RecruitingNot ApplicableNCT06849518
Study of Longitudinal Plasma PD-L1 Testing With Immunotherapy in Lung Cancer
Sponsor
Ballad Health
Enrollment
30 participants
Start Date
Feb 11, 2025
Study Type
INTERVENTIONAL
Conditions
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
Inclusion Criteria3
- 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 Criteria3
- No anti-PD-1/L1 monoclonal antibody treatment.
- Planned primary radiation therapy.
- Small-cell lung cancer histology.
Interventions
DIAGNOSTIC_TESTCirculogene liquid biopsy testing
A Circulogene liquid biopsy testing for plasma NGS ctDNA and plasma cfRNA PD-L1 expression.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06849518
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