GSK1572932A Antigen-Specific Cancer Immunotherapeutic as Adjuvant Therapy in Patients With Resectable MAGE-A3 Positive Non-Small Cell Lung Cancer
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 2,278
- 试验地点
- 621
- 主要终点
- Person Year Rate (PYAR) as Regards Disease-free Survival (DFS) in the No-CT Population
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Person Year Rate (PYAR) as Regards Disease-free Survival (DFS) in the No-CT Population
时间窗: 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.
Person Year Rate (PYAR) as Regards Disease-free Survival (DFS) in the Overall Population
时间窗: 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.
次要结局
- Kaplan-Meier Estimate (KME) of 2, 3, 4 and 5-year as Regards Disease-free Survival (DFS) in the CT 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))
- Person Year Rate (PYAR) as Regards Disease-free Specific Survival (DFSS) 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))
- Number of Patients With Abnormal Alanine Aminotransferase (ALT) Values by Maximum Grade(From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient))
- 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))
- 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))
- 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))
- Number of Humoral Responders as Regards Anti-Melanoma AntiGEn (MAGE)-A3 Antibodies (Anti-MAGE-A3 HR)(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))
- Health-related Quality of Life (HQL) Scores(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)
- 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))
- 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))
- 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))
- Number of Patients With Abnormal Neutrophils (NEU) Values by Maximum Grade(From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient))
- Kaplan-Meier Estimate (KME) of 2, 3, 4 and 5-year as Regards Disease-free Survival (DFS) in the No-CT 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))
- 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))
- 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))
- Number of Subjects Seropositive for Anti-Melanoma AntiGEn (MAGE)-A3 Antibodies (Anti-MAGE-A3 S+)(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))
- Number of Patients With Abnormal Alkaline Phosphatase (ALKP) Values by Maximum Grade(From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient))
- Number of Patients With Abnormal Bilirubin (BIL) Values by Maximum Grade(From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient))
- Person Year Rate (PYAR) as Regards Disease-free Specific Survival (DFSS) 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))
- Person Year Rate (PYAR) as Regards Disease-free Specific Survival (DFSS) in the CT Population(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))
- Number of Patients With Abnormal Alanine Aspartate Aminotransferase (AST) Values by Maximum Grade(From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient))
- Number of Subjects Seropositive for Anti-protein D (PD) Antibodies (Anti-PD S+)(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))
- Number of Patients With Abnormal Haemoglobin (HGB) Values by Maximum Grade(From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient))
- Number of Patients With Abnormal Leukocytes (LEU) Values by Maximum Grade(From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient))
- Number of Patients With Abnormal Lymphocytes (LYM) Values by Maximum Grade(From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient))
- Number of Patients With Serious Adverse Events (SAEs) - Up to Data Lock Point (DLP)(From screening (SCR) up to data lock point (DLP) on 23 January 2014 (up to 5 years per patient))
- Number of Humoral Responders as Regards Anti-protein D (PD) Antibodies (Anti-PD HR)(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))
- Number of Patients With Abnormal Creatinine (CREA) Values by Maximum Grade(From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient))
- Number of Patients With Abnormal Platelets (PLA) Values by Maximum Grade(From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient))
- Number of Patients With Any Adverse Events (AEs) and With AEs by Maximum Grade Reported - Up to Data Lock Point (DLP)(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))