Phase II, Open-Label, Single Arm Study of the Efficacy and Safety of X-396 Capsule in Patients With ROS1 Positive Advanced NSCLC
试验速览
- 阶段
- 2 期
- 入组人数
- 69
- 试验地点
- 1
- 主要终点
- Objective response rate (ORR) based on independent radiology review (IRC) according to RECIST 1.1
研究概览
简要总结
To assess treatment effectiveness and safety of oral X-396 capsule (Ensartinib) administered to Chinese patients with Advanced Non-Small Cell Lung Cancer (NSCLC) that is confirmed to be positive for a c-ROS Oncogene (ROS1) positive gene mutation (translocation or inversion).
详细描述
This is a phase II, multicenter, single-arm study in which the efficacy and safety of X-396 capsule (Ensartinib) will be assessed in adult Chinese patients with ROS1-positive (rearrangement or inversion) non-small cell lung cancer (NSCLC). Approximately 69 patients (59 for never-treated, and 10 for previously treated with crizotinib) with locally advanced or metastatic NSCLC carrying ROS1-rearrangement will be enrolled in the study.
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
- •Female or male, 18 years of age or older
- •Histologically or cytologically proven diagnosis of NSCLC that is locally advanced or metastatic
- •Positive for translocation or inversion events involving the ROS1 gene
- •Tyrosine kinase inhibitor (TKI) treatment-naive or have previously received no more than one systemic treatment regimen(s) such as chemotherapy (After a 3-week washout period)
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
- •Predicted survival ≥ 3 months
- •Drug related toxicities were relieved to grade 1, except for hair loss (based on NCI CTCAE v4.03)
- •Adequate organ function
- •At least 1 measurable tumor lesion as per RECIST v1.1
- •Asymptomatic central nervous system (CNS) metastases do not require the use of steroids or anticonvulsants.
- •Signed and dated informed consent
- •Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
- •Agree to use effective contraception during the study period and for at least 90 days after completion of the study treatment
排除标准
- •Current treatment on another systemic anti-cancer therapy
- •Prior therapy specifically directed against ROS1 fusion genes (except for the exploratory arm that will enroll patients pretreated with crizotinib)
- •Evidence of active malignancy within last 3 years
- •Previous therapeutic clinical trial must have completed at least 4 week prior to initiation of study drug
- •Prior surgery or immunotherapy must have completed at least 4 weeks, and radiation must have been completed at least 2 weeks prior to initiation of study drug
- •Known interstitial fibrosis or interstitial lung disease
- •Presence of active gastrointestinal disease or other condition that will interfere significantly with the absorption, distribution, metabolism, or excretion of study medication
- •Clinically significant cardiovascular disease
- •Patients with a known allergy or delayed hypersensitivity reaction to study drug or its excipient
- •Pregnant or breast feeding
- •Use of drugs or foods that are known potent CYP3A4 inhibitors or inducers
- •Inability or unwillingness to comply with study and/or follow-up procedures outlined in the protocol
- •Other serious illness or medical condition potentially interfering with the study
研究组 & 干预措施
X-396 Capsule
Single-arm trial whereby all consented, enrolled, eligible patients receive X-396 capsule, 225 mg once daily.
干预措施: X-396 Capsule (Drug)
结局指标
主要结局
Objective response rate (ORR) based on independent radiology review (IRC) according to RECIST 1.1
时间窗: 12 weeks
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), based on IRC.
次要结局
- Incidence of patients experiencing adverse events (AE)(36 months)
- Disease control rate (DCR) according to RECIST 1.1(12 weeks)
- ORR based on investigator assessment according to RECIST 1.1(12 weeks)
- Progression-free survival (PFS) based on IRC or investigator according to RECIST 1.1(36 months)
- Overall survival (OS)(36 months)
- Time to progression (TTP) based on IRC or investigator according to RECIST 1.1(36 months)
- Duration of response (DOR) based on IRC or investigator according to RECIST 1.1(36 months)
- Change From Baseline Scores on the functional assessment of cancer therapy - Lung (FACT-L) quality of life questionnaire(36 months)
- Intracranial overall response rate (iORR) by IRC and investigator assessment according to RECIST 1.1(12 weeks)