A Phase III, Open-Label, Randomized Study of Atezolizumab (Anti-PD-L1 Antibody) Compared With Gemcitabine+Cisplatin or Carboplatin for PD-L1-Selected, Chemotherapy Naive Patients With Stage IV Squamous Non-Small Cell Lung Cancer
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 8
- 试验地点
- 82
- 主要终点
- Progression-Free Survival (PFS) as Determined by the Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
研究概览
简要总结
This randomized, open-label study was designed to evaluate and compare the safety and efficacy of atezolizumab with gemcitabine + cisplatin or carboplatin in PD-L1 selected participants with chemotherapy-naive, Stage IV squamous NSCLC. The study was closed due to low patient enrollment and the Sponsor's decision to include patients with squamous NSCLC into the GO29431 study, NCT02409342. Therefore the planned objectives of this study are no longer applicable and formal analyses of efficacy or safety have not been performed.
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 or cytologically confirmed Stage IV squamous NSCLC
- •Tumor programmed death-ligand 1 (PD-L1) expression, as determined by immunohistochemistry (IHC) assay of archival tumor tissue or tissue obtained at screening
- •No prior treatment for Stage IV squamous NSCLC
- •Measurable disease as defined by RECIST v1.1
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- •Adequate hematologic and end-organ function
排除标准
- •Active or untreated central nervous system (CNS) metastases
- •Untreated or inadequately treated spinal cord compression
- •Leptomeningeal disease
- •Uncontrolled pleural effusion, pericardial effusion, or ascites
- •Uncontrolled tumor-related pain
- •Uncontrolled hypercalcemia
- •Any other malignancies within 5 years except those with negligible risk of metastasis or death
- •Pregnant or lactating women
- •Known hypersensitivity to any component of atezolizumab formulation or other study medication
- •History of autoimmune disease except controlled, treated hypothyroidism or type I diabetes
- •Prior allogeneic bone marrow or solid organ transplantation
- •Positive human immunodeficiency virus (HIV) test
- •Active hepatitis B or C
- •Active tuberculosis
- •Significant cardiovascular disease
- •Severe infection or major surgery within 4 weeks prior to randomization
- •Use of any approved anti-cancer therapy within 3 weeks prior to treatment
- •Use of an investigational agent or participation in another clinical trial within 4 weeks prior to randomization
- •Exposure to oral or IV antibiotics within 2 weeks or live attenuated vaccines within 4 weeks prior to randomization
- •Prior treatment with cluster of differentiation (CD) 137 agonists or immune checkpoint blockade therapies, anti-programmed death-1 (anti-PD-1), and anti-PD-L1 therapeutic antibodies
- •Treatment with immunostimulatory agents within 4 weeks or immunosuppressive agents within 2 weeks prior to randomization
研究组 & 干预措施
Atezolizumab
Participants will receive intravenous (IV) infusion of atezolizumab once on Day 1 of each 21-day cycle until loss of clinical benefit.
干预措施: Atezolizumab (Drug)
Gemcitabine + Cisplatin/Carboplatin
Participants will receive IV infusion of gemcitabine + cisplatin or gemcitabine + carboplatin once on Day 1 of each 21-day cycle for four or six cycles as per local standard of care.
干预措施: Carboplatin (Drug)
Gemcitabine + Cisplatin/Carboplatin
Participants will receive IV infusion of gemcitabine + cisplatin or gemcitabine + carboplatin once on Day 1 of each 21-day cycle for four or six cycles as per local standard of care.
干预措施: Cisplatin (Drug)
Gemcitabine + Cisplatin/Carboplatin
Participants will receive IV infusion of gemcitabine + cisplatin or gemcitabine + carboplatin once on Day 1 of each 21-day cycle for four or six cycles as per local standard of care.
干预措施: Gemcitabine (Drug)
结局指标
主要结局
Progression-Free Survival (PFS) as Determined by the Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
时间窗: Baseline up to death or disease progression, whichever occurs first (up to approximately 2.5 years)
次要结局
未报告次要终点