A Randomised, Open, Blank-controlled, Multi-centre Study of Anlotinib as Sequential Therapy in Patients With Unresectable NSCLC(Stage III) Who Have Not Progressed Following Definitive, Platinum-based, Concurrent Chemoradiation Therapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 4
- 主要终点
- Progression Free Survival (PFS)
研究概览
简要总结
Evaluate the efficacy and safety of Anlotinib following concurrent chemoradiation in patients with stage III unresectable non-small cell lung cancer
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
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1.Age at least 18 years.
- •2.Documented evidence of NSCLC (locally advanced, unresectable, Stage III).
- •3.Patients must have received at least 2 cycles of platinum-based chemotherapy concurrent with radiation therapy.
- •4.ECOG PS : 0 to
- •5.Estimated life expectancy of more than 12 weeks.
排除标准
- •1.Prior exposure to any anti-angiogenesis drugs.
- •2.Central lung carcinoma along with large vessels or tumor with cavum or necrosis.
- •3.Evidence of severe or uncontrolled systemic diseases, including active bleeding diatheses or active infections including hepatitis B, C and HIV.
- •4.Any unresolved toxicity CTCAE >Grade 2 from the prior chemoradiation therapy.
- •5.Evidence of uncontrolled illness such as symptomatic congestive heart failure, uncontrolled hypertension or COPD.
研究组 & 干预措施
Anlotinib
Anlotinib p.o, qd. Treatment from Day 1 of randomization(after concurrent chemoradiation 4-6 weeks) to disease progress or untolerated toxicity or consent withdrawal. The 2:1 ratio (Anlotinib to blank).
干预措施: Anlotinib (Drug)
结局指标
主要结局
Progression Free Survival (PFS)
时间窗: Estimated to be from baseline up to 3 years
the time from randomization until the date of objective disease progression (RECIST 1.1) or death (by any cause in the absence of progression)
次要结局
- Overall Survival at 24 months (OS24)(Estimated to be from baseline up to 3 years)
- Disease Control Rate at 12 months(DCR12)(Estimated to be from baseline up to 3 years)
- Overall Survival at 12 months (OS12)(Estimated to be from baseline up to 3 years)
- Recurrence rate at 12 months(Estimated to be from baseline up to 3 years)
- Disease Control Rate at 6 months(DCR6)(Estimated to be from baseline up to 3 years)
- Recurrence rate at 24 months(Estimated to be from baseline up to 3 years)
研究者
Anhui Shi, MD
Associate Chief Physician
Peking University Cancer Hospital & Institute