU, Service de Pneumologie, Besançon

28007

Hospital Gregorio Marañon, Madrid

28050

START Madrid. Centro Integral Oncologico Clara Campal, Madrid

29010

Hospital General Carlos Haya, Málaga

35033

Hôpital Pontchaillou, Rennes

40402

University of Louisville Hospital, Louisville

42055

CHU de Saint-Etienne, Hôpital Nord, Saint-Etienne

42270

Institut de Cancérologie Lucien Neuwirth, Saint-Priest-en-Jarez

43606

ProMedica Health System Inc, Toledo

44281

Chaim Sheba Medical Center, Ramat Gan

45042

Signal Point Clinical Research Center, Middletown

49372

Rabin Medical Center-Beilinson Campus, Petah Tikva

52621

Sapir Medical Center Meir Hospital, Kfar Saba

53100

A.O.U. Senese Policlinico Santa Maria alle Scotte, Siena

59037

CHRU de Lille Hopital Calmette, Lille

60569

Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego, Poznan

63000

CHU de Clermont-Ferrand, Hopital Gabriel Montpied, Clermont-Ferrand

63110

Washington University, St Louis

64239

Tel Aviv Sourasky Medical Center, Tel Aviv

66606

Cotton O'Neil Clinical Research Center, Topeka

67000

Nouvel Hôpital Civil, Strasbourg

68000

Hôpital Pasteur - Service de médecine F- Pavillon 43, Colmar

68070

CH Mulhouse Hopital Emile Muller Moenchsberg, Mulhouse

68167

Universitaetsklinikum Mannheim, Mannheim

70014

Centre Hospitalier Intercommunal de la Haute Saone, Vesoul

70300

Assaf Harofeh Medical Center, Beer Yaacov

72703

Highlands Oncology Group, Fayetteville

75014

Hopital Saint Joseph, Paris

75246

Mary Crowley Medical Research Center, Dallas

76100

Kaplan Medical Center, Rehovot

79606

Texas Oncology, P.A. - Abilene (South), Abilene

85259

Mayo Clinic Arizona, Scottsdale

87039

Clinique François Chénieux, Limoges

91120

Hadassah Ein Kerem Medical Center, Jerusalem

94010

Centre Hospitalier Intercommunal de Créteil, Créteil

20-954

Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie, Lublin

10-357

SP Zespol Gruzlicy i Chorob Pluc w Olsztynie, Olsztyn

05-400

Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy, Otwock

02-781

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

08035

Hospital Universitari Vall d'Hebron, Barcelona

08208

Corporació Sanitària Parc Taulí, Sabadell

B15 2TH

Queen Elizabeth Hospital, Birmingham

CF14 2TL

Velindre Hospital NHS Trust, Cardiff

PL6 8DH

Plymouth Oncology Centre, Plymouth

SO16 6YD

Southampton University Hospitals NHS Trust, Southampton

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Transgene

INDUSTRY

NCT01383148 - Phase IIB/III Of TG4010 Immunotherapy In Patients With Stage IV Non-Small Cell Lung Cancer | Biotech Hunter | Biotech Hunter