Clinical trial NCT04743752: Obstructive Sleep Apnea Influences Efficacy of PD-1-Based Immunotherapy Against Non-Small Cell Lung Cancer
Official title: Obstructive Sleep Apnea Influences Efficacy of Anti-Programmed-Death-1-Based Immunotherapy Against Non-Small Cell Lung Cancer - A Prospective Observational Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Obstructive Sleep Apnea
Non-small Cell Lung Cancer
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
First posted: 2021-02-08
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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).

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Histologically or cytologically confirmed, advanced NSCLC
2. Participants with no prior treatment for advanced NSCLC
3. Measurable disease as defined by RECIST v1.1
4. Eligible to receive first-line treatment including PD-1 antibody
5. Adequate hematologic and end organ function

Exclusion Criteria:

1. Severe infection within 4 weeks prior to recruitment.
2. Significant organ dysfunction or other serious diseases.
3. Previous or current OSA related treatment, including oral appliance, surgery, mechanical ventilation therapy.
4. Illness or condition that interferes with the participant's capacity to understand, follow and/or comply with study procedures.

Primary outcomes:
measure: Objective response rate(ORR)
timeFrame: From date of randomization until the date of first documented progression, assessed up to 48 months
Secondary outcomes:
measure: Progression-Free Survival (PFS)
timeFrame: 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
measure: Overall survival (OS)
timeFrame: From date of randomization until the date of death from any cause, assessed up to 48 months
measure: Compared the baseline sleep monitor results between Group NSCLC and Group OSA+NSCLC.
timeFrame: 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
measure: Factors associated with ORR in NSCLC patients
timeFrame: 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
measure: Factors associated with OS and PFS in NSCLC patients
timeFrame: 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
measure: Compared the baseline level of lymphocytes classification and count between Group NSCLC and Group OSA+NSCLC.
timeFrame: 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
measure: Compared the baseline level of inflammatory biomarkers between Group NSCLC and Group OSA+NSCLC.
timeFrame: 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
measure: The association between OSA and baseline inflammatory biomarkers, peripheral lymphocytes classification and count.
timeFrame: 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
measure: Compared the baseline gut microbiome between Group NSCLC and Group OSA+NSCLC.
timeFrame: 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
measure: The association between OSA and the diversity of gut microbiome.
timeFrame: 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
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
Study officials:
affiliation: Peking University First Hospital
name: Jing Ma, MD
role: STUDY_CHAIR
affiliation: Peking University First Hospital
name: Guangfa Wang, MD
role: STUDY_DIRECTOR
affiliation: Peking University First Hospital
name: Yuan Cheng
role: STUDY_DIRECTOR
affiliation: Peking University First Hospital
name: Ligong Nie
role: STUDY_DIRECTOR
References: