NCT05288569

irAE Prediction of Anti-PD-1/L1 in Lung Cancer

Immunological Biomarkers for Immune-related Adverse Events of Anti-PD-1/PD-L1 Immunotherapy in Lung Cancer: a Prediction Model

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 120 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

the purpose of this study is to identify multi-dimensional immunological biomarkers including cytokines, autoantibodies, and immune cell subtypes of immune-related adverse events (primary) and prognosis(secondary) in the anti-PD-1/anti-PD-L1 immunotherapy for lung cancer

Detailed description

After being informed of the study and potential risk, all patients giving written informed consent will undergo peripheral blood sample collection at baseline (before treatment ), 1month and 3month after treatment initiation, and when immune-related adverse events ever occur. The follow-up period will be 1 year for any occurrence of immune-related adverse events and 2 years follow-up for the prognosis.

Conditions

• Immune Checkpoint Inhibitors
• Lung Cancer

Timeline

• Start date: 2022-01-21
• Primary completion: 2023-09-01
• Completion: 2024-09-01
• First posted: 2022-03-21
• Last updated: 2023-04-07

Locations

1 site across 1 country: China