EUCTR2009-017591-24-DE进行中（未招募）不适用
A Randomized Phase 2 Study of LY2181308 in Combination with Docetaxel versus Docetaxel in Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer who Were Previously Treated with First Line Chemotherapy - JACW
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 180
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
- •Patients with non-small cell lung cancer with locally or advanced metastatic disease(Stage IIIB or IV at entry) not amenable to curative therapy and who have progressed after 1 line of chemotherapy
- •Measureable disease as defined by response evaluation criteria in solid tumors (RECIST)
- •ECOG Performance status of 0 to 1
- •Must make available any existing tumor tissue from the primary biopsy
- •Patients with prior radiation may be eligible if they meet certain criteria
- •Adequate bone marrow reserve and organ functioning
- •Women must have a negative pregnancy test and must comply with a highly reliable contraceptive method during and for 6 months after the treatment period. Must not be breastfeeding
- •Men must comply with a contraceptive regimen during and for 6 months after the treatment period
- •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
- •Currently enrolled in or discontinued a clinical trial involving an investigational drug/device within the last 30 days. Patients may be permitted to enter treatment before the 30 day waiting period in special circumstances
- •Pregnant or breastfeeding
- •Serious concomitant systemic disorders that would compromise the safety of the patient or the patient's ability to complete the study
- •Second primary malignancy that could affect compliance with the protocol or interpretation of the study results
- •Known allergy or hypersensitivity to docetaxel, taxanes, LY2181308, oligonucleotides, or any component of the formulations
- •Patients with documented central nervous system or brain metastasis at the time of study entry
- •Pre-existing neuropathy equivalent to a common terminology criteria for adverse events(CTCAE)code greater than or equal to 2
研究者
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