RecruitingNCT04807114

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

A Single-cell Approach to Identify Biomarkers of Efficacy and Toxicity for Immune Checkpoint Blockade in Non-small Cell Lung Cancer


Sponsor

Universitaire Ziekenhuizen KU Leuven

Enrollment

70 participants

Start Date

Feb 1, 2020

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 120 Years

Inclusion Criteria5

  • 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
  • Signed informed consent form

Exclusion Criteria1

  • • Collected material not suitable for further processing in this study (e.g. bad quality). This decision will be made in consultation with a lab technician and/or bio-informatician, specialized in single-cell analysis.

Interventions

DRUGImmune checkpoint inhibitor

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

DRUGChemotherapy + Immune checkpoint inhibitor

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


Locations(1)

Universitaire Ziekenhuizen Leuven

Leuven, Belgium

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT04807114


Related Trials