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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04187768
• Other study ID #: CTO-IUSCC-0701
• Status: Completed
• Start date: November 26, 2019
• Est. completion date: June 13, 2022

Study information

• Verified date: July 2022
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: June 13, 2022
• Est. primary completion date: June 13, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Healthy
• Lung Neoplasms
• Non Small Cell Lung Cancer
• Non Small Cell Lung Cancer Metastatic

Locations

Country	Name	City	State
United States	Indiana University Melvin & Bren Simon Cancer Center	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change in myeloid derived suppressive cells (MDSCs)	change in MDSCs before and after treatment	baseline and cycle 3
Primary	Mean change in B regulatory cells (Bregs)	change in Bregs before and after treatment	baseline and cycle 3
Primary	Mean change in T regulatory cells (Tregs) before and after treatment	change in Tregs before and after treatment	baseline and cycle 3
Secondary	Describe the programmed death-ligand 1 (PD-L1) expression profile on peripheral blood MDSCs, Bregs, and Tregs		baseline, cycle 3
Secondary	Describe the programmed death-ligand 1 (PD1) expression profile on peripheral blood MDSCs, Bregs, and Tregs		baseline, cycle 3