Phase IIB/III Of TG4010 Immunotherapy In Patients With Stage IV Non-Small Cell Lung Cancer
Summary
This is a Phase IIb/III randomized, double-blind, placebo-controlled study to compare the efficacy and safety of first-line therapy combined with TG4010 or placebo in stage IV non-small cell lung cancer (NSCLC). TG4010 is a suspension of recombinant Modified Vaccinia virus strain Ankara (MVA strain) carrying coding sequences for human MUC1 antigen and human interleukin-2 (IL2). TG4010 has been developed for use as an immunotherapy in cancer patients whose tumors express the MUC1 antigen. TG4010 is intended to induce a MUC1-specific cellular immune response and to produce a non-specific activation of several components of the immune system.
Timeline
- Start
- 2012-04
- Primary completion
- 2015-07
- Completion
- 2016-07
Outcome
Sources disagree · no verdict is set; each source's reading is shown below
paper the primary endpoint was met. reads as mixed primary results PMID 26727163 ↗
paper the primary endpoint was not met. reads as mixed primary results PMID 26727163 ↗
release “combination of TG4010 immunotherapy and chemotherapy has demonstrated significant efficacy in terms of progression-free survival and overall survival” reads as met primary endpoint transgene.com ↗
Publications
- Tosch C, Bastien B, Barraud L, Grellier B, Nourtier V, Gantzer M, Limacher JM, Quemeneur E, Bendjama K, Preville X. Viral based vaccine TG4010 induces broadening of specific immune response and improves outcome in advanced NSCLC. J Immunother Cancer. 2017 Sep 19;5(1):70. doi: 10.1186/s40425-017-0274-x.
- Quoix E, Lena H, Losonczy G, Forget F, Chouaid C, Papai Z, Gervais R, Ottensmeier C, Szczesna A, Kazarnowicz A, Beck JT, Westeel V, Felip E, Debieuvre D, Madroszyk A, Adam J, Lacoste G, Tavernaro A, Bastien B, Halluard C, Palanche T, Limacher JM. TG4010 immunotherapy and first-line chemotherapy for advanced non-small-cell lung cancer (TIME): results from the phase 2b part of a randomised, double-blind, placebo-controlled, phase 2b/3 trial. Lancet Oncol. 2016 Feb;17(2):212-223. doi: 10.1016/S1470-2045(15)00483-0. Epub 2015 Dec 23.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | TG4010 | Vaccine | 1e+08 unknown | Subcutaneous |