Randomized, Multicenter, Double-Blind, Phase 3 Trial Comparing the Efficacy of Ipilimumab Plus Etoposide/Platinum Versus Etoposide/Platinum in Subjects With Newly Diagnosed Extensive-Stage Disease Small Cell Lung Cancer (ED-SCLC)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,351
- 试验地点
- 43
- 主要终点
- Overall Survival (OS) in Participants Who Received at Least One Dose of Blinded Study Therapy
研究概览
简要总结
The purpose of the study is to determine whether the addition of Ipilimumab to Etoposide and Platinum therapy will extend the lives of patients with Extensive-Stage Disease Small Cell Lung Cancer (ED-SCLC) more than Etoposide and Platinum therapy alone.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Extensive-Stage Disease Small Cell Lung Cancer (ED-SCLC)
- •Eastern Cooperative Oncology Group (ECOG) of 0 or 1
排除标准
- •Prior systemic therapy for lung cancer
- •Symptomatic Central Nervous System (CNS) metastases
- •History of autoimmune disease
研究组 & 干预措施
Ipilimumab+Etoposide+Cisplatin/Carboplatin
Ipilimumab: IV solution, Intravenous (IV), 10 mg/kg, Once every 3 weeks for 4 doses, then every 12 weeks, Until progression of disease or unacceptable toxicity, or until the maximum treatment period of 3 years is reached
Etoposide: IV solution, IV, 100 mg/m2, Days 1-3 every 3 weeks, 4 cycles
Cisplatin: IV solution, IV, 75 mg/m2, Once every 3 weeks, 4 doses
Carboplatin: IV Solution, IV, Area Under the Curve (AUC) 5, Once every 3 weeks, 4 doses
干预措施: Ipilimumab (Biological)
Ipilimumab+Etoposide+Cisplatin/Carboplatin
Ipilimumab: IV solution, Intravenous (IV), 10 mg/kg, Once every 3 weeks for 4 doses, then every 12 weeks, Until progression of disease or unacceptable toxicity, or until the maximum treatment period of 3 years is reached
Etoposide: IV solution, IV, 100 mg/m2, Days 1-3 every 3 weeks, 4 cycles
Cisplatin: IV solution, IV, 75 mg/m2, Once every 3 weeks, 4 doses
Carboplatin: IV Solution, IV, Area Under the Curve (AUC) 5, Once every 3 weeks, 4 doses
干预措施: Etoposide (Drug)
Ipilimumab+Etoposide+Cisplatin/Carboplatin
Ipilimumab: IV solution, Intravenous (IV), 10 mg/kg, Once every 3 weeks for 4 doses, then every 12 weeks, Until progression of disease or unacceptable toxicity, or until the maximum treatment period of 3 years is reached
Etoposide: IV solution, IV, 100 mg/m2, Days 1-3 every 3 weeks, 4 cycles
Cisplatin: IV solution, IV, 75 mg/m2, Once every 3 weeks, 4 doses
Carboplatin: IV Solution, IV, Area Under the Curve (AUC) 5, Once every 3 weeks, 4 doses
干预措施: Cisplatin (Drug)
Ipilimumab+Etoposide+Cisplatin/Carboplatin
Ipilimumab: IV solution, Intravenous (IV), 10 mg/kg, Once every 3 weeks for 4 doses, then every 12 weeks, Until progression of disease or unacceptable toxicity, or until the maximum treatment period of 3 years is reached
Etoposide: IV solution, IV, 100 mg/m2, Days 1-3 every 3 weeks, 4 cycles
Cisplatin: IV solution, IV, 75 mg/m2, Once every 3 weeks, 4 doses
Carboplatin: IV Solution, IV, Area Under the Curve (AUC) 5, Once every 3 weeks, 4 doses
干预措施: Carboplatin (Drug)
Placebo matching Ipilimumab+Etoposide+Cisplatin/Carboplatin
Placebo matching Ipilimumab: IV solution, IV, 0 mg/kg, Once every 3 weeks for 4 doses, then every 12 weeks, Until progression of disease or unacceptable toxicity, or until the maximum treatment period of 3 years is reached
Etoposide: IV solution, IV, 100 mg/m2, Days 1-3 every 3 weeks, 4 cycles
Cisplatin: IV solution, IV, 75 mg/m2, Once every 3 weeks, 4 doses
Carboplatin: IV Solution, IV, Area Under the Curve (AUC) 5, Once every 3 weeks, 4 doses
干预措施: Placebo matching Ipilimumab (Biological)
Placebo matching Ipilimumab+Etoposide+Cisplatin/Carboplatin
Placebo matching Ipilimumab: IV solution, IV, 0 mg/kg, Once every 3 weeks for 4 doses, then every 12 weeks, Until progression of disease or unacceptable toxicity, or until the maximum treatment period of 3 years is reached
Etoposide: IV solution, IV, 100 mg/m2, Days 1-3 every 3 weeks, 4 cycles
Cisplatin: IV solution, IV, 75 mg/m2, Once every 3 weeks, 4 doses
Carboplatin: IV Solution, IV, Area Under the Curve (AUC) 5, Once every 3 weeks, 4 doses
干预措施: Etoposide (Drug)
Placebo matching Ipilimumab+Etoposide+Cisplatin/Carboplatin
Placebo matching Ipilimumab: IV solution, IV, 0 mg/kg, Once every 3 weeks for 4 doses, then every 12 weeks, Until progression of disease or unacceptable toxicity, or until the maximum treatment period of 3 years is reached
Etoposide: IV solution, IV, 100 mg/m2, Days 1-3 every 3 weeks, 4 cycles
Cisplatin: IV solution, IV, 75 mg/m2, Once every 3 weeks, 4 doses
Carboplatin: IV Solution, IV, Area Under the Curve (AUC) 5, Once every 3 weeks, 4 doses
干预措施: Cisplatin (Drug)
Placebo matching Ipilimumab+Etoposide+Cisplatin/Carboplatin
Placebo matching Ipilimumab: IV solution, IV, 0 mg/kg, Once every 3 weeks for 4 doses, then every 12 weeks, Until progression of disease or unacceptable toxicity, or until the maximum treatment period of 3 years is reached
Etoposide: IV solution, IV, 100 mg/m2, Days 1-3 every 3 weeks, 4 cycles
Cisplatin: IV solution, IV, 75 mg/m2, Once every 3 weeks, 4 doses
Carboplatin: IV Solution, IV, Area Under the Curve (AUC) 5, Once every 3 weeks, 4 doses
干预措施: Carboplatin (Drug)
结局指标
主要结局
Overall Survival (OS) in Participants Who Received at Least One Dose of Blinded Study Therapy
时间窗: Randomization until date of death, up to March 2015, approximately 38 months
Overall Survival was defined as the time from the date of randomization until the date of death from any cause. For participants without documentation of death, OS was censored on the last date the participant was known to be alive.
次要结局
- Overall Survival in All Randomized Participants(From randomization until date of death, up to March 2015, approximately 38 months)
- Progression Free Survival (PFS) Time in Participants Who Have Received at Least One Dose of Blinded Study Therapy(From randomization until disease progression, up to March 2015, approximately 38 months)