NCT00516685终止2 期
A Phase II/III Trial to Assess the Safety, Immunogenicity and Preliminary Efficacy of Recombinant Human EGF-rP64K/Montanide ISA 51 Vaccine Administered to Patients With Non-Small-Cell Lung Cancer (NSCLC) After Receiving Conventional First Line Chemotherapy
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 230
- 试验地点
- 11
- 主要终点
- Survival
研究概览
简要总结
The purpose of this study is to determine whether the recombinant human EGF-rP64K/Montanide ISA 51 vaccine is safe, immunogenic and effective in the treatment of stage IIIb/IV non-small-cell lung cancer (NSCLC).
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
- •Patients who have signed the informed consent form.
- •Patients who are eighteen years of age or over with histologically or cytologically confirmed NSCLC in advanced stages IIIb or IV, not amenable to any attempt of curative chemo-radiotherapy and/or surgery.
- •Patients with measurable lesions, defined as those measurable at least in one dimension (refered to higher diameter) and with a diameter equal or higher 20 mm using conventional techniques (PET, CT scan, MRI, Rx) or equal or higher 10 mm using CT scan.
- •Patients who have finished their last cycle of chemotherapy and/or radiotherapy not less than 4 weeks prior to randomization and not more than 8 weeks.
- •Female patients of reproductive potential must have negative pregnancy tests. Those female volunteers admitted to the study must be using a reliable means of contraception such as tubal ligation, oral contraceptive or IUD.
- •ECOG status 0 to
- •Patients with normal organ and bone marrow function, as defined by the parameters in accordance to that provided by the normal lab reference range.
- •Patients with no evidence of objective disease progression, 1 month after finishing first line chemotherapy as per RECIST.
排除标准
- •Patients who are candidates for combined modality treatment.
- •Patients who are receiving immunosuppressive therapy including corticosteroids.
- •Patients who have received immunotherapy within the previous 3 months.
- •Patients who have participated in a clinical study within the previous 30 days.
- •Patients who may be allergic to any component of the vaccine.
- •Medical reasons considered by the investigators as disqualification from the study such as significant uncontrolled co-morbid disease or potential non-compliance with the protocol.
- •Patients bearing brain metastasis from the primary lung tumor.
- •Patients bearing a second primary tumor.
- •Patients showing progressive disease after finishing first line chemotherapy.
研究组 & 干预措施
Vaccine Group
Experimental
Patients in this arm will receive a low dose of Cyclophosphamide and the recombinant human rEGF-P64K/Montanide ISA 51 vaccine in addition to Best Supportive Care.
干预措施: Recombinant Human rEGF-P64K/Montanide Vaccine (Biological)
Control Group
No Intervention
Patients in this arm will only receive Best Supportive Care.
结局指标
主要结局
Survival
时间窗: Two and a half years
次要结局
- Assessment of immunogenecity, safety as well as preliminary assessment of objective response, time of progression and quality of life(Two and a half years)
研究者
研究点 (11)
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