NCT02393625进行中（未招募）1 期
A Multi-center, Open-label Study to Assess the Safety and Efficacy of Combination Ceritinib (LDK378) and Nivolumab in Adult Patients With Anaplastic Lymphoma Kinase (ALK)-Positive Non-small Cell Lung Cancer (NSCLC)
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 57
- 试验地点
- 14
- 主要终点
- Maximum Tolerated Dose (MTD) and/or Recommended Dose for Expansion
研究概览
简要总结
This is an open label multi center trial to determine the safety and efficacy of ceritinib in combination with nivolumab in ALK-positive NSCLC patients
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed diagnosis of NSCLC that carries an ALK rearrangement
- •Stage IIIB or IV NSCLC or relapsed locally advanced or metastatic NSCLC
- •Presence of at least one measurable lesion as defined by RECIST 1.1
- •Patients who have received prior chemotherapy, other ALK inhibitors, biologic therapy, or other investigational agents, must have recovered from all toxicities related to prior anticancer therapies to grade ≤1 (CTCAE v 4.03). Patients with grade ≤ 2 peripheral neuropathy or any grade of alopecia, fatigue, nail changes or skin changes are allowed to enter the study
- •Patient has a WHO performance status 0-1
排除标准
- •Presence or history of a malignant disease other than NSCLC that has been diagnosed and/or required therapy within the past 3 years
- •Patients with an active, known or suspected autoimmune disease
- •Unable or unwilling to swallow tablets or capsules
- •Patient has other severe, acute, or chronic medical conditions including uncontrolled diabetes mellitus or psychiatric conditions or laboratory abnormalities that in the opinion of the Investigator may increase the risk associated with study participation, or that may interfere with the interpretation of study results
研究组 & 干预措施
Dose Escalation
Experimental
干预措施: Ceritinib (LDK378) (Drug)
Dose Expansion
Experimental
干预措施: Ceritinib (LDK378) (Drug)
Dose Escalation
Experimental
干预措施: Nivolumab (Drug)
Dose Expansion
Experimental
干预措施: Nivolumab (Drug)
结局指标
主要结局
Maximum Tolerated Dose (MTD) and/or Recommended Dose for Expansion
时间窗: Study Day 42 (6 weeks)
Overall response rate (ORR)
时间窗: 24 Weeks
ORR (complete response (CR)+ partial response (PR)) per RECIST 1.1 as assessed by investigator
次要结局
- Progression Free Survival (PFS)(24 weeks)
- Overall survival (OS)(24 weeks)
- Time to Response (TTR)(24 weeks)
- Duration of Response (DOR)(24 weeks)
- Disease Control Rate (DCR)(24 weeks)
研究者
研究点 (14)
Loading locations...
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