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

N
Nasser Hanna, MD

Primary Investigator

Overview

Researchers would like to study how certain biomarkers (signs in your genes that show how well your body responds to a treatment for a disease or condition) change before, during, and after your standard of care treatment for your non-small cell lung cancer (NSCLC). The purpose of this study is to better understand how your genes may change over the course of your treatment. 

Eligibility

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Non Small Cell Lung Cancer
  • Age: Between 18 Years - 100 Years
  • Gender: All

Inclusion Criteria: 

NSCLC Subjects 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 TPS of at least 1%.  

7.Subjects with ECOG performance status of 0-2.

Healthy Controls 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.Willingness to undergo blood draw

Exclusion Criteria: 

NSCLC Subjects 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.

 

Healthy Subjects Exclusion Criteria:

1.Diagnosis of NSCLC or any other cancer

2.Known immunodeficiency

3.Serious acute or chronic disease (determined at the discretion of the treating physician) such as cardiovascular disease, COPD, diabetes, or autoimmune disorder

Updated on 20 Nov 2022. Study ID: 1908650279

Interested in the study?

Select a study center that’s convenient for you, and get in touch with the study team.

Contact a study center