Evaluation of TRILACICLIB in Chinese Patients With Extensive-stage Small Cell Lung Cancer (ES-SCLC) for Chemotherapy-induced Myelosuppression, Antitumor Effects of Combination Regimens, and Safety in a Real-world Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Incidence of severe neutropenia (SN)
研究概览
简要总结
This is a single-arm, real-world study in Chinese patients with extensive stage small cell lung cancer. The purpose of this study was to evaluate Trilaciclib's protection against chemotherapy-induced bone marrow suppression, the safety and the impact on the antitumor effects of the combination with chemotherapy in Chinese patients with ES-SCLC in the real world. Patients with ES-SCLC who already use or plan to use Trilaciclib will be invited to participate in the study. Data were collected from 28 days prior to initial chemotherapy (platinum/etoposide or topotecan systemic chemotherapy) after patients signed informed consent until patients died, dropped out of the study, lost to follow-up, informed withdrawal, or study termination. The end time of the study was defined as withdrawal of information, loss of follow-up or death of all enrolled patients, or 12 months after the last patient was enrolled, whichever happened earlier.
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntarily participate and sign informed consent;
- •must be at least 18 years when fisrt dose of Trilaciclib, regardless of gender:
- •Patients with extensive small-cell lung cancer confirmed by histology or cytology
- •Patients suitable for Trilaciclib combined with platinum/etoposide or Trilaciclib combined with topotecan treatment
排除标准
- •Patient is currently participating in other Interventional clinical studies;
- •Patients received systemic chemotherapy other than the regimens recommended in inclusion criteria 4 During Trilaciclib treatment.
研究组 & 干预措施
Trilaciclib, carboplatin, etoposide, Topotecan
Trilaciclib plus Carboplatin combined with Etoposide OR Topotecan (ES-SCLC patients)
干预措施: Trilaciclib (Drug)
结局指标
主要结局
Incidence of severe neutropenia (SN)
时间窗: during Trilaciclib plus chemotherapy assessed up to 6 months
Incidence of severe neutropenia (SN)
次要结局
- The incidence of febrile neutropenia(during Trilaciclib plus chemotherapy assessed up to 6 months)
- Incidence of G-CSF treatment(during Trilaciclib plus chemotherapy assessed up to 6 months)
- The number and frequency of all-caused chemotherapy drugs reduction(during Trilaciclib plus chemotherapy assessed up to 6 months)
- Incidence of pulmonary infection serious adverse events(during Trilaciclib plus chemotherapy assessed up to 6 months)
- duration of response(during Trilaciclib plus chemotherapy assessed up to 6 months)
- Progression-free survival time(during Trilaciclib plus chemotherapy assessed up to 6 months)
- Incidence of grade 3 and 4 hematologic toxicity(during Trilaciclib plus chemotherapy assessed up to 6 months)
- Incidence of red blood cell (RBC) transfusions at or after week 5(during Trilaciclib plus chemotherapy assessed up to 6 months)
- The incidence of platelet transfusion(during Trilaciclib plus chemotherapy assessed up to 6 months)
- Objective response rate(during Trilaciclib plus chemotherapy assessed up to 6 months)
- Disease control rate(during chemotherapy assessed up to 6 months)
- Incidence of intravenous or oral antibiotic administration in treatment(during Trilaciclib plus chemotherapy assessed up to 6 months)
- Changes of absolute neutrophil count, platelet count, absolute lymphocyte count (ALC) and hemoglobin over time(during Trilaciclib plus chemotherapy assessed up to 6 months)
- The incidence of ESA administration in treatment(during Trilaciclib plus chemotherapy assessed up to 6 months)
- composite end point - Significant hematologic adverse event (occurrence of any of the following events：all-cause hospitalization; all-cause dose reduction; Febrile neutropenia; Severe neutropenia )(during Trilaciclib plus chemotherapy assessed up to 6 months)
- Incidence of infectious serious adverse events(during Trilaciclib plus chemotherapy assessed up to 6 months)
- The incidence of TPO administration in treatment(during Trilaciclib plus chemotherapy assessed up to 6 months)
- verall survival(maximun up to 1.5 years)