Trial · NCT00480025
GSK1572932A Antigen-Specific Cancer Immunotherapeutic as Adjuvant Therapy in Patients With Non-Small Cell Lung Cancer
NCT00480025, Phase 3, Terminated, GlaxoSmithKline; results first posted 2019-01-30
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. GSK1572932A Antigen-Specific Cancer Immunotherapeutic as Adjuvant Therapy in Patients With Non-Small Cell Lung Cancer. Trials, record NCT00480025. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00480025
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- GSK1572932A Antigen-Specific Cancer Immunotherapeutic as Adjuvant Therapy in Patients With Non-Small Cell Lung Cancer
- NCT number
- NCT00480025
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 2,278 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Lung Cancer, Non-Small Cell
- Interventions
- GSK1572932A Antigen-Specific Cancer Immunotherapeutic, Placebo Control
- First posted
- 2007-05-30
- Last updated
- 2020-12-22
- Other registries' IDs
- eudract:2007-001283-73
- Results first posted
- 2019-01-30
Source ClinicalTrials.gov
Registered outcomes32
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Person Year Rate (PYAR) as Regards Disease-free Survival (DFS) in the Overall Population | 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) | 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. |
| Primary | Person Year Rate (PYAR) as Regards Disease-free Survival (DFS) in the No-CT Population | 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) | 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. |
| Secondary | Person Year Rate (PYAR) as Regards Disease-free Survival (DFS) in the CT Population | 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) | 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. |
| Secondary | Person Year Rate (PYAR) as Regards Overall-survival (OS) in the Overall Population | 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) | 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. |
| Secondary | Person Year Rate (PYAR) as Regards Overall-survival (OS) in the No-CT Population | 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) | 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. |
| Secondary | Person Year Rate (PYAR) as Regards Overall-survival (OS) in the CT Population | 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) | 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. |
| Secondary | Person Year Rate (PYAR) as Regards Lung-cancer Specific Survival (LCSS) in the Overall Population | 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) | 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. |
| Secondary | Person Year Rate (PYAR) as Regards Lung-cancer Specific Survival (LCSS) in the No-CT Population | 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) | 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. |
| Secondary | Person Year Rate (PYAR) as Regards Lung-cancer Specific Survival (LCSS) in the CT Population | 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) | 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. |
| Secondary | Kaplan-Meier Estimate (KME) of 2, 3, 4 and 5-year as Regards Disease-free Survival (DFS) in the Overall Population | 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) | 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. |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 registered outcomesOutcomes32
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Person Year Rate (PYAR) as Regards Disease-free Survival (DFS) in the Overall Population | 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) | The Total Treated population - as randomized included patients in the treatment group as allocated by the randomization system at the start of the study. | events/person-years | NUMBER |
| PRIMARY | Person Year Rate (PYAR) as Regards Disease-free Survival (DFS) in the No-CT Population | 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) | The Total Treated population - as randomized included patients in the treatment group as allocated by the randomization system at the start of the study. | events/person-years | NUMBER |
| SECONDARY | Person Year Rate (PYAR) as Regards Disease-free Survival (DFS) in the CT Population | 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) | The Total Treated population - as randomized included patients in the treatment group as allocated by the randomization system at the start of the study. | events/person-years | NUMBER |
| SECONDARY | Person Year Rate (PYAR) as Regards Overall-survival (OS) in the Overall Population | 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) | The Total Treated population - as randomized included patients in the treatment group as allocated by the randomization system at the start of the study. | events/person-years | NUMBER |
| SECONDARY | Person Year Rate (PYAR) as Regards Overall-survival (OS) in the No-CT Population | 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) | The Total Treated population - as randomized included patients in the treatment group as allocated by the randomization system at the start of the study. | events/person-years | NUMBER |
| SECONDARY | Person Year Rate (PYAR) as Regards Overall-survival (OS) in the CT Population | 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) | The Total Treated population - as randomized included patients in the treatment group as allocated by the randomization system at the start of the study. | events/person-years | NUMBER |
