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

Sponsor

Indiana University (Other)

Overall Status

Completed

CT.gov ID

NCT04187768

Collaborator

(none)

Enrollment

Location

30.6

Actual Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Non Small Cell Lung Cancer Non Small Cell Lung Cancer Metastatic Healthy

Study Design

Study Type:

Observational

Actual Enrollment :

29 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Nov 26, 2019

Actual Primary Completion Date :

Jun 13, 2022

Actual Study Completion Date :

Jun 13, 2022

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Indiana University Melvin & Bren Simon Cancer Center	Indianapolis	Indiana	United States	46202

Sponsors and Collaborators

Indiana University

Investigators

Principal Investigator: Nasser Hanna, MD, Indiana Unversity

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Nasser Hanna, Professor of Medicine, Tom and Julie Wood Family Foundation Professor of Lung Cancer Clinical Research, Indiana University

ClinicalTrials.gov Identifier:

NCT04187768

Other Study ID Numbers:

CTO-IUSCC-0701

First Posted:

Dec 5, 2019

Last Update Posted:

Jul 20, 2022

Last Verified:

Jul 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Nasser Hanna, Professor of Medicine, Tom and Julie Wood Family Foundation Professor of Lung Cancer Clinical Research, Indiana University

Blood Donation

Lung Cancer

Non Small Cell Lung Cancer

Additional relevant MeSH terms:

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Study Results

No Results Posted as of Jul 20, 2022