ACTRN12607000173493招募中3 期
A multi-center phase III randomized, double-blind placebo-controlled study of the cancer vaccine Stimuvax® (L-BLP25 or BLP25 liposome vaccine) in non-small cell lung cancer (NSCLC) subjects with unresectable stage III disease to compare the survival duration of all randomized subjects by treatment arm.
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 1,322
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 ot stated（—）
- 性别
- All
入选标准
- •Histologically or cytologically documented unresectable stage III NSCLC. -Documented stable disease or objective response, according to Response Evaluation Criteria in Solid Tumors (RECIST), after primary chemo-radiotherapy (either sequential or concomitant) for unresectable stage III disease, within 4 weeks (28 days) prior to randomization.-Receipt of concomitant or sequential chemo-radiotherapy, consisting of a minimum of two cycles of platinum-based chemotherapy and a minimum radiation dose of = 50 Gy. Subjects must have completed the primary thoracic chemo-radiotherapy at least four weeks (28 days) and no later than 12 weeks (84 days) prior to randomization. Subjects who received prophylactic brain irradiation as part of primary chemo-radiotherapy are eligible.-Geographically accessible for ongoing follow-up, and committed to comply with the designated visits.-An ECOG (The Eastern Cooperative Oncology Group) performance status of 0-1.
排除标准
- •Pre-Therapies:-Undergone lung cancer specific therapy (including surgery) other than primary chemo-radiotherapy.-Receipt of immunotherapy (e.g. interferons, tumor necrosis factor [TNF], interleukins, or biological response modifiers [granulocyte macrophage colony stimulating factor {GM-CSF}, granulocyte colony stimulating factor {G-CSF}, macrophage-colony stimulating factor {M-CSF}], monoclonal antibodies) within 4 weeks (28 days) prior to randomization. -Receipt of investigational systemic drugs (including off-label use of approved products) within 4 weeks (28 days) prior to randomization. Disease Status:-Metastatic disease.-Malignant pleural effusion at initial diagnosis and at study entry.-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 that in the opinion of the investigator could compromise the safety of the subject in this study. -A recognized immunodeficiency disease including cellular immunodeficiencies, hypogammaglobulinemia or dysgammaglobulinemia; subjects who have hereditary or congenital immunodeficiencies. -Any preexisting medical condition requiring chronic steroid or immunosuppressive therapy (steroids for the treatment of radiation pneumonitis are allowed).-Known Hepatitis B and/or C. Physiological Functions:-Clinically significant hepatic dysfunction.-Clinically significant renal dysfunction.-Clinically significant cardiac disease.-Splenectomy.-Infectious process that in the opinion of the investigator could compromise the subject’s ability to mount an immune response. Standard Safety:-Pregnant or breast-feeding women, women of childbearing potential, unless using effective contraception as determined by the investigator. -Known drug abuse/alcohol abuse.-Legal incapacity or limited legal capacity
研究者
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