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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05288569
• Other study ID #: JS-2853
• Status: Recruiting
• Start date: January 21, 2022
• Est. completion date: September 2024

Study information

• Verified date: March 2023
• Source: Peking Union Medical College Hospital
• Contact: Huaxia Yang
• Phone: +86-13488869596
• Email: yanghuaxia2013[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: September 2024
• Est. primary completion date: September 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Immune Checkpoint Inhibitors
• Lung Cancer
• Lung Neoplasms

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

References & Publications (1)

Yang H, Yao Z, Zhou X, Zhang W, Zhang X, Zhang F. Immune-related adverse events of checkpoint inhibitors: Insights into immunological dysregulation. Clin Immunol. 2020 Apr;213:108377. doi: 10.1016/j.clim.2020.108377. Epub 2020 Mar 2. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	occurrence of immune-related adverse event (irAE)	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	12 months since immunotherapy initiation
Secondary	Overall Survival	Patients will be followed up for 2 years to investigate Overall Survival	24 months since immunotherapy initiation
Secondary	Progression Free Survival.	Patients will be followed up for 2 years to investigate Progression Free Survival.	24 months since immunotherapy initiation