Belgian Hospital conducts a clinical rial of a Single-cell Approach to Identify Biomarkers of Efficacy and Toxicity for ICI in NSCLC
Universitaire Ziekenhuizen Leuven is recruiting patients for the clinical trial of A Single-cell Approach to Identify Biomarkers of Efficacy and Toxicity for ICI in NSCLC.
The main goal of this 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.
February 1, 2020 is the study start date. The indicative completion of the clinical trial will be expected in January 31, 2024.
The study will take place at the Universitaire Ziekenhuizen Leuven, Leuven, Belgium.
Among primary outcome measures is the Immune cell proportions, as determined by scRNA-seq, present in peripheral blood of ICI-treated st.IV NSCLC patients attaining objective response or not attaining objective response, before and after 1 cycle of ICI.
By identifying and statistically comparing the percentages of immune cell subtypes present in responding vs. non-responding patients' peripheral blood, investigators aim to:
- understand which immune processes drive response or resistance to ICI
- identify putative molecular biomarkers
- identify putative therapeutic targets
Among study population are patients treated with first-line anti-PD-1 Pembrolizumab (+- chemotherapy) for stage IV non-small cell lung cancer.
The conditions that allow participation:
- Adult M/F/X (>= 18 years)
- Histologically and clinically confirmed diagnosis of non-small cell lung cancer (according to IASLC Staging Handbook in Thoracic Oncology v7)
- Patients receiving first-line treatment per guidelines
- Not included in other clinical trials
The page dedicated to this clinical trial can be found here: https://ichgcp.net/clinical-trials-registry/NCT04807114
