Anlotinib Plus Docetaxel for the Treatment of EGFR/ALK/ROS1 Mutation-negative Advanced Nonsquamous NSCLC
Anlotinib Plus Docetaxel Versus Docetaxel for Treatment of EGFR/ALK/ROS1 Mutation-negative Advanced Nonsquamous NSCLC After Disease Progression on Platinum-based Therapy : a Multicentre, Double-blind, Randomised Explorative Trial
研究概览
详细说明
This is a multicentre randomised controlled clinical trial conducted in China to compare the effectiveness and safety of Anlotinib Plus Docetaxel in patients of EGFR/ALK/ROS1 mutation-negative Advanced nonsquamous Non-squamous Non-small Cell Lung Cancer.
Eligible patients will be randomized to arm A and arm B:
Arm A: Patients on the anlotinib and docetaxel arm received 75mg/m2 docetaxel as intravenous infusion on day 1 of a 21-day cycle and 12mg anlotinib orally daily on day 1to 14 of a 21-day cycle. Arm B: Patients on the docetaxel arm received 75mg/m2 docetaxel as intravenous infusion on day 1 of a 21-day cycle.
研究类型
注册 (预期的)
阶段
- 阶段2
联系人和位置
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- signed and dated informed consent
- diagnosed with non squamous advanced NSCLC (phase IIIB/IIIC/IV) through pathology,with measurable nidus(using RECIST 1.1)
- have failed for platinum two drugs chemotherapy
- EGFR/ALK/ROS1 mutation-negative
- ECOG PS:0-1,Expected Survival Time: Over 3 months
- main organs function is normal
- the woman patients of childbearing age who must agree to take contraceptive methods (e.g. intrauterine device, contraceptive pill or condom) during the research and within another 2 months after it; who are not in the lactation period and examined as negative in blood serum test or urine pregnancy test within 7 days before the research; The man patients who must agree to take contraceptive methods during the research and within another 2 months after it
Exclusion Criteria:
- Small Cell Lung Cancer (including small cell cancer and other kinds of cancer mixed with non-small cell cancer)
- squamous non small cell lung cancer (including adenosine squamous cell carcinoma )
- have not used docetaxel before(except adjunctive therapy)
- iconography (CT or MRI) shows that the tumor vessels have 5 mm or less, or Cardiovascular involvement by Central tumor ; Or obvious lung empty or necrotic tumor
- patients with brain or central nervous system metastases, including leptomeningeal disease, or CT/MRI examination revealed brain or leptomeningeal disease) (28 days before the random treatment has been completed and the symptoms of patients with brain metastases from stable can into the group, but need to the cerebral MRI, CT or vein angiography confirmed as without symptoms of cerebral hemorrhage)
- patients are participating in other clinical studies less than 4 weeks from the end of a previous clinical study
- other kinds of malignancies within 5 years or for now
- have got non remissive toxic reactions derived from previous therapies, which is over level 1 in CTC AE (4.0), alopecia NOT included
- abnormal coagulation (INR > 1.5 or prothrombin time (PT) > ULN + 4 seconds or APTT ULN > 1.5), with bleeding tendency or be treated with thrombolysis and anticoagulation
- urine routines show urine protein≥ ++, or urine protein quantity≥ 1.0 g during 24 hours
- uncontrollable hypertensive (systolic blood pressure or greater 160 mmHg or diastolic blood pressure or greater 90 mmHg, despite the best drug treatment)
- the effects of surgery or trauma had been eliminated for less than 14 days before admission to the study group
- patients with severe infections , and need to receive Systemic antibiotic treatment
- significant cardiac disease as defined as: grade II or greater myocardial infarction, unstable arrhythmia(Including corrected QT interval (QTc )period between male or greater 450 ms, female or greater 470 ms); New York Heart Association (NYHA) grade II or greater heart dysfunction , or Echocardiography reveal left ventricular ejection fraction (LVEF)Less than 50%
- patients with NCI-CTCAE grade II or greater peripheral neuropathy, except due to trauma
- pleural effusion or ascites, resulting in respiratory syndrome (≥CTC AE level 2)
- serious, non-healing wound, ulcer, or bone fracture
- decompensated diabetes or high dose glucocorticoid treatment of other contraindication
- has an obvious factor influencing oral drug absorption, such as unable to swallow, chronic diarrhea and intestinal obstruction, etc
- has Clinically significant hemoptysis Within 3 months before Random (daily hemoptysis than 50 ml;Or significant clinical significance of bleeding symptoms or have definite bleeding tendency, such as gastrointestinal bleeding, bleeding ulcers, baseline period + + and above of fecal occult blood, or vasculitis, etc
- has venous thromboembolism events Within 6 months before Random, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism, etc
- whole body antitumor treatment was planned in the first 4 weeks(except diphosphonate) or during this study, including cytotoxic therapy, signal transduction inhibitors, immunotherapy, Chinese medicine with antitumor effect. Field scale radiotherapy (EF-RT) within 4 weeks before grouping or limited field radiotherapy before grouping were carried out in 2 weeks ;
- a known history of HIV testing positive or acquired immunodeficiency syndrome (AIDS)
- untreated active hepatitis (hepatitis b: HBsAg positive and HBV DNA more than 1 x 103 copy /ml; Hepatitis c: HCV RNA is positive and liver function is abnormal); Combined with hepatitis b and hepatitis c infection
- serious diseases that endanger patients' safety or affect patients' completion of research,according to the researchers' judgment
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:安罗替尼加多西紫杉醇
安罗替尼(12mg QD PO d1-14,每个周期 21 天)和多西紫杉醇(75mg/m2 IV d1)
|
安罗替尼(12mg QD PO d1-14,每个周期 21 天)和多西紫杉醇(75mg/m2 IV d1)
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有源比较器:多西紫杉醇
多西他赛 (75mg/m2 IV d1)
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多西他赛 (75mg/m2 IV d1)
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
无进展生存期
大体时间:每 42 天直至 PD 或死亡(最多 24 个月)
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无进展生存
|
每 42 天直至 PD 或死亡(最多 24 个月)
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
操作系统
大体时间:从随机分组到死亡(最多 24 个月)
|
总生存期
|
从随机分组到死亡(最多 24 个月)
|
反应率
大体时间:每 42 天一次,直到不能耐受毒性或 PD(最多 24 个月)
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客观反应率
|
每 42 天一次,直到不能耐受毒性或 PD(最多 24 个月)
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直流电阻率
大体时间:每 42 天一次,直到不能耐受毒性或 PD(最多 24 个月)
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疾病控制率
|
每 42 天一次,直到不能耐受毒性或 PD(最多 24 个月)
|
安全性(以不良事件作为安全性和耐受性衡量标准的参与者人数)
大体时间:直到 21 天安全随访
|
以不良事件作为安全性和耐受性衡量标准的参与者人数
|
直到 21 天安全随访
|
合作者和调查者
调查人员
- 首席研究员:Xiaohua Hu, MD、First Affiliated Hospital of Guangxi Medical University
研究记录日期
研究主要日期
学习开始 (预期的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
安罗替尼加多西紫杉醇的临床试验
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Hunan Province Tumor Hospital尚未招聘
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Hunan Province Tumor Hospital尚未招聘
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InBios International, Inc.Biomedical Advanced Research and Development Authority; Fast-Track Drugs & Biologics, LLC完全的
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Azienda Sanitaria Locale Napoli 2 Nord招聘中
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Fondazione Policlinico Universitario Agostino Gemelli...尚未招聘尿路感染 | 输尿管支架相关症状