A Study of Endostar in Combination With Chemotherapy Followed by Endostar Maintenance Therapy in Patients With Stage IIIB/IV Non-small Cell Lung Cancer (NSCLC)
试验速览
- 阶段
- 4 期
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Progression Free Survival (PFS)
研究概览
简要总结
This single arm study will assess the safety and efficacy of Endostar combined with chemotherapy (Gemcitabine plus Platinum-based chemotherapy) followed by Endostar maintenance therapy in patients with stage IIIB/IV non-small cell lung cancer (NSCLC).
详细描述
All eligible patients will receive Endostar in combination with Gemcitabine plus Platinum-based chemotherapy for 4 cycles (21 days for each cycle). Endostar treatment will continue after completion of chemotherapy cycles until disease progression. Efficacy will be evaluated every two cycles.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histological or cytological diagnosis of inoperable stage IIIB/IV NSCLC
- •At least one measurable lesion
- •Age of 18-75 years
- •Life expectancy > 3 months
- •ECOG performance status 0-2
- •Adequate hematologic, renal, and hepatic function
排除标准
- •Prior systemic chemotherapy for NSCLC
- •Evidence of any unstable diseases (serious infection, grade 4 hypertension, unstable angina, congestive heart-failure, compromised renal or hepatic function, nonhealing wound or bone fracture)
- •Concurrent anticoagulation therapy
- •Evidence of bleeding diathesis or coagulopathy
- •Pregnant or lactating women
- •Allergic to E.coli preparation
研究组 & 干预措施
Endostar with chemotherapy
All eligible patients will receive Endostar in combination with Gemcitabine plus Platinum-based chemotherapy for 4 cycles (21 days for each cycle). Endostar treatment will continue after completion of chemotherapy cycles until disease progression.
干预措施: Endostar (Drug)
Endostar with chemotherapy
All eligible patients will receive Endostar in combination with Gemcitabine plus Platinum-based chemotherapy for 4 cycles (21 days for each cycle). Endostar treatment will continue after completion of chemotherapy cycles until disease progression.
干预措施: Gemcitabine-Cisplatin chemotherapy (Drug)
结局指标
主要结局
Progression Free Survival (PFS)
时间窗: July 2011
次要结局
- Objective Response Rate (ORR)(July 2011)
- Overall Survival (OS)(July 2011)
- Survival Rate(one year)
- Adverse Events(July 2011)
- Clinical Benefit Response (CBR)(July 2011)