Obstructive Sleep Apnea Influences Efficacy of Anti-Programmed-Death-1-Based Immunotherapy Against Non-Small Cell Lung Cancer - A Prospective Observational Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Objective response rate(ORR)
研究概览
简要总结
This prospective, observational cohort study aims to explore the influence of obstructive sleep apnea(OSA) on the efficacy of PD-1-based immunotherapy in patients with non-small cell lung cancer(NSCLC). Patients who had no prior treatment for advanced NSCLC and are intended to receive PD-1/PD-L1 antibody will be recruited. According to sleep monitor results, participants will be divided into Group NSCLC and Group OSA+NSCLC. Primary outcome is the objective remission rate(ORR).
详细描述
This is a single-center, prospective, observational cohort study. Patients who had no prior treatment for advanced NSCLC and are intended to receive PD-1/PD-L1 antibody will be recruited and followed for 4 years. According to the baseline sleep monitor results, participants will be divided into Group NSCLC(AHI<15), and Group OSA+NSCLC(AHI≥15), and then explore the influence of obstructive sleep apnea on the efficacy of PD-1-based immunotherapy. The baseline level of white blood cell count (WBC); absolute neutrophil count (ANC); absolute lymphocyte count (ALC); ANC to ALC (ANC:ALC) ratio; interleukin 6 (IL-6); C-reactive Protein (CRP) in peripheral blood, lymphocytes classification and count by flow cytometry, and gut microbiome analysis by quantitative metagenomics will also be measured to further search for the possible mechanisms. Primary outcome is the objective remission rate (ORR), secondary outcomes include overall survival (OS) and progression free survival (PFS).
The study protocol has been approved by the Peking University First Hospital Institutional Review Board (IRB). Any protocol modifications will be submitted for the IRB review and approval.
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
- •Histologically or cytologically confirmed, advanced NSCLC
- •Participants with no prior treatment for advanced NSCLC
- •Measurable disease as defined by RECIST v1.1
- •Eligible to receive first-line treatment including PD-1 antibody
- •Adequate hematologic and end organ function
排除标准
- •Severe infection within 4 weeks prior to recruitment.
- •Significant organ dysfunction or other serious diseases.
- •Previous or current OSA related treatment, including oral appliance, surgery, mechanical ventilation therapy.
- •Illness or condition that interferes with the participant's capacity to understand, follow and/or comply with study procedures.
结局指标
主要结局
Objective response rate(ORR)
时间窗: From date of randomization until the date of first documented progression, assessed up to 48 months
ORR, the percentage of complete response (CR) or partial response (PR) according to RECIST 1.1 standard definition.CR: disappearance of all target and non-target lesions and (if applicable) normalization of tumor marker level; or reduction in short axis of any pathological lymph nodes (whether target or non-target) to less than (\<) 10 mm. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters; or persistence of one or more non-target lesion(s) and/or (if applicable) maintenance of tumor marker level above the normal limits.
次要结局
- Factors associated with ORR in NSCLC patients(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months)
- Overall survival (OS)(From date of randomization until the date of death from any cause, assessed up to 48 months)
- Compared the baseline gut microbiome between Group NSCLC and Group OSA+NSCLC.(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months)
- The association between OSA and the diversity of gut microbiome.(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months)
- Factors associated with OS and PFS in NSCLC patients(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months)
- The association between OSA and baseline inflammatory biomarkers, peripheral lymphocytes classification and count.(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months)
- Progression-Free Survival (PFS)(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months)
- Compared the baseline level of inflammatory biomarkers between Group NSCLC and Group OSA+NSCLC.(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months)
- Compared the baseline sleep monitor results between Group NSCLC and Group OSA+NSCLC.(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months)
- Compared the baseline level of lymphocytes classification and count between Group NSCLC and Group OSA+NSCLC.(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months)
研究者
Jing MA
Prof.&MD
Peking University First Hospital