Immunotherapy Proof-of-Concept Study - Determination of miRNA biomarkers to predict response and autoimmune complications in lung cancer patients treated with immune checkpoint inhibitors.

• Conditions: C34.1; Upper lobe, bronchus or lung

• Registration Number: DRKS00029028
• Lead Sponsor: Hummingbird Diagnostics GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2021-02-09
• Study Start: 2022-05-27
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 320

Inclusion Criteria

Male or female patient older than 18 years whose suitable blood samples are available at the Lung Biobank Heidelberg.
- Diagnosed stage IV lung cancer
- Treatment with immune checkpoint inhibitor (anti-PD1 or anti-PD-L1 antibody, e.g. nivolumab, pembrolizumab or atezolizumab).

Exclusion Criteria

none

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The main objective of this study is to identify specific miRNA or miRNA signatures in whole blood that predict response in NSCLC patients on therapy with immune checkpoint inhibitors.

Secondary Outcome Measures

Name	Time	Method
- Determine the sensitivity and specificity of an identified miRNA biomarker signature.<br>- Predicting the development of autoimmune complications in lung cancer patients receiving immune checkpoint inhibitor therapy by detecting miRNAs.