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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00480025
Registration number
NCT00480025
Ethics application status
Date submitted
29/05/2007
Date registered
30/05/2007
Titles & IDs
Public title
GSK1572932A Antigen-Specific Cancer Immunotherapeutic as Adjuvant Therapy in Patients With Non-Small Cell Lung Cancer
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Scientific title
GSK1572932A Antigen-Specific Cancer Immunotherapeutic as Adjuvant Therapy in Patients With Resectable MAGE-A3 Positive Non-Small Cell Lung Cancer
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Secondary ID [1]
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2007-001283-73
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Secondary ID [2]
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109493
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Lung Cancer, Non-Small Cell
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Condition category
Condition code
Cancer
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Lung - Mesothelioma
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Cancer
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Lung - Non small cell
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Cancer
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0
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Lung - Small cell
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Other - GSK1572932A Antigen-Specific Cancer Immunotherapeutic
Treatment: Other - Placebo Control
Experimental: GSK1572932 Group - Patients received up to 13 doses of GSK1572932, 5 doses every 3 weeks followed by 8 doses every 12 weeks.
Placebo comparator: Placebo Group - Patients received up to 13 doses of placebo, 5 doses every 3 weeks followed by 8 doses every 12 weeks.
Treatment: Other: GSK1572932A Antigen-Specific Cancer Immunotherapeutic
Intramuscular administration, 13 doses
Treatment: Other: Placebo Control
Intramuscular administration, 13 doses
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Intervention code [1]
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Treatment: Other
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Person Year Rate (PYAR) as Regards Disease-free Survival (DFS) in the Overall Population
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Assessment method [1]
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DFS = time interval from randomization to 1st evidence of recurrence/death, if occurring before. All recurrence types were included, including local, regional \& distant metastasis \& 2nd primary lung cancer (i.e. local recurrence, defined as a tumor within same lung or at bronchial stump; regional recurrence, involving a clinically or radiologically manifest disease in mediastinum or supraclavicular nodes; \& distant recurrence \[any tumor arising in contralateral lung or outside hemithorax\]). Deaths occurring without prior documentation of recurrence were considered as event \& not censored. If no event occurred by time of analysis, time to event was censored at last assessment date of patient. New 1ry cancers outside lungs were not considered as event. PYAR= n (number of subjects reported with at least 1 event) divided by T (sum of follow-up period \[in years\] censored at 1st occurrence of event in group). Median DFS estimates were obtained non-parametrically by Kaplan-Meier method.
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Timepoint [1]
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From administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
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Primary outcome [2]
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Person Year Rate (PYAR) as Regards Disease-free Survival (DFS) in the No-CT Population
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Assessment method [2]
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DFS = time interval from randomization to 1st evidence of recurrence/death, if occurring before. All recurrence types were included, including local, regional \& distant metastasis \& 2nd primary lung cancer (i.e. local recurrence, defined as a tumor within same lung or at bronchial stump; regional recurrence, involving a clinically or radiologically manifest disease in mediastinum or supraclavicular nodes; \& distant recurrence \[any tumor arising in contralateral lung or outside hemithorax\]). Deaths occurring without prior documentation of recurrence were considered as event \& not censored. If no event occurred by time of analysis, time to event was censored at last assessment date of patient. New 1ry cancers outside lungs were not considered as event. PYAR= n (number of subjects reported with at least 1 event) divided by T (sum of follow-up period \[in years\] censored at 1st occurrence of event in group). Median DFS estimates were obtained non-parametrically by Kaplan-Meier method.
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Timepoint [2]
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From administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
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Secondary outcome [1]
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Person Year Rate (PYAR) as Regards Disease-free Survival (DFS) in the CT Population
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Assessment method [1]
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DFS = time interval from randomization to 1st evidence of recurrence/death, if occurring before. All recurrence types were included, including local, regional \& distant metastasis \& 2nd primary lung cancer (i.e. local recurrence, defined as a tumor within same lung or at bronchial stump; regional recurrence, involving a clinically or radiologically manifest disease in mediastinum or supraclavicular nodes; \& distant recurrence \[any tumor arising in contralateral lung or outside hemithorax\]). Deaths occurring without prior documentation of recurrence were considered as event \& not censored. If no event occurred by time of analysis, time to event was censored at last assessment date of patient. New 1ry cancers outside lungs were not considered as event. PYAR = n (number of subjects reported with at least 1 event) divided by T (sum of follow-up period \[in years\] censored at 1st occurrence of event in group). Median DFS estimates were obtained non-parametrically by Kaplan-Meier method.
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Timepoint [1]
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From administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
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Secondary outcome [2]
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Person Year Rate (PYAR) as Regards Overall-survival (OS) in the Overall Population
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Assessment method [2]
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OS was defined as the time interval from randomization to the date of death, irrespective of the cause of death. Patients still alive were censored at the last visit they were known to be alive. PYAR = n (number of subjects reported with at least 1 event) divided by T (sum of follow-up period \[in years\] censored at 1st occurrence of event in group). Median OS estimates were obtained non-parametrically by Kaplan-Meier method.
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Timepoint [2]
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From administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
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Secondary outcome [3]
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Person Year Rate (PYAR) as Regards Overall-survival (OS) in the No-CT Population
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Assessment method [3]
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OS was defined as the time interval from randomization to the date of death, irrespective of the cause of death. Patients still alive were censored at the last visit they were known to be alive. PYAR = n (number of subjects reported with at least 1 event) divided by T (sum of follow-up period \[in years\] censored at 1st occurrence of event in group). Median OS estimates were obtained non-parametrically by Kaplan-Meier method.
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Timepoint [3]
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From administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
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Secondary outcome [4]
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Person Year Rate (PYAR) as Regards Overall-survival (OS) in the CT Population
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Assessment method [4]
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OS was defined as the time interval from randomization to the date of death, irrespective of the cause of death. Patients still alive were censored at the last visit they were known to be alive. PYAR = n (number of subjects reported with at least 1 event) divided by T (sum of follow-up period \[in years\] censored at 1st occurrence of event in group). Median OS estimates were obtained non-parametrically by Kaplan-Meier method.
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Timepoint [4]
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From administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
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Secondary outcome [5]
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Person Year Rate (PYAR) as Regards Lung-cancer Specific Survival (LCSS) in the Overall Population
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Assessment method [5]
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LCSS was defined as the time interval from randomization to the date of death due to lung cancer. Deaths due to other or unknown causes were censored at the date of death. PYAR = n (number of subjects reported with at least 1 event) divided by T (sum of follow-up period \[in years\] censored at 1st occurrence of event in group). Median OS estimates were obtained non-parametrically by Kaplan-Meier method.
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Timepoint [5]
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From administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
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Secondary outcome [6]
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Person Year Rate (PYAR) as Regards Lung-cancer Specific Survival (LCSS) in the No-CT Population
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Assessment method [6]
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LCSS was defined as the time interval from randomization to the date of death due to lung cancer. Deaths due to other or unknown causes were censored at the date of death. PYAR = n (number of subjects reported with at least 1 event) divided by T (sum of follow-up period \[in years\] censored at 1st occurrence of event in group). Median OS estimates were obtained non-parametrically by Kaplan-Meier method.
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Timepoint [6]
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From administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
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Secondary outcome [7]
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Person Year Rate (PYAR) as Regards Lung-cancer Specific Survival (LCSS) in the CT Population
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Assessment method [7]
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LCSS was defined as the time interval from randomization to the date of death due to lung cancer. Deaths due to other or unknown causes were censored at the date of death. PYAR = n (number of subjects reported with at least 1 event) divided by T (sum of follow-up period \[in years\] censored at 1st occurrence of event in group). Median OS estimates were obtained non-parametrically by Kaplan-Meier method.
