JPRN-jRCT2080222222
已完成
3 期
A phase III, multi-center, randomized, open-label study of oral LDK378 versus standard chemotherapy in adult patients with ALK rearranged (ALK-positive) advanced non-small cell lung cancer who have been treated previously with chemotherapy (platinum doublet) and crizotinib
ovartis Pharma. K.K.0 个研究点目标入组 231 人2013年9月11日
概览
- 阶段
- 3 期
- 干预措施
- 未指定
- 疾病 / 适应症
- on small cell lung cancer
- 发起方
- ovartis Pharma. K.K.
- 入组人数
- 231
- 状态
- 已完成
- 最后更新
- 2年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •1\. Patient has a histologically or cytologically confirmed diagnosis of non\-small cell lung cancer (NSCLC) that is anaplastic lymphoma kinase (ALK) positive as assessed by the FDA approved Abbott FISH Test.
- •2\. Patient has stage IIIB or IV diagnosis and must have received one or two prior regimens (including platinum\- doublet) of cytotoxic chemotherapy for the treatment of locally advanced or metastatic NSCLC.
- •3\. Patient has at least one measurable lesion as defined by RECIST 1\.1\. A previously irradiated site lesion may only be counted as a target lesion if there is clear sign of progression since the irradiation
- •4\. Patients must have received previous treatment with crizotinib for the treatment of locally advanced or metastatic NSCLC.
排除标准
- •1\. Patient with known hypersensitivity to any of the excipients of LDK378 (microcrystalline cellulose, mannitol, crospovidone, colloidal silicon dioxide and magnesium stearate)
- •2\. Patient with a history of severe hypersensitivity reaction to pemetrexed or docetaxel or any known excipients of these drugs.
- •3\. Patient with symptomatic central nervous system (CNS) metastases who is neurologically unstable or has required increasing doses of steroids within the 2 weeks prior to screening to manage CNS symptoms.
结局指标
主要结局
未指定
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