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

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

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

Study Overview

• Status: Completed
• Conditions: Healthy; Non Small Cell Lung Cancer; Non Small Cell Lung Cancer Metastatic

• Study Type: Observational
• Enrollment (Actual): 29

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University Melvin & Bren Simon Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Healthy Group; Healthy volunteers will donate a sample of blood to be used as controls
NSCLC Group; 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?

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	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

Collaborators and Investigators

• Sponsor: Indiana University
• Investigators: Principal Investigator: Nasser Hanna, MD, Indiana Unversity

Study record dates

Study Major Dates

• Study Start (Actual): November 26, 2019
• Primary Completion (Actual): June 13, 2022
• Study Completion (Actual): June 13, 2022

Study Registration Dates

• First Submitted: December 3, 2019
• First Submitted That Met QC Criteria: December 3, 2019
• First Posted (Actual): December 5, 2019

Study Record Updates

• Last Update Posted (Actual): July 20, 2022
• Last Update Submitted That Met QC Criteria: July 19, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Lung Cancer; Non Small Cell Lung Cancer; Blood Donation
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: CTO-IUSCC-0701

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No