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Timepoint [7]
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From administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
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Secondary outcome [8]
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Kaplan-Meier Estimate (KME) of 2, 3, 4 and 5-year as Regards Disease-free Survival (DFS) in the Overall Population
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Assessment method [8]
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DFS = time interval from randomization to 1st evidence of recurrence/death, if occurring before. All recurrence types were included, including local, regional \& distant metastasis \& 2nd primary lung cancer (i.e. local recurrence, defined as a tumor within same lung or at bronchial stump; regional recurrence, involving a clinically or radiologically manifest disease in mediastinum or supraclavicular nodes; \& distant recurrence \[any tumor arising in contralateral lung or outside hemithorax\]). Deaths occurring without prior documentation of recurrence were considered as event \& not censored. If no event occurred by time of analysis, time to event was censored at last assessment date of patient. New 1ry cancers outside lungs were not considered as event. Median DFS KMEs in % were obtained non-parametrically by Kaplan-Meier method and confidence intervals (CIs) calculated using the Greenwood formula for standard error computation.
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Timepoint [8]
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KME assessed at 2, 3, 4 and 5-year (Y) post Dose 1 of treatment. Follow-up period was from administration of 1st dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
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Secondary outcome [9]
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Kaplan-Meier Estimate (KME) of 2, 3, 4 and 5-year as Regards Disease-free Survival (DFS) in the No-CT Population
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Assessment method [9]
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0
DFS = time interval from randomization to 1st evidence of recurrence/death, if occurring before. All recurrence types were included, including local, regional \& distant metastasis \& 2nd primary lung cancer (i.e. local recurrence, defined as a tumor within same lung or at bronchial stump; regional recurrence, involving a clinically or radiologically manifest disease in mediastinum or supraclavicular nodes; \& distant recurrence \[any tumor arising in contralateral lung or outside hemithorax\]). Deaths occurring without prior documentation of recurrence were considered as event \& not censored. If no event occurred by time of analysis, time to event was censored at last assessment date of patient. New 1ry cancers outside lungs were not considered as event. Median DFS KMEs in % were obtained non-parametrically by Kaplan-Meier method and confidence intervals (CIs) calculated using the Greenwood formula for standard error computation.
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Timepoint [9]
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KME assessed at 2, 3, 4 and 5-year (Y) post Dose 1 of treatment Follow-up period was from administration of 1st dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
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Secondary outcome [10]
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Kaplan-Meier Estimate (KME) of 2, 3, 4 and 5-year as Regards Disease-free Survival (DFS) in the CT Population
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Assessment method [10]
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0
DFS = time interval from randomization to 1st evidence of recurrence/death, if occurring before. All recurrence types were included, including local, regional \& distant metastasis \& 2nd primary lung cancer (i.e. local recurrence, defined as a tumor within same lung or at bronchial stump; regional recurrence, involving a clinically or radiologically manifest disease in mediastinum or supraclavicular nodes; \& distant recurrence \[any tumor arising in contralateral lung or outside hemithorax\]). Deaths occurring without prior documentation of recurrence were considered as event \& not censored. If no event occurred by time of analysis, time to event was censored at last assessment date of patient. New 1ry cancers outside lungs were not considered as event. Median DFS KMEs in % were obtained non-parametrically by Kaplan-Meier method and confidence intervals (CIs) calculated using the Greenwood formula for standard error computation.
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Timepoint [10]
0
0
KME assessed at 2, 3, 4 and 5-year (Y) post Dose 1 of treatment. Follow-up period was from administration of 1st dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
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Secondary outcome [11]
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Person Year Rate (PYAR) as Regards Disease-free Specific Survival (DFSS) in the Overall Population
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Assessment method [11]
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DFSS was defined as the interval from randomization to the date of disease recurrence or death due to lung cancer. Patients who had died due to another cause than lung cancer were censored on their date of death and patients alive at the time of analysis were censored on the date of last assessment. Patients with no assessment post-randomization were censored on the date of randomization. PYAR = n (number of subjects reported with at least 1 event) divided by T (sum of follow-up period \[in years\] censored at 1st occurrence of event in group). Median DFS estimates were obtained non-parametrically by Kaplan-Meier method.
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Timepoint [11]
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0
From administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
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Secondary outcome [12]
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0
Person Year Rate (PYAR) as Regards Disease-free Specific Survival (DFSS) in the No-CT Population
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Assessment method [12]
0
0
DFSS was defined as the interval from randomization to the date of disease recurrence or death due to lung cancer. Patients who had died due to another cause than lung cancer were censored on their date of death and patients alive at the time of analysis were censored on the date of last assessment. Patients with no assessment post-randomization were censored on the date of randomization. PYAR = n (number of subjects reported with at least 1 event) divided by T (sum of follow-up period \[in years\] censored at 1st occurrence of event in group). Median DFS estimates were obtained non-parametrically by Kaplan-Meier method.
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Timepoint [12]
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0
From administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
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Secondary outcome [13]
0
0
Person Year Rate (PYAR) as Regards Disease-free Specific Survival (DFSS) in the CT Population
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Assessment method [13]
0
0
DFSS was defined as the interval from randomization to the date of disease recurrence or death due to lung cancer. Patients who had died due to another cause than lung cancer were censored on their date of death and patients alive at the time of analysis were censored on the date of last assessment. Patients with no assessment post-randomization were censored on the date of randomization. PYAR = n (number of subjects reported with at least 1 event) divided by T (sum of follow-up period \[in years\] censored at 1st occurrence of event in group). Median DFS estimates were obtained non-parametrically by Kaplan-Meier method.
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Timepoint [13]
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Period of follow-up was from administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
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Secondary outcome [14]
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Number of Subjects Seropositive for Anti-Melanoma AntiGEn (MAGE)-A3 Antibodies (Anti-MAGE-A3 S+)
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Assessment method [14]
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A seropositive subject for anti-MAGE-A3 antibodies was a subject with anti-MAGE-A3 antibodies \>= the seropositivity cut-off of 27 Enzyme-linked immunosorbent assay (ELISA) units per millilitre (EL.U/mL).
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Timepoint [14]
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Pre-treatment (PRE), at Weeks (W) 6 and 12, at Months (M) 9, 12, 18 and 30 and at one year after treatment concluding time point, i.e. at follow-up visit 2 at W120 added of one year (At 12M post W120)
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Secondary outcome [15]
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Number of Humoral Responders as Regards Anti-Melanoma AntiGEn (MAGE)-A3 Antibodies (Anti-MAGE-A3 HR)
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Assessment method [15]
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A seropositive/seronegative subject for anti-MAGE-A3 antibodies was a subject with anti-MAGE-A3 antibodies \>=/\< the seropositivity cut-off of 27 Enzyme-linked immunosorbent assay (ELISA) units per millilitre (EL.U/mL). A humoral responder as regards anti-MAGE-A3 antibodies was defined as 1) for initially seronegative patients, a patient with post-administration Anti-MAGE-A3 antibody concentration \>= 27 EL.U/mL; 2) for initially seropositive patients: post-treatment administration antibody concentration \>= 2 fold the pre-treatment antibody concentration.
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Timepoint [15]
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0
At Weeks (W) 6 and 12, at Months (M) 9, 12, 18 and 30 and at one year after treatment concluding time point, i.e. at follow-up visit 2 at W120 added of one year (at 12M post W120)
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Secondary outcome [16]
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Number of Subjects Seropositive for Anti-protein D (PD) Antibodies (Anti-PD S+)
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Assessment method [16]
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A seropositive subject for anti-PD antibodies was a subject with anti-PD antibodies \>= the seropositivity cut-off of 100 Enzyme-linked immunosorbent assay (ELISA) units per millilitre (EL.U/mL).
