A Double-Blind, Placebo-Controlled, Multicenter, Randomized Study Evaluating the Prophylactic Use of Pegylated Recombinant Human Granulocyte Colony Stimulating Factor (rhG-CSF) on the Incidence of Neutropenia in Subjects With Advanced Non-Small-Cell Lung Cancer (NSCLC) Treated With Myelosuppressive Chemotherapy
试验速览
- 阶段
- 3 期
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Rate of grade 3/4 neutropenia in cycle 1
研究概览
简要总结
Neutropenia is one of the most frequent adverse effects of chemotherapy, and the main factor to limit the dosage and the continuation of chemotherapy. A newly pegylated rhG-CSF was independently developed by JIANGSU HENGRUI Medicine Co., Ltd, China. Phase 1a, 1b and phase 2 trials have shown that pegylated rhG-CSF has decreased renal clearance, increased plasma half-life, and prolonged efficacy in compare with filgrastim. The purpose of this study is to determine the safety and effectiveness of pegylated rhG-CSF in preventing neutropenia following chemotherapy in patients with advanced NSCLC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Investigator diagnosis of staged III or IV NSCLC
- •Age 18 to 70 years
- •ECOG performance status ≤ 1
- •Chemotherapy naïve
- •Body weight ≥ 45kg
- •Hemoglobin ≥ 100g/L; white blood cell ≥ 4.0×109/L; absolute neutrophil count ≥1.5 × 109/L; platelet count ≥ 100 × 109/L
- •Alanine transarninase ≤1.5×ULN; aspartate aminotransferase ≤1.5×ULN; serum creatinine ≤1.5×ULN; total bilirubin ≤1.5×ULN
排除标准
- •History of systematic chemotherapy or radical radiation therapy
- •Prior bone marrow or stem cell transplantation
- •Received systemic antibiotics treatment within 72 h of chemotherapy
- •Pregnancy or lactation
研究组 & 干预措施
Placebo
Staged III or IV NSCLC patients receiving chemotherapy and placebo in cycle 1 and rhG-CSF in cycle 2 to 4
干预措施: placebo and rhG-CSF 5ug/kg/d (Drug)
结局指标
主要结局
Rate of grade 3/4 neutropenia in cycle 1
时间窗: 21 days
the rate of ANC lower than 1.0 × 109/L
次要结局
- Incidence of febrile neutropenia in cycle 1(21 days)
- Rate of grade 3/4 neutropenia and incidence of febrile neutropenia in cycle 2 to 4(Through 2 to 4 cycles)
- Time to neutrophil recovery in the 4 chemotherapy cycles(Through 4 cycles)
- Duration of 3/4 neutropenia in the 4 chemotherapy cycles(Through 4 cycles)
- Objective response rate(Through 4 cycles)
- Progress free survival(Through 4 cycles)
- Overall survival(Through 4 cycles)
- Exploratory biomarkers research(Through 4 cycles)