Study of Longitudinal Plasma PD-L1 Testing With Immunotherapy in Lung Cancer
Not Applicable
Recruiting
- Conditions
- Lung Cancer (NSCLC)
- Registration Number
- NCT06849518
- Lead Sponsor
- Ballad Health
- Brief Summary
This is a prospective pilot study to assess dynamic changes of plasma cell-free RNA (cfRNA) PD-L1 expression in patients with lung cancer undergoing immune checkpoint inhibitor (ICI) based therapy. Results will be correlated with radiographic assessment of immunotherapy treatment response and plasma NGS ctDNA.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
- 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.
- 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.
- 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
- No anti-PD-1/L1 monoclonal antibody treatment.
- Planned primary radiation therapy.
- Small-cell lung cancer histology.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Correlation of plasma cfRNA PD-L1 by qPCR expression* with ICI treatment and response. up to 24 months Circulogene ImmunoClear Assay
- Secondary Outcome Measures
Name Time Method Correlation of plasma cfRNA PD-L1 expression* results with any available tissue PD-L1 protein expression. up to 24 months Circulogene ImmunoClear Assay
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
How does longitudinal cfRNA PD-L1 monitoring correlate with tumor immune evasion mechanisms in NSCLC during ICI therapy?
What comparative effectiveness data exist for plasma cfRNA PD-L1 testing versus tissue PD-L1 assessment in predicting ICI response in NSCLC?
Which biomarkers (e.g., ctDNA, cfRNA PD-L1 dynamics) best predict durable response to immune checkpoint inhibitors in NSCLC patients?
What adverse event profiles are associated with longitudinal ICI therapy combined with serial PD-L1 liquid biopsy monitoring in NSCLC?
How do PD-L1 inhibitors (e.g., pembrolizumab, atezolizumab) combined with ctDNA analysis improve treatment monitoring in NSCLC compared to standard approaches?
Trial Locations
- Locations (1)
Ballad Health Cancer Care
🇺🇸Kingsport, Tennessee, United States