A Phase 1/2 Randomized Trial of BMS-986012 in Combination With Platinum and Etoposide as First-line Therapy in Extensive-Stage Small Cell Lung Cancer
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 12
- 试验地点
- 4
- 主要终点
- Discontinuations due to AEs
研究概览
简要总结
The purpose of this this study is to administer BMS-986012 in Combination with Platinum and Etoposide as First-line Therapy in Extensive Small Cell Lung Cancer.
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
- 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
- •Male and Females 18 years of age or older
- •Pulmonary SCLC documented by histology or cytology
- •Extensive disease (Stage IV) SCLC
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
排除标准
- •Prior systemic therapy for lung cancer
- •Symptomatic brain metastases
- •Grade 2 peripheral neuropathy
- •Active or chronic infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV
- •Other active malignancies or prior malignancy within 2 years
- •Other protocol defined inclusion/exclusion criteria could apply
研究组 & 干预措施
Experimental Arm 3A
BMS-986012/Platinum/Etoposide
干预措施: Platinum (Drug)
Experimental Arm 1
BMS-986012/Cisplatin/Etoposide
干预措施: BMS-986012 (Drug)
Experimental Arm 1
BMS-986012/Cisplatin/Etoposide
干预措施: Cisplatin (Drug)
Experimental Arm 1
BMS-986012/Cisplatin/Etoposide
干预措施: Etoposide (Drug)
Experimental Arm 2
BMS-986012/Carboplatin/Etoposide
干预措施: BMS-986012 (Drug)
Experimental Arm 2
BMS-986012/Carboplatin/Etoposide
干预措施: Etoposide (Drug)
Experimental Arm 2
BMS-986012/Carboplatin/Etoposide
干预措施: Carboplatin (Drug)
Experimental Arm 3A
BMS-986012/Platinum/Etoposide
干预措施: BMS-986012 (Drug)
Experimental Arm 3A
BMS-986012/Platinum/Etoposide
干预措施: Etoposide (Drug)
Active Comparator Arm 3B
Platinum/Etoposide
干预措施: Etoposide (Drug)
Active Comparator Arm 3B
Platinum/Etoposide
干预措施: Platinum (Drug)
结局指标
主要结局
Discontinuations due to AEs
时间窗: Cycle 1, Day 1 up to approximately 26 months.
Number of participants with adverse events (AEs)
时间窗: Cycle 1, Day 1 up to approximately 26 months.
Number of participants with serious adverse events (SAEs )
时间窗: Date of enrollment up to approximately 26 months.
Number of participants with laboratory toxicity grade shift from baseline
时间窗: Cycle 1, Day 1 up to approximately 26 months.
Number of participants who died due to AEs
时间窗: Cycle 1, Day 1 up to approximately 26 months.
Progression Free Survival
时间窗: From date of first dose or randomization until date of confirmed disease progression, up to 2 years
次要结局
- Area under the plasma concentration-time curve from time 0 to time of last quantifiable concentration(AUC(0-T))(Cycle 1 Day 1 up to 60 days after last dose)
- Maximum observed serum concentration(Cmax)(Cycle 1 Day 1 up to 60 days after last dose)
- Time of maximum observed serum concentration(Tmax)(Cycle 1 Day 1 up to 60 days after last dose)
- Observed serum concentration at the end of a dosing interval(Ctau)(Cycle 1 Day 1 up to 60 days after last dose)
- Area under the concentration-time curve in 1 dosing interval(AUC(TAU))(Cycle 1 Day 1 up to 60 days after last dose)
- Characterization of Immunogenicity(Cycle 1 Day 1 up to 60 days after last dose)