A Prospective, Single-arm, and Exploratory Phase II Clinical Study of Trilaciclib Combined With Lateral Ventricular Chemotherapy in the Treatment of Advanced Non-small Cell Lung Cancer With Leptomeningeal Metastasis
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Duration of severe neutropenia (DSN)
研究概览
简要总结
To observe the efficacy of Trilaciclib combined with lateral ventricular chemotherapy in the treatment of non-small cell lung cancer with leptomeningeal metastasis。
详细描述
A single-arm, open-label, interventional study was conducted in 25 NSCLC patients with leptomeningeal metastases to observe the efficacy of Trilaciclib combined with lateral ventricular chemotherapy in the treatment of non-small cell lung cancer with leptomeningeal metastases, and to evaluate the incidence and duration of severe neutropenia in the first cycle.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •must be at least 18 years when fisrt dose of Trilaciclib, regardless of gender；
- •ECOG-PS score of 0-1，and no worsening in the 2 weeks before the study drug；
- •expected survival≥12 weeks；
- •Advanced non-small cell lung cancer with leptomeningeal metastasis；
- •with an Ommaya sac has been implanted；
- •At least one measurable lesion meeting RECIST1.1 criteria was present；
- •Laboratory tests met the following criteria: hemoglobin ≥100 g/L (female), 110g/L (male) ；neutrophil count ≥ 2×109/L ；platelet count ≥100×109/L; Creatinine ≤ 15mg/L or creatinine clearance (CrCl) ≥ 60 mL/min (Cockcroft-Gault formula); Total bilirubin ≤ 1.5× upper limit of normal value (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × ULN or 5× ULN (for patients with liver metastases); Albumin ≥ 30 g/L;
- •Patients of reproductive age(including female and male patients'female companions)must use effective birth control measures;
- •Voluntarily participate and sign informed consent;
排除标准
- •Patients of reproductive age(including female and male patients'female companions)must use effective birth control measures;
- •Stroke or cardio-cerebrovascular event within 6 months before enrollment;
- •QTcF interval > 480msec at screening, QTcF > 500msec for patients with implanted ventricular pacemakers;
- •Previous hematopoietic stem cell or bone marrow transplantation;
- •Allergy to the study drug or its components;
- •If the investigator considers that it is not suitable to participate in this study.
研究组 & 干预措施
Trilaciclib+Pemetrexed
Patients were treated with Trilaciclib (240mg/m2, administered within 4 hours before each chemotherapy,Q3W) and pemetrexed (30mg,Q3W) until disease progression as assessed by the investigator according to RECIST 1.1 criteria or withdrawal or discontinuation criteria were met.
干预措施: combination of Trilaciclib and Pemetrexed (Drug)
结局指标
主要结局
Duration of severe neutropenia (DSN)
时间窗: During Trilaciclib plus chemotherapy assessed up to 21 days
Duration of severe neutropenia in cycle 1
次要结局
- Incidence of Treatment-Emergent Adverse Events(Up to 2 years)
- Incidence of grade 3 and 4 hematologic toxicity(during Trilaciclib plus chemotherapy assessed up to 1 years)
- Incidence of G-CSF treatment(during Trilaciclib plus chemotherapy assessed up to 1 years)
- Incidence of platelet transfusion(during Trilaciclib plus chemotherapy assessed up to 1 years)