NCT00091663已完成3 期
A Multicenter, Open-Label, Phase IIIb Trial of Tarceva (Erlotinib Hydrochloride) in Patients With Advanced Non-Small Cell Lung Cancer
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 5,000
- 试验地点
- 184
研究概览
简要总结
This is a Phase IIIb, multicenter, open-label trial of daily oral Tarceva in patients with advanced (inoperable Stage IIIb or IV) NSCLC who have progressed following standard chemotherapy treatment.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
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
- •Written (signed) informed consent(s)
- •Inoperable and incurable, locally advanced, recurrent or metastatic NSCLC
- •Relapse following standard chemotherapy (combination chemotherapy such as two-drug combination chemotherapy, or a single-agent chemotherapy agent for elderly or poor performance status patients)
- •Age >=18 years
- •ECOG performance status of 0 to 3
- •Recovered from the toxic effects of prior therapy
- •Able to comply with study and follow-up procedures
- •Able to take oral medication
- •Use of an effective means of contraception (for patients with reproductive potential)
- •Granulocyte count >=1.0 x 10^9/L
- •Platelet count >=75 x 10^9/L
- •Serum bilirubin <1.5 x upper limit of normal (ULN)
- •SGOT (AST) <2 x ULN unless elevation is clearly due to liver metastases; then SGOT (AST) must be <5 x ULN
- •Serum creatinine <=1.5 mg/dL
排除标准
- •Any unstable systemic disease (including active infection, unstable angina, congestive heart failure, myocardial infarction within the last 6 months, hepatic, renal, or metabolic disease)
- •Prior therapy with any systemic HER1/EGFR small molecule inhibitor, including gefitinib (Iressa), erlotinib (Tarceva), or other investigational agents in this class
- •History of another malignancy in the past 2 years unless the malignancy has been adequately treated and is associated with a 5-year anticipated survival of >=90%
- •Known central nervous system (CNS) metastases that have not yet been definitively treated with surgery and/or radiation or that are symptomatic or unstable
- •Nursing mothers or pregnant females
研究者
研究点 (184)
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