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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Enrolling

Conditions: Immune Checkpoint Inhibitors; Lung Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT05288569

JS-2853

Details and patient eligibility

About

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

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18-80 years of age
• Stage I-IV Lung Cancer confirmed by histopathology or imaging techniques
• Receiving anti-PD-1/anti-PD-L1 immunotherapy (with indication and no contraindication)

Exclusion criteria

• Other cancer treatment
• Other malignancies