Study of Trilaciclib and Lurbinectedin in 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
- 2
- 主要终点
- The duration of grade 4 neutropenia
研究概览
简要总结
Lung cancer is by far the leading cause of cancer death among both men and women worldwide and the second most common cancer in terms of new cases. Small cell lung cancer (SCLC) is the deadliest form of lung cancer. The standard first-line treatment is the combination of carboplatin, etoposide, and atezolizumab. While response rates for this regimen are high (roughly 60%), the duration of response is short, typically 4 months. Following progression after the 1st line treatment of SCLC, there is no consensus regarding subsequent therapy. Lurbinectedin is FDA approved and is increasingly preferred in clinical practice. Toxicity was significant, but appeared favorable compared to historic results with topotecan, leading to the adoption of this therapy for second-line SCLC. The toxicity profile was dominated by myelosuppression.
This study investigates the effect of Trilaciclib on myelosuppression rate in subjects with platinum refractory extensive stage (ES)- SCLC receiving Lurbinectedin as well as the clinical synergy of Trilaciclib and Lurbinectedin combination.
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
- •Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information.
- •Age ≥ 18 years at the time of consent.
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
- •Measurable disease according to RECIST v1.1 within 28 days prior to start of treatment.
- •Previous treatment with a platinum agent, PD1 or PDL1 agent.
排除标准
- •Active infection requiring systemic therapy.
- •Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study).
- •Treatment with any investigational drug within 4 weeks prior to start of treatment.
- •A known allergy or sensitivity to either study drug or its excipients.
- •Subject is receiving prohibited medications or treatments as listed in the protocol.
研究组 & 干预措施
Trilaciclib and Lurbinectedin
Subjects with platinum refractory extensive stage small cell lung cancer receiving laciclib and Lurbinectedin
干预措施: Trilaciclib (Drug)
Trilaciclib and Lurbinectedin
Subjects with platinum refractory extensive stage small cell lung cancer receiving laciclib and Lurbinectedin
干预措施: Lurbinectedin (Drug)
结局指标
主要结局
The duration of grade 4 neutropenia
时间窗: Up to 21 days
The median duration of subjects that experience grade 4 neutropenia as graded by the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0 will be reported.
The proportion of grade 4 neutropenia
时间窗: Up to 21 days
The proportion of subjects that experience grade 4 neutropenia as graded by the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0 will be determined. CTCAE is descriptive terminology that can be used for Adverse Event (AE) grading and reporting. Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local, or noninvasive intervention indicated; limiting age-appropriate instrumental Activities of Daily Living (ADL). Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE.
次要结局
- Dose Intensity of Chemotherapy/ Number of chemotherapy cycles(Up to 8 months)
- QOL assessments FACT-An(Up to 5 years)
- The number of grade 3/4 anemia, grade 3/4 thrombocytopenia, and febrile neutropenia(Up to 8 months)
- Use of secondary/reactive supportive measures(Up to 8 months)
- Dose Intensity of Chemotherapy/ the total chemotherapy dose(Up to 8 months)
- QOL assessments FACT-L(Up to 5 years)
- Dose Intensity of Chemotherapy/ Number of chemotherapy dose reductions(Up to 8 months)
- The kinetics of response(Up to 5 years)
- The mean duration of grade 4 neutropenia(Up to 21 days)
- Dose Intensity of Chemotherapy/ Number of chemotherapy delays(Up to 8 months)
- Progression-free survival (PFS)(Up to 5 years)
- Overall Response Rate (ORR)(Up to 5 years)
- Overall survival (OS)(Up to 5 years)