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Timepoint [16]
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0
Pre-treatment (PRE), at Weeks (W) 6 and 12, at Months (M) 9, 12, 18 and 30 and at one year after treatment concluding time point, i.e. at follow-up visit 2 at W120 added of one year (at 12M post W120)
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Secondary outcome [17]
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0
Number of Humoral Responders as Regards Anti-protein D (PD) Antibodies (Anti-PD HR)
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Assessment method [17]
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0
A seropositive/seronegative subject for anti-PD antibodies was a subject with anti-PD antibodies =/\< the seropositivity cut-off of 100 Enzyme-linked immunosorbent assay (ELISA) units per millilitre (EL.U/mL). A humoral responder as regards anti-PD antibodies was defined as 1) for initially seronegative patients, a patient with post-administration anti-PD antibody concentration = 100 EL.U/mL; 2) for initially seropositive patients: post-administration antibody concentration = 2 fold the pre-vaccination antibody concentration.
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Timepoint [17]
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0
At Weeks (W) 6 and 12, at Months (M) 9, 12, 18 and 30 and at one year after treatment concluding time point, i.e. at follow-up visit 2 at W120 added of one year (at 12M post W120)
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Secondary outcome [18]
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Health-related Quality of Life (HQL) Scores
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Assessment method [18]
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HQL was assessed using the EQ-5D generic health state classification and valuation system. The number and percentage of patients with each score within each dimension of the EQ-5D questionnaire (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) were tabulated at each assessment for each group. Each of these scores can take 3 levels: no problem (level 1), moderate problem (level 2) or extreme problem (level 3). Resulting descriptive mean and standard deviation (SD) for the EQ-5D Utility Value (EQ-5D UV) were tabulated. Valid EQ-5D data were defined as questionnaires assessed 1) on day of and before treatment administration; or 2) on day after treatment administration for W0, W6, W12; or 3)during follow-up visits or at time of recurrence. The EQ-5D total score ranges from -0.016 (worst health state) to 1.000 (best health state).
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Timepoint [18]
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At Week (W) 0 on day of treatment (DoT) (W0 DoT), W0 on day post treatment (DpT) (W0 DpT), W6 DoT, W6 DpT, W12 DoT, W12 DpT, Month (M) 6, M9, M12, M24, 6M post W120, at recurrence, and at 12M post W120
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Secondary outcome [19]
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Number of Patients With Abnormal Alanine Aminotransferase (ALT) Values by Maximum Grade
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Assessment method [19]
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0
The status of each patient as regards ALT laboratory values at baseline (SCR) up to DLP was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were unknown (UNK), Grade 0 (G0), G1 and G2. CTC grade statuses reported at DLP were G0, G1, G2, G3, G4, and UNK.
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Timepoint [19]
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0
From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
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Secondary outcome [20]
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0
Number of Patients With Abnormal Alanine Aspartate Aminotransferase (AST) Values by Maximum Grade
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Assessment method [20]
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0
The status of each patient as regards AST laboratory values at baseline (SCR) up to DLP was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were unknown (UNK), Grade 0 (G0), G1 and G2. CTC grade statuses reported at DLP were G0, G1, G2, G3, G4, and UNK.
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Timepoint [20]
0
0
From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
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Secondary outcome [21]
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0
Number of Patients With Abnormal Alkaline Phosphatase (ALKP) Values by Maximum Grade
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Assessment method [21]
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0
The status of each patient as regards ALKP laboratory values at baseline (SCR) up to DLP was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were unknown (UNK), Grade 0 (G0), G1 and G2. CTC grade statuses reported at DLP were G0, G1, G2, G3, G4, and UNK.
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Timepoint [21]
0
0
From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
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Secondary outcome [22]
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0
Number of Patients With Abnormal Bilirubin (BIL) Values by Maximum Grade
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Assessment method [22]
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0
The status of each patient as regards BIL laboratory values at baseline (SCR) up to DLP was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were unknown (UNK), Grade 0 (G0) and G1. CTC grade statuses reported at DLP were G0, G1, G2, G3, G4, and UNK.
Query!
Timepoint [22]
0
0
From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
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Secondary outcome [23]
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0
Number of Patients With Abnormal Creatinine (CREA) Values by Maximum Grade
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Assessment method [23]
0
0
The status of each patient as regards CREA laboratory values at baseline (SCR) up to DLP was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were unknown (UNK), Grade 0 (G0), G1 and G2. CTC grade statuses reported at DLP were G0, G1, G2, G3, G4, and UNK.
Query!
Timepoint [23]
0
0
From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
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Secondary outcome [24]
0
0
Number of Patients With Abnormal Haemoglobin (HGB) Values by Maximum Grade
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Assessment method [24]
0
0
The status of each patient as regards HGB laboratory values at baseline (SCR) up to DLP was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were unknown (UNK), Grade 0 (G0), G1, G2 and G3. CTC grade statuses reported at DLP were G0, G1, G2, G3, G4, and UNK.
Query!
Timepoint [24]
0
0
From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
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Secondary outcome [25]
0
0
Number of Patients With Abnormal Leukocytes (LEU) Values by Maximum Grade
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Assessment method [25]
0
0
The status of each patient as regards LEU laboratory values at baseline (SCR) up to DLP was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were unknown (UNK), Grade 0 (G0), G1, G2 and G3. CTC grade statuses reported at DLP were G0, G1, G2, G3, G4, and UNK.
Query!
Timepoint [25]
0
0
From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
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Secondary outcome [26]
0
0
Number of Patients With Abnormal Lymphocytes (LYM) Values by Maximum Grade
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Assessment method [26]
0
0
The status of each patient as regards LYM laboratory values at baseline (SCR) up to DLP was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were unknown (UNK), Grade 0 (G0), G1, G2 and G3. CTC grade statuses reported at DLP were G0, G1, G2, G3, G4, and UNK.
Query!
Timepoint [26]
0
0
From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
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Secondary outcome [27]
0
0
Number of Patients With Abnormal Neutrophils (NEU) Values by Maximum Grade
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Assessment method [27]
0
0
The status of each patient as regards NEU laboratory values at baseline (SCR) up to DLP was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were unknown (UNK), Grade 0 (G0), G1, G2, G3 and G4. CTC grade statuses reported at DLP were G0, G1, G2, G3, G4, and UNK.
Query!
Timepoint [27]
0
0
From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
Query!
Secondary outcome [28]
0
0
Number of Patients With Abnormal Platelets (PLA) Values by Maximum Grade
Query!
Assessment method [28]
0
0
The status of each patient as regards PLA laboratory values at baseline (SCR) up to DLP was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were unknown (UNK), Grade 0 (G0), G1 and G3. CTC grade statuses reported at DLP were G0, G1, G2, G3, G4, and UNK.
Query!
Timepoint [28]
0
0
From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
Query!
Secondary outcome [29]
0
0
Number of Patients With Any Adverse Events (AEs) and With AEs by Maximum Grade Reported - Up to Data Lock Point (DLP)
Query!
Assessment method [29]
0
0
An AE was any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs reported are here below tabulated irrespective of grade, as well as graded by maximum grade reported according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. Maximum grade reported and tabulated were Grade 1 (G1), G2, G3, G4 and G5. Any here below is defined as irrespective of CTC grade reported.
Query!
Timepoint [29]
0
0
Within the 31-day follow-up period post treatment administration, up to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
Query!
Secondary outcome [30]
0
0
Number of Patients With Serious Adverse Events (SAEs) - Up to Data Lock Point (DLP)
Query!
