Obstructive Sleep Apnea Influences Efficacy of PD-1-Based Immunotherapy Against Non-Small Cell Lung Cancer

Peking University

Status: Enrolling

Conditions: Non-small Cell Lung Cancer; Obstructive Sleep Apnea

Study type: Observational

Funder types: Other

Identifiers

NCT04743752

2020-405

Details and patient eligibility

About

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).

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

200 participants in 2 patient groups

Group OSA+NSCLC

Description:

According to the baseline sleep monitor results, participants will be divided into Group OSA+NSCLC if apnea hypopnea index(AHI) no less than 15.

Group NSCLC

Description:

According to the baseline sleep monitor results, participants will be divided into Group NSCLC if apnea hypopnea index(AHI) less than 15.