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
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.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression free survival at 6 months
Elisabeth QUOIX, M.D.
Hôpital Lyautey, Service de Pneumologie
United States: Food and Drug Administration