A Randomized, Double-Blind, Placebo-Controlled Study of Trilaciclib vs Placebo in Patients With Extensive Stage Small Cell Lung Cancer (ES-SCLC) Receiving Topotecan Chemotherapy
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 302
- 试验地点
- 1
- 主要终点
- Overall survival (OS)
研究概览
简要总结
This is a multicenter, randomized, double-blind, placebo-controlled study to assess whether trilaciclib administered prior to topotecan is non-inferior to placebo administered prior to topotecan with regard to overall survival.
详细描述
The study will include 3 study phases: Screening Phase, Treatment Phase, and Survival Follow-up Phase. Patients randomized in this study will receive trilaciclib/placebo + topotecan 1.5 mg/m2 until disease progression, unacceptable toxicity, withdrawal of consent, Investigator decision to discontinue treatment, or the end of the trial, whichever comes first.
Trilaciclib was approved by the United States (US) Food and Drug Administration (FDA) as a treatment to decrease the incidence of chemotherapy-induced myelosuppression in adult patients when administered prior to a platinum/etoposide-containing regimen or topotecan-containing regimen for ES-SCLC. As a post-marketing requirement, the FDA asked the Sponsor to conduct a study in patients with ES-SCLC undergoing chemotherapy to evaluate survival and disease progression following trilaciclib administration in patients treated with a platinum/etoposide-containing regimen or topotecan-containing regimen with at least 2 years of follow-up. This study is designed to fulfill this requirement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •ES-SCLC with confirmed diagnosis of SCLC by histology or cytology
- •Progression during or after prior first or second line chemotherapy. First-line regimen must have been a platinum-containing combination.
- •Measurable or evaluable disease as defined by RECIST v1.1
排除标准
- •History of topotecan (or other topoisomerase I inhibitor) or trilaciclib treatment for SCLC
- •Any chemotherapy, immunotherapy, biologic, investigational, or hormonal therapy for cancer treatment within 3 weeks, except for adjuvant hormonal therapy for breast cancer and prostate cancer
- •Presence of brain metastases/leptomeningeal disease requiring immediate treatment with radiation therapy or steroids
- •Radiotherapy within 2 weeks
- •History of ILD/pneumonitis
- •History of other malignancies, except for curatively treated solid tumors with no evidence of disease for ≥ 2 years or other NCS cancers
研究组 & 干预措施
Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.5 mg/m²
Patients randomized 1:1 to trilaciclib. Patients receive trilaciclib (240 mg/m²) administered once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle.
Following administration of trilaciclib on Days 1 to 5, patients receive topotecan (1.5 mg/m²)
干预措施: Trilaciclib (Drug)
Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.5 mg/m²
Patients randomized 1:1 to trilaciclib. Patients receive trilaciclib (240 mg/m²) administered once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle.
Following administration of trilaciclib on Days 1 to 5, patients receive topotecan (1.5 mg/m²)
干预措施: Topotecan (Drug)
Placebo + Topotecan 1.5 mg/m²
Patients are randomized 1:1 to placebo. Patients receive placebo administered once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle.
Following administration of placebo on Days 1 to 5, patients receive topotecan (1.5 mg/m²).
干预措施: Placebo (Drug)
Placebo + Topotecan 1.5 mg/m²
Patients are randomized 1:1 to placebo. Patients receive placebo administered once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle.
Following administration of placebo on Days 1 to 5, patients receive topotecan (1.5 mg/m²).
干预措施: Topotecan (Drug)
结局指标
主要结局
Overall survival (OS)
时间窗: From date of randomization until date of death due to any cause for those who died; or date of last contact known as alive for those who survived in the study (censored cases), assessed up to 52 months
To assess the effect of trilaciclib on OS compared with placebo in patients receiving topotecan
次要结局
- RBC related myeloprotection efficacy(From date of randomization until end of Week 5)
- Platelet related myeloprotection efficacy(From date of randomization until end of treatment, assessed up to 52 months)
- Chemotherapy dosing(From the date of randomization until end of treatment, assessed up to 52 months)
- Incidence of Treatment-Emergent Adverse Events as Assessed by CTCAE(From the date of randomization until end of treatment, assessed up to 52 months)
- Anti-tumor efficacy(From date of first objective response of complete response (CR) or partial response (PR) and the first date that progressive disease is objectively documented or death, whichever comes first, assessed up to 52 months)
- Neutrophil-related myeloprotection efficacy(From date of randomization until end of treatment, assessed up to 52 months)
- Myeloprotection efficacy(From date of randomization until end of treatment, assessed up to 52 months)