Assessment method [30]
0
0
A SAE is any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, was a congenital anomaly/birth defect in the offspring of a study subject, or was a Grade 4 AE according to CTC for Adverse Events, Version 3.0. Events part of natural course of lung cancer (i.e., disease progression, recurrence) were captured towards clinical efficacy assessment (CEA) and were not reported as SAEs. Death due to a progressive disease was similarly recorded towards CEA, but not as an SAE. However, if progression of lung cancer disease was greater than normally be expected, or if investigators considered that there was a causal relationship between treatment or protocol design/procedures and disease progression/ recurrence, then it was reported as SAE. Any new cancer (non-related to lung cancer) was reported as SAE.
Query!
Timepoint [30]
0
0
From screening (SCR) up to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
Query!
Eligibility
Key inclusion criteria
Inclusion criteria:
* Male or female patient with completely resected, pathologically proven stage IB, II or IIIA NSCLC.
* Written informed consent for MAGE-A3 expression screening on tumor biopsy has been obtained from the patient prior to shipment of the sample for expression testing (before or just after surgical resection), and written informed consent for the complete study has been obtained prior to the performance of any other protocol-specific procedure.
* Patient is = 18 years of age at the time of signature of the first informed consent form.
* The patient's tumor shows expression of MAGE-A3 gene
* The surgical technique for resection of the patient's tumor is anatomical, involving at least a lobectomy or a sleeve lobectomy;
* The mediastinal lymph node sampling is done according to study protocol guidelines;
* The patient is free of metastasis, as confirmed by a negative baseline computer tomogram (CT scan) of the chest, upper abdomen and CT scan or MRI of the brain.
Other examinations should be performed as clinically indicated. Note that if randomization is taking place within 8 weeks after surgery, brain CT scans or brain MRI performed up to 4 weeks before surgery do not have to be repeated.
* ECOG performance status of 0, 1 or 2 at the time of randomization.
* Adequate bone-marrow reserve, adequate renal function and adequate hepatic function as assessed by standard laboratory criteria, and defined as:
Absolute neutrophil count = 1.0 x 10E9/L Platelet count = 75 x 10E9/L Serum creatinine = 1.5 times the Upper Limit of Normal (ULN)
= 3.0 times the ULN if due to platinum adjuvant chemotherapy Total bilirubin = 1.5 times the ULN Alanine transaminase (ALAT) = 2.5 times the ULN
* If the patient is female, she must be of non-childbearing potential, i.e. have a current tubal ligation, hysterectomy, ovariectomy or be post menopausal, or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to administration of study treatment, have a negative pregnancy test and continue such precautions during all study treatment period and for 2 months after completion of the injection series.
* In the view of the investigator, the patient can and will comply with the requirements of the protocol.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
Exclusion criteria
* The primary tumor was removed by segmentectomy or wedge resection.
* The patient shows any evidence of residual tumor after surgery.
* The patient has received any anti-cancer specific treatment, including radiotherapy, immunotherapy, chemotherapy or neo-adjuvant chemotherapy, except:
For the treatment of previous malignancies as allowed by the protocol (i.e., non-melanoma skin cancers or carcinoma in situ of the cervix or effectively treated malignancy that has been in remission for over 5 years), Administration of adjuvant platinum-based chemotherapy for the treatment of the current NSCLC is allowed between surgery and randomization.
* The patient has previous or concomitant malignancies at other sites, except effectively treated non-melanoma skin cancers or carcinoma in situ of the cervix or effectively treated malignancy that has been in remission for over 5 years and highly likely to have been cured.
* History of allergic disease or reactions likely to be exacerbated by any component of the study investigational product.
* The patient has an autoimmune disease such as, but not limited to, multiple sclerosis, lupus, and inflammatory bowel disease. Patients with vitiligo are not excluded.
* The patient requires concomitant treatment with systemic corticosteroids, or any other immunosuppressive agents.
Note: The use of prednisone, or equivalent, <0.5 mg/kg/day (absolute maximum 40 mg/day), or inhaled corticosteroids for COPD or topical steroids is permitted.
* The patient has received a major organ allograft.
* The patient is known to be HIV-positive.
* The patient has an uncontrolled bleeding disorder.
* The patient has uncontrolled congestive heart failure or hypertension, unstable heart disease (coronary artery disease or myocardial infarction) or uncontrolled arrhythmia at the time of enrolment.
* The patient needs home oxygenation.
* The patient has psychiatric or addictive disorders that may compromise his/her ability to give informed consent, or to comply with the trial procedures.
* The patient has other concurrent severe medical problems, unrelated to the malignancy, that would significantly limit full compliance with the study or expose the patient to unacceptable risk.
* The patient has received any investigational or non-registered medicinal product other than the study medication within the 30 days preceding the first dose of study medication, or plans to receive such a drug during the study period.
* For female patients: the patient is pregnant or lactating.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Stopped early
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
4/10/2007
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
23/09/2014
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
2278
Query!
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,TAS,VIC,WA
Query!
Recruitment hospital [1]
0
0
GSK Investigational Site - Garran
Query!
Recruitment hospital [2]
0
0
GSK Investigational Site - Camperdown
Query!
Recruitment hospital [3]
0
0
GSK Investigational Site - Tweed Heads
Query!
Recruitment hospital [4]
0
0
GSK Investigational Site - Waratah
Query!
Recruitment hospital [5]
0
0
GSK Investigational Site - Westmead
Query!
Recruitment hospital [6]
0
0
GSK Investigational Site - Chermside
Query!
Recruitment hospital [7]
0
0
GSK Investigational Site - South Brisbane
Query!
Recruitment hospital [8]
0
0
GSK Investigational Site - Woolloongabba
Query!
Recruitment hospital [9]
0
0
GSK Investigational Site - Adelaide
Query!
Recruitment hospital [10]
0
0
GSK Investigational Site - Hobart
Query!
Recruitment hospital [11]
0
0
GSK Investigational Site - Box Hill
Query!
Recruitment hospital [12]
0
0
GSK Investigational Site - Fitzroy
Query!
Recruitment hospital [13]
0
0
GSK Investigational Site - Heidelberg
Query!
Recruitment hospital [14]
0
0
GSK Investigational Site - Richmond
Query!
Recruitment hospital [15]
0
0
GSK Investigational Site - Nedlands
Query!
Recruitment hospital [16]
0
0
GSK Investigational Site - Perth
Query!
Recruitment postcode(s) [1]
0
0
2606 - Garran
Query!
Recruitment postcode(s) [2]
0
0
2050 - Camperdown
Query!
Recruitment postcode(s) [3]
0
0
2485 - Tweed Heads
Query!
Recruitment postcode(s) [4]
0
0
2298 - Waratah
Query!
Recruitment postcode(s) [5]
0
0
2145 - Westmead
Query!
Recruitment postcode(s) [6]
0
0
4032 - Chermside
Query!
Recruitment postcode(s) [7]
0
0
4101 - South Brisbane
Query!
Recruitment postcode(s) [8]
0
0
4102 - Woolloongabba
Query!
Recruitment postcode(s) [9]
0
0
5000 - Adelaide
Query!
Recruitment postcode(s) [10]
0
0
7000 - Hobart
Query!
Recruitment postcode(s) [11]
0
0
3128 - Box Hill
Query!
Recruitment postcode(s) [12]
0
0
3065 - Fitzroy
Query!
Recruitment postcode(s) [13]
0
0
3084 - Heidelberg
Query!
Recruitment postcode(s) [14]
0
0
3121 - Richmond
Query!
Recruitment postcode(s) [15]
0
0
6009 - Nedlands
Query!
