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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00029028

Enrollment

320

Registered

2022-05-27

Start date

2019-05-06

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

C34.1

Interventions

Group 1: This study is a retrospective analysis of data from patients with stage IV NSCLC whose blood samples were collected prior to their treatment with immune checkpoint inhibitors (anti-PD1 or ant

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

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

Exclusion criteria: none

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
- Determine the sensitivity and specificity of an identified miRNA biomarker signature. - Predicting the development of autoimmune complications in lung cancer patients receiving immune checkpoint inhibitor therapy by detecting miRNAs.	—

Countries

Germany

Contacts

Public ContactKaja Tikk

Hummingbird Diagnostics GmbH

ktikk@hb-dx.com0049062219143355

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026