Healthy, Non Small Cell Lung Cancer, Non Small Cell Lung Cancer Metastatic
Conditions
Keywords
Blood Donation, Lung Cancer, Non Small Cell Lung Cancer
Brief summary
This is a blood collection study being conducted to better understand and describe the immunological blood profile changes in patients with advanced non small cell lung cancer undergoing treatment with checkpoint inhibitor therapy. Blood will be collected from healthy volunteers and patients with non small cell lung cancer
Interventions
None listed
Sponsors
Indiana University
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. ≥ 18 years old at the time of informed consent 2. Written informed consent and HIPAA authorization for release of personal health information. 3. Subjects with histologically and radiographically confirmed NSCLC. 4. Subjects must have stage IV disease or recurrent disease. 5. Subjects should be treatment naïve (systemic therapies) or have received prior chemotherapy in the first line setting. Prior radiation or surgery is permissible. 6. Subjects who are eligible to receive single agent immunotherapy must have documentation of a PD-L1 Tumor Proportion Score (TPS) of at least 1%. 7. Subjects with Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
Exclusion criteria
1. Subjects with curable or potentially curable NSCLC. 2. Subjects should not have contraindications to treatment with immune checkpoint inhibitors per standard criteria. 3. Patients with targetable mutations eligible for treatment with molecularly targeted small molecule inhibitor therapy. 4. Subjects eligible for combination treatment with chemoimmunotherapy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean change in myeloid derived suppressive cells (MDSCs) | baseline and cycle 3 | change in MDSCs before and after treatment |
| Mean change in B regulatory cells (Bregs) | baseline and cycle 3 | change in Bregs before and after treatment |
| Mean change in T regulatory cells (Tregs) before and after treatment | baseline and cycle 3 | change in Tregs before and after treatment |
Secondary
| Measure | Time frame |
|---|---|
| Describe the programmed death-ligand 1 (PD-L1) expression profile on peripheral blood MDSCs, Bregs, and Tregs | baseline, cycle 3 |
| Describe the programmed death-ligand 1 (PD1) expression profile on peripheral blood MDSCs, Bregs, and Tregs | baseline, cycle 3 |
Countries
United States
Outcome results
None listed