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Brief Title: Immunotherapy With TG4010 in Patients With Advanced Non-Small Cell Lung Cancer
Official Title: A Phase IIb Multicentric Controlled Study Evaluating the Therapeutic Vaccine TG4010(MVA-MUC1-IL2) as an Adjunct to Standard Chemotherapy in Advanced Non Small Cell Lung Cancer
Study ID: NCT00415818
Brief Summary: The primary Objective is to assess the efficacy of TG4010 combined to chemotherapy in comparison with chemotherapy alone in patients with advanced non small cell lung cancer.
Detailed Description: In the experimental arm patients receive subcutaneous injections of TG4010 at the dose of 108 pfu in combination with chemotherapy treatment whereas patients in the control arm receive chemotherapy alone. The chemotherapy associates cisplatin and gemcitabine and is given for up to 6 cycles or progressive disease, whichever occurs first. TG4010 is administered once per week for 6 weeks, then once every 3 weeks in combination with chemotherapy and thereafter as monotherapy until documentation of progressive disease. Tumor response will be evaluated every 6 weeks by a CT-scan and results will be available before starting an additional treatment period of 6 weeks. The tumor response taken into account will be for each patient the best overall response obtained during the study. The endpoint of the study is based on Progression Free Survival (PFS) at 6 months.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Centre Hospitalier Belfort-Montbeliard, Belfort, , France
CHU, Service de Pneumologie, Besancon, , France
Centre Hospitalier Général, Service de Pneumologie, Briey, , France
Centre François Baclesse, Caen, , France
Hôpital Pasteur - Service de médecine F- Pavillon 43, Colmar, , France
Centre Oscar Lambret, Lille, , France
Institut Paoli-Calmettes, Service d'oncologie médicale, Marseille, , France
Centre Hospitalier Lyon Sud, Pierre-Bénite, , France
CHRU Hôpital de Pontchaillou, Rennes, , France
Hôpital Lyautey - Service de Pneumologie, Strasbourg, , France
Centre Hospitalier de la Haute Saône, Service de Pneumologie - Allergologie, Vesoul, , France
Asklepios Fachkliniken, Zentrum für Pneumonologie, Gauting, , Germany
Thoraxklinik Heidelberg, Heidelberg, , Germany
Lungenklinik Krankenhaus Merheim, Köln, , Germany
Klinikum Mannheim der Ruprecht-Karls, Mannheim, , Germany
Klinikum Offenburg, Medizinische Klinik II, Offenburg, , Germany
Fejér Megyei Szent György Kórház, Székesfehérvár, , Hungary
Oddział II Chorób Płuc i Gruźlicy, Bialystok, , Poland
Kujawsko-Pomorskie Centrum Pulmonologii, Bydgoszcz, , Poland
Oddział Chemioterapii, Krakow, , Poland
Oddział III Chorób Płuc i Gruźlicy, Otwock, , Poland
Oddział Onkologii Klinicznej, Poznan, , Poland
Dolnośląskie Centrum, Wrocław, , Poland
Name: Elisabeth QUOIX, M.D.
Affiliation: Hôpital Lyautey, Service de Pneumologie
Role: PRINCIPAL_INVESTIGATOR