A Phase II Clinical Trial to Investigate Efficacy and Safety of Apatinib as a Single Agent in RET-fusion Gene Positive Non-small Cell Lung Cancer Who Failed to Previous Treatment.
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Objective Response Rate (ORR)
研究概览
简要总结
RET fusions are present in 1% to 2% of unselected population of non-small cell lung cancer (NSCLC). Existing US Food and Drug Administration-approved inhibitors of RET tyrosine kinase show promising therapeutic effects in a non-small cell lung cancer patients. Apatinib is an oral multi-kinase inhibitors including RET fusions. This study is designed to evaluate the safety and tolerability of Apatinib in patients with RET fusion positive advanced NSCLC.
详细描述
To observe objective response rate (ORR) of apatinib in RET fusion positive pre-treated advanced NSCLC.
To observe Progression free survival （PFS）. To assess the overall survival (OS). To assess safety and tolerability. To evaluate quality of life. To explore the relationship between biomarkers and the toxicity/efficacy of apatinib.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged ≥18 and ≤80 years.
- •ECOG performance status of 0 to
- •Life expectancy of more than 12 weeks.
- •At least one measurable lesion exists.(RECIST 1.1)
- •Histologically or cytologic confirmed RET fusion positive advanced Non-small cell lung cancer who failed to prior therapies.
- •Required laboratory values including following parameters: ANC: ≥ 1.5 x 10^9/L, Platelet count: ≥ 80 x 10^9/L, Hemoglobin: ≥ 90 g/L, Total bilirubin: ≤ 1.5 x upper limit of normal, ULN, ALT and AST: ≤ 1.5 x ULN, BUN and creatine clearance rate: ≥ 50 mL/min LVEF: ≥ 50% QTcF: < 470 ms
- •Signed informed consent
- •Females of child-bearing potential must have negative serum pregnancy test. Sexually active male and those having childbearing potential must practice contraception during the study.
排除标准
- •Squamous carcinoma (including adeno-squamous carcinoma), small cell lung cancer
- •Subjects with third space fluid that can not be controled by drainage or other methods.
- •Obvious cavity or necrosis formed in the tumor
- •Uncontrolled hypertension
- •Hymoptysis, more than 2.5ml daily
- •Thrombosis in 12 months, including pulmonary thrombosis, stroke, or deep venous thrombosis
- •Received big surgery, had bone fracture or ulcer in 4 weeks
- •Urine protein >++, or urine protein in 24 hours> 1.0g
- •pregnant or lactating woman
- •Receiving any other antitumor therapy.
- •Known history of hypersensitivity to apatinib or any of it components.
研究组 & 干预措施
Apatinib single agent arm
Apatinib, single agent, 750mg once daily p.o until disease progression
干预措施: Apatinib single agent arm (Drug)
结局指标
主要结局
Objective Response Rate (ORR)
时间窗: change from baseline in tumor size every 6-8 weeks after the initiation of apatinib, up to 24 months
To evaluate ORR every 6-8 weeks after initiation of apatinib
次要结局
- Progression Free Survival (PFS)(24 months)
- Safety and Tolerability as measured by adverse events(24 months)
- overall survival (OS)(24 months)
- quality of life (QOL, measured by questionnaire)(24 months)
研究者
Caicun Zhou
Professor
Tongji University