NCT04699968撤回2 期
Phase II Clinical Trial of SHR-1701 With or Without Famitinib in the Treatment of Advanced or Metastatic NSCLC
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- ORR
研究概览
简要总结
The study is being conducted to evaluate the efficacy and safety of SHR-1701 with or without famitinib in patients with advanced or metastatic NSCLC
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
- •voluntarily participate in the study and sign the informed consent form;
- •18 to 75 years old, both male and female;
- •histologically or cytologically confirmed stage IIIB-IV or recurrent NSCLC
- •one prior platinum-containing chemotherapy for advanced or metastatic disease;
- •measurable lesions by RECIST v1.1;
- •ECOG score: 0-1;
- •life expectancy ≥ 3 months;
- •adequate hematological, hepatic and renal function;
- •non-surgically sterile female subjects of childbearing age must have a negative serum HCG test.
排除标准
- •histologically or cytologically confirmed mixed SCLC and NSCLC;
- •known sensitising EGFR mutation and/or ALK translocation in patients with non-squamous NSCLC;
- •tumor infiltration into the great vessels on imaging;
- •active CNS metastases;
- •malignancies other than NSCLC within 5 years;
- •anticancer therapy within 4 weeks before the start of trial treatment;
- •persisting toxicity related to prior therapy of Grade > 1;
- •treatment with systemic immunostimulatory agents within 4 weeks;
- •treatment with systemic immunosuppressive agents within 2 weeks;
- •autoimmune diseases;
- •interstitial lung disease or other lung diseases that is symptomatic or may interfere the management of suspected drug-related pulmonary toxicity;
- •clinically significant cardiovascular or cerebrovascular diseases;
- •inadequately controlled hypertension;
- •history of hemoptysis (≥ 2.5mL of bright red blood per episode) within 1 month;
- •venous or arterial thrombosis within 6 months;
- •evidence of bleeding diathesis or coagulopathy;
- •use of anticoagulants or thrombolytic agents that has not been stable;
- •active Tuberculosis infection;
- •significant acute or chronic infections within 1 month;
- •known history of testing positive test for HIV or known AIDS;
- •hepatitis B virus or hepatitis C virus infection;
- •allergic to any component of the treatment regimen;
- •other conditions that in the opinion of the investigator would make participation in this clinical trial inappropriate.
研究组 & 干预措施
Treatment group A
Experimental
干预措施: SHR-1701，Famitinib (Drug)
Treatment group B
Experimental
干预措施: SHR-1701 (Drug)
结局指标
主要结局
ORR
时间窗: determined by RECIST v1.1, up to approximately 1 year
Objective Response Rate
次要结局
- DCR(determined by RECIST v1.1, up to approximately 1 year)
- DoR(determined by RECIST v1.1, up to approximately 1 year)
- OS(up to approximately 1 year)
- AEs+ SAEs(determined by NCI-CTCAE V5.0, from the first drug administration to within 90 days for the last SHR-1701 dose)
- PFS(determined by RECIST v1.1, up to approximately 1 year)
研究者
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