Study Stopped
Study early termination was due to slow recruitment and difficulties at achieving the required enrolment for the study.
Cancer Immunotherapy GSK1572932A as Adjuvant Therapy for Patients With Tumor-antigen-positive Non-Small Cell Lung Cancer
Cancer Immunotherapeutic GSK1572932A as Adjuvant Therapy for Patients With MAGE-A3-positive Non-Small Cell Lung Cancer
1 other identifier
interventional
71
6 countries
26
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started May 2007
Longer than P75 for phase_1
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 2, 2007
CompletedFirst Posted
Study publicly available on registry
April 3, 2007
CompletedStudy Start
First participant enrolled
May 11, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 4, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
August 8, 2013
CompletedMay 15, 2017
May 1, 2017
6.2 years
April 2, 2007
May 12, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
The anti-MAGE-A3 seroconversion
After the fourth dose of ASCI and at the end of treatment
The anti-protein D seroconversion
After the fourth dose of ASCI and at the end of treatment
The anti-CpG seroconversion
After the fourth dose of ASCI and at the end of treatment
The MAGE-A3 cellular (T cell) response
After the fourth dose of ASCI and at the end of treatment
Occurrence of adverse events, including abnormal hematological and biochemical laboratory values
During the study
Occurrence of serious adverse events
During the study
Study Arms (4)
Cohort 1
EXPERIMENTALPatients with resected stage IB, II or IIIA tumors who are due for standard chemotherapy with cisplatin and vinorelbine. These patients will receive chemo-and immunotherapy in parallel.
Cohort 2
EXPERIMENTALPatients with resected stage IB, II or IIIA tumors who are due for standard chemotherapy with cisplatin and vinorelbine. These patients will first receive chemotherapy and then immunotherapy
Cohort 3
EXPERIMENTALPatients with resected stage IB, II or IIIA tumors who are not due for chemotherapy. These patients will receive immunotherapy only.
Cohort 4
EXPERIMENTALPatients with unresectable stage III tumors, following standard chemotherapy and/or radiotherapy. These patients will receive immunotherapy only.
Interventions
Intramuscular injection, 8 doses
Four cycles with doses based on patient's body surface area, intravenous administration
Four cycles with doses based on patient's body surface area , intravenous administration
Eligibility Criteria
You may qualify if:
- Written informed consent obtained,
- Aged 18 or more,
- Pathologically proven stage IB, II or III NSCLC,
- Tumor expresses MAGE-A3,
- Free of distant metastasis,
- For Cohort 1, all of the following:
- Completely resected stage IB, II or IIIA NSCLC,
- Anatomical tumor resection, involving at least a lobectomy, and nodal sampling as per center standard
- ECOG performance status = 0 or 1
- Due to receive adjuvant chemotherapy as permitted in the protocol
- Not received, not receiving, and not due to receive adjuvant radiotherapy (except stage III patients)
- First administration of chemotherapy can be scheduled within 4-12 weeks after surgery
- For Cohort 2, all of the following:
- Resected stage IB, II or IIIA NSCLC,
- Anatomical tumor resection, involving at least a lobectomy, and nodal sampling as per center standard
- +22 more criteria
You may not qualify if:
- Previous or concomitant other malignancies, except if effectively treated and considered by the investigator highly likely to have been cured
- Pregnant or lactating
- History of anaphylaxis or severe allergic reaction
- Concurrent severe medical problems, unrelated to the malignancy, limiting full compliance with the study or exposing the patient to unacceptable risk
- Psychiatric or addictive disorders compromising the ability to give informed consent, or to comply with the trial procedures
- HIV-positive
- Require treatment with systemic corticosteroids, or other immunosuppressive agents
- Need home oxygenation
- Received or plan to receive investigational or non-registered product other than the study medication from 30 days before first dose of study medication and during whole study period
- History of chronic alcohol consumption and/or drug abuse
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (26)
GSK Investigational Site
Genk, 3600, Belgium
GSK Investigational Site
Leuven, 3000, Belgium
GSK Investigational Site
Liège, 4000, Belgium
GSK Investigational Site
Edmonton, Alberta, T6G 1Z2, Canada
GSK Investigational Site
Greenfield Park, Quebec, J4V 2H1, Canada
GSK Investigational Site
Montreal, Quebec, H4J 1C5, Canada
GSK Investigational Site
Montpellier, 34295, France
GSK Investigational Site
Pierre-Bénite, 69495, France
GSK Investigational Site
Saint-Herblain, 44805, France
GSK Investigational Site
Strasbourg, 67091, France
GSK Investigational Site
Hemer, North Rhine-Westphalia, 58675, Germany
GSK Investigational Site
Mainz, Rhineland-Palatinate, 55131, Germany
GSK Investigational Site
Halle, Saxony-Anhalt, 06120, Germany
GSK Investigational Site
Großhansdorf, Schleswig-Holstein, 22927, Germany
GSK Investigational Site
Bad Berka, Thuringia, 99437, Germany
GSK Investigational Site
Hamburg, 20246, Germany
GSK Investigational Site
Udine, Friuli Venezia Giulia, 33100, Italy
GSK Investigational Site
Rome, Lazio, 00152, Italy
GSK Investigational Site
Genoa, Liguria, 16132, Italy
GSK Investigational Site
Milan, Lombardy, 20132, Italy
GSK Investigational Site
Milan, Lombardy, 20141, Italy
GSK Investigational Site
Wythenshawe, Greater Manchester, M23 9LT, United Kingdom
GSK Investigational Site
Bebington, Wirral, CH63 4JY, United Kingdom
GSK Investigational Site
London, SE1 9RT, United Kingdom
GSK Investigational Site
Nottingham, NG5 1PB, United Kingdom
GSK Investigational Site
Southampton, SO16 6YD, United Kingdom
Related Publications (1)
Pujol JL, Vansteenkiste JF, De Pas TM, Atanackovic D, Reck M, Thomeer M, Douillard JY, Fasola G, Potter V, Taylor P, Bosquee L, Scheubel R, Jarnjak S, Debois M, de Sousa Alves P, Louahed J, Brichard VG, Lehmann FF. 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. J Thorac Oncol. 2015 Oct;10(10):1458-67. doi: 10.1097/JTO.0000000000000653.
PMID: 26309191DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 2, 2007
First Posted
April 3, 2007
Study Start
May 11, 2007
Primary Completion
August 4, 2013
Study Completion
August 8, 2013
Last Updated
May 15, 2017
Record last verified: 2017-05
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.