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

NCT04807114 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 70

Last updated 2024-07-01

No results posted yet for this study

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.

Conditions

  • Lung Diseases, Interstitial
  • NSCLC
  • Immunotherapy

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%)

Sponsors & Collaborators

  • KU Leuven

    collaborator OTHER

  • Universitaire Ziekenhuizen KU Leuven

    lead OTHER

Principal Investigators

  • Els Wauters, MD, PhD · University Hospitals - KU Leuven

Eligibility

Min Age
18 Years
Max Age
120 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-01
Primary Completion
2025-01-31
Completion
2025-01-31

Countries

  • Belgium

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04807114 on ClinicalTrials.gov