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

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

Pharmaceutical study code

TG4010.14

Information for the public

B/BE/11/BVW1 - Information publique (préparée par le notifiant)

B/BE/11/BVW1 - Informatie voor het publiek (voorbereid door de kennisgever)

B/BE/11/BVW1 - Public information (prepared by the notifier)

B/BE/11/BVW1 - Summary Notification Information format (SNIF)

Public information presented according to the provisions of Directive 2001/18/EC

Information related to the decision procedure

B/BE/11/BVW1 - Advice Biosafety Advisory Council

30 September 2011 : The Biosafety Advisory Council issues a positive advice (with conditions) for this trial.

B/BE/11/BVW1 - Decision of the Federal Minister (FINAL DECISION)

21/11/2011: The Federal Minister gives a final decision (positive) for this trial.