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 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)
EU record number: 
B/BE/11/BVW1
EudraCT number: 
2011-001468-23
Pharmaceutical study code: 
TG4010.14
Company / Sponsor: 
Transgene
Phase: 
IIb/III
Treated organism: 
Humans
Indication category: 
Cancer therapy
Disease: 
Non-Small Cell Lung cancer
Therapeutic approach: 
Immunotherapy
Genetic modification: 
sequences coding for human mucine 1 (MUC1) antigen and interleukin-2 (IL2)
Method of transfer of nucleic acid of interest: 
Attenuated Vaccinia Virus (Ankara Strain)
Administered biological material: 
Recombinant Attenuated Vaccinia Virus
Route of administration: 
subcutaneous
Locations in Belgium: 
Antwerpen, Libramont, Liège, Gosselies; CU: ZNA Middelheim; Centre hospitalier de l'Ardenne; CHU Liège; Clinique ND de Grâce, Gosselies; Ziekenhuis Oost-Limburg; Centre Hospitalier de l'Ardenne
Nr of subjects: 
1018 worlwide - 30 patients foreseen in Belgium
Foreseen duration: 
4 years
Type of procedure: 
Contained use and Deliberate release
Current status: 
Authorized

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