NCT01935154已完成2 期
Phase II Study of Vx001 Vaccine in HLA-A*0201 Positive Patients With TERT Positive Stage IV or Recurrent Stage I-III NSCLC
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 221
- 试验地点
- 70
- 主要终点
- Time-to-event comparison of overall survival (OS) in Vx-001 treated vs placebo treated patients.
研究概览
简要总结
Patients with stage IV or recurrent stage I-III NSCLC with documented disease control (objective response or stable disease) within 3 weeks after platinum based 1st line chemotherapy; only HLA-A*0201 positive patients with TERT expressing tumors will be included.
The objective of the trial is survival rate at 12 months.
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
- •Male or female ≥18 years of age;
- •Documented stage IV NSCLC as defined by IASLC Lung Cancer Staging Project (7th edition) or recurrent stage I-III disease at least 6 months after resection or after the end of adjuvant chemotherapy or after standard locoregional treatment as defined by the American College of Chest Physicians;
- •Patients treated with 4 cycles platinum based 1st line chemotherapy as defined by the American College of Chest Physicians (i.e. radiotherapy are not allowed except palliative radiotherapy of bone metastasis);
- •Documented HLA-A*0201 positivity, as determined by a local laboratory;
- •TERT-positive NSCLC, as assessed by a central laboratory; for this, availability of adequate tissue biopsy from the primary tumor, lymph nodes or distant metastases is a prerequisite;
- •CR, PR, or SD according to RECIST 1.1 criteria after the completion of platinum-based first-line chemotherapy;
- •ECOG performance status 0, 1;
排除标准
- •Mixed small cell and NSCLC histologies;
- •Patients with stage IV or recurrent NSCLC who have been previously treated with therapy other than platinum-based first-line chemotherapy;
- •Prior treatment with cancer vaccines;
- •Prior treatment with immunotherapy (e.g., interferons, interleukins, TNF, or biological response modifiers, such as GM-CSF etc) within four weeks prior to randomization;
- •Prior treatment with hormone (including corticosteroids) within 2 weeks prior to randomization;
- •Prior treatment with any investigational drugs, within 4 weeks prior to randomization;
- •Patients with brain metastases;
研究组 & 干预措施
Placebo
Placebo Comparator
Placebo will be administered evey 3 weeks from w0 to W15 than every 12 weeks until disease progression.
干预措施: Placebo (Drug)
Vx-001
Experimental
Vx-001 will be administered evey 3 weeks from w0 to W15 than every 12 weeks until disease progression.
干预措施: Vx-001 (Drug)
结局指标
主要结局
Time-to-event comparison of overall survival (OS) in Vx-001 treated vs placebo treated patients.
时间窗: 12 months
次要结局
- Overall survival rate(12 months)
- Comparison of Time to Treatment Failure in Vx-001 treated vs placebo treated patients.(Traitement failure)
研究者
研究点 (70)
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