Phase 2 Randomized, Non-Comparative Study Of CP-675,206 Or Best Supportive Care Immediately Following First-Line, Platinum-Based Therapy In Patients With Stage IIIB (With Effusion) Or Stage IV Non-Small Cell Lung Cancer That Has Responded Or Remained Stable
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- The length of time until there is evidence of disease progression in patients treated with CP-675,206 and in patients receiving best supportive care.
研究概览
简要总结
The purpose of this trial is to study how long patients can remain progression free when they receive CP-675,206, compared to how long patients can remain progression free when they receive best supportive care. If you choose to take part, you will be randomized to receive either CP-675,206 as maintenance therapy or best supportive care. Best supportive care means you will not receive any study drug or other treatment for your cancer. Best supportive care could include treatment with antibiotics, analgesic drugs (medicine for pain), blood transfusions or psychosocial and nutritional support, depending on your needs. You have a 50% chance of being randomized to receive CP-675,206.
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
- •Stage IIIb (with effusion) or stage IV disease that has responded or remained stable after 6 cycles of a platinum containing 1st-line regimen
- •Patients must be able to be randomized between 3 and no more than 6 weeks after the last dose of first-line therapy.
排除标准
- •No other systemic therapy except 1st-line platinum based treatment
- •Symptomatic or uncontrolled brain mets or uncontrolled pleural effusions.
研究组 & 干预措施
Arm A
干预措施: CP-675,206 (Drug)
Arm B
干预措施: best supportive care (Drug)
结局指标
主要结局
The length of time until there is evidence of disease progression in patients treated with CP-675,206 and in patients receiving best supportive care.
时间窗: 3 months to 2 years from randomization
次要结局
- Survival(2 years)
- Levels of study drug in blood samples taken at specified time points.(up to 2 years)
- Whether polymorphisms of certain genes influence safety.(up to 2 years)
- Health-related quality of life outcomes.(up to 2 years)
- Tumor response(up to 2 years)
- Number of patients with adverse events as a measure of safety of CP-675,206 when administered to patients with NSCLC(up to 2 years)
- Blood levels of any human anti-human antibody response(up to 2 years)
- Immune response.(up to 2 years)
- Efficacy(up to 2 years)