Ensure Extension Study to Assess the PFS of First-Line Erlotinib (Tarceva®) and Erlotinib After the Time of Disease Progression in Chinese Population Enrolled in the Ensure Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 45
- 主要终点
- Progression Free Survival (PFS) Based on Well-documented and Verifiable Progression Events
研究概览
简要总结
This trial is an extension to ENSURE, a study of erlotinib versus gemcitabine/cisplatin combination chemotherapy as the first-line treatment for patients with non-small-cell lung cancer (NSCLC) with mutations in the tyrosine kinase domain of EGFR.
This study is designed to examine the efficacy of erlotinib versus gemcitabine/cisplatin as a second-line treatment in NSCLC patients from the ENSURE trial (NCT01342965). Patients previously treated with gemcitabine/cisplatin will be given erlotinib daily until disease progression or unacceptable toxicity occurs. Patients previously treated with erlotinib will be given cisplatin on Day 1 and gemcitabine on Days 1 and 8 of 3-week chemotherapy cycles until disease progression, unacceptable toxicity or up to 4 cycles (whichever comes first).
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant in ENSURE trial
- •Disease progression during first-line treatment
排除标准
- 未提供
研究组 & 干预措施
Erlotinib-Chemotherapy
Erlotinib in first-line treatment, followed by chemotherapy in the second-line treatment
干预措施: Erlotinib (Drug)
Erlotinib-Chemotherapy
Erlotinib in first-line treatment, followed by chemotherapy in the second-line treatment
干预措施: Chemotherapy (Drug)
Chemotherapy-Erlotinib
Chemotherapy in first-line treatment, followed by erlotinib in the second-line treatment
干预措施: Erlotinib (Drug)
Chemotherapy-Erlotinib
Chemotherapy in first-line treatment, followed by erlotinib in the second-line treatment
干预措施: Chemotherapy (Drug)
结局指标
主要结局
Progression Free Survival (PFS) Based on Well-documented and Verifiable Progression Events
时间窗: within 3 years, 9 months (data cut-off December 2014)
Progression free survival is defined as the time of randomization in ENSURE study to progressive disease (PD) while on second-line treatment or death from any cause, whichever occurred first during the second-line treatment.
次要结局
- Participants With Adverse Events(start of second-line treatment to data cut-off in December 2014 (within 12 months))