Analysis of Nutritional Biomarkers to Predict the Efficacy of Immunotherapy by Anti-PD/PDL1 Checkpoints Inhibitors in Metastatic Non-small Cell Lung Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- 6-month Progression-free survival
研究概览
简要总结
CERTIM is a cohort created in July 2015 to set up a multidisciplinary follow-up of cancer patients treated with immune checkpoint inhibitors.
From the CERTIM cohort, we conducted a longitudinal, prospective, observational study (ELY) in two tertiary university centers (Cochin hospital and European Georges Pompidou Hospital), which included patients between August 2016 and October 2019 and ended follow-up in April 2020.
Patients were treated with nivolumab, at a dose of 3 mg/kg every 2 weeks, or pembrolizumab, at a dose of 2mg/kg every 3 weeks. The investigators report findings from an evaluation of rest energy expenditure (REE) assessed using indirect calorimetry in the outpatient setting before treatment with checkpoints inhibitors.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •18 years or older
- •Stage IV histologically proven Non Small Cell Lung Cancer (NSCLC)
- •Monotherapy with nivolumab or pembrolizumab.
- •Patients were required to have measurable disease per the Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1.
排除标准
- •Active malignancy other than NSCLC,
- •ALK or EGFR mutated NSCLC
- •Anticancer therapy or surgery within the past 2 weeks or inability to breathe under the calorimetry.
结局指标
主要结局
6-month Progression-free survival
时间窗: 6 months after start of treatment
Calculated as the percentage of participants alive and without disease progression, as assessed by the Investigator using RECIST v1.1
次要结局
未报告次要终点
研究者
Camille Levalois
Co-investigator
Hôpital Cochin