NCT03922997已完成3 期
An Open-Label, Singe Arm, Multicenter Study to Investigate the Safety and Efficacy of Atezolizumab (Tecentriq) in Previously-Treated Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer
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
- 101
- 试验地点
- 7
- 主要终点
- Serious Adverse Event Incidence Rates
研究概览
简要总结
This is a phase III, single-arm, multicenter study of the long-term safety and efficacy of atezolizumab treatment in patients with Stage IIIb or Stage IV non-small cell lung cancer (NSCLC) who have progressed following standard systemic chemotherapy (including if given in combination with anti-PD-1 therapy or after anti-PD-1 as monotherapy).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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 documented Stage IIIb or Stage IV NSCLC that has progressed following standard systemic chemotherapy (including if given in combination with anti-PD-1 therapy or after anti-PD-1 as monotherapy). Patients with a previously detected EGFR mutation or ALK fusion oncogene will be excluded from this study. Overall, patients should not have received more than two lines of systemic chemotherapy. Patients who have discontinued first-line or second-line systemic chemotherapy, targeted therapy, or anti-PD-1 therapy due to intolerance are also eligible.
- •The last dose of prior systemic anticancer therapy must have been administered ≥ 21 days prior to the first study treatment.
- •The last dose of prior anti-PD-1 therapy must have been administered
- •Measurable disease, as defined by Response Evaluation Criteria for Solid Tumors, Version 1.1 (RECIST v1.1)
- •Patients with asymptomatic CNS metastases (treated or untreated), as determined by CT or MRI evaluation during screening and prior radiographic evaluation, are eligible
- •ECOG performance status 0, 1, or 2
- •Life expectancy ≥ 12 weeks
- •Adequate hematologic and end-organ function
- •For women of childbearing potential: agreement to remain abstinent or use contraceptive methods that result in a failure rate of < 1% per year during the treatment period and for at least 5 months after the last dose of atezolizumab
- •Patients must have recovered from all acute toxicities from previous therapy, excluding alopecia and toxicities related to prior anti-PD-1-therapy
排除标准
- •Patients with EGFR mutation or ALK fusion oncogene
- •Symptomatic CNS metastases
- •Spinal cord compression not definitively treated with surgery and/or radiation or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for ≥ 2 weeks prior to the first study treatment
- •Leptomeningeal disease
- •Uncontrolled pericardial effusion or ascites requiring recurrent drainage procedures
- •Pregnant or lactating, or intending to become pregnant during the study
- •Evidence of significant uncontrolled concomitant disease that could affect compliance with the protocol, including significant liver disease
- •Significant cardiovascular disease
- •Significant renal disorder requiring dialysis or indication for renal transplant
- •Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days prior to study treatment initiation
- •Major surgical procedure within 4 weeks prior to study treatment initiation or anticipation of need for a major surgical procedure during the course of the study other than for diagnosis
- •Prior allogeneic stem cell or solid organ transplantation
研究组 & 干预措施
Atezolizumab
Experimental
Participants will receive atezolizumab intravenously on the first day of each cycle. Atezolizumab treatment will continue until investigator-assessed loss of clinical benefit, unacceptable toxicity, investigator or patient decision to withdraw from therapy, or death (whichever occurs first).
干预措施: Atezolizumab (Drug)
结局指标
主要结局
Serious Adverse Event Incidence Rates
时间窗: Baseline up to approximately 3 years
The incidence of serious adverse events (SAEs) related to atezolizumab.
次要结局
- Progression-Free Survival (PFS)(Baseline up to approximately 3 years)
- Overall Survival (OS) Rate(Baseline to 2 years)
- Duration of Response (DOR)(Baseline up to approximately 3 years)
- OS(Baseline up to approximately 3 years)
- Objective Response Rate (ORR)(Baseline up to approximately 3 years)
- EQ-5D-5L Index-Based and VAS scores(Day 1 of first 3 cycles, then with tumor assessments every 6 weeks for 48 weeks from study treatment date; thereafter every 9 weeks until progressive disease or until treatment discontinuation (up to approximately 3 years))
- EORTC QLQ-LC13 score(Day 1 of first 3 cycles, then with tumor assessments every 6 weeks for 48 weeks from study treatment date; thereafter every 9 weeks until progressive disease or until treatment discontinuation (up to approximately 3 years))
研究者
研究点 (7)
Loading locations...
相似试验
已完成
2 期
A Study to Investigate the Efficacy and Safety of Atezolizumab (Tecentriq) in Previously-Treated Patients With Advanced Thymic CarcinomaCarcinoma, ThymicNCT04321330Hoffmann-La Roche34
已完成
4 期
A Study of Atezolizumab (Tecentriq) to Investigate Long-term Safety and Efficacy in Previously-treated Participants With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC)Carcinoma, Non-Small-Cell LungNCT03285763Hoffmann-La Roche619
已完成
3 期
A Study of Atezolizumab in Combination With Bevacizumab Versus Sunitinib in Participants With Untreated Advanced Renal Cell Carcinoma (RCC)Renal Cell CarcinomaNCT02420821Hoffmann-La Roche915
进行中（未招募）
3 期
A Study of Atezolizumab in High PD-L1 Expression, Chemotherapy-Naïve Patients With Stage IV Non-Squamous or Squamous Non-Small Cell Lung CancerNon-Small Cell Lung CancerNCT05047250Hoffmann-La Roche60
已完成
3 期
A Study of Atezolizumab in Combination With Carboplatin or Cisplatin + Pemetrexed Compared With Carboplatin or Cisplatin + Pemetrexed in Participants Who Are Chemotherapy-Naive and Have Stage IV Non-Squamous Non-Small Cell Lung Cancer (NSCLC) (IMpower 132)Non-Small Cell Lung CancerNCT02657434Hoffmann-La Roche578