Study of Longitudinal Plasma PD-L1 Testing With Immunotherapy in Lung Cancer

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• 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.

Locations
United States
Tennessee
Ballad Health Cancer Care
RECRUITING
Kingsport
Contact Information
Primary
Charles Mays, PhD, CCRP, CCRC
Charles.Mays@balladhealth.org
423-431-5654
Time Frame
Start Date: 2025-02-11
Estimated Completion Date: 2027-03-01
Participants
Target number of participants: 30
Treatments
Other: plasma NGS ctDNA and plasma cfRNA PD-L1 expression
Related Therapeutic Areas
Sponsors
Leads: Ballad Health

This content was sourced from clinicaltrials.gov