EUCTR2006-005306-31-IT进行中（未招募）不适用
Randomized, Double-Blind, Placebo-Controlled, Phase 2Study of Gemcitabine and Cisplatin Plus Enzastaurinversus Gemcitabine and Cisplatin Plus Placebo,Followed by Maintenance Enzastaurin or Placebo inChemonaive Patients with Advanced, Unresectable, orMetastatic (Stage IIIB or IV) Non-Small Cell Lung Cancer - ND
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- ELI LILLY
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •[1] Have histologic or cytologic diagnosis of advanced NSCLC (Stage
- •IIIB disease with pleural effusion and/or positive supraclavicular
- •nodes, or Stage IV disease) not amenable to curative treatment
- •[2] Have measurable disease
- •[3] Prior radiation therapy is allowed to <25% of the bone marrow
- •[4] Have a performance status of 0, 1, or 2 on the Eastern Cooperative
- •Oncology group (ECOG) scale
- •[5] Have adequate organ function
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •[1] Have a second primary malignancy that is clinically detectable at the
- •time of consideration for study enrollment
- •[2] Have documented central nervous system (CNS) metastases (except if
- •adequately treated and stable for at least 4 weeks). Imaging is required
- •in symptomatic patients to rule out brain or other CNS metastases, but
- •is not required in asymptomatic patients
- •[3] Have had myocardial infarction occurring <6 months before inclusion,
- •uncontrolled arrhythmia, symptomatic angina pectoris, or cardiac
- •failure not controlled by medications [4] Have peripheral neuropathy of NCI CTCAE Grade 2 or above
- •[5]Are unable or unwilling to discontinue use of carbamazepine,
- •phenobarbital, or phenytoin at least 14 days prior to study therapy
研究者
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