NCT04922658进行中（未招募）2 期
A Phase II, Single-arm, Two-cohorts, Open-label, Single Center Study of Surufatinib or Surufatinib Combined With Vinorelbine as Third-line and Posterior Line Treatment in Patients With Non-Small Cell Lung Cancer
Affiliated Cancer Hospital & Institute of Guangzhou Medical University1 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2020年6月3日最近更新:
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）
- 发起方
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Progression-free survival (PFS)
研究概览
简要总结
A phase II study to assess the efficacy and safety of Surufatinib or Surufatinib combined with Vinorelbine as third-line and posterior line treatment in patients with NSCLC
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of written Informed Consent Form (ICF) prior to any study specific procedures
- •Age ≥ 18 years, ≤80 years
- •Histologically or cytologically confirmed advanced NSCLC
- •At least two or more systemic therapies prior treatment of cytotoxic chemotherapy, treatment failure or intolerable toxicities
- •Patients must have measurable lesions
- •Expected overall survival ≥6 months
- •AST, ALT and alkaline phosphatase ≤ 2.5 times the upper limit of normal (ULN)，Serum bilirubin ≤ 1.5 x ULN，creatinine<ULN
- •Prothrombin time (PT), international standard ratio (INR) ≤1.5 × ULN
- •Women of childbearing age must be willing to use adequate contraceptives during the study period of drug treatment
排除标准
- •Patients have received Surufatinib treatment
- •Patients with small cell lung cancer (including mixed small cell lung cancer and non-small cell lung cancer)
- •EGFR mutation /ALK rearrangement positive but not using relevant targeted drugs
- •Central squamous cell carcinoma with cavity or non-small cell lung cancer with hemoptysis (> 50 ml / D)
- •Have received other systemic anti-tumor therapies within 2 weeks before recruited(eg.chemotherapy or radiotherapy, immunotherapy, biological or hormonal therapy, or any VEGFR inhibitor treatment)
- •Participated in the clinical trials of other drugs that have not been approved or marketed in China and received the corresponding experimental drug treatment within 2 weeks before enrollment
- •systolic blood pressure > 140mmHg or diastolic blood pressure > 90mmHg regardless of any antihypertensive drugs; Or patients need more than two antihypertensive drugs
- •Clinically significant electrolyte abnormality
- •Proteinuria ≥ 2+ (1.0g/24hr)
- •Patients have untreated central nervous system metastasis
- •Received any operation or invasive treatment or operation (except venous catheterization, puncture and drainage, etc.) within 4 weeks before enrollment
- •Patients have not recovered from all toxicities associated with prior anti-tumor therapy ,to acceptable baseline status, or a National Cancer Institute Common Terminology Criteria for Adverse Events(NCI CTCAE v5.0) Grade of 0 or 1, except for alopecia and oxaliplatin induced neurotoxicity ≤ 2 , and the previous surgery did not recover completely
- •Dysphagia or known malabsorption of drugs
- •Active gastric and duodenal ulcer, ulcerative colitis or uncontrolled hemorrhage in GI
- •Have evidence or history of bleeding tendency within 2 months after enrollment, the researcher assessed that moderate or severe bleeding tendency was not suitable for enrollment
- •Patients had other malignant tumors in the past 5 years or at the same time (except for the cured skin basal cell carcinoma and cervical carcinoma in situ);
- •Pregnant or lactating women
- •Allergic to Surufatinib/Vinorelbine
- •History of immunodeficiency, including HIV positive, other acquired or congenital immunodeficiency diseases, or organ transplantation
- •Patients with acute myocardial infarction, severe / unstable angina pectoris or coronary artery bypass grafting within 6 months before admission; Or a history of arterial thrombosis or deep venous thrombosis
- •There are concomitant diseases (such as severe hypertension, diabetes, thyroid disease, active infection, etc.) that seriously endanger the safety of patients or affect the completion of the study, or any laboratory abnormalities that are not suitable for participating in the clinical trial according to the judgment of the researcher
- •Serious psychological or mental disorders that may affect the compliance study
研究组 & 干预措施
Surufatinib
Experimental
干预措施: Surufatinib (Drug)
Surufatinib plus Vinorelbine
Experimental
干预措施: Surufatinib Plus Vinorelbine (Drug)
结局指标
主要结局
Progression-free survival (PFS)
时间窗: up to 12 months
To assess the efficacy of Surufatinib or Surufatinib Combined With Vinorelbine for NSCLC , patients by assessment of progression free survival (PFS) using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
次要结局
- Objective response rate (ORR)(up to 12 months)
- Disease control rate (DCR)(up to 12 months)
- Overall survival (OS)(up to 36 months)
研究者
研究点 (1)
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