Clinical Research Directory
Browse clinical research sites, groups, and studies.
A Single-cell Approach to Identify Biomarkers of Efficacy and Toxicity for ICI in NSCLC
Sponsor: Universitaire Ziekenhuizen KU Leuven
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.
Official title: A Single-cell Approach to Identify Biomarkers of Efficacy and Toxicity for Immune Checkpoint Blockade in Non-small Cell Lung Cancer
Key Details
Gender
All
Age Range
18 Years - 120 Years
Study Type
OBSERVATIONAL
Enrollment
70
Start Date
2020-02-01
Completion Date
2025-01-31
Last Updated
2024-07-01
Healthy Volunteers
No
Interventions
Immune checkpoint inhibitor
Standard-of-care treatment for st.IV NSCLC (no driver mutation, PD-L1 \> 50%)
Chemotherapy + Immune checkpoint inhibitor
Standard-of-care treatment for st.IV NSCLC (no driver mutation, PD-L1 \< 50%)
Locations (1)
Universitaire Ziekenhuizen Leuven
Leuven, Belgium