A Study to Evaluate the Efficacy and Safety of Anlotinib Plus Pemetrexed as the 1-line Treatment of Patients With Platinum Intolerant Advanced Non-squamous NSCLC, With Pemetrexed Control.
试验速览
- 阶段
- 4 期
- 入组人数
- 106
- 试验地点
- 1
- 主要终点
- Proportion of patients alive and progression free at 6 months (APF6)
研究概览
简要总结
Evaluate the efficacy and safety of Anlotinib plus Pemetrexed as the 1-line treatment of patients with Platinum intolerant advanced non-squamous NSCLC, with Pemetrexed 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
- None
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥70 years old and ECOG PS=0-2 or ≥18 years old and ECOG PS=2
- •Diagnosed with advanced or recurrent non-squamous NSCLC (phase IIIB/IV) through pathology, with measurable nidus(using RECIST 1.1)
- •No prior systemic treatment for non-squamous NSCLC
- •Negative in EGFR&ALK&ROS1
- •Main organs function is normal
排除标准
- •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
- •Symptoms of brain metastases cannot be controlled and treated within less than 21 days
- •Have participated in other clinical trials of anti-tumor medicine within 4 weeks
- •Get any severe diseases or the ones that cannot be controlled
研究组 & 干预措施
Anlotinib plus Pemetrexed
Anlotinib plus Pemetrexed
干预措施: Anlotinib plus Pemetrexed (Drug)
Pemetrexed
Pemetrexed
干预措施: Pemetrexed (Drug)
结局指标
主要结局
Proportion of patients alive and progression free at 6 months (APF6)
时间窗: Estimated to be from baseline up to 2 years
the number (%) of patients who are alive and progression free per RECIST 1.1 at 6 months after randomization per Kaplan-Meier estimate of progression free survival at 6 months.
次要结局
- Progression Free Survival(PFS)(Estimated to be from baseline up to 2 years)
- Objective Response Rate(ORR)(Estimated to be from baseline up to 2 years)
- Overall Survival(OS)(Estimated to be from baseline up to 2 years)
- Disease Control Rate(DCR)(Estimated to be from baseline up to 2 years)