A Multicenter Phase IIb Randomised, Controlled Study of BLP25 Liposome Vaccine for Active Specific Immunotherapy of Non-Small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 171
- 试验地点
- 1
- 主要终点
- Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Death, and TEAEs With Cancer and Leukemia Group B (CALGB) Toxicity Grade 3 or 4
研究概览
简要总结
This is a prospective open label, controlled, randomized study to test the safety and efficacy of active specific immunotherapy with tecemotide (L-BLP25) for the treatment of subjects with Stage IIIB or Stage IV non-small cell lung cancer (NSCLC). To be eligible, subjects entering the trial will have to demonstrate either stable disease or a clinical response after first-line treatment (chemotherapy alone, or chemotherapy and radiotherapy) and have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2. Following a 3 week washout period, subjects will be stratified by disease status (either Stage IIIB locoregional disease or Stage IIIB with malignant pleural effusion and Stage IV), and randomized to either best supportive care (BSC) plus tecemotide (L-BLP25) treatment or BSC alone.
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
- None
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
- •Stage IIIB or Stage IV NSCLC
- •Stable disease or a clinical response following first-line treatment, consisting of either chemotherapy alone or chemotherapy and radiotherapy. Subjects must have completed the first-line treatment at least 3 weeks prior to study entry
- •Eastern Cooperative Oncology Group (ECOG) performance status of greater than or equal to (>=) 2
- •Ability to understand and willingness to sign a written informed consent
- •Other protocol-defined inclusion criteria could apply
排除标准
- •Received immunotherapy within 4 weeks prior to study entry
- •Received immunosuppressive drugs within 3 weeks prior to study entry
- •Subjects with known brain metastases
- •Past or current history of neoplasm other than lung carcinoma, except for curatively treated non-melanoma skin cancer, in situ carcinoma of the cervix or other cancer curatively treated and with no evidence of disease for at least 5 years
- •Autoimmune disease or immunodeficiency
- •Clinically significant hepatic, renal or cardiac dysfunction
- •Subjects with clinically significant active infection
- •Pregnant or breast feeding women, women of childbearing potential, unless using effective contraception as determined by the investigator
- •Other protocol-defined exclusion criteria could apply
研究组 & 干预措施
Tecemotide (L-BLP25) plus Best Supportive Care (BSC)
干预措施: Tecemotide (L-BLP25) (Biological)
Tecemotide (L-BLP25) plus Best Supportive Care (BSC)
干预措施: Single low dose cyclophosphamide (Drug)
Tecemotide (L-BLP25) plus Best Supportive Care (BSC)
干预措施: Best Supportive Care (BSC) (Other)
Best Supportive Care (BSC) Alone
干预措施: Best Supportive Care (BSC) (Other)
结局指标
主要结局
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Death, and TEAEs With Cancer and Leukemia Group B (CALGB) Toxicity Grade 3 or 4
时间窗: From the first dose of study drug administration until 30 days after the last dose of study drug administration or assessed until cut-off date (15 March 2006)
An adverse event (AE) was defined as any new untoward medical occurrences/worsening of pre-existing medical condition, whether or not related to study drug. A serious AE was an AE that results in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. Treatment-emergent are events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Number of participants with TEAEs, serious TEAEs, TEAEs leading to death, and TEAEs with CALGB toxicity Grade 3 or 4 were reported.
Overall Survival Time
时间窗: Time from randomization to death or last day known to be alive, reported between day of first participant randomized that is, 08 August 2000, up to cut-off (15 March 2006)
Time from randomization to death or last day known to be alive. Participants without event were censored at the last date known to be alive or at the clinical cut-off date (15 March 2006), whichever was earlier.
次要结局
- Functional Assessment of Cancer Therapy (FACT-L) Questionnaire Score(At baseline, Week 4, Week 8 and then at 12 Week intervals beginning at week 19 until withdrawal/discontinuation from the study.)
- Number of Participants With Positive T-cell Proliferation(Time from randomization until cut-off date (15 March 2006))
- Number of Participants With Elevated CA27-29 Antigen Levels(Study entry, Week 8)