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

NCT04187768 | Completed DMC

• 1 other identifier: CTO-IUSCC-0701
• Study Type: observational
• Target: 29
• Locations: 1 country
• Sites: 1

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

Conditions

Non Small Cell Lung Cancer; Non Small Cell Lung Cancer Metastatic; Healthy

Keywords

Blood Donation; Lung Cancer; Non Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• 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

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• ≥ 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Indiana University Melvin & Bren Simon Cancer Center

Indianapolis, Indiana, 46202, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

10 mL of blood will be collected at each time point

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Nasser Hanna, MD

  Indiana Unversity

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine, Tom and Julie Wood Family Foundation Professor of Lung Cancer Clinical Research

Study Record Dates

• First Submitted: December 3, 2019
• First Posted: December 5, 2019
• Study Start: November 26, 2019
• Primary Completion: June 13, 2022
• Study Completion: June 13, 2022
• Last Updated: July 20, 2022

Record last verified: 2022-07

Locations

US (1)