A Phase II, Open-Label, Multicenter, Single-Arm Study to Investigate the Efficacy and Safety of Atezolizumab as Neoadjuvant and Adjuvant Therapy in Patients With Stage IB, II, IIIA, or Selected IIIB Resectable and Untreated Non-Small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 181
- 试验地点
- 19
- 主要终点
- Percentage of Participants With Major Pathologic Response (MPR)
研究概览
简要总结
This study was designed to evaluate the safety and efficacy of neoadjuvant and adjuvant atezolizumab in participants with resectable Non-Small Cell Lung Cancer (NSCLC). Neoadjuvant therapy consisted of two 21-day cycles with atezolizumab. Following surgery, adjuvant therapy consisted of up to 12 months of atezolizumab in participants who demonstrate clinical benefit with neoadjuvant therapy. All participants who undergo surgery entered a surveillance period, which consisted of standardized blood sample collection and Chest CT Scans, for up to 2 years. All participants were monitored for disease recurrence and survival for up to 3 years after last dose of study drug.
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
- •Pathologically documented Stage IB, II, IIIA, or selected IIIB, including T3N2 or T4 (by size criteria, not by mediastinal invasion) NSCLC
- •Adequate pulmonary and cardiac function
- •Available biopsy of primary tumor with adequate samples
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
排除标准
- •NSCLC that is clinically T4 by virtue of mediastinal organ invasion or Stage IIIB by virtue of N3 disease
- •Any prior therapy for lung cancer within 3 years.
- •Prior treatment with anti-PD-1 or PD-L1 therapies
- •History or risk of autoimmune disease
研究组 & 干预措施
Atezolizumab
Participants received two cycles of atezolizumab as neoadjuvant therapy prior to surgery. Participants who demonstrated clinical benefit were eligible to receive up to 12 months of atezolizumab.
干预措施: Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody (Drug)
结局指标
主要结局
Percentage of Participants With Major Pathologic Response (MPR)
时间窗: After surgery (approximately 10 weeks)
Major pathologic response was defined as ≤10% of viable tumor cells as scored by a pathologist, based on surgical resection as defined by prior studies. Percentages have been rounded off to the nearest decimal point.
次要结局
- Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) for PD-L1-Positive Versus PD-L1-Negative Participants(Pre-surgery (Day 36 +/- 3 days), after 2 doses of neoadjuvant treatment with atezolizumab)
- Percentage of Participants With Major Pathologic Response for PD-L1-Positive Versus PD-L1-Negative Participants(After surgery (approximately 10 weeks))
- Number of Participants With at Least One Adverse Event(From first study dose of atezolizumab until 90 days after the last study dose of atezolizumab (up to 18 months))
- Percentage of Participants With Major Pathologic Response (MPR) by Mutation Load(Up to 13 weeks)
- Percentage of Participants With Major Pathologic Response (MPR) by Neoantigen Score(Up to 13 weeks)
- Percentage of Participants With Major Pathologic Response (MPR) by Gene Expression Signatures: Gene Set Variation Analysis (GSVA)(Up to 13 weeks)
- Percentage of Participants With Major Pathologic Response (MPR) by Gene Expression Signatures: xCell Immune Score(Up to 13 weeks)