NCT02813785已完成3 期
A Phase III, Open-Label, Multicenter, Randomized Study to Investigate the Efficacy and Safety of Atezolizumab (Anti-PD-L1 Antibody) Compared With Docetaxel in Patients With Non-Small Cell Lung Cancer After Failure With Platinum-Containing Chemotherapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 565
- 试验地点
- 38
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
This Phase III, multicenter, open-label, randomized, controlled study is designed to evaluate the efficacy and safety of the anti-programmed death-ligand 1 (PD-L1) antibody atezolizumab compared with docetaxel in participants with locally advanced or metastatic NSCLC who have progressed during or following a platinum-containing regimen. Treatment may continue until disease progression, loss of clinical benefit, or unacceptable toxicity.
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
- •Histologically documented, locally advanced or metastatic NSCLC
- •Representative formalin-fixed paraffin-embedded (FFPE) tumor specimens available or at least 12 unstained, freshly cut serial sections with associated pathology report that are evaluable for PD-L1 expression and epidermal growth factor receptor (EGFR) mutation status prior to enrollment, except for known sensitizing EGFR mutations in which case 10 unstained slides are required and there is no need for central testing of EGFR mutation status
- •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 and/or neoadjuvant regimen or combined modality with curative intent
- •Measurable disease per RECIST v1.1
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •Life expectancy greater than or equal to (>/=) 12 weeks
- •Adequate hematologic and end organ function
- •Agreement to remain abstinent or use contraceptive methods among women of childbearing potential or male partners of women of childbearing potential
- •Recovery from all acute toxicities from previous therapy
排除标准
- •Active or untreated central nervous system (CNS) metastases
- •Spinal cord compression not definitively treated or not clinically stable
- •Leptomeningeal disease
- •Uncontrolled pleural or pericardial effusions or ascites requiring recurrent drainage
- •Uncontrolled tumor-related pain
- •Uncontrolled hypercalcemia
- •Malignancies other than NSCLC within 5 years prior to randomization, except for those curatively treated with negligible risk of metastasis or death
- •Pregnant or lactating women
- •Significant cardiovascular, pulmonary, or autoimmune disease
- •Severe infection or major surgery within 4 weeks, or antibiotic treatment within 2 weeks prior to randomization
- •Prior treatment with or hypersensitivity to study drug(s) or related compounds
- •Inability to discontinue strong cytochrome P450 (CYP) 3A4 inhibitors
- •Prior allogeneic bone marrow or solid organ transplant
- •Known PD-L1-negative expression status
- •Positive human immunodeficiency virus (HIV) or active hepatitis B or C
- •Receipt of a live attenuated vaccine within 4 weeks prior to randomization
- •Treatment with systemic immunomodulators within 4 weeks or five half-lives (whichever is shorter) prior to randomization
- •Treatment with systemic corticosteroids within 2 weeks prior to randomization
研究组 & 干预措施
Atezolizumab
Experimental
Participants will receive atezolizumab until loss of clinical benefit and will thereafter enter survival follow-up until death, loss to follow-up, withdrawal, or study end.
干预措施: Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody (Drug)
Docetaxel
Active Comparator
Participants will receive docetaxel until disease progression per standard RECIST v1.1 criteria or unacceptable toxicity and will thereafter enter survival follow-up until death, loss to follow-up, withdrawal, or study end.
干预措施: Docetaxel (Drug)
结局指标
主要结局
Overall Survival (OS)
时间窗: Baseline until death from any cause (up to approximately 3 years)
次要结局
- Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1(Baseline until disease progression or death from any cause (up to approximately 3 years))
- Percentage of Participants with Adverse Events(From start of treatment until 90 days after treatment discontinuation or initiation of other anti-cancer therapy (up to approximately 3 years))
- Health-Related Quality of Life According to EORTC QLQ-C30 Score(Day 1 of every cycle (cycle length of 21 days) until/at treatment discontinuation (up to approximately 3 years))
- Percentage of Participants with Objective Response According to RECIST v1.1(Baseline until disease progression or death from any cause (up to approximately 3 years))
- Duration of Objective Response According to RECIST v1.1(From first objective response until disease progression or death from any cause (up to approximately 3 years))
- Percentage of Participants with Anti-Therapeutic Antibodies (ATAs) to Atezolizumab(Predose (0 hours) on Day 1 of Cycles 1, 2, 3, 4, 8, 16, and every eight cycles thereafter (cycle length of 21 days) until/at treatment discontinuation (up to approximately 3 years) and 120 days after last dose (up to approximately 3 years overall))
- Health-Related Quality of Life According to EORTC QLQ-LC13 Score(Day 1 of every cycle (cycle length of 21 days) until/at treatment discontinuation (up to approximately 3 years))
- Minimum Observed Serum Concentration (Cmin) of Atezolizumab(Predose (0 hours) on Day 1 of Cycles 1, 2, 3, 4, 8, 16, and every eight cycles thereafter (cycle length of 21 days) until/at treatment discontinuation (up to approximately 3 years) and 120 days after last dose (up to approximately 3 years overall))
- Time to Deterioration (TTD) in Lung Cancer Symptoms According to European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) Core 30 C30)(From start of treatment until treatment discontinuation (up to approximately 3 years))
- TTD in Lung Cancer Symptoms According to EORTC QLQ Lung Cancer Module (LC13)(From start of treatment until treatment discontinuation (up to approximately 3 years))
研究者
研究点 (38)
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