SUNRISE: A Phase III, Randomized, Double-Blind, Placebo-Controlled Multicenter Trial of Bavituximab Plus Docetaxel Versus Docetaxel Alone in Patients With Previously Treated Stage IIIb/IV Non-Squamous Non Small-Cell Lung Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 582
- 试验地点
- 1
- 主要终点
- Overall Survival
研究概览
简要总结
The primary purpose of this research study is to see whether adding bavituximab (an investigational drug) to the standard chemotherapy drug docetaxel, will improve the results of the treatment for non-small-cell lung cancer.
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
- Double (Participant, Investigator)
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 at least 18 years of age
- •Histologically or cytologically confirmed and documented stage IIIb/IV non-squamous NSCLC according to the American Joint Committee on Cancer Staging Manual (7th Edition)
- •Radiographic disease recurrence or progression during or after front-line platinum-based doublet chemotherapy. For patients with known epidermal growth factor receptor (EGFR) activating mutations or anaplastic lymphoma kinase (ALK) translocations, appropriate targeted treatment should have been used. Mutation testing is not required.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •Adequate hematologic, renal and hepatic function
排除标准
- •Squamous, small cell, carcinoid, adenosquamous, large-cell neuroendocrine, or mixed histology containing small-cell or squamous-cell NSCLC
- •Known history of bleeding disorders, eg, von Willebrand disease or hemophilia
- •Cavitary tumors or tumors invading or abutting large blood vessels
- •Clinically significant bleeding such as gross hematuria, GI bleeding, and hemoptysis within the 6 months before screening
- •Thromboembolic events (eg, deep vein thrombosis, pulmonary embolism, arterial thrombosis) within 6 months of screening
- •Grade 2 or higher peripheral neuropathy
研究组 & 干预措施
bavituximab plus docetaxel
Six 21-day cycles of docetaxel plus weekly bavituximab. Patients who have not experienced disease progression will continue to receive bavituximab weekly until progression.
干预措施: bavituximab (Biological)
bavituximab plus docetaxel
Six 21-day cycles of docetaxel plus weekly bavituximab. Patients who have not experienced disease progression will continue to receive bavituximab weekly until progression.
干预措施: Docetaxel (Drug)
placebo plus docetaxel
Six 21-day cycles of docetaxel plus weekly placebo. Patients who have not experienced disease progression will continue to receive placebo weekly until progression.
干预措施: Docetaxel (Drug)
placebo plus docetaxel
Six 21-day cycles of docetaxel plus weekly placebo. Patients who have not experienced disease progression will continue to receive placebo weekly until progression.
干预措施: Placebo (for bavituximab) (Other)
结局指标
主要结局
Overall Survival
时间窗: Approximately up to 36 months
次要结局
- Progression-free survival(Approximately up to 36 months)
- Overall Response Rate(Approximately up to 36 months)
- Safety(Approximately up to 36 months)