Recruitment postcode(s) [16]
0
0
6001 - Perth
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alabama
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Arizona
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Arkansas
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
California
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Colorado
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Connecticut
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Delaware
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
District of Columbia
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Florida
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Georgia
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Hawaii
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Idaho
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Illinois
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Indiana
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Iowa
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
Kentucky
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
Louisiana
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
Maryland
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
Massachusetts
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
Michigan
Query!
Country [21]
0
0
United States of America
Query!
State/province [21]
0
0
Minnesota
Query!
Country [22]
0
0
United States of America
Query!
State/province [22]
0
0
Missouri
Query!
Country [23]
0
0
United States of America
Query!
State/province [23]
0
0
Montana
Query!
Country [24]
0
0
United States of America
Query!
State/province [24]
0
0
Nebraska
Query!
Country [25]
0
0
United States of America
Query!
State/province [25]
0
0
Nevada
Query!
Country [26]
0
0
United States of America
Query!
State/province [26]
0
0
New Hampshire
Query!
Country [27]
0
0
United States of America
Query!
State/province [27]
0
0
New Jersey
Query!
Country [28]
0
0
United States of America
Query!
State/province [28]
0
0
New York
Query!
Country [29]
0
0
United States of America
Query!
State/province [29]
0
0
North Carolina
Query!
Country [30]
0
0
United States of America
Query!
State/province [30]
0
0
Ohio
Query!
Country [31]
0
0
United States of America
Query!
State/province [31]
0
0
Oklahoma
Query!
Country [32]
0
0
United States of America
Query!
State/province [32]
0
0
Oregon
Query!
Country [33]
0
0
United States of America
Query!
State/province [33]
0
0
Pennsylvania
Query!
Country [34]
0
0
United States of America
Query!
State/province [34]
0
0
Rhode Island
Query!
Country [35]
0
0
United States of America
Query!
State/province [35]
0
0
South Carolina
Query!
Country [36]
0
0
United States of America
Query!
State/province [36]
0
0
Tennessee
Query!
Country [37]
0
0
United States of America
Query!
State/province [37]
0
0
Texas
Query!
Country [38]
0
0
United States of America
Query!
State/province [38]
0
0
Utah
Query!
Country [39]
0
0
United States of America
Query!
State/province [39]
0
0
Virginia
Query!
Country [40]
0
0
United States of America
Query!
State/province [40]
0
0
Washington
Query!
Country [41]
0
0
United States of America
Query!
State/province [41]
0
0
Wisconsin
Query!
Country [42]
0
0
Argentina
Query!
State/province [42]
0
0
Buenos Aires
Query!
Country [43]
0
0
Argentina
Query!
State/province [43]
0
0
Córdova
Query!
Country [44]
0
0
Argentina
Query!
State/province [44]
0
0
Río Negro
Query!
Country [45]
0
0
Argentina
Query!
State/province [45]
0
0
Santa Fe
Query!
Country [46]
0
0
Argentina
Query!
State/province [46]
0
0
Quilmes
Query!
Country [47]
0
0
Argentina
Query!
State/province [47]
0
0
Tucuman
Query!
Country [48]
0
0
Austria
Query!
State/province [48]
0
0
Graz
Query!
Country [49]
0
0
Austria
Query!
State/province [49]
0
0
Innsbruck
Query!
Country [50]
0
0
Austria
Query!
State/province [50]
0
0
Linz
Query!
Country [51]
0
0
Austria
Query!
State/province [51]
0
0
Salzburg
Query!
Country [52]
0
0
Austria
Query!
State/province [52]
0
0
Vienna
Query!
Country [53]
0
0
Austria
Query!
State/province [53]
0
0
Wels
Query!
Country [54]
0
0
Belgium
Query!
State/province [54]
0
0
Antwerpen
Query!
Country [55]
0
0
Belgium
Query!
State/province [55]
0
0
Brussels
Query!
Country [56]
0
0
Belgium
Query!
State/province [56]
0
0
Bruxelles
Query!
Country [57]
0
0
Belgium
Query!
State/province [57]
0
0
Charleroi
Query!
Country [58]
0
0
Belgium
Query!
State/province [58]
0
0
Duffel
Query!
Country [59]
0
0
Belgium
Query!
State/province [59]
0
0
Edegem
Query!
Country [60]
0
0
Belgium
Query!
State/province [60]
0
0
Genk
Query!
Country [61]
0
0
Belgium
Query!
State/province [61]
0
0
Hasselt
Query!
Country [62]
0
0
Belgium
Query!
State/province [62]
0
0
Jette
Query!
Country [63]
0
0
Belgium
Query!
State/province [63]
0
0
Leuven
Query!
Country [64]
0
0
Belgium
Query!
State/province [64]
0
0
Liège
Query!
Country [65]
0
0
Belgium
Query!
State/province [65]
0
0
Namur
Query!
Country [66]
0
0
Brazil
Query!
State/province [66]
0
0
Minas Gerais
Query!
Country [67]
0
0
Brazil
Query!
State/province [67]
0
0
Rio Grande Do Sul
Query!
Country [68]
0
0
Brazil
Query!
State/province [68]
0
0
São Paulo
Query!
Country [69]
0
0
Brazil
Query!
State/province [69]
0
0
Rio de Janeiro
Query!
Country [70]
0
0
Canada
Query!
State/province [70]
0
0
Alberta
Query!
Country [71]
0
0
Canada
Query!
State/province [71]
0
0
British Columbia
Query!
Country [72]
0
0
Canada
Query!
State/province [72]
0
0
Nova Scotia
Query!
Country [73]
0
0
Canada
Query!
State/province [73]
0
0
Ontario
Query!
Country [74]
0
0
Canada
Query!
State/province [74]
0
0
Quebec
Query!
Country [75]
0
0
Canada
Query!
State/province [75]
0
0
Québec
Query!
Country [76]
0
0
China
Query!
State/province [76]
0
0
Guangdong
Query!
Country [77]
0
0
China
Query!
State/province [77]
0
0
Guangxi
Query!
Country [78]
0
0
China
Query!
State/province [78]
0
0
Hubei
Query!
Country [79]
0
0
China
Query!
State/province [79]
0
0
Jiangsu
Query!
Country [80]
0
0
China
Query!
State/province [80]
0
0
Jilin
Query!
Country [81]
0
0
China
Query!
State/province [81]
0
0
Sichuan
Query!
Country [82]
0
0
China
Query!
State/province [82]
0
0
Zhejiang
Query!
Country [83]
0
0
China
Query!
State/province [83]
0
0
Beijing
Query!
Country [84]
0
0
China
Query!
State/province [84]
0
0
Changsha
Query!
Country [85]
0
0
China
Query!
State/province [85]
0
0
Guangzhou
Query!
Country [86]
0
0
China
Query!
State/province [86]
0
0
Harbin
Query!
Country [87]
0
0
China
Query!
State/province [87]
0
0
Shanghai
Query!
Country [88]
0
0
China
Query!
State/province [88]
0
0
Tianjin
Query!
Country [89]
0
0
China
Query!
State/province [89]
0
0
Wuhan
Query!
Country [90]
0
0
Czechia
Query!
State/province [90]
0
0
Brno
Query!
Country [91]
0
0
Czechia
Query!
State/province [91]
0
0
Ostrava
Query!
Country [92]
0
0
Czechia
Query!
State/province [92]
0
0
Plzen
Query!
Country [93]
0
0
Czechia
Query!
State/province [93]
0
0
Praha 5
Query!
Country [94]
0
0
Czechia
Query!
State/province [94]
0
0
Praha 8
Query!
Country [95]
0
0
Czechia
Query!
State/province [95]
0
0
Usti nad Labem
Query!
