Lung Cancer (NSCLC)
Conditions
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.
Interventions
DIAGNOSTIC_TESTCirculogene liquid biopsy testing
A Circulogene liquid biopsy testing for plasma NGS ctDNA and plasma cfRNA PD-L1 expression.
Sponsors
Ballad Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
A Circulogene liquid biopsy testing for plasma NGS ctDNA and plasma cfRNA PD-L1 expression will be drawn (i) pre-treatment, (ii) at cycle 2 treatment, (iii) every other cycle while on combined doublet chemotherapy-immune treatment, (iv) at 3 months post-starting treatment, (v) at 6 months post-starting treatment, and (vi) upon discontinuation of ICI treatment due to planned completed duration of ICI treatment or upon progressing disease. ICI treatment and radiographic evaluations will be standard of care as determined by the treating oncologist.
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Correlation of plasma cfRNA PD-L1 by qPCR expression* with ICI treatment and response. | up to 24 months | Circulogene ImmunoClear Assay |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Correlation of plasma cfRNA PD-L1 expression* results with any available tissue PD-L1 protein expression. | up to 24 months | Circulogene ImmunoClear Assay |
Countries
United States
Contacts
Primary ContactCharles Mays, PhD, CCRP, CCRC
Outcome results
None listed