RecruitingNCT04807114

A Single-cell Approach to Identify Biomarkers of Efficacy and Toxicity for ICI in NSCLC

A Single-cell Approach to Identify Biomarkers of Efficacy and Toxicity for Immune Checkpoint Blockade in Non-small Cell Lung Cancer


Sponsor

Universitaire Ziekenhuizen KU Leuven

Enrollment

70 participants

Start Date

Feb 1, 2020

Study Type

OBSERVATIONAL

Conditions

Summary

The main goal of this prospective non-interventional exploratory study is to characterize the tumor micro-environment of advanced NSCLC in single-cell resolution, prior to immune checkpoint blockade exposure, and correlate the findings to clinical outcome. This approach will allow to generate new hypotheses regarding mechanism of action of ICI and (primary) resistance mechanisms. The long-term goal is that these novel mechanistic insights will be translated to a clinical setting to develop better biomarkers of ICI efficacy. Importantly, since the investigators will also sequentially profile the immune composition of peripheral blood, this research offers an opportunity to develop circulating (non-invasive) biomarkers. A second aim is to characterize the immune cell composition of bronchoalveolar lavage (BAL) fluid from these ICI-treated cancer patients if they would develop ICI-pneumonitis. These mechanistic insights can directly lead to putative diagnostic biomarkers and therpeutic targets. Since single-cell profiling of blood samples will also be performed, circulating biomarkers of ICI toxicity can also be identified, making non-invasive diagnosis feasible.


Eligibility

Min Age: 18 YearsMax Age: 120 Years

Plain Language Summary

Simplified for easier understanding

This study is analyzing blood and tumor samples from people with non-small cell lung cancer (NSCLC) who are receiving immunotherapy as their first treatment, to identify biological markers that predict who will respond well — and who may experience serious side effects. **You may be eligible if...** - You are 18 or older - You have been diagnosed with non-small cell lung cancer (confirmed by biopsy) - You are starting first-line treatment per standard guidelines - You are not currently enrolled in another clinical trial **You may NOT be eligible if...** - You are enrolled in another clinical trial - You have not consented to providing samples - Your lung cancer diagnosis is not confirmed histologically Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGImmune checkpoint inhibitor

Standard-of-care treatment for st.IV NSCLC (no driver mutation, PD-L1 \> 50%)

DRUGChemotherapy + Immune checkpoint inhibitor

Standard-of-care treatment for st.IV NSCLC (no driver mutation, PD-L1 \< 50%)


Locations(1)

Universitaire Ziekenhuizen Leuven

Leuven, Belgium

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT04807114


Related Trials