| SECONDARY | Person Year Rate (PYAR) as Regards Lung-cancer Specific Survival (LCSS) in the Overall Population | 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) | The Total Treated population - as randomized included patients in the treatment group as allocated by the randomization system at the start of the study. | events/person-years | NUMBER |
| SECONDARY | Person Year Rate (PYAR) as Regards Lung-cancer Specific Survival (LCSS) in the No-CT Population | 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) | The Total Treated population - as randomized included patients in the treatment group as allocated by the randomization system at the start of the study. | events/person-years | NUMBER |
| SECONDARY | Person Year Rate (PYAR) as Regards Lung-cancer Specific Survival (LCSS) in the CT Population | 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) | The Total Treated population - as randomized included patients in the treatment group as allocated by the randomization system at the start of the study. | events/person-years | NUMBER |
| SECONDARY | Kaplan-Meier Estimate (KME) of 2, 3, 4 and 5-year as Regards Disease-free Survival (DFS) in the Overall Population | 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) | The Total Treated population - as randomized included patients in the treatment group as allocated by the randomization system at the start of the study. | percent probability | MEDIAN |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 outcomesResults by group676
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Person Year Rate (PYAR) as Regards Disease-free Survival (DFS) in the Overall Population | GSK1572932 Group | 0.17 | events/person-years | ||
| Person Year Rate (PYAR) as Regards Disease-free Survival (DFS) in the Overall Population | Placebo Group | 0.168 | events/person-years | ||
| Person Year Rate (PYAR) as Regards Disease-free Survival (DFS) in the No-CT Population | GSK1572932 No-CT Group | 0.169 | events/person-years | ||
| Person Year Rate (PYAR) as Regards Disease-free Survival (DFS) in the No-CT Population | Placebo No-CT Group | 0.178 | events/person-years | ||
| Person Year Rate (PYAR) as Regards Disease-free Survival (DFS) in the CT Population | GSK1572932 CT Group | 0.172 | events/person-years | ||
| Person Year Rate (PYAR) as Regards Disease-free Survival (DFS) in the CT Population | Placebo CT Group | 0.158 | events/person-years | ||
| Person Year Rate (PYAR) as Regards Overall-survival (OS) in the Overall Population | GSK1572932 Group | 0.082 | events/person-years | ||
| Person Year Rate (PYAR) as Regards Overall-survival (OS) in the Overall Population | Placebo Group | 0.081 | events/person-years | ||
| Person Year Rate (PYAR) as Regards Overall-survival (OS) in the No-CT Population | GSK1572932 No-CT Group | 0.084 | events/person-years | ||
| Person Year Rate (PYAR) as Regards Overall-survival (OS) in the No-CT Population | Placebo No-CT Group | 0.086 | events/person-years |
1 to 10 of 676Source ClinicalTrials.gov
See all 676 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | GSK1572932 Group | 1,515 | |
| Overall Study | STARTED | Placebo Group | 757 | |
| Overall Study | COMPLETED | GSK1572932 Group | 763 | |
| Overall Study | COMPLETED | Placebo Group | 388 | |
| Overall Study | NOT COMPLETED | GSK1572932 Group | 752 | |
| Overall Study | NOT COMPLETED | Placebo Group | 369 |
Source ClinicalTrials.gov
Adverse events820
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Arthralgia | Musculoskeletal and connective tissue disorders | GSK1572932 Group | 105 | 1,515 | 161 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Placebo Group | 31 | 757 | 35 |
| other | Asthenia | General disorders | GSK1572932 Group | 92 | 1,515 | 199 |
| other | Asthenia | General disorders | Placebo Group | 26 | 757 | 55 |
| other | Chills | General disorders | GSK1572932 Group | 118 | 1,515 | 249 |
| other | Chills | General disorders | Placebo Group | 7 | 757 | 16 |
| other | Cough | Respiratory, thoracic and mediastinal disorders | GSK1572932 Group | 131 | 1,515 | 155 |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Placebo Group | 71 | 757 | 80 |
| other | Decreased appetite | Metabolism and nutrition disorders | GSK1572932 Group | 79 | 1,515 | 112 |
| other | Decreased appetite | Metabolism and nutrition disorders | Placebo Group | 28 | 757 | 30 |
1 to 10 of 820Source ClinicalTrials.gov
See all 820 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | GSK1572932 Group | 30 | 1,515 |
| Total, all-cause mortality | Placebo Group | 17 | 757 |
| Total, other adverse events | GSK1572932 Group | 1,225 | 1,515 |
| Total, other adverse events | Placebo Group | 300 | 757 |
| Total, serious adverse events | GSK1572932 Group | 330 | 1,515 |
| Total, serious adverse events | Placebo Group | 164 | 757 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| GSK1572932 Group vs Placebo Group: Number of Patients With Serious Adverse Events (SAEs) - Up to Data Lock Point (DLP) | Trial comparisons |
| GSK1572932 Group vs Placebo Group: deaths from any cause | Trial comparisons |
| GSK1572932 Group vs Placebo Group: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00480025
GET https://conductscience.org/api/trials/v1/NCT00480025/registered?page=2