Actively Recruiting

Age: 18Years - 120Years
All Genders
NCT04807114

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

Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2024-07-01

70

Participants Needed

1

Research Sites

260 weeks

Total Duration

On this page

Sponsors

U

Universitaire Ziekenhuizen KU Leuven

Lead Sponsor

K

KU Leuven

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 120Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult male, female, or other (18 years or older)
  • Histologically and clinically confirmed diagnosis of non-small cell lung cancer (stage IV) according to IASLC guidelines
  • Patients must be receiving first-line treatment following guidelines
  • Not currently participating in other clinical trials
  • Signed informed consent form
Not Eligible

You will not qualify if you...

  • Tumor or blood samples collected are not suitable for single-cell analysis due to poor quality, as determined by lab specialists

AI-Screening

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Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Universitaire Ziekenhuizen Leuven

Leuven, Belgium, 3000

Actively Recruiting

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Research Team

E

Els Wauters

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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