Identifying biomarkers for lung cancer treatment response and toxicity
A Single-cell Approach to Identify Biomarkers of Efficacy and Toxicity for Immune Checkpoint Blockade in Non-small Cell Lung Cancer
This study is testing if looking at immune cells in lung cancer patients can help predict how well they will respond to a new type of treatment and if they might experience side effects.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 70 (estimated) |
| Ages | 18 Years to 120 Years |
| Sex | All |
| Sponsor | Universitaire Ziekenhuizen KU Leuven Academic / other |
| Locations | 1 site (Leuven) |
| Trial ID | NCT04807114 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the tumor micro-environment of advanced non-small cell lung cancer (NSCLC) at a single-cell level before treatment with immune checkpoint inhibitors (ICIs). By analyzing tumor biopsies and peripheral blood, the study seeks to correlate immune cell composition with clinical outcomes, potentially leading to the development of new biomarkers for ICI efficacy and resistance. Additionally, the study will investigate immune cell profiles in bronchoalveolar lavage fluid from patients who develop ICI-pneumonitis, providing insights into diagnostic and therapeutic strategies.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with histologically confirmed advanced non-small cell lung cancer who are starting first-line treatment.
Not a fit: Patients with unsuitable biopsy material or those participating in other clinical trials may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved biomarkers that enhance the effectiveness of immunotherapy for lung cancer patients.
How similar studies have performed: While similar studies have explored immune profiling in cancer, this specific approach using single-cell analysis in NSCLC is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria: * 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 criteria: • 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.
Where this trial is running
Leuven
- Universitaire Ziekenhuizen Leuven — Leuven, Belgium (Recruiting)
Study contacts
- Principal investigator: Els Wauters, MD, PhD — University Hospitals - KU Leuven
- Study coordinator: Els Wauters
- Email: els.wauters@uzleuven.be
- Phone: +3216340942
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.