NCT04884009Unknown2 期
An Open-label, Multicenter PhaseⅡ Study of SHR-1701 in Combination With or Without Famitinib Malate for the Treatment of Extensive Stage Small Cell Lung Cancer After Previous Systemic Chemotherapy Failure
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 106
- 主要终点
- Objective response rate (ORR) based on RECIST 1.1 criteria
研究概览
简要总结
The study is being conducted to evaluate the efficacy and safety of SHR-1701 in combination with or without famitinib malate for the treatment of extensive stage small cell lung cancer after the failure of previous systemic chemotherapy
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients voluntarily participated in the clinical study, understood the study procedures and are able to sign the informed consent form.
- •18 to 75 years old, male or female.
- •Histologically or cytologically confirmed extensive stage small cell lung cancer（ED-SCLC）.
- •ECOG Performance Status of 0 or
- •Adequate hematological, hepatic and renal function.
- •Female subjects of child-bearing potential must have a negative serum HCG test before treatment.
排除标准
- •Histologically or cytologically confirmed mixed SCLC and NSCLC.
- •Untreated central nervous system metastases.
- •Cancerous meningitis (meningeal metastasis).
- •Uncontrolled pleural effusion, pericardial effusion or ascites.
- •Tumor infiltration into the great vessels on imaging;
- •Hemoptysis symptoms and maximum daily hemoptysis ≥ 2.5ml occurred within 1 month.
- •Uncontrolled tumor-related pain.
- •Malignancies other than SCLC within 5 years.
- •Systemic antitumor therapy was received 4 weeks prior to trial treatment.
- •History of autoimmune diseases.
- •Significant cardiovascular disease.
- •Inadequately controlled hypertension.
- •Known history of testing positive test for HIV or known AIDS.
- •Patients with active hepatitis B or hepatitis C
- •Severe infections within 4 weeks prior to trial treatment.
- •Active tuberculosis.
研究组 & 干预措施
SHR-1701+ Famitinib
Experimental
干预措施: SHR-1701； Famitinib (Drug)
SHR-1701
Experimental
干预措施: SHR-1701 (Drug)
结局指标
主要结局
Objective response rate (ORR) based on RECIST 1.1 criteria
时间窗: up to approximately 1 year.
次要结局
- Disease control rate (DCR) based on RECIST 1.1 criteria(up to approximately 1 year.)
- Overall survival (OS)(up to approximately 1 year)
- Duration of response (DoR)(up to approximately 1 year)
- Progression free survival (PFS) based on RECIST 1.1 criteria(up to approximately 1 year.)
- AEs+ SAEs determined by NCI-CTCAE V5.0(Baseline until up to 90 days after end of treatment.)
研究者
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