NCT05042375招募中3 期
A Randomized, Open-Label, Controlled, Multi-center Phase Ⅲ Study of Camrelizumab Combined With Famitinib Malate Versus Pembrolizumab in Treatment Naïve Subjects With PD-L1-Positive Recurrent or Metastatic Non-Small Cell Lung Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 450
- 试验地点
- 80
- 主要终点
- PFS assessed by BIRC
研究概览
简要总结
The study is being conducted to evaluate the efficacy, and safety of camrelizumab combined with famitinib malate vs. pembrolizumab in treatment naïve subjects with programmed death-ligand 1(PD-L1)-positive recurrent or metastatic non-small cell lung cancer (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
- •Have a histologically or cytologically confirmed diagnosis of metastatic NSCLC (stage IV according to the TNM staging criteria [8th edition] published by the International Association for the Study of Lung Cancer [IASLC]), or NSCLC that recurs after curable surgery, radiotherapy, or radiochemotherapy.
- •Have measurable disease based on RECIST v1.
- •ECOG PS score: 0-
- •Have a life expectancy of at least 3 months.
- •Non-surgically sterilized female subjects or women of childbearing potential must be negative for a serum pregnancy test within 3 days prior to the first dose and must be non-lactating. Female subjects of childbearing potential and male subjects with partners of childbearing potential must agree to take highly effective contraceptive measures during the study period and within 6 months after the last dose of study drugs.
- •Have voluntarily agreed to participate by giving written informed consent for the study, have good compliance, and cooperate with follow-up visits.
排除标准
- •Accompanied with EGFR activating mutation, ALK fusion gene positive or ROS1 mutation.
- •Have uncontrolled clinically symptomatic pleural effusion, pericardial effusion, or ascites.
- •Have known history of prior malignancy in the past 3 years.
- •Have had an allogeneic tissue/solid organ transplant.
- •Have active pulmonary tuberculosis.
- •Have clinical symptoms of the heart or heart diseases that are not well controlled.
- •Have hypertension which cannot be well controlled by antihypertensives
- •Urinalysis has indicated that the urine protein is ≥ ++ and quantitative test of urine protein has confirmed that the 24-h urine protein is > 1.0 g.
- •Have a thrombosis tendency or are currently receiving thrombolysis/anticoagulation therapy.
- •Have received major surgery within 4 weeks prior to randomization; or palliative radiotherapy within 2 weeks prior to randomization; or have not recovered from the toxicities and/or complications of previous interventions to NCI-CTCAE Grade ≤
- •Have known history of arterial/venous thrombosis within 6 months prior to randomization, such as cerebrovascular accidents, deep vein thrombosis and pulmonary embolism.
- •Have received prior therapy with anti-PD-1/PD-L1 monoclonal antibodies, anti-CTLA-4 monoclonal antibodies, or small molecule VEGFR inhibitors.
- •Have known allergies to other monoclonal antibodies or any component of famitinib.
- •Are currently participating and receiving study therapy or have participated in a study and received the last dose of study drug within 4 weeks (or 5 half-lives of the study drug) prior to randomization.
- •Have other potential factors that may affect the study results or result in the premature discontinuation as determined by the investigator, such as alcoholism, drug abuse, substance abuse, other serious diseases (including mental illness) requiring concomitant treatment, serious laboratory abnormalities, or family or social factors that could affect the safety of medication.
研究组 & 干预措施
camrelizumab + famitinib
Experimental
干预措施: camrelizumab + famitinib (Drug)
pembrolizumab
Experimental
干预措施: pembrolizumab (Drug)
camrelizumab
Experimental
干预措施: camrelizumab (Drug)
结局指标
主要结局
PFS assessed by BIRC
时间窗: up to 3 years
Progression-Free-Survival, defined as the time from randomization to the first occurrence of disease progression as determined by IRC with use of RECIST v1.1 or death from any cause, whichever occurs first.
次要结局
- DCR(up to 3 years)
- DoR(up to 3 years)
- TTF(up to 3 years)
- AEs+SAEs(from the first drug administration to within 90 days for the last SHR-1210 dose)
- ORR(up to 3 years)
- OS(up to 4 years)
- PFS assessed by investigator(up to 3 years)
研究者
研究点 (80)
Loading locations...
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