NCT01996332已完成2 期
An Open-label Study of the Effect of Tarceva Monotherapy on Treatment Response in Patients With Advanced Non-small Cell Lung Cancer for Whom Tarceva Monotherapy is Considered the Best Option
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 1,805
- 主要终点
- Time to Disease Progression or Death by Line of Treatment
研究概览
简要总结
This study will evaluate the efficacy and safety of oral Tarceva in patients with advanced NSCLC for whom Tarceva monotherapy is considered the best therapeutic option. The anticipated time on study treatment is 3-12 months.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult patients >=18 years of age;
- •locally advanced or metastatic NSCLC (Stage IIIB or IV);
- •not a candidate for curative surgery or radical chemotherapy;
- •no brain metastases, or clinically stable metastases for >=2 months.
排除标准
- •radiotherapy over the previous 2 weeks;
- •weight loss >10% in the previous 6 weeks.
研究组 & 干预措施
Tarceva Arm
Experimental
干预措施: erlotinib [Tarceva] (Drug)
结局指标
主要结局
Time to Disease Progression or Death by Line of Treatment
时间窗: Baseline, every 6-8 weeks up to 3 years until disease progression or death
Time to progression or death was defined as the time from inclusion to the date of disease progression or death, whichever occurred first.
次要结局
- Overall Survival (OS) by Line of Treatment(Baseline, every 6-8 weeks up to 3 years, or until death)
- Percentage of Participants Achieving Clinical Benefit by Line of Treatment(Baseline, every 6-8 weeks up to 3 years or until death)
研究者
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