Actively Recruiting
A Single-cell Approach to Identify Biomarkers of Efficacy and Toxicity for Immune Checkpoint Blockade in Non-small Cell Lung Cancer
Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2024-07-01
70
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
Universitaire Ziekenhuizen KU Leuven
Lead Sponsor
K
KU Leuven
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying advanced non-small cell lung cancer (NSCLC) patients to better understand how the immune system interacts with tumors before treatment with immune checkpoint inhibitors (ICI). This observational study aims to identify new biomarkers related to how well patients respond to these therapies and explore mechanisms behind resistance. They also seek to find markers for immune-related side effects like ICI-pneumonitis by analyzing immune cells in blood and lung fluid samples. The study collects tumor biopsies from 70 stage IV NSCLC patients before they start treatment with ICIs. These samples undergo detailed single-cell RNA and TCR sequencing to identify different immune and stromal cell types and their gene activity. Blood samples are similarly analyzed to compare immune cell profiles. For patients developing ICI-related lung inflammation, bronchoalveolar lavage fluid will also be studied to find diagnostic markers. Treatments include either anti-PD-1 monotherapy or combination of anti-PD-1 with chemotherapy, according to standard care based on PD-L1 levels. Participants will be monitored from inclusion through about two years, during which immune cell proportions in tumor biopsies, blood, and lung fluid will be measured and correlated with treatment response. Researchers will use advanced bioinformatics to identify immune cell clusters and gene programs to understand immune activation and suppression. This comprehensive monitoring aims to develop new non-invasive biomarkers to guide future treatment and management of NSCLC patients receiving immune checkpoint therapies.
CONDITIONS
Brief Title
A Single-cell Approach to Identify Biomarkers of Efficacy and Toxicity for ICI in NSCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Histologically and clinically confirmed diagnosis of non-small cell lung cancer
- Patients receiving first-line treatment according to guidelines
- Not currently enrolled in any other clinical trials
- Signed informed consent form
You will not qualify if you...
- Collected material not suitable for further processing due to poor quality, as determined by specialized lab staff
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - Within 1 week before treatment start
Participants undergo routine medically required tumor biopsies and blood sampling to collect samples for experimental single-cell analyses.
1 visit (in-person) for tumor biopsy and blood sampling
Duration - Up to approximately 2 years
Participants who receive standard-of-care immune checkpoint inhibitor treatment (with or without chemotherapy) are observed to assess immune cell profiles in tumor and blood samples over time.
Periodic sample collections and assessments as per routine care
Trial Site Locations
Total: 1 location
1
Universitaire Ziekenhuizen Leuven
Leuven, Belgium, 3000
Actively Recruiting
Research Team
E
Els Wauters
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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