Spots Global Cancer Trial Database for Phase IIB/III Of TG4010 Immunotherapy In Patients With Stage IV Non-Small Cell Lung Cancer
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Trial Identification
Brief Title: Phase IIB/III Of TG4010 Immunotherapy In Patients With Stage IV Non-Small Cell Lung Cancer
Official Title: A Phase IIB/III Randomized, Double-blind, Placebo Controlled Study Comparing First Line Therapy With or Without TG4010 Immunotherapy Product in Patients With Stage IV Non-Small Cell Lung Cancer (NSCLC)
Study ID: NCT01383148
Conditions
Study Description
Brief Summary: This is a Phase IIb/III randomized, double-blind, placebo-controlled study to compare the efficacy and safety of first-line therapy combined with TG4010 or placebo in stage IV non-small cell lung cancer (NSCLC). TG4010 is a suspension of recombinant Modified Vaccinia virus strain Ankara (MVA strain) carrying coding sequences for human MUC1 antigen and human interleukin-2 (IL2). TG4010 has been developed for use as an immunotherapy in cancer patients whose tumors express the MUC1 antigen. TG4010 is intended to induce a MUC1-specific cellular immune response and to produce a non-specific activation of several components of the immune system.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Mayo Clinic Arizona, Scottsdale, Arizona, United States
Cotton O'Neil Clinical Research Center, Topeka, Kansas, United States
University of Louisville Hospital, Louisville, Kentucky, United States
Massachusetts General Hospital, Cambridge, Maryland, United States
Oncology/Hematology P.C., Rockville, Maryland, United States
Washington University, St. Louis, Missouri, United States
Highlands Oncology Group, Fayetteville, North Carolina, United States
Signal Point Clinical Research Center, Middletown, Ohio, United States
ProMedica Health System Inc, Toledo, Ohio, United States
Abington Hematology Oncology Associates Inc, Willow Grove, Pennsylvania, United States
Texas Oncology, P.A. - Abilene (South), Abilene, Texas, United States
Mary Crowley Medical Research Center, Dallas, Texas, United States
ZNA Middelheim, Antwerpen, , Belgium
Clinique Nôtre-Dame de Grâce, Gosselies, , Belgium
Centre Hospitalier de l'Ardenne, Libramont, , Belgium
C. H. U. Sart-Tilman, Liège, , Belgium
CHU, Service de Pneumologie, Besancon, , France
Centre François Baclesse, Caen, , France
CHU de Clermont-Ferrand, Hopital Gabriel Montpied, Clermont-Ferrand, , France
Hôpital Pasteur - Service de médecine F- Pavillon 43, Colmar, , France
Centre Hospitalier Intercommunal de Créteil, Créteil, , France
CHRU de Lille Hopital Calmette, Lille, , France
Clinique François Chénieux, Limoges, , France
Institut Paoli-Calmettes, Service d'oncologie médicale, Marseille, , France
CH Mulhouse Hopital Emile Muller Moenchsberg, Mulhouse, , France
Hopital Saint Joseph, Paris, , France
Hôpital Pontchaillou, Rennes Cedex 09, , France
CHU de Saint-Etienne, Hôpital Nord, Saint Etienne Cedex 02, , France
Institut de Cancérologie Lucien Neuwirth, Saint Priest en Jarez, , France
Centre Médical Alfred Leune, Sainte Feyre, , France
Nouvel Hôpital Civil, Strasbourg, , France
Centre Hospitalier Intercommunal de la Haute Saone, Vesoul cedex, , France
Universitaetsklinikum Hamburg-Eppendorf, Hamburg, , Germany
Universitaetsklinikum Mannheim, Mannheim, , Germany
Orszagos Onkologiai Intezet, Budapest, , Hungary
Semmelweis Egyetem AOK, Budapest, , Hungary
Orszagos Koranyi TBC es Pulmonologiai Intezet, Budapest, , Hungary
Kenezy Korhaz-Rendelointezet Eu Szolgaltato Nonprofit Kft, Debrecen, , Hungary
Bekes Megyei Kepviselotestulet Pandy Kalman Korhaza, Gyula, , Hungary
Petz Aladár Megyei Oktató kórház, Győr, , Hungary
Matrai Gyogyintezet, Matrahaza, , Hungary
Tolna Megyei Onkormanyzat Balassa Janos Korhaza, Szekszard, , Hungary
Fejér Megyei Szent György Kórház, Székesfehérvár, , Hungary
Komarom-Esztergom Megyei Onkorm. Szent Borbala Korhaza, Tatabanya, , Hungary
Tudogyogyintezet Torokbalint, Torokbalint, , Hungary
Zala Megyei Korhaz, Zalaegerszeg, , Hungary
Assaf Harofeh Medical Center, Beer Yaacov, , Israel
Hadassah Ein Kerem Medical Center, Jerusalem, , Israel
Sapir Medical Center Meir Hospital, Kfar-Saba, , Israel
Rabin Medical Center-Beilinson Campus, Petah-Tikva, , Israel
Chaim Sheba Medical Center, Ramat Gan, , Israel
Kaplan Medical Center, Rehovot, , Israel
Tel Aviv Sourasky Medical Center, Tel Aviv, , Israel
IEO Istituto Europeo di Oncologia, Milano, , Italy
Azienda Ospedaliera di Perugia Ospedale S.Maria della Miseri, Perugia, , Italy
A.O.U. Senese Policlinico Santa Maria alle Scotte, Siena, , Italy
Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie, Lublin, , Poland
SP Zespol Gruzlicy i Chorob Pluc w Olsztynie, Olsztyn, , Poland
Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy, Otwock, , Poland
Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego, Poznan, , Poland
Centrum Onkologii-Instytut im. M. Sklodowskiej Curie, Warszawa, , Poland
Hospital Universitari Vall d'Hebron, Barcelona, , Spain
Hospital Universitario Reina Sofia, Cordoba, , Spain
ICO Girona - Hospital Dr Josep Trueta, Girona, , Spain
Hospital Gregorio Marañon, Madrid, , Spain
START Madrid. Centro Integral Oncologico Clara Campal, Madrid, , Spain
Hospital General Carlos Haya, Malaga, , Spain
Corporació Sanitària Parc Taulí, Sabadell, , Spain
Queen Elizabeth Hospital, Birmingham, , United Kingdom
Velindre Hospital NHS Trust, Cardiff, , United Kingdom
Plymouth Oncology Centre, Plymouth, , United Kingdom
Southampton University Hospitals NHS Trust, Southampton, , United Kingdom
Contact Details
Name: QUOIX Elisabeth, Prof
Affiliation: Hôpitaux Universitaires de Strasbourg
Role: PRINCIPAL_INVESTIGATOR
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