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RECRUITING
NCT04807114

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

Sponsor: Universitaire Ziekenhuizen KU Leuven

View on ClinicalTrials.gov

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

DRUG

Immune checkpoint inhibitor

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

DRUG

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