A Phase II, Multicenter, Single-arm Study of MPDL3280A in Patients With PD-L1-Positive Locally Advanced or Metastatic Non-small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 138
- 试验地点
- 31
- 主要终点
- Percentage of Participants With Objective Response According to Modified Response Evaluation Criteria in Solid Tumors (RECIST)
研究概览
简要总结
This multicenter, single-arm study will evaluate the efficacy and safety of atezolizumab (MPDL3280A) in participants with PD-L1-positive locally advanced or metastatic NSCLC. Participants will receive an intravenous (IV) dose of 1200 milligrams (mg) atezolizumab (MPDL3280A) on Day 1 of 21-day cycles until disease progression.
Eligible participants will be categorized in to three groups as follows:
- Participants with no prior chemotherapy for advanced disease;
- Participants who progress during or following a prior-platinum based chemotherapy regimen for advanced disease (2L+participants);
- Participants who are 2L+ and previously treated for brain metastases.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Stage IIIB (not eligible for definitive chemoradiotherapy), Stage IV, or recurrent NSCLC
- •PDL1-positive status as determined by an immunohistochemistry assay performed by a central laboratory. A positive result in chemotherapy, chemoradiation of the tumor sample biopsy will satisfy the eligibility criterion
- •Eastern Cooperative Oncology group Performance Status of 0 or 1
- •Life expectancy greater than or equal to 12 weeks
- •Measurable disease, as defined by Response Evaluation Criteria in Solid Tumors Version 1.1
- •Adequate hematologic and end organ function
排除标准
- •Any approved anti-cancer therapy, including chemotherapy, or hormonal therapy within 3 weeks prior to initiation of study treatment; the following exceptions are allowed. Hormone-replacement therapy or oral contraceptives, and tyrosine kinase inhibitors approved for treatment of NSCLC discontinued greater than 7 days prior to Cycle 1 Day 1
- •Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days prior to enrollment
- •Known central nervous system disease, including treated brain metastases in the following participants:
- •who will not receive prior chemotherapy for advanced disease
- •who progress during or following a prior-platinum based chemotherapy regimen for advanced disease (referred as 2L+ participants)
- •Participants with a history of treated asymptomatic brain metastases are allowed in the 2L+ participants and previously treated for brain metastases.
- •Leptomeningeal disease
- •Uncontrolled tumor-related pain
- •Uncontrolled hypercalcemia
研究组 & 干预措施
Atezolizumab (MPDL3280): 1L Participants
Participants with no prior chemotherapy for advanced NSCLC disease will receive atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until disease progression.
干预措施: Atezolizumab (MPDL3280A) [TECENTRIQ], an engineered anti-PDL1 antibody (Drug)
Atezolizumab (MPDL3280): 2L+ Participants
Participants who progress during or following a prior platinum-based chemotherapy regimen without restriction to maximum number of prior therapies will receive atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
干预措施: Atezolizumab (MPDL3280A) [TECENTRIQ], an engineered anti-PDL1 antibody (Drug)
Atezolizumab (MPDL3280): 2L+ Brain Metastases Participants
Participants with previously treated brain metastases and who progress during or following a prior platinum-based chemotherapy regimen without restriction to the maximum number of prior therapies, will receive atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
干预措施: Atezolizumab (MPDL3280A) [TECENTRIQ], an engineered anti-PDL1 antibody (Drug)
结局指标
主要结局
Percentage of Participants With Objective Response According to Modified Response Evaluation Criteria in Solid Tumors (RECIST)
时间窗: Baseline, and Day 1 of Cycle 1 (21-day cycle), then every 6 weeks for the first 12 months and then every 9 weeks thereafter until disease progression (up to 20 months)
Objective response was defined as a complete response (CR) or partial response (PR), as determined by investigator according to modified RECIST criteria. Modified RECIST was derived from RECIST v1.1 conventions and immune related response criteria. CR was defined as disappearance of all tumor lesions (target lesion \[TL\] and non-target lesion \[non-TL\]) and no new measurable or unmeasurable lesions, all lymph node short axes must be less than 10 millimeters (mm), and PR was defined as at least 30 percent (%) decrease in sum of diameter of TLs and all new measurable lesions since baseline in absence of CR, and both confirmed by consecutive assessment greater than or equal to 4 weeks from date first documented. Participants not meeting these criteria, including participants without at least one post-baseline response assessment were considered as non-responders.
次要结局
- Percentage of Participants With Objective Response According to RECIST Version 1.1 (v1.1)(Baseline, and Day 1 of Cycle 1 (21-day cycle), then every 6 weeks for the first 12 months and then every 9 weeks thereafter until disease progression (up to 20 months))
- Minimum Plasma Concentration (Cmin) for Atezolizumab(Pre-dose (0 hour) on Day 1 of Cycles 2, 3, 4, 8, and 16)
- Percentage of Participants With 6-Month Duration of Objective Response(Month 6)
- Percentage of Participants With Disease Progression or Death According to RECIST v1.1(Baseline to the first occurrence of progression or death, whichever occurs earlier (up to 20 months))
- Progression-Free Survival (PFS) According to RECIST v1.1(Baseline to the first occurrence of progression or death, whichever occurs earlier (up to 20 months))
- Percentage of Participants With PFS at Month 6, Month 12 and Month 30 According to RECIST v1.1(Months 6, 12 and 30)
- Duration of Objective Response According to RECIST v1.1(Baseline, and Day 1 of Cycle 1 (21-day cycle), then every 6 weeks for the first 12 months and then every 9 weeks thereafter until disease progression (up to 20 months))
- Percentage of Participants With Disease Progression or Death According to Modified RECIST(Baseline to the first occurrence of progression or death, whichever occurs earlier (up to 20 months))
- PFS According to Modified RECIST(Baseline to the first occurrence of progression or death, whichever occurs earlier (up to 20 months))
- Percentage of Participants With PFS at Month 6, Month 12 and Month 30 According to Modified RECIST(Months 6, 12 and 30)
- Percentage of Participants With Death(Baseline till death or up to 20 months, whichever occurred first)
- Overall Survival (OS)(Baseline till death or up to 20 months, whichever occurred first)
- Maximum Plasma Concentration (Cmax) for Atezolizumab(Pre-dose (0 hour) and 30 minutes after infusion on Day 1 of Cycle 1)