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Spots Global Cancer Trial Database for Immunotherapy With TG4010 in Patients With Advanced Non-Small Cell Lung Cancer

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Trial Identification

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

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Elisabeth QUOIX, M.D.

Affiliation: Hôpital Lyautey, Service de Pneumologie

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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