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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
148
MVA-MUC1-IL2: Dose of 10exp8 plaque forming units (pfu). Chemotherapy: Arm 1 and Arm 2 Intravenous CT: cisplatin (75mg/m² at Day 1) and gemcitabine (1250mg/m² at Days 1 and 8) every 3 weeks, for up to six cycles or until progressive disease, whichever occurred first.
Centre Hospitalier Belfort-Montbeliard
Belfort, France
Progression free survival at 6 months
Time frame: 6 months
Response Rate according to WHO criteria
Time frame: 6 months
Time to progression
Time frame: 6 months
Overall survival
Quality of life
Time frame: every 6 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
CHU, Service de Pneumologie
Besançon, 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
...and 13 more locations