Testing blood samples for lung cancer treatment response
Study of Longitudinal Plasma PD-L1 Testing With Immunotherapy in Lung Cancer
This study is testing if blood tests can show how well immune therapy works for people with advanced lung cancer who can't have surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Sex | All |
| Sponsor | Ballad Health Academic / other |
| Drugs / interventions | radiation, immunotherapy |
| Locations | 1 site (Kingsport, Tennessee) |
| Trial ID | NCT06849518 on ClinicalTrials.gov |
What this trial studies
This pilot study aims to evaluate changes in plasma cell-free RNA PD-L1 expression in patients with lung cancer who are receiving immune checkpoint inhibitor therapy. It will involve liquid biopsy testing to assess how these changes correlate with the effectiveness of the treatment as measured by radiographic imaging. The study focuses on patients with advanced non-small cell lung cancer who are not candidates for surgery and are undergoing specific immunotherapy regimens.
Who should consider this trial
Good fit: Ideal candidates are patients diagnosed with stage IV or inoperable stage IIIB non-small cell lung cancer receiving anti-PD-1/L1 based immunotherapy.
Not a fit: Patients who are not receiving anti-PD-1/L1 monoclonal antibody treatment or those with small-cell lung cancer will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved monitoring of treatment responses in lung cancer patients, allowing for more personalized therapy adjustments.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in using liquid biopsies for monitoring treatment responses in various cancers.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. All patients with a diagnosis of stage IV or inoperable stage IIIB NSCLC without planned primary radiation therapy undergoing anti-PD-1/L1 based ICI treatment. 2. Chemo-immune or dual anti-PD-1/L1 with anti-CTLA-4 based regimens are eligible as long as receiving an anti-PD-1/L1 monoclonal antibody. 3. A documented informed consent will be obtained prior to inclusion in the study. All discussions with patients will be held in strictest confidence and out of earshot of the general public. Patients will be fully informed that their participation in the study is voluntary. Patients may decline to be part of the study. Their decision to participate in the study will not affect the care they receive. Exclusion Criteria: 1. No anti-PD-1/L1 monoclonal antibody treatment. 2. Planned primary radiation therapy. 3. Small-cell lung cancer histology.
Where this trial is running
Kingsport, Tennessee
- Ballad Health Cancer Care — Kingsport, Tennessee, United States (Recruiting)
Study contacts
- Study coordinator: Charles Mays, PhD, CCRP, CCRC
- Email: Charles.Mays@balladhealth.org
- Phone: 423-431-5654
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.