A Phase II, Multi-center, Open-label, Single-Arm Study to Evaluate the Efficacy and Safety of Oral LDK378 Treatment for Patients With ALK-Positive Non-Small Cell Lung Cancer Previously Treated With Alectinib
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Overall Response Rate (ORR) to LDK378 by Investigator Assessment
研究概览
简要总结
This was a single-arm, open-label, multicenter, phase II study to evaluate the efficacy and safety of the ALK inhibitor LDK378 when used as single agent in patients with ALK-rearranged stage IIIB or IV NSCLC previously treated with alectinib. Treatment with LDK378 750 mg qd continued until the patient experienced disease progression as determined by the investigator according to RECIST 1.1, unacceptable toxicity that precluded further treatment, pregnancy, start of a new anticancer therapy, discontinued treatment at the discretion of the patient or investigator, lost to follow-up, death, or study was terminated by Sponsor.
详细描述
Study completed as per protocol. 'Switched to commercial drug' implies that after the primary and secondary objectives were achieved, one patient continued the study treatment as they did not meet the progression disease or AE to be discontinued from the treatment. But after the regulatory approval, Novartis decided to close the study, the 1 patient switched to commercially available drug.
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
- •Histologically or cytologically confirmed diagnosis of Stage IIIb or IV NSCLC that carries an ALK rearrangement as determined locally by Vysis ALK Break Apart FISH Probe Kit (Abbott Molecular Inc.) test.
- •Patients must have NSCLC that has progressed at study enrollment.
- •Patients must have received previous treatment with alectinib for treatment of locally advanced or metastatic NSCLC. Prior therapy with crizotinib as ALK inhibitor therapy in addition to alectinib is allowed. Alectinib doesn't need to be the last therapy prior to study enrollment. No particular sequence of prior alectinib and crizotinib is required for enrollment.
- •Patients must be chemotherapy-naïve or have received only one line of prior cytotoxic chemotherapy.
- •Age 18 years or older at the time of informed consent.
排除标准
- •Patients with known hypersensitivity to any of the excipients of LDK
- •Prior therapy with other ALK inhibitor investigational agents except crizotinib and alectinib.
- •Prior systemic anti-cancer (including investigational) therapy aside from alectinib, crizotinib and one regimen of previous cytotoxic chemotherapy for locally advanced or metastatic NSCLC.
- •Patients with symptomatic central nervous system (CNS) metastases who are neurologically unstable or have required increasing doses of steroids within the 2 weeks prior to study entry to manage CNS symptoms.
- •Patient with history of interstitial lung disease or interstitial pneumonitis, including clinically significant radiation pneumonitis.
- •Patients with history of carcinomatous meningitis.
- •Patient with a concurrent malignancy or history of a malignant disease other than NSCLC that has been diagnosed and/or required therapy within the past 3 years.
- •Patient has clinically significant, uncontrolled heart disease and/or recent cardiac event (within 6 months)
研究组 & 干预措施
LDK378 (Ceritinib)
Participants who received LDK378 750mg once daily on a 28 day cycle.
干预措施: LDK378 (Drug)
结局指标
主要结局
Overall Response Rate (ORR) to LDK378 by Investigator Assessment
时间窗: Until disease progression or unacceptable toxicity occurs, or patient withdrawal up to 798 days
ORR, defined as the percentage of participants with a best overall confirmed response of complete response (CR) or partial response (PR) in the whole body as assessed per RECIST 1.1 by the 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; 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
- Time to Tumor Response (TTR)(6 cycles of 28 days up to 798 days)
- Duration of Response (DOR)(6 cycles of 28 days up to 798 days)
- Progression Free Survival (PFS)(6 cycles of 28 days up to 798 days)
- Disease Control Rate (DCR)(6 cycles of 28 days up to 798 days)
- Overall Survival (OS)(6 cycles of 28 days up to 798 days)
- Overall Intracranial Response Rate (OIRR)(6 cycles of 28 days up to 798 days)