Actively Recruiting
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
Eligibility Criteria
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
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
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Universitaire Ziekenhuizen Leuven
Leuven, Belgium, 3000
Actively Recruiting
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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