NCT02332512Unknown3 期
A Randomized, Double-blind, Placebo-controlled, Phase III Trial of Apatinib as 3rd/4th Line Treatment in Patients With Advanced Non-Squamous Non-Small Cell Lung Cancer Harboring Wild-type Epidermal Growth Factor Receptor (EGFR)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 入组人数
- 417
- 试验地点
- 2
- 主要终点
- Overall Survival（OS)
研究概览
简要总结
Apatinib is a new kind of selective Vascular Endothelial Growth Factor Receptor 2(VEGFR-2) tyrosine kinase inhibitor (TKI). The investigators have finished the preclinical,phase I and phase II clinical studies and found its promising anti-tumor activity and tolerable toxicities. A disease-control rate of 61.1% and a mPFS of 4.7 months were showed in apatinib phase II study in patients with NSCLC.
The study aims to compare the efficacy and safety of apatinib to placebo in advanced non-squamous non-small cell lung cancer patients.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects >/= 18 years and </=70 years of age at the time of Informed Consent.
- •Advanced relapsed or refractory predominantly NSCLC with documented wild-type EGFR.
- •At least one measurable lesion according to RECIST 1.
- •Failure of second line of chemotherapy.
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-
- •Patients must have recovered from any AEs of prior treatments before randamization.
- •Adequate bone marrow,liver and renal function as assessed by the following laboratory tests conducted within 1 week before randomization. HB ≥ 90g/L; ANC≥1.5×10E+9/L; PLT≥80×10E+9/L; ALT and AST < 2.5×ULN; TBIL ≤1.25×ULN; Cr ≤1.25×ULN;CL>45 ml/min.
- •Life expectancy of at least three months.
- •Written informed consent and the willingness and ability to comply with all aspects of the protocol.
排除标准
- •Presence of types of small-cell, squamous-cell, adeno-squamous-cell lung cancer.
- •Pregnant or breast-feeding women.
- •Suffered from grade II or above myocardial ischemia or myocardial infarction, uncontrolled arrhythmias (including QT interval male ≥ 450 ms, female≥ 470 ms).Severe or uncontrolled systemic disease such as clinically significant hypertension(systolic pressure >/= 140 mm Hg and/or diastolic pressure >/= 90 mm Hg), and Grade III-IV cardiac insufficiency, according to NYHA criteria or echocardiography check: LVEF<50%.
- •Factors to affect oral administration(inability to swallow tablets,GI tract resection, chronic bacillary diarrhea and intestinal obstruction).
- •Coagulation disfunction,hemorrhagic tendency or receiving anticoagulant therapy>/= CTCAE 2 pneumorrhagia or >/= CTCAE 3 hemorrhage in other organs within 4 weeks.
- •Bone fracture or wounds that was not cured.
- •Arterial thrombus or phlebothrombosis within 12 months and taking anticoagulant agents.
- •Mental diseases and psychotropic substances abuse.
- •Previous treatment with an trial agent within 4 weeks
- •Previous treatment with VEGFR,platelet derived growth factor receptor(PDGFR) TKIs.
- •Proteinuria ≥ (++) or 24 hours total urine protein > 1.0 g.
- •Other coexisting malignant disease (except basal-cell carcinoma and carcinoma in situ of uterine cervix).
研究组 & 干预措施
Apatinib
Experimental
Apatinib tablet administered orally, 750 mg,once daily until progression
干预措施: Apatinib (Drug)
Placebo
Placebo Comparator
Placebo tablet administered orally, once a day until progression
干预措施: Placebo (Drug)
结局指标
主要结局
Overall Survival（OS)
时间窗: 24 months
Overall survival (OS) was defined as the time from date of randomization to date of death due to any cause.The date the patient was recorded alive of last follow-up.Median time results from unstratified Kaplan-Meier estimates.
次要结局
- Duration of response (DoR)(24 months)
- Disease control rate (DCR)(24 months)
- Mean Change From Baseline in European Organization for Research and Treatment of Cancer core quality of life questionnaire (EORTC QLQ-C30)(24 months)
- Objective response rate (ORR)(24 months)
- Progression free survival (PFS)(24 months)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
3 期
Phase III Study of Apatinib Tablets in the Treatment of Advanced or Metastatic Gastric CancerAdvanced or Metastatic Gastric CancerNCT01512745Jiangsu HengRui Medicine Co., Ltd.267
已完成
2 期
A Study of Apatinib in Patients With Advanced Non-squamous and Non-small Cell Lung CancerNon-Small-Cell Lung CancerNCT01270386Jiangsu HengRui Medicine Co., Ltd.136
已完成
2 期
Apatinib Versus Placebo as a Third Line Treatment in Patients With Advanced or Metastatic Gastric CancerGastric CarcinomaNCT00970138Fudan University141
终止
2 期
Compare Apatinib Plus Chemotherapy Drug Versus Chemotherapy Drug as Second-line Treatment in NSCLCNonsmall Cell Lung CancerNCT03256721Fuzhou General Hospital37
已完成
2 期
Dose Finding and Pharmacokinetics/Pharmacodynamics Study of Apatinib in the Treatment of Advanced Colorectal CancerColorectal CancerNCT01531777Jiangsu HengRui Medicine Co., Ltd.40