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

Recruiting

• Conditions: Immune Checkpoint Inhibitors; Lung Cancer

• Registration Number: NCT05288569
• Lead Sponsor: Peking Union Medical College Hospital

Brief 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.

Study Timeline

• Study Start: 2022-01-21
• Study First Submitted: 2022-03-11
• Study First Submitted QC: 2022-03-18
• Study First Posted: 2022-03-21
• Status Verified: 2023-03
• Last Update Submitted: 2023-04-05
• Last Update Posted: 2023-04-07
• Primary Completion: 2023-09
• Study Completion: 2024-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
occurrence of immune-related adverse event (irAE)	12 months since immunotherapy initiation	Any adverse events occured within 12 months since immunotherapy initiation will be independently evaluated by two clinicians to determine whether it is irAE and all the clinical characteristics of irAE will be documented

Secondary Outcome Measures

Name	Time	Method
Overall Survival	24 months since immunotherapy initiation	Patients will be followed up for 2 years to investigate Overall Survival
Progression Free Survival.	24 months since immunotherapy initiation	Patients will be followed up for 2 years to investigate Progression Free Survival.

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, China