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B-GT/26: Regulatory and clinical data
(Authors: M. Sneyers and M. Goossens - Last revised:
April 5, 2012
)
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 nonsmall cell lung cancer (NSCLC) | ||
Company or sponsor |
Transgene & Quintiles | ||
Pharmaceutical study code |
TG4010.14 | ||
| EudraCT number | 2011-001468-23 | ||
Phase |
phase IIb/III | ||
Unicenter/multicenter study |
multicentric | ||
| Clinical data | see table 2 | ||
Installations |
ZNA Middelheim | Centre hospitalier de l'Ardenne | CHU Liège |
Authorisation procedure 1 |
contained use, subsequent use (see relevant regulation) | contained use, subsequent use (see relevant regulation) | contained use, subsequent use (see relevant regulation) |
Application numbers |
SBB/219/2011/1024 |
SBB/219/2012/0083 | SBB/219/2012/0347 |
User(s) |
Dr. Danny Galderman | Dr. F. Forget | Dr. Léon Bosquee |
Receipt date |
06/12/2011 | 18/01/2012 | 23/03/2012 |
| Authorisation procedure 2 | deliberate release for research and development purposes (see regulation in French - in Dutch) | ||
| Application number | B/BE/11/BVW1 | ||
| 30/09/2011 | |||
Authorisation date |
21/11/2011 |
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Status |
trial ready to start |
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