NCT03753685进行中（未招募）2 期
Efficacy and Safety of X-396(Ensartinib) in ALK-Positive NSCLC Patients With Brain Metastases: A Phase Ⅱ, Open-Label, Single Arm, Multicenter Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Intracranial objective response rate (iORR) based on investigator assessment according to RNAO-BM.
研究概览
简要总结
To assess efficacy and safety of oral X-396 (Ensartinib) capsule in Chinese ALK-positive NSCLC patients with brain metastases, eligible patients will be enrolled with objective responses being primary outcome measures.
详细描述
In this phase Ⅱ, open-label, single arm, multicenter study, efficacy and safety of oral X-396 capsule (Ensartinib) in 37 Chinese ALK-positive NSCLC patients with brain metastases will be assessed. Eligible patients will receive 225mg X-396 capsules once daily and objective responses of brain metastasis based on investigator assessment according to Response Assessment in Neuro-Oncology (RANO) are primary outcome measures.
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 locally advance or recurrent/metastatic NSCLC that was positive for ALK mutations.
- •Contrast-enhanced MRI or CT confirmed parenchymal brain metastases with at least one measurable lesion (according to RANO and RECIST 1.1), which was not previously treated with radiotherapy.
- •At most once treated with chemotherapy, which must have been completed at least 4 weeks before the initiation of study treatment. Any adverse events related to previous chemotherapy treatment have disappeared.
- •Female or male, 18 years of age or older
- •A Karnofsky Performance Status score of at least
- •An expected survival time of at least 12 weeks.
- •Adequate organ functions, defined as absolute neutrophils count ≥1.5*10^9/L，platelets count ≥80*10^9/L, hemoglobin concentration≥ 9 g/dL, total bilirubin ≤1.5 *ULN (upper limits of normal), ALT≤2.5 *ULN, AST≤2.5 *ULN, creatinine≤1.5 *ULN.
- •Drug related toxicities has been relieved to grade 1 (based on NCI CTCAE v4.03), except for hair loss.
- •Being willing and able to comply with scheduled visits, treatment plans, laboratory tests and other study procedures.
- •Signed and dated informed consent.
排除标准
- •Currently under treatment of other systemic anti-cancer therapies.
- •Evidence of active malignancy within last 5 years.
- •Patients who participated in other clinical trials within last 4 weeks before the initiation of study treatment.
- •Patients who received surgery or immunotherapy within last 4 weeks before the initiation of study treatment, or received radiotherapy within last 2 weeks before the initiation of study treatment.
- •Patients who previously received organ transplantation or stem cell transplantation.
- •Patients with clinically significant cardiovascular and cerebrovascular diseases.
- •Patients with dysphagia, active gastrointestinal diseases or other conditions that will interfere significantly with the absorption, distribution, metabolism or excretion of study medication.
- •Patients who are active carrier of hepatitis B (HBsAg positive and HBV-DNA ≥500IU/mL), hepatitis C virus antibody, treponema pallidum antibody or HIV antibody.
- •Patients with interstitial lung disease history or signs of active interstitial lung disease.
- •Pregnant and lactating women.
- •Patients with known allergy or delayed hypersensitivity reaction to study drug or its excipients.
- •Patients who need to receive drugs which could induce QT/QTc interval prolongation or torsade de pointes, or drugs which are potent CYP3A4 inhibitors or inducers within last 14 days before the initiation of study treatment and during the study.
- •Patients who are currently under treatment of warfarin or other coumarin anticoagulants.
- •Patients with other illness or medical conditions potentially interfering with the study treatment.
研究组 & 干预措施
X-396(Ensartinib) Capsule
Experimental
干预措施: X-396(Ensartinib) Capsule (Drug)
结局指标
主要结局
Intracranial objective response rate (iORR) based on investigator assessment according to RNAO-BM.
时间窗: 12 weeks
iORR per RANO-BM calculated as the proportion of patients with a best intracranial overall response defined as complete response (CR) or partial response (PR), based on investigator assessment.
次要结局
- Time to progression based on intracranial response (iTTP) according to RANO-BM.(36 months)
- Duration of response based on intracranial response (iDOR) according to RANO-BM.(36 months)
- Duration of response based on intracranial response (iDOR) according to RECIST 1.1(36 months)
- Objective response rate (ORR) based on overall response according to RECIST 1.1.(12 weeks)
- Progression-free survival based on overall response (PFS) according to RECIST 1.1(36 months)
- Time to progression based on intracranial response (iTTP) according to RECIST 1.1(36 months)
- Disease control rate based on intracranial response (iDCR) according to RANO-BM.(12 weeks)
- Progression-free survival based on intracranial response (iPFS) according to RANO-BM(36 months)
- Disease control rate based on intracranial response (iDCR) according to RECIST 1.1(12 weeks)
- Progression-free survival based on intracranial response (iPFS) according to RECIST 1.1(36 months)
- Disease control rate based on overall response (DCR) according to RECIST 1.1(12 weeks)
- Duration of response based on overall response (DOR) according to RECIST 1.1(36 months)
- Intracranial objective response rate (iORR) based on intracranial response according to RECIST 1.1(12 weeks)
- Time to progression based on overall response (TTP) according to RECIST 1.1(36 months)
- Overall survival (OS)(36 months)
- Incidence of patients experiencing adverse events.(36 months)
研究者
研究点 (1)
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