Country [96]
0
0
Estonia
Query!
State/province [96]
0
0
Tallinn
Query!
Country [97]
0
0
Estonia
Query!
State/province [97]
0
0
Tartu
Query!
Country [98]
0
0
Finland
Query!
State/province [98]
0
0
Helsinki
Query!
Country [99]
0
0
Finland
Query!
State/province [99]
0
0
Oulu
Query!
Country [100]
0
0
Finland
Query!
State/province [100]
0
0
Tampere
Query!
Country [101]
0
0
Finland
Query!
State/province [101]
0
0
Turku
Query!
Country [102]
0
0
France
Query!
State/province [102]
0
0
Angers cedex 9
Query!
Country [103]
0
0
France
Query!
State/province [103]
0
0
Bayonne
Query!
Country [104]
0
0
France
Query!
State/province [104]
0
0
Beauvais
Query!
Country [105]
0
0
France
Query!
State/province [105]
0
0
Bethune Cedex
Query!
Country [106]
0
0
France
Query!
State/province [106]
0
0
Bordeaux
Query!
Country [107]
0
0
France
Query!
State/province [107]
0
0
Brest cedex
Query!
Country [108]
0
0
France
Query!
State/province [108]
0
0
Bron
Query!
Country [109]
0
0
France
Query!
State/province [109]
0
0
Caen
Query!
Country [110]
0
0
France
Query!
State/province [110]
0
0
Elbeuf
Query!
Country [111]
0
0
France
Query!
State/province [111]
0
0
Lille
Query!
Country [112]
0
0
France
Query!
State/province [112]
0
0
Limoges Cedex
Query!
Country [113]
0
0
France
Query!
State/province [113]
0
0
Lorient cedex
Query!
Country [114]
0
0
France
Query!
State/province [114]
0
0
Lyon cedex 08
Query!
Country [115]
0
0
France
Query!
State/province [115]
0
0
Lyon
Query!
Country [116]
0
0
France
Query!
State/province [116]
0
0
Marseille cedex 20
Query!
Country [117]
0
0
France
Query!
State/province [117]
0
0
Meaux
Query!
Country [118]
0
0
France
Query!
State/province [118]
0
0
Metz
Query!
Country [119]
0
0
France
Query!
State/province [119]
0
0
Montpellier
Query!
Country [120]
0
0
France
Query!
State/province [120]
0
0
Mulhouse Cedex
Query!
Country [121]
0
0
France
Query!
State/province [121]
0
0
Nantes
Query!
Country [122]
0
0
France
Query!
State/province [122]
0
0
Nice
Query!
Country [123]
0
0
France
Query!
State/province [123]
0
0
Nîmes
Query!
Country [124]
0
0
France
Query!
State/province [124]
0
0
Paris cedex 20
Query!
Country [125]
0
0
France
Query!
State/province [125]
0
0
Paris Cedex 5
Query!
Country [126]
0
0
France
Query!
State/province [126]
0
0
Paris
Query!
Country [127]
0
0
France
Query!
State/province [127]
0
0
Perpignan
Query!
Country [128]
0
0
France
Query!
State/province [128]
0
0
Périgueux cedex
Query!
Country [129]
0
0
France
Query!
State/province [129]
0
0
Reims
Query!
Country [130]
0
0
France
Query!
State/province [130]
0
0
Rennes Cedex 09
Query!
Country [131]
0
0
France
Query!
State/province [131]
0
0
Rouen
Query!
Country [132]
0
0
France
Query!
State/province [132]
0
0
Saint Herblain
Query!
Country [133]
0
0
France
Query!
State/province [133]
0
0
Saint-Priest en Jarez
Query!
Country [134]
0
0
France
Query!
State/province [134]
0
0
Saint-Quentin
Query!
Country [135]
0
0
France
Query!
State/province [135]
0
0
St Grégoire
Query!
Country [136]
0
0
France
Query!
State/province [136]
0
0
Toulon cedex 09
Query!
Country [137]
0
0
France
Query!
State/province [137]
0
0
Toulouse cedex 9
Query!
Country [138]
0
0
France
Query!
State/province [138]
0
0
Vannes
Query!
Country [139]
0
0
France
Query!
State/province [139]
0
0
Villefranche sur Saône
Query!
Country [140]
0
0
Germany
Query!
State/province [140]
0
0
Baden-Wuerttemberg
Query!
Country [141]
0
0
Germany
Query!
State/province [141]
0
0
Bayern
Query!
Country [142]
0
0
Germany
Query!
State/province [142]
0
0
Brandenburg
Query!
Country [143]
0
0
Germany
Query!
State/province [143]
0
0
Hessen
Query!
Country [144]
0
0
Germany
Query!
State/province [144]
0
0
Mecklenburg-Vorpommern
Query!
Country [145]
0
0
Germany
Query!
State/province [145]
0
0
Niedersachsen
Query!
Country [146]
0
0
Germany
Query!
State/province [146]
0
0
Nordrhein-Westfalen
Query!
Country [147]
0
0
Germany
Query!
State/province [147]
0
0
Rheinland-Pfalz
Query!
Country [148]
0
0
Germany
Query!
State/province [148]
0
0
Saarland
Query!
Country [149]
0
0
Germany
Query!
State/province [149]
0
0
Sachsen-Anhalt
Query!
Country [150]
0
0
Germany
Query!
State/province [150]
0
0
Sachsen
Query!
Country [151]
0
0
Germany
Query!
State/province [151]
0
0
Schleswig-Holstein
Query!
Country [152]
0
0
Germany
Query!
State/province [152]
0
0
Thueringen
Query!
Country [153]
0
0
Germany
Query!
State/province [153]
0
0
Berlin
Query!
Country [154]
0
0
Germany
Query!
State/province [154]
0
0
Bremen
Query!
Country [155]
0
0
Germany
Query!
State/province [155]
0
0
Hamburg
Query!
Country [156]
0
0
Greece
Query!
State/province [156]
0
0
Athens
Query!
Country [157]
0
0
Greece
Query!
State/province [157]
0
0
Chania
Query!
Country [158]
0
0
Greece
Query!
State/province [158]
0
0
Heraklion
Query!
Country [159]
0
0
Greece
Query!
State/province [159]
0
0
Larissa
Query!
Country [160]
0
0
Greece
Query!
State/province [160]
0
0
Marousi
Query!
Country [161]
0
0
Greece
Query!
State/province [161]
0
0
Neo Faliro
Query!
Country [162]
0
0
Greece
Query!
State/province [162]
0
0
Patra
Query!
Country [163]
0
0
Greece
Query!
State/province [163]
0
0
Piraeus
Query!
Country [164]
0
0
Greece
Query!
State/province [164]
0
0
Pylaia
Query!
Country [165]
0
0
Greece
Query!
State/province [165]
0
0
Thessaloniki
Query!
Country [166]
0
0
Hong Kong
Query!
State/province [166]
0
0
Kowloon
Query!
Country [167]
0
0
Hong Kong
Query!
State/province [167]
0
0
Shatin
Query!
Country [168]
0
0
Hungary
Query!
State/province [168]
0
0
Budapest
Query!
Country [169]
0
0
Hungary
Query!
State/province [169]
0
0
Deszk
Query!
Country [170]
0
0
Hungary
Query!
State/province [170]
0
0
Gyula
Query!
Country [171]
0
0
Hungary
Query!
State/province [171]
0
0
Gyor
Query!
Country [172]
0
0
Hungary
Query!
State/province [172]
0
0
Miskolc
Query!
Country [173]
0
0
Hungary
Query!
State/province [173]
0
0
Mátraháza
Query!
Country [174]
0
0
Hungary
Query!
