A Phase II, Open-label, Multicenter, Randomized Study to Investigate the Efficacy and Safety of MPDL3280A (Anti-PD-L1 Antibody) Compared With Docetaxel in Patients With Non-Small Cell Lung Cancer After Platinum Failure
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 287
- 试验地点
- 65
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
This multicenter, open-label, randomized study will evaluate the efficacy and safety of Atezolizumab compared with docetaxel in participants with advanced or metastatic non-small cell lung cancer after platinum failure. Participants will be randomized to receive either Atezolizumab 1200 milligram (mg) intravenously every 3 weeks or docetaxel 75 milligram per meter square (mg/m^2) intravenously every 3 weeks. Treatment with Atezolizumab may be continued as long as participants are experiencing clinical benefit as assessed by the investigator, i.e., in the absence of unacceptable toxicity or symptomatic deterioration attributed to disease progression.
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
- •Adult participants, >/= 18 years of age
- •Locally advanced or metastatic (Stage IIIB, Stage IV, or recurrent) non-small cell lung cancer (NSCLC)
- •Representative formalin-fixed paraffin-embedded (FFPE) tumor specimens
- •Disease progression during or following treatment with a prior platinum-containing regimen for locally advanced, unresectable/inoperable or metastatic NSCLC or disease recurrence within 6 months of treatment with a platinum-based adjuvant/neoadjuvant regimen
- •Measurable disease, as defined by RECIST v1.1
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
排除标准
- •Known active or untreated central nervous system (CNS) metastases as determined by CT or MRI evaluation during screening and prior radiographic assessments
- •Malignancies other than NSCLC within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death and treated with expected curative outcome
- •History of autoimmune disease
- •History of idiopathic pulmonary fibrosis (including pneumonitis), drug-induced pneumonitis, organizing pneumonia, or evidence of active pneumonitis on screening chest CT scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted.
- •Active hepatitis B or hepatitis C
- •Prior treatment with docetaxel
- •Prior treatment with CD137 agonists, anti-CTLA4, anti-PD-1, or anti-PD-L1 therapeutic antibody or pathway-targeting agents
研究组 & 干预措施
Docetaxel
Participants received docetaxel 75 milligram per meter square (mg/m^2) administered intravenously on Day 1 of each 21 day cycle until disease progression or unacceptable toxicity or death.
干预措施: Docetaxel (Drug)
Atezolizumab
Participants were administered atezolizumab intravenously on Day 1 of each 21 day cycle at a fixed dose of 1200 mg. Atezolizumab treatment were to continued as long as participants were experiencing clinical benefit as assessed by the investigator.
干预措施: Atezolizumab (Drug)
结局指标
主要结局
Overall Survival (OS)
时间窗: From the time of randomization to the date of death due to any cause or up to data cut off date: 01 Dec 2015 (up to 28 months)
Overall Survival (OS) was defined as the time from the date of randomization to the date of death due to any cause. Data for participants who were not reported as dead at the time of analysis was censored at the date when they were last known to be alive.
次要结局
- Objective Response Rate (ORR)(Baseline until date of death due to any cause or up to data cut off date: 01 Dec 2015 (up to 28 months))
- Duration of Response (DOR)(From the time of randomization to the date of death due to any cause or up to data cut off date: 01 Dec 2015 (up to 28 months))
- ORR (Modified RECIST)(From the time of randomization to the date of death due to any cause or up to data cut off date: 08 May 2015 (up to 21 months))
- PFS (Modified RECIST)(From the time of randomization to the date of death due to any cause or up to data cut off date: 08 May 2015 (up to 21 months))
- Progression-Free Survival (PFS)(From the time of randomization to the date of death due to any cause or up to data cut off date: 01 Dec 2015 (up to 28 months))
- DOR (Modified RECIST)(From the time of randomization to the date of death due to any cause or up to data cut off date: 08 May 2015 (up to 21 months))