Immunological Profile Changes In Patients With Advanced Non-Small Cell Lung Cancer

Study Overview
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Brief Summary
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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

Official Title
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Immunological Profile Changes In Patients With Advanced Non-Small Cell Lung Cancer Undergoing Treatment With Checkpoint Inhibitor Monotherapy

Conditions
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Non Small Cell Lung Cancer, Non Small Cell Lung Cancer Metastatic, Healthy

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥ 18 years old at the time of informed consent Written informed consent and HIPAA authorization for release of personal health information. Subjects with histologically and radiographically confirmed NSCLC. Subjects must have stage IV disease or recurrent disease. Subjects should be treatment naïve (systemic therapies) or have received prior chemotherapy in the first line setting. Prior radiation or surgery is permissible. Subjects who are eligible to receive single agent immunotherapy must have documentation of a PD-L1 Tumor Proportion Score (TPS) of at least 1%. Subjects with Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. Exclusion Criteria: Subjects with curable or potentially curable NSCLC. Subjects should not have contraindications to treatment with immune checkpoint inhibitors per standard criteria. Patients with targetable mutations eligible for treatment with molecularly targeted small molecule inhibitor therapy. Subjects eligible for combination treatment with chemoimmunotherapy.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Healthy Group<br>Healthy volunteers will donate a sample of blood to be used as controls | |
| NSCLC Group<br>Patients with advanced NSCLC will have blood collected prior to treatment and after completing 3 cycles of immune checkpoint therapy. . If a patient is noted to have progressive disease after 2 cycles of treatment, a sample will be collected after the 2nd cycle. If a patient is noted to have pseudoprogression (determined at the discretion of the treating physician), an additional sample may be collected after 3 cycles of therapy. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change in myeloid derived suppressive cells (MDSCs) | change in MDSCs before and after treatment | baseline and cycle 3 | 
| Mean change in B regulatory cells (Bregs) | change in Bregs before and after treatment | baseline and cycle 3 | 
| Mean change in T regulatory cells (Tregs) before and after treatment | change in Tregs before and after treatment | baseline and cycle 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Blood Donation, Lung Cancer, Non Small Cell Lung Cancer