NCT01015443终止3 期
A Multi-national, Double-blind, Placebo-controlled, Randomized, Phase III Clinical Trial of the Cancer Vaccine Stimuvax® (L-BLP25 or BLP25 Liposome Vaccine) in Asian Subjects With Stage III, Unresectable, Non-small Cell Lung Cancer (NSCLC) Who Have Demonstrated Either Stable Disease or Objective Response Following Primary Chemo-radiotherapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 285
- 试验地点
- 47
- 主要终点
- Overall Survival (OS) Time
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 Asian subjects with unresectable stage III non-small cell lung cancer in comparison to a placebo plus best supportive care (a so-called placebo controlled study).
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 Version 1.0 (RECIST v1.0) after primary concomitant chemo-radiotherapy for unresectable stage III disease, within four weeks (28 days) prior to randomization
- •Receipt of concomitant chemo-radiotherapy. The chemotherapy-part must have been platinum-based, must have been administered with a minimum of two cycles overlap with radiotherapy (one cycle lasts either 3 or 4 weeks depending on the chemotherapy regimen), and a minimum of two platinum-based chemotherapy administrations must have been given during radiotherapy. Purely radio sensitizing doses of chemotherapy are not acceptable. Radiotherapy must have delivered a radiation dose of >= (greater than or equal to) 50 Gray (Gy). Induction or consolidation chemotherapy is allowed and if given, should be accounted as part of primary thoracic chemoradiotherapy. 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 or 1
- •A platelet count >= the lower limit of normal for the site or >= 100 x 10^9 per liter (/Liter) (whichever is greater); white blood cell (WBC) >= 2.5 x 10^9/Liter and haemoglobin >= 90 gram per liter (g/L)
- •>=18 years of age (or minimum age of legal consent consistent with local regulations, if minimum is greater than [>] 18 years of age)
- •Other protocol defined inclusion criteria could apply
排除标准
- •Pre-Therapies*:
- •Prior sequential chemo-radiotherapy
- •Lung-cancer-specific therapy (including surgery) other than primary chemoradiotherapy
- •Immunotherapy (e.g., interferons, tumor necrosis factor [TNF], interleukins, or biological response modifiers [granulocyte macrophage colony stimulating factor {GMCSF}, granulocyte colony stimulating factor {G-CSF}, macrophage-colony stimulating factor {M-CSF}], monoclonal antibodies) within four weeks (28 days) prior to randomization
- •Investigational systemic drugs (including off-label use of approved products) within four weeks (28 days) prior to randomization
- •Disease Status:
- •Metastatic disease
- •Malignant pleural effusion at initial diagnosis and/or at trial 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 active Hepatitis B infection and/or Hepatitis C infection
- •Signs and symptoms suggestive of transmissible spongiform encephalopathy, or of family members who suffer(ed) from such
- •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 breastfeeding women, women of childbearing potential, unless using effective contraception as determined by the investigator
- •Known drug abuse or alcohol abuse
- •Participation in another clinical trial (excluding purely observational studies) within the past 28 days
- •Requires concurrent treatment with a non-permitted drug
- •Known hypersensitivity to any of the trial treatment ingredients
- •Legal incapacity or limited legal capacity
- •Any other reason that, in the opinion of the investigator precludes the subject from participating in the trial
研究组 & 干预措施
Investigational Arm
Experimental
Tecemotide (L-BLP25) + Single low dose cyclophosphamide + Best supportive care (BSC)
干预措施: Tecemotide (Biological)
Investigational Arm
Experimental
Tecemotide (L-BLP25) + Single low dose cyclophosphamide + Best supportive care (BSC)
干预措施: Single low dose cyclophosphamide (Drug)
Investigational Arm
Experimental
Tecemotide (L-BLP25) + Single low dose cyclophosphamide + Best supportive care (BSC)
干预措施: Best Supportive Care (BSC) (Other)
Control Arm
Placebo Comparator
Saline + Placebo + Best supportive care (BSC)
干预措施: Placebo (Drug)
Control Arm
Placebo Comparator
Saline + Placebo + Best supportive care (BSC)
干预措施: Saline (Other)
Control Arm
Placebo Comparator
Saline + Placebo + Best supportive care (BSC)
干预措施: Best Supportive Care (BSC) (Other)
结局指标
主要结局
Overall Survival (OS) Time
时间窗: From the date of randomization until death, assessed up to 5.6 years
OS time was measured as the time (in months) between the date of randomization and the date of death. For subjects alive or lost to follow-up at time of analysis, the time between the date of randomization and the date on which the subject was last known alive was calculated and used as a censored observation in the analysis.
次要结局
- Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Discontinuation and TEAEs Leading to Death(From the first dose of study drug administration until 42 days after the last dose of study drug administration, assessed up to 5.6 years)
- Progression Free Survival (PFS)(From the date of randomization to PD, assessed up to 5.6 years)
- Time to Treatment Failure (TTF)(From the date of randomization to the date of first missed treatment, assessed up to 5.6 years)
- Time to Symptom Progression (TTSP)(From the date of randomization to the date of symptomatic progression, assessed up to 5.6 years)
- Time to Progression (TTP)(From the date of randomization to the date of radiological confirmation of PD, assessed up to 5.6 years)
研究者
研究点 (47)
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