State/province [174]
0
0
Nyíregyháza
Query!
Country [175]
0
0
Hungary
Query!
State/province [175]
0
0
Pozva
Query!
Country [176]
0
0
Hungary
Query!
State/province [176]
0
0
Pécs
Query!
Country [177]
0
0
Hungary
Query!
State/province [177]
0
0
Szombathely
Query!
Country [178]
0
0
Hungary
Query!
State/province [178]
0
0
Székesfehérvár
Query!
Country [179]
0
0
India
Query!
State/province [179]
0
0
Ahmedabad
Query!
Country [180]
0
0
India
Query!
State/province [180]
0
0
Bangalore
Query!
Country [181]
0
0
India
Query!
State/province [181]
0
0
Hyderabad
Query!
Country [182]
0
0
India
Query!
State/province [182]
0
0
Mumbai
Query!
Country [183]
0
0
Ireland
Query!
State/province [183]
0
0
Dublin
Query!
Country [184]
0
0
Ireland
Query!
State/province [184]
0
0
Galway
Query!
Country [185]
0
0
Israel
Query!
State/province [185]
0
0
Beer-Sheva
Query!
Country [186]
0
0
Israel
Query!
State/province [186]
0
0
Haifa
Query!
Country [187]
0
0
Israel
Query!
State/province [187]
0
0
Jerusalem
Query!
Country [188]
0
0
Israel
Query!
State/province [188]
0
0
Kfar Saba
Query!
Country [189]
0
0
Israel
Query!
State/province [189]
0
0
Ramat Gan
Query!
Country [190]
0
0
Israel
Query!
State/province [190]
0
0
Zrifin
Query!
Country [191]
0
0
Italy
Query!
State/province [191]
0
0
Campania
Query!
Country [192]
0
0
Italy
Query!
State/province [192]
0
0
Emilia-Romagna
Query!
Country [193]
0
0
Italy
Query!
State/province [193]
0
0
Friuli-Venezia-Giulia
Query!
Country [194]
0
0
Italy
Query!
State/province [194]
0
0
Lazio
Query!
Country [195]
0
0
Italy
Query!
State/province [195]
0
0
Liguria
Query!
Country [196]
0
0
Italy
Query!
State/province [196]
0
0
Lombardia
Query!
Country [197]
0
0
Italy
Query!
State/province [197]
0
0
Piemonte
Query!
Country [198]
0
0
Italy
Query!
State/province [198]
0
0
Puglia
Query!
Country [199]
0
0
Italy
Query!
State/province [199]
0
0
Sardegna
Query!
Country [200]
0
0
Italy
Query!
State/province [200]
0
0
Sicilia
Query!
Country [201]
0
0
Italy
Query!
State/province [201]
0
0
Toscana
Query!
Country [202]
0
0
Italy
Query!
State/province [202]
0
0
Umbria
Query!
Country [203]
0
0
Italy
Query!
State/province [203]
0
0
Veneto
Query!
Country [204]
0
0
Japan
Query!
State/province [204]
0
0
Aichi
Query!
Country [205]
0
0
Japan
Query!
State/province [205]
0
0
Chiba
Query!
Country [206]
0
0
Japan
Query!
State/province [206]
0
0
Ehime
Query!
Country [207]
0
0
Japan
Query!
State/province [207]
0
0
Fukuoka
Query!
Country [208]
0
0
Japan
Query!
State/province [208]
0
0
Hiroshima
Query!
Country [209]
0
0
Japan
Query!
State/province [209]
0
0
Hyogo
Query!
Country [210]
0
0
Japan
Query!
State/province [210]
0
0
Kanagawa
Query!
Country [211]
0
0
Japan
Query!
State/province [211]
0
0
Niigata
Query!
Country [212]
0
0
Japan
Query!
State/province [212]
0
0
Osaka
Query!
Country [213]
0
0
Japan
Query!
State/province [213]
0
0
Shizuoka
Query!
Country [214]
0
0
Japan
Query!
State/province [214]
0
0
Tokyo
Query!
Country [215]
0
0
Korea, Republic of
Query!
State/province [215]
0
0
Kyunggi-do
Query!
Country [216]
0
0
Korea, Republic of
Query!
State/province [216]
0
0
Seongnam-si
Query!
Country [217]
0
0
Korea, Republic of
Query!
State/province [217]
0
0
Seoul
Query!
Country [218]
0
0
Netherlands
Query!
State/province [218]
0
0
Amsterdam
Query!
Country [219]
0
0
Netherlands
Query!
State/province [219]
0
0
Harderwijk
Query!
Country [220]
0
0
Netherlands
Query!
State/province [220]
0
0
Heerlen
Query!
Country [221]
0
0
Netherlands
Query!
State/province [221]
0
0
Leeuwarden
Query!
Country [222]
0
0
Netherlands
Query!
State/province [222]
0
0
Nieuwegein
Query!
Country [223]
0
0
Norway
Query!
State/province [223]
0
0
Oslo
Query!
Country [224]
0
0
Norway
Query!
State/province [224]
0
0
Trondheim
Query!
Country [225]
0
0
Poland
Query!
State/province [225]
0
0
Bialystok
Query!
Country [226]
0
0
Poland
Query!
State/province [226]
0
0
Bydgoszcz
Query!
Country [227]
0
0
Poland
Query!
State/province [227]
0
0
Checiny
Query!
Country [228]
0
0
Poland
Query!
State/province [228]
0
0
Gdansk
Query!
Country [229]
0
0
Poland
Query!
State/province [229]
0
0
Glucholazy
Query!
Country [230]
0
0
Poland
Query!
State/province [230]
0
0
Krakow
Query!
Country [231]
0
0
Poland
Query!
State/province [231]
0
0
Lodz
Query!
Country [232]
0
0
Poland
Query!
State/province [232]
0
0
Lublin
Query!
Country [233]
0
0
Poland
Query!
State/province [233]
0
0
Poznan
Query!
Country [234]
0
0
Poland
Query!
State/province [234]
0
0
Rzeszow
Query!
Country [235]
0
0
Poland
Query!
State/province [235]
0
0
Szczecin
Query!
Country [236]
0
0
Poland
Query!
State/province [236]
0
0
Warszawa
Query!
Country [237]
0
0
Poland
Query!
State/province [237]
0
0
Wroclaw
Query!
Country [238]
0
0
Poland
Query!
State/province [238]
0
0
Zakopane
Query!
Country [239]
0
0
Russian Federation
Query!
State/province [239]
0
0
Chelyabinsk
Query!
Country [240]
0
0
Russian Federation
Query!
State/province [240]
0
0
Kazan
Query!
Country [241]
0
0
Russian Federation
Query!
State/province [241]
0
0
Kursk
Query!
Country [242]
0
0
Russian Federation
Query!
State/province [242]
0
0
Moscow
Query!
Country [243]
0
0
Russian Federation
Query!
State/province [243]
0
0
St. Petersburg
Query!
Country [244]
0
0
Russian Federation
Query!
State/province [244]
0
0
Stavropol
Query!
Country [245]
0
0
Russian Federation
Query!
State/province [245]
0
0
Ufa,
Query!
Country [246]
0
0
Singapore
Query!
State/province [246]
0
0
Singapore
Query!
Country [247]
0
0
Spain
Query!
State/province [247]
0
0
Barcelona
Query!
Country [248]
0
0
Spain
Query!
State/province [248]
0
0
Granada
Query!
Country [249]
0
0
Spain
Query!
State/province [249]
0
0
Leganes
Query!
Country [250]
0
0
Spain
Query!
State/province [250]
0
0
Lerida
Query!
Country [251]
0
0
Spain
Query!
State/province [251]
0
0
Madrid
Query!
