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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 120
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Belgium
Universitaire Ziekenhuizen Leuven
RECRUITING
Leuven
Contact Information
Primary
Els Wauters
els.wauters@uzleuven.be
+3216340942
Time Frame
Start Date: 2020-02-01
Estimated Completion Date: 2025-01-31
Participants
Target number of participants: 70
Treatments
NSCLC st.IV (PD-L1 > 50%)
Anti-PD-1 monotherapy
NSCLC st.IV (PD-L1 < 50%)
Combination anti-PD-1 + chemotherapy
Sponsors
Leads: Universitaire Ziekenhuizen KU Leuven
Collaborators: KU Leuven

This content was sourced from clinicaltrials.gov