A Phase II, Multicenter, Single-arm Study of Oral LDK378 in Adult Patients With ALK-activated Non-small Cell Lung Cancer Previously Treated With Chemotherapy and Crizotinib
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 18
- 主要终点
- Overall Response Rate (ORR) to LDK378 Per Investigator Assessment
研究概览
简要总结
A single-arm, open-label, multicenter, phase II study. Treatment with LDK378 750 mg qd continued until the patient experienced unacceptable toxicity that precluded further treatment, discontinued treatment at the discretion of the investigator or patient, started a new anti-cancer therapy and/or died. LDK378 could be continued beyond RECIST-defined progressive disease (PD) as assessed by the investigator if, in the judgment of the investigator, there was evidence of clinical benefit. In these patients tumor assessment would continue as per the schedule of assessments until treatment with LDK378 was permanently discontinued. Patients who discontinued the study medication in the absence of progression continued to be followed for tumor assessment until the time of PD as assessed by the investigator
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
LDK378
Patients treated with ceritinib/LDK378 750 mg once-daily, fasted
干预措施: LDK378 (Drug)
结局指标
主要结局
Overall Response Rate (ORR) to LDK378 Per Investigator Assessment
时间窗: 6 cycles of 28 days up to 24 weeks
ORR per RECIST 1.1 calculated as the percentage of patients with a best overall confirmed response defined as complete response or partial response (CR+PR) as assessed by investigator. CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm 1. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
次要结局
- Duration of Response (DOR) by Investigator(6 cycles of 28 days up to 24 weeks)
- Progression-free Survival (PFS) Per Investigator(6 cycles of 28 days up to 24 weeks)
- Overall Intracranial Response Rate (OIRR) Per Investigator(6 cycles of 28 days up to 24 weeks)
- ORR Per Blinded Independent Review Committee (BIRC) Assessment(6 cycles of 28 days up to 24 weeks)
- Duration of Response (DOR) by BIRC(6 cycles of 28 days up to 24 weeks)
- Disease Control Rate (DCR)(6 cycles of 28 days up to 24 weeks)
- Time to Response (TTR) Per Investigator(6 cycles of 28 days up to 24 weeks)
- Time to Response (TTR) Per BIRC(6 cycles of 28 days up to 24 weeks)
- Progression-free Survival (PFS) Per BIRC(6 cycles of 28 days up to 24 weeks)
- Overall Survival (OS)(6 cycles of 28 days up to 24 weeks)
- Overall Intracranial Response Rate (OIRR) Per BIRC(6 cycles of 28 days up to 24 weeks)