Obstructive Sleep Apnea Influences Efficacy of Anti-Programmed-Death-1-Based Immunotherapy Against Non-Small Cell Lung Cancer - A Prospective Observational Cohort Study

Status: Recruiting
Location: See location...
Study Type: Observational
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
China
Peking University First Hospital
RECRUITING
Beijing
Contact Information
Primary
Jing Ma, MD
majjmail@163.com
+8613651357974
Backup
Guangfa Wang, MD
wangguangfa@hotmail.com
+8613810644029
Time Frame
Start Date: 2021-02-23
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 200
Treatments
Group OSA+NSCLC
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
According to the baseline sleep monitor results, participants will be divided into Group NSCLC if apnea hypopnea index(AHI) less than 15.
Related Therapeutic Areas
Lung Cancer
Obstructive Sleep Apnea
Non-Small Cell Lung Cancer (NSCLC)
Sponsors
Leads: Peking University First Hospital

This content was sourced from clinicaltrials.gov

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