Pilot Study of the Contribution of Fractional Exhaled Nitric Oxide as a Prognostic Marker of Response to Anti-PD-L1 Immunotherapy in Non-small Cell Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Response to immunotherapy by CT scan
研究概览
简要总结
Based on the use of the patient's natural defences, immunotherapy mobilizes the immune system to recognize and destroy cancer cells, and it has revolutionized the treatment of lung cancer.
However, the effectiveness of immunotherapy varies from patient to patient. At present, we have no weak markers to predict with certainty the efficacy of immunotherapy treatment in a given individual.
Current scientific data identifies a number of molecules produced by the cancer cells and their environment which can be detected by various means (blood tests, breath analysis, etc.).
The aim of this study is to understand whether the amount of nitric oxide (NO) present in the breath is a more accurate predictor of response to immunotherapy.
Participation in this study involves breath testing (to measure FeNO (Fractional exhaled Nitric Oxide)) before receiving the first infusion of immunotherapy, and at the follow-up visit after the 4th course of immunotherapy.
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
- •Patients with metastatic NSCLC
- •Patient not previously treated
- •PD-L1 tumor expression > 50%, to be treated with immunotherapy alone after validation by a multidisciplinary consultation meeting.
- •Patients over 18 years of age
- •Patient having given his/her non-opposition
- •Patient who speaks and reads French
排除标准
- •Patients previously treated for NSCLC
- •Patient with oncogene addiction or a first-line targetable rearrangement
- •Patient not suitable for immunotherapy alone
- •Patient having received corticosteroid treatment in the 15 days prior to FeNO.
- •Patient on inhaled corticosteroid at time of inclusion.
- •Blood eosinophilia > 500 /mm3
- •Patient on 24-hour oxygen therapy
- •Contraindication to immunotherapy
- •Inability to perform FeNO measurement manoeuvres
- •Pregnant, parturient or breast-feeding women
- •Person under judicial protection (curatorship, guardianship)
- •Person subject to limited judicial protection
- •Adult unable to express their non-opposition
- •Patient refusing to participate in the study
研究组 & 干预措施
Patients
Patients with metastatic non-small-cell lung cancer
干预措施: Measurement of FeNO (Other)
结局指标
主要结局
Response to immunotherapy by CT scan
时间窗: after 4 courses of immunotherapy, an average of 9 weeks
Evaluation according to RECIST criteria by comparing FeNO levels between patients responding and not responding to immunotherapy.
次要结局
未报告次要终点