NCT02388919已完成2 期
A Registered Randomized, Double-Blind, Placebo-Controlled (2:1), Multi-Centered Clinical Trial of Anlotinib as a Treatment for Advanced Non-Small Cell Lung Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 439
- 试验地点
- 40
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
Evaluate the efficacy and safety of Anlotinib as the 3-line treatment of patients with advanced non-small lung cancer, with placebo control.
详细描述
Anlotinib (AL3818) is a kind of innovative medicines approved by State Food and Drug Administration（SFDA:2011L00661） which was researched by Jiangsu Chia-tai Tianqing Pharmaceutical Co., Ltd. Anlotinib is a kinase inhibitor of receptor tyrosine with multi-targets, especially for VEGFR1、VEGFR2、VEGFR3、FGFR1/2/3、PDGFRa/β c-Kit and MET.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed and dated informed consent
- •Diagnosed with advanced NSCLC (phase IIIB/IV) through pathology, with measurable nidus(using RECIST 1.1)
- •at least two systematic chemotherapy with upwards of 3-line treatments or cannot suffer
- •Patients must provide detectable specimen (from tumor tissue or hydrothorax) before participating, who negative in EGFR&ALK can participate or who positive in EGFR&ALK, have or have not drug tolerance after the treatment with relative targeted drugs
- •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 6 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 6 months after it
排除标准
- •have used Anlotinib before
- •Small Cell Lung Cancer (including small cell cancer and other kinds of cancer mixed with non-small cell cancer)
- •examined as positive in EGFR&ALK mutation detection and never take the treatment of TKIs
- •central lung squamous carcinoma along with cavum, or non-small cell lung cancer along with hemoptysis (>50ml/day)
- •other kinds of malignancies within 5 years or for now
- •plan to take systemic anti-tumor therapy within 4 weeks before grouping or during the medicine-taking period of this research, including Cytotoxic Therapy, Signal Transduction Inhibitor, and Immunotherapy (or who use Mitomycin C within 6 weeks before taking the treatment with experimental drug); The patients who have already taken Extended Field Radiotherapy (EF-RT) within 4 weeks before grouping or Limited Field Radiotherapy with proposed assessment of nidus within 2 weeks before grouping
- •have got non remissive toxic reactions derived from previous therapies, which is over level 1 in CTC AE (4.0), alopecia NOT included
- •with kinds of factors which affect oral medicine (e.g. failing to swallow, gastrointestinal tract getting resected, chronic diarrhea and ileus)
- •pleural effusion or ascites, resulting in respiratory syndrome (≥CTC AE level 2)
- •symptoms of brain metastases cannot be controlled and treated within less than 2 months
- •get any severe diseases or the ones that cannot be controlled
- •take major surgical treatments, open biopsy, or get overt traumatic injury within 28 days before grouping
- •have any habitus or medical history of hemorrhage, however severe it is; the patients who have non healing wounds, ulcer or fracture after any events with hemorrhage or bleeding (≥CTCAE level 3)
- •get arterial/venous thrombosis within 6 months, such as cerebrovascular accidents (including temporary ischemic stoke), deevenous thrombosis, and pulmonary embolism
- •ever abuse psychiatric drugs and cannot abstain or who are diagnosed with mental disorder
- •have participated in other clinical trials of anti-tumor medicine within 4 weeks
- •diagnosed with disease which will severely endanger the security of patients or influence the completion of this research.
研究组 & 干预措施
Anlotinib
Experimental
Anlotinib p.o, qd and it should be continued until disease progress or toxicity cannot be tolerated or patients withdraw consent
干预措施: Anlotinib (Drug)
Placebo
Placebo Comparator
Placebo p.o, qd and it should be continued until disease progress or patients withdraw consent
干预措施: Placebo (Drug)
结局指标
主要结局
Overall Survival (OS)
时间窗: From randomization until death (up to 24 months)
次要结局
- Progress free survival (PFS)(each 42 days up to PD or death(up to 24 months))
- Objective Response Rate (ORR)(each 42 days up to intolerance the toxicity or PD (up to 24 months))
- Disease Control Rate (DCR)(each 42 days up to intolerance the toxicity or PD (up to 24 months))
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability(Until 30 day safety follow-up visit)
研究者
研究点 (40)
Loading locations...
相似试验
终止
1 期
A Study of Intravenous MK-8226 in Participants With Moderate-to-Severe Atopic Dermatitis (MK-8226-003)Atopic DermatitisNCT01732510Merck Sharp & Dohme LLC65
已完成
3 期
Trial of Linaclotide in Patients With Chronic ConstipationChronic ConstipationNCT00730015Ironwood Pharmaceuticals, Inc.643
已完成
3 期
This Study Will Investigate the Efficacy and Safety of A4250 in Children With PFIC Types 1 or 2PFIC1PFIC2NCT03566238Albireo62
进行中（未招募）
1 期
Randomized Phase III, Double-Blind, Placebo-Controlled Multicenter Trial of Everolimus in Combination with Trastuzumab and Paclitaxel, as First Line Therapy in Women with HER2 Positive Locally Advanced or Metastatic Breast CancerHER2+ locally advanced or metastatic breast cancerMedDRA version: 9.1 Level: LLT Classification code 10065430 Term: HER-2 positive breast cancerEUCTR2008-006556-21-FRovartis Pharma Service AG719
进行中（未招募）
1 期
A clinical trial of Everolimus in Combination with Trastuzumab and Paclitaxel, as First Line Therapy in Women with HER2 Positive Locally Advanced or Metastatic Breast CancerEUCTR2008-006556-21-DEovartis Pharma Service AG719