A Prospective, Single-arm, Exploratory Clinical Study of Trilaciclib Combined With Chemotherapy in the Treatment of Advanced Non-small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Incidence of febrile neutropenia (FN)
研究概览
简要总结
The aim of this study is to investigate the safety and efficacy of the prophylactic use of Trilaciclib in patients with non-small cell lung cancer (NSCLC) receiving platinum-based chemotherapy, so as to provide more evidence-based medical evidence for the optimal diagnosis and treatment strategy in this population.
详细描述
This is a single-arm, exploratory clinical study. Eligible patients were treated with Trilaciclib before the first cycle of chemotherapy, and their peripheral blood samples were tested on days 3,7,14,21±1 after chemotherapy. At the same time, the incidence of FN, the use of antibiotics, the safety, the number of patients who delayed the second cycle of treatment, the number of patients who reduced the dose of chemotherapy, the number of patients who reduced the dose of chemotherapy due to neutropenia, and the number of patients who discontinued chemotherapy were observed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 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
- •Age above 18 years old (including 18 years old)，regardless of gender；
- •ECOG-PS score of 0-1,；
- •expected survival≥12 weeks；
- •There was no tumor deterioration in the 2 weeks prior to study drug treatment.
- •Advanced non-small cell lung cancer without systemic chemotherapy.
- •At least one tumor lesion with a maximum diameter ≥10 mm (short diameter ≥15 mm if it is a lymph node) that could be measured accurately at baseline according to RECIST1.1 criteria. Baseline tumor imaging was performed within 28 days before the first dose.
- •Women of childbearing age should use appropriate contraception and should not breastfeed from screening until 3 months after discontinuation of study treatment.
- •Male subjects should use barrier contraception (i.e., condoms) for 3 months from screening until discontinuation of study treatment.
- •All subjects voluntarily participated and signed the informed consent form in person.
排除标准
- •Uncontrolled ischemic heart disease or clinically significant congestive heart failure (NYHA class III or IV);
- •stroke or cardio-cerebrovascular event within 6 months before enrollment;
- •QTcF interval > 480msec at screening or > 500msec for patients with implanted ventricular pacemakers;
- •Previous hematopoietic stem cell or bone marrow transplantation;
- •Allergy to the study drug or its components;
- •Others considered by the investigator to be unsuitable for this study.
研究组 & 干预措施
Trilaciclib plus chemotherapy
Patients with lung adenocarcinoma were treated with Trilaciclib (240mg/m2, d1, within 4 hours before each chemotherapy) combined with pemetrexed and carboplatin (dose according to the guideline recommendation, d1, Q3W). "For squamous lung cancer, Trilaciclib (d1, 240mg/m2, 4 hours before each chemotherapy) plus paclitaxel/albumin-bound paclitaxel plus carboplatin (dose according to guideline recommendation, d1), Q3W." In the second cycle, patients were left to their own discretion with or without treaclib combination therapy.
干预措施: Trilaciclib Injection (Drug)
结局指标
主要结局
Incidence of febrile neutropenia (FN)
时间窗: during Trilaciclib plus chemotherapy assessed up to 21 days
Incidence of febrile neutropenia in the first treatment cycle
次要结局
- Number of medication delays(At the end of Cycle 1 (each cycle is 28 days))
- Antibiotic Use rate(during Trilaciclib plus chemotherapy assessed up to 21 days)
- Incidence of Treatment-Emergent Adverse Events(Up to 2 years)
- Number of chemotherapy dose reductions(At the end of Cycle 1 (each cycle is 28 days))
研究者
Liu Yangchen
Director
Taixing People's Hospital