A Single-arm, Open, Single-center, Prospective and Exploratory Clinical Study of Surufatinib Combined With Tislelizumab in the Treatment of Advanced Lung Cancer With Neuroendocrine Differentiation
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 29
- 主要终点
- Progression-Free Survival (PFS)
研究概览
简要总结
Currently, there are no standard treatment and relevant exploration for NSCLC patients with NED. The study aims to explore the efficacy and safety of surufatinib combined with tislelizumab in the treatment of NSCLC with NED, in order to provide a new treatment option for NSCLC patients with NED.
详细描述
This is a single-arm, open, single-center, prospective and exploratory clinical study. We planned to enroll 29 patients who would receive surufatinib plus tislelizumab until disease progression, intolerance, or withdrawal of consent. The study aims to explore the efficacy and safety of surufatinib combined with tislelizumab in the treatment of NSCLC with NED, in order to provide a new treatment option for NSCLC patients with NED.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histopathologically confirmed locally advanced or metastatic unresectable lung cancer (IIIB-IV) with an abnormal NED or NE phenotype (without neuroendocrine morphologic features and positive immunohistochemical expression of at least one neuroendocrine marker (CD56, CgA, Syn));
- •Have at least one measurable lesion according to RECIST v1.1;
- •ECOG performance status: 0-1;
- •Patients who were deemed by the investigator to be eligible for first-line single-agent immunotherapy or who progressed on first-line standard therapy;
- •Urine protein < ++ . If Urine protein ≥ ++ ,the amount of urine protein in 24 hours ≤1.0g;
- •Expected survival time > 3 months;
排除标准
- •Pulmonary neuroendocrine tumors (typical carcinoid, atypical carcinoid, small cell carcinoma, large cell neuroendocrine carcinoma);
- •Prior anti-VEGF/VEGFR-targeted therapy or anti-PD (L)1 antibody;
- •Have uncontrolled hypertension, defined as systolic blood pressure >150 mmHg or diastolic blood pressure >90 mm Hg, while under anti-hypertension treatment;
- •Patients with active ulcer, intestinal perforation and intestinal obstruction;
- •With active bleeding or bleeding tendency;
- •Severe history of cardiovascular and cerebrovascular diseases;
- •Other malignancies diagnosed within the previous 5 years, except basal cell carcinoma or cervical carcinoma in situ after radical resection.
研究组 & 干预措施
Surufatinib + tislelizumab
干预措施: Surufatinib (Drug)
Surufatinib + tislelizumab
干预措施: Tislelizumab (Drug)
结局指标
主要结局
Progression-Free Survival (PFS)
时间窗: approximately 1 years
time from first-dose to the first documented disease progression or death
次要结局
- Objective response rate (ORR)(approximately 1 years)
- Disease Control Rate (DCR)(approximately 1 years)
研究者
Puyuan Xing
Chief Medical Officer
National Cancer Center, China