A Phase IV, Multicenter, Non-randomized, Open-labeled Study to Evaluate the Efficacy of Gefitinib (IRESSA®) as a Second-line Therapy in NSCLC Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 156
- 试验地点
- 2
- 主要终点
- Objective Response Rate(ORR)
研究概览
简要总结
The purpose of this study is to evaluate ORR (Objective Response Rate) of gefitinib as a second-line therapy for NSCLC patients based on RECIST (Response Evaluation Criteria in Solid Tumors Group) and check up ORR difference by EGFR mutation, gender, smoking history, and type of tumor.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathological Diagnosis of local advanced/metastatic Non Small Cell Lung Carcinoma
- •Previously failed the first-line chemotherapy
- •Patient who can provide sample for EGFR mutation test
排除标准
- •Central Nervous System metastasis or spinal cord compression that has not yet been definitively treated with surgery and/or radiation
- •Any evidence of clinically active interstitial lung disease
结局指标
主要结局
Objective Response Rate(ORR)
时间窗: Every 8 weeks until progression disease or death or Data Cut off date (2 January 2009)
Primary efficacy endpoint is a change in the proportion of subjects showing overall objective response rate(ORR) from baseline to final tumor assessment point after treatment. As per RECIST, the percentage of subjects indicating PR (partial response) or CR (complete response) will be calculated. According RECIST criteria, CR(complete response) - the disappearance of all target lesions and 'PR(partial response) - at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameter.
次要结局
- Period of Progression-Free Survival(Every 8 weeks until progression disease or death or Data Cut off date (2 January 2009))
- Quality of Life and Symptom Improvement Based on Functional Assessment of Cancer Therapy-Lung (FACT-L)(Every 8 weeks until progression disease or death or Data Cut off date (2 January 2009))
- Overall Survival(Every 8 weeks until progression disease or death or Data Cut off date (2 January 2009) and every 12 weeks after progression until death or death.)
- Adverse Event(Every 8 weeks until progression disease or death or Data Cut off date (2 January 2009))