NCT04691817招募中1 期
A Phase Ib-II Trial of Tocilizumab and Atezolizumab in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Refractory to 1st Line Immune Checkpoint Inhibitor-Based Therapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Overall response rate (ORR)
研究概览
简要总结
This is a research study to evaluate the safety and effectiveness of tocilizumab in combination with atezolizumab to treat non-small cell lung cancer.
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
- •Advanced non-squamous NSCLC (Stage IV or recurrent after initial curative intent therapy) in adults age 18 or older
- •Prior exposure to at least 1 line of therapy
- •Exposure to a including checkpoint inhibitor in line of therapy immediately prior to enrollment on trial
- •ECOG PS 0-2
排除标准
- •Presence of a driver mutation that is susceptible to targeted therapy
- •No greater than CTCAE v5 grade 3 toxicity attributed to prior immunotherapy
- •Other active invasive malignancy requiring ongoing therapy
- •Evidence of progressing or untreated brain metastases
- •Evidence or history of leptomeningeal disease
- •Uncontrolled tumor related pain
- •History of an autoimmune disease or IPF
研究组 & 干预措施
Atezolizumab and Tocilizumab
Experimental
Participants receive Atezolizumab 1200mg IV and Tocilizumab 6mg/kg IV (or Tocilizumab 4mg/kg IV) every 21 days
干预措施: Atezolizumab (Drug)
Atezolizumab and Tocilizumab
Experimental
Participants receive Atezolizumab 1200mg IV and Tocilizumab 6mg/kg IV (or Tocilizumab 4mg/kg IV) every 21 days
干预措施: Tocilizumab (Drug)
结局指标
主要结局
Overall response rate (ORR)
时间窗: From first dose of protocol treatment until radiologic disease assessment at 12 weeks.
Assess the proportion of patients with a radiologic response by RECIST 1.1 at 12 weeks.
次要结局
- Progression free survival (PFS).(From 1st dose of treatment until 1st radiologic disease progression, unequivocal clinical progression, or death due to any cause censored at the last scheduled disease assessment on study if no progression date registered, assessed up to 24 months.)
- Overall survival (OS)(From first dose of protocol treatment until death due to any cause or last patient contact alive until 3 months after study closure.)
- Dose Limiting Toxicities of the combination(From first dose of protocol treatment until 49 days post treatment)
研究者
研究点 (2)
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