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.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- EMD Serono
- 入组人数
- 1,513
- 试验地点
- 93
- 主要终点
- Overall Survival
研究概览
简要总结
The purpose of this study is to determine whether the cancer vaccine tecemotide (L-BLP25) in addition to best supportive care is effective in prolonging the lives of subjects with unresectable stage III non-small cell lung cancer, compared to best supportive care alone.
A local ancillary (sub) study in European centers will evaluate the immune response in peripheral blood after tecemotide (L-BLP25) or placebo vaccination.
详细描述
Ancillary Trial: An exploratory investigation of immune response in peripheral blood after tecemotide (L-BLP25) or placebo vaccination.
The ancillary study is a sub-study within START. This is an exploratory investigation of the immune response in peripheral blood after tecemotide (L-BLP25) or placebo vaccination. The main objective is to evaluate whether administration of single-shot, low-dose cyclophosphamide followed by tecemotide (L-BLP25) vaccinations induces specific immune response in peripheral blood to BLP25 (the mucinous glycoprotein 1 [MUC1] antigen) as well as a modulation of cellular and soluble components of the immune response in subjects with unresectable stage III NSCLC.
Twenty-five of the European START sites will participate in the ancillary study.
Sample size: up to 60 to 80 subjects
All inclusion criteria specified in the START clinical trial protocol except for hemoglobin >= 100 gram/Liter (g/L)
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 or cytologically documented unresectable stage III non-small cell lung cancer (NSCLC)
- •Documented stable disease or objective response, according to Response Evaluation Criteria in Solid Tumors (RECIST), after primary chemoradiotherapy (either sequential or concomitant) for unresectable stage III disease, within 4 weeks (28 days) prior to randomization
- •Receipt of concomitant or sequential chemoradiotherapy, consisting of a minimum of two cycles of platinum-based chemotherapy and a minimum radiation dose of >=50 Gray (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 Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- •A platelet count > 140 x 10^9/Liter; white blood cells (WBC) > 2.5 x 10^9/Liter and hemoglobin > 90 gram per liter (g/L)
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/or 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
- •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
研究组 & 干预措施
Tecemotide (L-BLP25)
干预措施: Tecemotide (L-BLP25) (Biological)
Tecemotide (L-BLP25)
干预措施: Single low dose cyclophosphamide (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Overall Survival
时间窗: Up to 66 months
Overall survival time was defined as the time from randomization to death. Participants without events were censored at the last date they were known to be alive or the clinical cut-off date, whatever was earlier.
次要结局
- Time To Symptom Progression (TTSP) as Measured by the Lung Cancer Symptom Scale (LCSS)(Up to 66 months)
- Time To Progression (TTP)(Up to 66 months)
- One-, Two- and Three-year Survival Rate(Years 1, 2, and 3)
- Number of Participants With Treatment Emergent Adverse Events and Injection Site Reactions(From first dose up to 42 days after the last dose of the trial treatment)