A Phase II, Multicenter, Single-arm Study to Evaluate Safety and Efficacy of Alkotinib Capsule in Patients With ALK-positive Non-small Cell Lung Cancer Previously Treated With Crizotinib
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Objective response rate (ORR) based on independent radiology review
研究概览
简要总结
The main purpose of the study is to evaluate safety and efficacy of Alkotinib capsule in patients with ALK-positive non-small cell lung cancer previously treated with crizotinib.While exploring the relationship between biomarkers and drug efficacy and safety.
详细描述
The drug being tested in this study is called alkotinib. Alkotinib has been demonstrated to benefit people with ALK+ NSCLC.
The study is a non-control study.
The study will enroll approximately 104 participants. All participants will take alkotinib 300mg throughout the study.
This multi-center trial will be conducted in China. The overall time to participate in this study is 3 years. Participants will make multiple visits to the site, and 28 days after last dose of study drug for a follow-up assessment.
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
- •Evidence of positive ALK.
- •Patients must have demonstrated progression during or after crizotinib treatment.
- •Age 18 years or older at the time of informed consent.
- •Eastern cooperative oncology group performance status (ECOG PS) of 0-2
- •At least one measurable lesion by response evaluation criteria in solid tumors (RECIST) version 1.1 (v1.1).
- •Willingness and ability to comply with the trial and follow-up procedures.
排除标准
- •chemotherapy, radiation therapy, immunotherapy within 4 weeks.
- •Presence of active gastrointestinal (GI) disease or other condition that will interfere significantly with the absorption, distribution, metabolism, or excretion of study medications.
- •Uncontrolled mass of pleural effusion, pericardial effusion, and peritoneal effusion
研究组 & 干预措施
Alkotinib 400mg QD
400mg orally once daily. Take Alkotinib at least 1 hour before or at least 2 hours after a meal.
干预措施: Alkotinib Capsules (Drug)
结局指标
主要结局
Objective response rate (ORR) based on independent radiology review
时间窗: 24 months
ORR per RECIST 1.1 calculated as the proportion of patients with a best overall response defined as complete response (CR) or partial response (PR).
次要结局
- Overall survival (OS)(36 months)
- Progression-free survival (PFS) as assessed by independent radiology review and investigator(36 months)