Impact of obstructive sleep apnea on immunotherapy effectiveness in lung cancer
Obstructive Sleep Apnea Influences Efficacy of Anti-Programmed-Death-1-Based Immunotherapy Against Non-Small Cell Lung Cancer - A Prospective Observational Cohort Study
This study is testing how obstructive sleep apnea affects the success of a new lung cancer treatment in patients who haven't had any treatment before.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Peking University First Hospital Academic / other |
| Drugs / interventions | immunotherapy |
| Locations | 1 site (Beijing, Beijing) |
| Trial ID | NCT04743752 on ClinicalTrials.gov |
What this trial studies
This observational cohort study investigates how obstructive sleep apnea (OSA) affects the efficacy of PD-1-based immunotherapy in patients with advanced non-small cell lung cancer (NSCLC). Participants, who have not received prior treatment for NSCLC, will be monitored for four years and categorized based on their sleep apnea severity. The study will assess various biological markers and outcomes, including objective remission rate, overall survival, and progression-free survival, to understand the mechanisms behind any observed effects. The research is conducted at Peking University First Hospital and has received ethical approval.
Who should consider this trial
Good fit: Ideal candidates are patients with advanced non-small cell lung cancer who have not received prior treatment and are eligible for PD-1 antibody therapy.
Not a fit: Patients with severe infections, significant organ dysfunction, or those who have previously received treatment for obstructive sleep apnea may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for lung cancer patients with obstructive sleep apnea.
How similar studies have performed: While the specific interaction between obstructive sleep apnea and PD-1-based immunotherapy is novel, related studies have explored the impact of comorbidities on cancer treatment outcomes.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Beijing, Beijing
- Peking University First Hospital — Beijing, Beijing, China (Recruiting)
Study contacts
- Study coordinator: Jing Ma, MD
- Email: majjmail@163.com
- Phone: +8613651357974
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.