NCT00455572

Cancer Immunotherapy GSK1572932A as Adjuvant Therapy for Patients With Tumor-antigen-positive Non-Small Cell Lung Cancer

Terminated Phase 1 Last updated 15 May 2017

What this trial tests

Phase 1 trial testing Immunotherapeutic GSK1572932A in Lung Cancer, Non-Small Cell in 71 participants. Terminated before completion.

Timeline

11 May 2007

Primary endpoint
4 August 2013

8 August 2013

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	71
Start date	11 May 2007
Primary completion	4 August 2013
Estimated completion	8 August 2013
Sites	26 locations across France, Italy, Belgium, United Kingdom, Germany, Canada

Drugs / interventions tested

• Immunotherapeutic GSK1572932A — full drug profile →
• Cisplatin (CDDP) — full drug profile →
• Vinorelbine (vinorelbine) — full drug profile →
• Radiotherapy — full drug profile →

Conditions studied

• Lung Cancer, Non-Small Cell — all drugs for Lung Cancer, Non-Small Cell →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

18 and older, any sex, with Lung Cancer, Non-Small Cell. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this clinical trial is to find out how successfully non-small-cell lung cancer patients are able to give an immune response to injections of the immunotherapeutic product GSK1572932A, and to find out more about the safety of this treatment. A course of eight injections will be administered over 21 weeks; including screening for suitability and all tests, the duration of the study for a patient will be 30-35 weeks. During this period various tests will be performed, including physical examinations and blood tests. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. The biology of cancer testis antigens: putative function, regulation and therapeutic potential.
   Fratta E, Coral S, Covre A, Parisi G, et al · · 2011 · cited 290× · PMID 21376678 · DOI 10.1016/j.molonc.2011.02.001
2. A Comprehensive Guide to the MAGE Family of Ubiquitin Ligases.
   Lee AK, Potts PR. · · 2017 · cited 112× · PMID 28300603 · DOI 10.1016/j.jmb.2017.03.005
3. Trial Watch: Peptide-based anticancer vaccines.
   Pol J, Bloy N, Buqué A, Eggermont A, et al · · 2015 · cited 91× · PMID 26137405 · DOI 10.4161/2162402x.2014.974411
4. Trial watch: Peptide vaccines in cancer therapy.
   Vacchelli E, Martins I, Eggermont A, Fridman WH, et al · · 2012 · cited 74× · PMID 23264902 · DOI 10.4161/onci.22428
5. Cancer/testis antigens and urological malignancies.
   Kulkarni P, Shiraishi T, Rajagopalan K, Kim R, et al · · 2012 · cited 50× · PMID 22710665 · DOI 10.1038/nrurol.2012.117
6. Safety and Immunogenicity of MAGE-A3 Cancer Immunotherapeutic with or without Adjuvant Chemotherapy in Patients with Resected Stage IB to III MAGE-A3-Positive Non-Small-Cell Lung Cancer.
   Pujol JL, Vansteenkiste JF, De Pas TM, Atanackovic D, et al · · 2015 · cited 48× · PMID 26309191 · DOI 10.1097/jto.0000000000000653
7. Cancer testis antigen and immunotherapy.
   Krishnadas DK, Bai F, Lucas KG. · · 2013 · cited 43× · PMID 27471684 · DOI 10.2147/itt.s35570
8. Radioresistance of Non-Small Cell Lung Cancers and Therapeutic Perspectives.
   Césaire M, Montanari J, Curcio H, Lerouge D, et al · · 2022 · cited 35× · PMID 35740495 · DOI 10.3390/cancers14122829