NCT00252707已完成3 期
A Multicentre, Randomised, Open-Label, Parallel-Group, Phase III Post-Marketing Clinical Study to Compare the Overall Survival Between Gefitinib and Docetaxel in Patients With Advanced or Metastatic (Stage IIIB/IV), or Recurrent Non-Small Cell Lung Cancer, Who Have Failed One or Two Chemotherapy Regimens
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 484
- 试验地点
- 40
- 主要终点
- Determine the overall survival with these treatments as the primary outcome.
研究概览
简要总结
In this study, among the patients with non-small cell lung cancer, those with metastasis or recurrence and previous treatment with chemotherapy will receive gefitinib or docetaxel, and we will compare the effectiveness and safety of gefitinib with docetaxel.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •You are "histologically" or "cytologically" confirmed to have recurrent or metastatic NSCLC
- •You have been treated with chemotherapy including platinums for NSCLC.
排除标准
- •You have received treatment for non-small lung cancer within 4 weeks before your participation in this study (except for specific therapies)
- •You have or had any disease of acute lung injury, idiopathic pulmonary fibrosis, pulmonary pneumonia, or pneumoconiosis evident on the X-ray
- •You have or had any disease of radiation pneumonia or drug-induced pneumonia, which requires treatment with corticosteroids
结局指标
主要结局
Determine the overall survival with these treatments as the primary outcome.
次要结局
- Determine the followings as the secondary outcome variables:
- - Progression-free survival (PFS)
- - Time to treatment failure (TTF)
- - Objective tumour response (CR, PR) and the disease control rate (CR, PR, SD [≥12 weeks]) based on the RECIST guidelines
- - Lung cancer subscale (LCS)
- - QOL according to FACT-L questionnaire
- - Frequency and severity of adverse events.
- Determine the followings as the exploratory outcome variables:
- - Biomarkers related to expression, activation and dimerisation of EGFR and other ErbB family receptors and associated pathways including downstream signalling pathways
- - Biomarkers related to somatic (non-inheritable) mutation analyses of genes of the ErbB family, their signalling pathways and associated pathways which are thought to be influenced by gefitinib in tumour cells.
研究者
研究点 (40)
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