NCT05470595进行中（未招募）2 期
A Phase II, Single-arm Trial of Atezolizumab/Platinum/Etoposide for the Treatment of Advanced Large-cell Neuroendocrine Cancer of the Lung
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 67
- 试验地点
- 30
- 主要终点
- Overall survival
研究概览
简要总结
This phase II clinical trial evaluates the efficacy, safety and tolerability of Atezolizumab in addition to standard of care chemotherapy (Platinum/Etoposide) in LCNEC.
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
- •Written informed consent
- •Patients with locally advanced or metastatic large-cell neuroendocrine carcinoma of the lung (LCNEC) without curative treatment options (patients with mixed histology are eligible if LCNEC is the predominant histology i.e. ≥50%)
- •Previously untreated with systemic therapy (note: patients relapsing after curative radio chemotherapy or adjuvant chemotherapy are eligible if relapse occurs ≥6 months after discontinuation of curative treatment)
- •Planned treatment with Carboplatin or Cisplatin and Etoposide (SoC)
- •ECOG performance status: 0-2
- •age ≥18 years
- •measurable disease according to RECIST v1.1
- •adequate organ function defined as:
- •ALAT/ASAT ≤2.5x ULN or ≤3.5x ULN in case of liver metastases
- •Bilirubin ≤1.5x ULN or ≤2.5x ULN in case of liver metastases
- •Creatinine ≤1.5x ULN or Creatinine clearance according to Cockroft-Gault >60 ml/min
- •Neutrophils ≥1 Gpt/l, Platelets >50 Gpt/l unless caused by bone marrow carcinosis
排除标准
- •Symptomatic brain metastases (patients with asymptomatic brain metastases are allowed provided they are stable without steroid treatment for at least 3 weeks)
- •Severe autoimmune disease (patients with endocrine autoimmune disorders are allowed as long as they are on stable substitution treatment)
- •Severe uncontrolled infection
- •Prior treatment with either Atezolizumab or other immune checkpoint inhibitor
- •Any prior treatment for metastatic disease
研究组 & 干预措施
Atezolizumab/Platinum/Etoposide
Experimental
Atezolizumab/Platinum/Etoposide Platinum will be cisplatin or carboplatin at the investigators discretion.
干预措施: Atezolizumab (Drug)
结局指标
主要结局
Overall survival
时间窗: appr. 72 months
To assess the efficacy of Atezolizumab in addition to standard of care chemotherapy (Platinum/Etoposide) in LCNEC as measured by overall survival.
次要结局
- Disease Control Rate (DCR)(appr. 72 months)
- Incidence, intensity, seriousness, relationship to Atezolizumab, and outcome of adverse events graded according to NCI CTCAE (v5.0).(appr. 72 months)
- Immune Objective Response Rate (iORR)(appr. 72 months)
- Immune Progression Free Survival (iPFS)(appr. 72 months)
- Duration of Response (DoR)(appr. 72 months)
- Progression Free Survival (PFS)(appr. 72 months)
- Progression Free Survival (PFS) rate at one year(1 year)
- Immune Progression Free Survival (iPFS) rate at one year(1 year)
- Overall survival at one year(1 year)
- Objective Response Rate (ORR)(appr. 72 months)
研究者
研究点 (30)
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