A Phase II, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Adjuvant Platinum-Doublet Chemotherapy, With or Without Atezolizumab, in Patients Who Are ctDNA Positive After Complete Surgical Resection of Stage IB to Select IIIB Non-Small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- ctDNA Clearance Rate at 6 Months
研究概览
简要总结
This is a Phase II, multicenter, double-blind, randomized study designed to evaluate the efficacy and safety of adjuvant treatment with atezolizumab in combination with platinum-doublet chemotherapy followed by atezolizumab compared with adjuvant placebo in combination with platinum-doublet chemotherapy followed by placebo in patients with Stage IB to IIIB (T3N2) NSCLC following surgical resection who are positive for ctDNA.
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
- Double (Participant, Investigator)
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
- •Complete resection (R0) and pathologically confirmed Stage IB to select IIIB NSCLC (8th edition)
- •Submission of pre-surgery blood sample and surgically resected tumor tissue slides or block
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- •Normal life expectancy excluding lung cancer mortality risk
- •Positive ctDNA status in plasma confirmed by central laboratory testing after surgical resection and prior to start of adjuvant therapy.
排除标准
- •Resected NSCLC with positive margins (R1 or R2)
- •NSCLC with histology of large cell neuroendocrine carcinoma or sarcomatoid carcinoma
- •Mixed NSCLC and SCLC histology
- •Any prior therapy for lung cancer, including neoadjuvant therapy, or radiotherapy
- •NSCLC with an activating EGFR mutation or ALK fusion oncogene
- •Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies
研究组 & 干预措施
Arm B: Placebo + platinum-doublet followed by placebo maintenance
干预措施: Paclitaxel (Drug)
Arm A: Atezolizumab + platinum-doublet followed by atezolizumab maintenance
干预措施: Atezolizumab (Drug)
Arm A: Atezolizumab + platinum-doublet followed by atezolizumab maintenance
干预措施: Carboplatin (Drug)
Arm A: Atezolizumab + platinum-doublet followed by atezolizumab maintenance
干预措施: Cisplatin (Drug)
Arm A: Atezolizumab + platinum-doublet followed by atezolizumab maintenance
干预措施: Pemetrexed (Drug)
Arm A: Atezolizumab + platinum-doublet followed by atezolizumab maintenance
干预措施: Gemcitabine (Drug)
Arm A: Atezolizumab + platinum-doublet followed by atezolizumab maintenance
干预措施: Paclitaxel (Drug)
Arm B: Placebo + platinum-doublet followed by placebo maintenance
干预措施: Placebo (Drug)
Arm B: Placebo + platinum-doublet followed by placebo maintenance
干预措施: Carboplatin (Drug)
Arm B: Placebo + platinum-doublet followed by placebo maintenance
干预措施: Cisplatin (Drug)
Arm B: Placebo + platinum-doublet followed by placebo maintenance
干预措施: Pemetrexed (Drug)
Arm B: Placebo + platinum-doublet followed by placebo maintenance
干预措施: Gemcitabine (Drug)
结局指标
主要结局
ctDNA Clearance Rate at 6 Months
时间窗: Randomization up to 6 months
ctDNA clearance rate at 6 months after randomization, defined as the proportion of participants with undetectable ctDNA at 6 months in the post-operative ctDNA+ participants.
Disease-Free Survival (DFS)
时间窗: Randomization up to approximatly 159 months
Disease-free survival (DFS), as assessed by the investigator, and defined as the time from randomization to the date of occurrence of any of the following, whichever occurs first: First documented local or distant recurrence of non-small cell lung cancer (NSCLC) after an integrated assessment of radiographic data, biopsy sample results (if available), and clinical status; Occurrence of new primary NSCLC (non-small cell lung cancer); Death from any cause in the post-operative ctDNA+ participants
次要结局
- ctDNA Clearance Rate at 12 Months(Randomization up to 12 months)
- Overall ctDNA Clearance Rate(Randomization up to approximately 159 months)
- Duration of ctDNA Clearance(Up to approximatly 159 months)
- DFS Rate(Randomization to 2 years and 3 years)
- Percentage of Pariticipants with Adverse Events(Randomization up to approximatly 159 months)
- Overall ctDNA Clearance Rate in the PD-L1 TC>=1% Population(Randomization up to approximately 159 months)
- Overall survival (OS)(Randomization to death from any cause (up to approximately 159 months))
- OS Rate(Randomization to 2 years and 3 years)
- Time to Confirmed Deterioration (TTCD) in Patient-Reported Functioning and Global Health (GHS)/Quality of Life (QoL)(Up to approximately 159 months)