A Multi-center, Non-randomized, Open Label Safety Study of BLP25 Liposome Vaccine (L-BLP25) in Non-Small Cell Lung Cancer (NSCLC) Patients With Unresectable Stage III Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 22
- 主要终点
- Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs With CALGB-ECTC Grade 3 or 4, TEAEs Leading to Discontinuation, TEAEs Leading to Death, and Injection Site Reactions (ISRs)
研究概览
简要总结
The primary objective is to document the safety of tecemotide (L-BLP25) phase III formulation in non-small cell lung cancer (NSCLC) subjects with unresectable Stage III disease. This population includes Stage IIIA NSCLC subjects, a population not studied in former clinical studies with this vaccine. The secondary objective is to document the survival of subjects treated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Histologically documented unresectable stage III NSCLC. Mediastinal (N2) involvement must be confirmed by biopsy
- •Stable disease or clinical response after primary therapy of chemo-radiation treatment for unresectable stage III disease
- •Primary therapy should be a minimum of 2 cycles of Platinum-based first-line chemotherapy, given concurrent with thoracic radiation. The combined modality should consist of either:
- •induction (2 cycles) chemotherapy followed by concurrent chemo-radiation therapy; or
- •concurrent chemo-radiation therapy followed by 2 cycles of consolidation chemotherapy; or
- •concurrent chemoradiation therapy alone
- •A minimum radiation dose of greater than or equal to (>=) 6,000 centigray (cGy) should be administered. Subjects must have completed the primary therapy at least 4 weeks and no later than 6 months prior to study entry
- •Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to (<=) 1
- •Ability to understand and willingness to sign a written informed consent
- •Other protocol defined inclusion criteria could apply
排除标准
- •Undergone lung cancer specific therapy (including surgery) prior to primary chemo-radiation therapy
- •Received immunotherapy/systemic immunosuppressive drugs/investigational systemic drugs within 4 weeks prior to study entry
- •Subjects with brain metastases, pleural effusion, unless cytologically confirmed to be non-malignant
- •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 dysfunction or cardiac diseases
- •Clinically significant active infection
- •Pregnant or lactating, women of childbearing potential, unless using effective contraception as determined by the investigator
- •Other protocol defined inclusion criteria could apply
研究组 & 干预措施
Tecemotide(L-BLP25)+Cyclophosphomide+best standard of care
干预措施: Single low dose cyclophosphamide (Drug)
Tecemotide(L-BLP25)+Cyclophosphomide+best standard of care
干预措施: Tecemotide (L-BLP25) (Biological)
Tecemotide(L-BLP25)+Cyclophosphomide+best standard of care
干预措施: Best standard of care (BSC) (Other)
结局指标
主要结局
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs With CALGB-ECTC Grade 3 or 4, TEAEs Leading to Discontinuation, TEAEs Leading to Death, and Injection Site Reactions (ISRs)
时间窗: Up to data cut-off date (17 September 2007)
TEAEs occurred between the first dose of study drug and up to 42 days after the last dose that were absent before treatment or that worsened relative to pretreatment state. A serious TEAE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAEs with Cancer and Leukemia Group B Extended Clinical Toxicity Criteria (CALGB-ECTC) Grade 3 or 4 were also reported.
次要结局
- Progression Free Survival (PFS) Time(Up to data cut-off date (17 September 2007))
- Survival Time(Up to data cut-off date (17 September 2007))