Country [252]
0
0
Spain
Query!
State/province [252]
0
0
Málaga
Query!
Country [253]
0
0
Spain
Query!
State/province [253]
0
0
Oviedo
Query!
Country [254]
0
0
Spain
Query!
State/province [254]
0
0
Sabadell
Query!
Country [255]
0
0
Spain
Query!
State/province [255]
0
0
San Sebastian de los Reyes
Query!
Country [256]
0
0
Spain
Query!
State/province [256]
0
0
Santander
Query!
Country [257]
0
0
Spain
Query!
State/province [257]
0
0
Santiago de Compostela
Query!
Country [258]
0
0
Spain
Query!
State/province [258]
0
0
Sevilla
Query!
Country [259]
0
0
Spain
Query!
State/province [259]
0
0
Valencia
Query!
Country [260]
0
0
Sweden
Query!
State/province [260]
0
0
Lund
Query!
Country [261]
0
0
Sweden
Query!
State/province [261]
0
0
Stockholm
Query!
Country [262]
0
0
Sweden
Query!
State/province [262]
0
0
Uppsala
Query!
Country [263]
0
0
Switzerland
Query!
State/province [263]
0
0
Aarau
Query!
Country [264]
0
0
Switzerland
Query!
State/province [264]
0
0
Basel
Query!
Country [265]
0
0
Switzerland
Query!
State/province [265]
0
0
Bern
Query!
Country [266]
0
0
Switzerland
Query!
State/province [266]
0
0
Bruderholz
Query!
Country [267]
0
0
Switzerland
Query!
State/province [267]
0
0
Thun
Query!
Country [268]
0
0
Switzerland
Query!
State/province [268]
0
0
Zuerich
Query!
Country [269]
0
0
Taiwan
Query!
State/province [269]
0
0
Kaohsiung
Query!
Country [270]
0
0
Taiwan
Query!
State/province [270]
0
0
Taichung
Query!
Country [271]
0
0
Taiwan
Query!
State/province [271]
0
0
Tainan
Query!
Country [272]
0
0
Taiwan
Query!
State/province [272]
0
0
Taipei
Query!
Country [273]
0
0
Taiwan
Query!
State/province [273]
0
0
Taoyuan
Query!
Country [274]
0
0
Thailand
Query!
State/province [274]
0
0
Bangkok
Query!
Country [275]
0
0
Thailand
Query!
State/province [275]
0
0
Chiang Mai
Query!
Country [276]
0
0
Thailand
Query!
State/province [276]
0
0
Hat yai
Query!
Country [277]
0
0
Ukraine
Query!
State/province [277]
0
0
Dnipropetrovsk
Query!
Country [278]
0
0
Ukraine
Query!
State/province [278]
0
0
Donetsk
Query!
Country [279]
0
0
Ukraine
Query!
State/province [279]
0
0
Kharkiv
Query!
Country [280]
0
0
Ukraine
Query!
State/province [280]
0
0
Kyiv
Query!
Country [281]
0
0
Ukraine
Query!
State/province [281]
0
0
Lviv
Query!
Country [282]
0
0
Ukraine
Query!
State/province [282]
0
0
Odesa
Query!
Country [283]
0
0
Ukraine
Query!
State/province [283]
0
0
Simferopol
Query!
Country [284]
0
0
Ukraine
Query!
State/province [284]
0
0
Uzhgorod
Query!
Country [285]
0
0
Ukraine
Query!
State/province [285]
0
0
Vinnytsia
Query!
Country [286]
0
0
United Kingdom
Query!
State/province [286]
0
0
Cambridgeshire
Query!
Country [287]
0
0
United Kingdom
Query!
State/province [287]
0
0
Greater Manchester
Query!
Country [288]
0
0
United Kingdom
Query!
State/province [288]
0
0
Leicestershire
Query!
Country [289]
0
0
United Kingdom
Query!
State/province [289]
0
0
Midlothian
Query!
Country [290]
0
0
United Kingdom
Query!
State/province [290]
0
0
Surrey
Query!
Country [291]
0
0
United Kingdom
Query!
State/province [291]
0
0
Aberdeen
Query!
Country [292]
0
0
United Kingdom
Query!
State/province [292]
0
0
Bebington
Query!
Country [293]
0
0
United Kingdom
Query!
State/province [293]
0
0
Belfast
Query!
Country [294]
0
0
United Kingdom
Query!
State/province [294]
0
0
Birmingham
Query!
Country [295]
0
0
United Kingdom
Query!
State/province [295]
0
0
Cambridge
Query!
Country [296]
0
0
United Kingdom
Query!
State/province [296]
0
0
Dundee
Query!
Country [297]
0
0
United Kingdom
Query!
State/province [297]
0
0
Glasgow
Query!
Country [298]
0
0
United Kingdom
Query!
State/province [298]
0
0
Inverness
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United Kingdom
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Leeds
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United Kingdom
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Liverpool
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United Kingdom
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London
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United Kingdom
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Maidstone
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United Kingdom
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Sheffield
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
GlaxoSmithKline
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Ethics approval
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Summary
Brief summary
The purpose of this clinical trial is to demonstrate the benefit of the immunotherapeutic product GSK1572932A when given to patients with Non-Small Cell Lung Cancer, after removal of their tumor. A course of 13 injections will be administered over 27 months. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
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Trial website
https://clinicaltrials.gov/study/NCT00480025
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Trial related presentations / publications
Vansteenkiste JF, Cho BC, Vanakesa T, De Pas T, Zielinski M, Kim MS, Jassem J, Yoshimura M, Dahabreh J, Nakayama H, Havel L, Kondo H, Mitsudomi T, Zarogoulidis K, Gladkov OA, Udud K, Tada H, Hoffman H, Bugge A, Taylor P, Gonzalez EE, Liao ML, He J, Pujol JL, Louahed J, Debois M, Brichard V, Debruyne C, Therasse P, Altorki N. Efficacy of the MAGE-A3 cancer immunotherapeutic as adjuvant therapy in patients with resected MAGE-A3-positive non-small-cell lung cancer (MAGRIT): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2016 Jun;17(6):822-835. doi: 10.1016/S1470-2045(16)00099-1. Epub 2016 Apr 27. Dizier B, Callegaro A, Debois M, Dreno B, Hersey P, Gogas HJ, Kirkwood JM, Vansteenkiste JF, Sequist LV, Atanackovic D, Goeman J, van Houwelingen H, Salceda S, Wang F, Therasse P, Debruyne C, Spiessens B, Brichard VG, Louahed J, Ulloa-Montoya F. A Th1/IFNgamma Gene Signature Is Prognostic in the Adjuvant Setting of Resectable High-Risk Melanoma but Not in Non-Small Cell Lung Cancer. Clin Cancer Res. 2020 Apr 1;26(7):1725-1735. doi: 10.1158/1078-0432.CCR-18-3717. Epub 2019 Nov 15. Zhu J, Yuan Y, Wan X, Yin D, Li R, Chen W, Suo C, Song H. Immunotherapy (excluding checkpoint inhibitors) for stage I to III non-small cell lung cancer treated with surgery or radiotherapy with curative intent. Cochrane Database Syst Rev. 2021 Dec 6;12(12):CD011300. doi: 10.1002/14651858.CD011300.pub3.
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Public notes
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Contacts
Principal investigator
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GSK Clinical Trials
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GlaxoSmithKline
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
IPD for this study is available via the Clinical Study Data Request site.
Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
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When will data be available (start and end dates)?
IPD is available via the Clinical Study Data Request site (click on the link provided below)
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Available to whom?
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://www.clinicalstudydatarequest.com/Posting.aspx?ID=4790
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT00480025