Clinical trial NCT04187768: Immunological Profile Changes In Patients With Advanced Non-Small Cell Lung Cancer
Official title: Immunological Profile Changes In Patients With Advanced Non-Small Cell Lung Cancer Undergoing Treatment With Checkpoint Inhibitor Monotherapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non Small Cell Lung Cancer
Non Small Cell Lung Cancer Metastatic
Healthy
Keywords: Blood Donation
Lung Cancer
Non Small Cell Lung Cancer
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2019-12-05
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with advanced NSCLC and healthy volunteers with no diagnosis of cancer, known immunodeficiency or other serious chronic illness

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


Eligibility criteria: 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.

Primary outcomes:
measure: Mean change in myeloid derived suppressive cells (MDSCs)
timeFrame: baseline and cycle 3
measure: Mean change in B regulatory cells (Bregs)
timeFrame: baseline and cycle 3
measure: Mean change in T regulatory cells (Tregs) before and after treatment
timeFrame: baseline and cycle 3
Secondary outcomes:
measure: Describe the programmed death-ligand 1 (PD-L1) expression profile on peripheral blood MDSCs, Bregs, and Tregs
timeFrame: baseline, cycle 3
measure: Describe the programmed death-ligand 1 (PD1) expression profile on peripheral blood MDSCs, Bregs, and Tregs
timeFrame: baseline, cycle 3
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University Melvin & Bren Simon Cancer Center
state: Indiana
Study officials:
affiliation: Indiana Unversity
name: Nasser Hanna, MD
role: PRINCIPAL_INVESTIGATOR
References: