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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-120
SponsorUniversitaire Ziekenhuizen KU Leuven

About this trial

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 criteria

Qualifiers

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

Disqualifiers

None

Trial design

Treatments tested in this trial

  • Immune checkpoint inhibitor
  • Chemotherapy + Immune checkpoint inhibitor

Treatment groups

70 Participants
are divided into 2 treatment groups

Sponsors and collaborators