Immunological Profile Changes In Patients with Advanced Non-Small Cell Lung Cancer Undergoing Treatment with Checkpoint Inhibitor Monotherapy
Study on Gene Changes During Lung Cancer Treatment
Brief description of study.
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 of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Non Small Cell Lung Cancer
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Age: 18 years - 100 years
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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
This study investigates how certain biomarkers, which are signs in your genes that indicate how well your body responds to treatment, change before, during, and after standard care for non-small cell lung cancer (NSCLC). The purpose of this study is to better understand the genetic changes that occur over the course of treatment for NSCLC, a type of lung cancer.
Participants will undergo procedures including blood draws to monitor these genetic changes. The study will involve comparing the biomarkers in NSCLC patients with those in healthy controls to identify any significant differences or patterns.
- Who can participate: Adults aged 18 and older with confirmed NSCLC, either stage IV or recurrent, who are either treatment-naïve or have had prior chemotherapy, are eligible. Healthy adults willing to undergo a blood draw may also participate.
- Study details: Participants will have blood samples taken at different times to study changes in their genes. Healthy controls will also provide blood samples for comparison. A placebo is not used in this study.
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