Prospective Trial Assessing Real World Outcomes Response to Pembro in Black Patients w/ NSCLC

Eligibility Criteria

• * Be willing and able to provide written informed consent/assent.
• * Must be ≥ 18 years of age on day of signing informed consent.
• * Be Black / African American per self-report.
• * Have an ECOG performance status of 0- 2.
• * Have histologically or cytologically confirmed, advanced/metastatic NSCLC.
• * Be treatment naïve in the advanced/metastatic/recurrent disease setting.
• * No known EGFR/ALK/ROS1 tumor mutations. Liquid biopsies are acceptable.
• * Patients who received platinum-containing adjuvant chemotherapy, neoadjuvant chemotherapy or definitive chemoradiation and/or neoadjuvant and/or adjuvant immunotherapy and/or consolidation immunotherapy therapy given for locally advanced disease and developed recurrent (local or metastatic) disease ≥ 6 months of completing therapy are eligible.
• * Be planned/eligible to receive first-line therapy in the advanced/metastatic setting.
• * Have testing status for PDL1 tissue status.
• * Participants who have AEs due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline. Participants with any grade endocrine-related AEs who are adequately treated with hormone replacement or participants who have ≤Grade 2 neuropathy are eligible.
• * Adequate organ function.
• * Female subjects of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
• * Female subjects of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile or abstain from heterosexual activity for the course of the study through 180 days after the last dose if treated with pembrolizumab plus chemotherapy, or 120 days after the last dose if treated with pembrolizumab monotherapy. Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for \> 1 year.
• * Male subjects should agree to use an adequate method of barrier contraception starting with the first dose of study therapy through 180 days after the last dose if treated with pembrolizumab plus chemotherapy.
• * Does not plan or is ineligible to receive pembrolizumab with or without chemotherapy per institutional standard/treating provider.
• * History of allogenic tissue/solid organ transplant.