Immunological Markers Predictive of Response and Toxicity to Checkpoint in Metastatic Non-Small-cell Lung Cancers
试验速览
- 阶段
- 不适用
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Change of biological markers of immunity under immunotherapy at 6 months
研究概览
简要总结
A prospective, observational, single-center study to determine the proportion of patients who have or will develop changes in biological markers of immunity during immunotherapy treatment.
详细描述
The study will run for 12 months with a 6-month follow-up at the inclusion of the last patient.
Patients will be included from the initiation of immunotherapy treatment regardless of the line.The routine immunological workup will be performed before the first immunotherapy infusion in order to analyze a certain number of immunological markers (autoantibodies, RF, LDH, complement (C3 C4), anti-tissue antibodies, lymphocyte immunophenotyping). This assessment will then be performed at progression, at the appearance of side effects requiring the immunotherapy to be stopped, or at 6 months of follow-up in case of continuation of the immunotherapy.
The investigators will evaluate the response to the treatment, the progression via re-evaluation assessments performed in standard practice (every 3 to 4 courses depending on the type of immunotherapy) as well as the appearance of side effects throughout the follow-up will be evaluate.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •Major patient
- •Metastatic non-small cell lung cancer
- •Initiation of anti PDL1 therapy (NIVOLUMAB, PEMBROLIZUMAB or ATEZOLIZUAMB) in daily practice
- •No objection made
排除标准
- •Autoimmune disease diagnosed prior to initiation of immune checkpoint inhibitor therapy.
- •Previous immune-modulating therapy (including corticosteroid therapy greater than 10 mg/day)
- •Patient with prior checkpoint inhibitor therapy
- •Patient with a contraindication to immunotherapy
- •Patient under legal protection
- •Refusal to participate
结局指标
主要结局
Change of biological markers of immunity under immunotherapy at 6 months
时间窗: Day 0 and month 6 (M6)
Determine the proportion of patients who have or will develop a change in biological markers of immunity under immunotherapy at 6 months or, failing that, at the end of the immunotherapy (FAN and/or RF and/or anti-tissue and/or decrease in acquired complement verified on the difference between 6 months and inclusion, lymphocyte immunophenotyping)
次要结局
- Impact of autoimmune toxicity on OS(Day 0 and month 6 (M6))
- Impact of complement(Day 0 and month 6 (M6))
- Impact of autoimmune toxicity on PFS(Day 0 and month 6 (M6))
- Impact of clinical factors(Day 0 and month 6 (M6))
- Study the clinical factors influencing the immune profile(Day 0 and month 6 (M6))
- Impact on autoimmune toxicity(Day 0 and month 6 (M6))
- Impact of CRP and lymphopenia(Day 0 and month 6 (M6))
- Impact on Overall Survival (OS) and Progression Free Survival (PFS)(Day 0 and Six month after (M6))