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

Recruiting now · Phase 2

Conditions studied: Non-small Cell Lung Cancer

In brief

This is a non-registrational, cohort study enrolling eligible Black patients diagnosed with histologically or cytologically, advanced/metastatic NSCLC without known EGFR/ALK/ROS1 tumor mutations, and who are ≥ 18 years of age, ECOG performance status 0-2, and may have detectable ctDNA at baseline.

Key facts

Study ID

NCT06745882

Run by

H. Lee Moffitt Cancer Center and Research Institute

People needed

318

Starts

2025-06-13

Expected to finish

2030-01-01

Last updated by the study team

2026-07-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• Cohorts 1, 2a and b: Exclusion Criteria:
• 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.
• Cohort 2a and b Only: Exclusion Criteria:
• Received prior treatment chemotherapy and/or immune checkpoint inhibitor therapy in the advanced/metastatic setting for lung cancer.
• Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy at doses
• ≥ 10 mg prednisone or any other form of systemic immunosuppressive therapy at C1D1. Subjects are permitted to use topical, ocular, intra-articular, intranasal, and inhalational corticosteroids (with minimal systemic absorption). Physiologic replacement doses of systemic corticosteroids are permitted (i.e., ≤ 10 mg/day prednisone equivalents). A brief course (≤ 7 days) of corticosteroids for prophylaxis (e.g., contrast dye allergy) or for treatment of non-autoimmune conditions (e.g., delayed-type hypersensitivity reaction caused by contact allergen) is permitted.
• Has active autoimmune disease that has required active systemic treatment in the past 2 years [i.e., with use of disease modifying agents, corticosteroids in doses greater than 10 mg of prednisone daily (or equivalent) or immunosuppressive drugs]. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
• Subjects are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger.
• Has an active infection requiring systemic therapy.

Where it is running

• Moffitt Cancer Center — Tampa, Florida, United States (enrolling)
• Johns Hopkins Sidney Kimmel Comprehensive Cancer Center — Baltimore, Maryland, United States (enrolling)
• TidalHealth Peninsula Regional — Salisbury, Maryland, United States (enrolling)
• Montefiore Medical Cancer Center — The Bronx, New York, United States (enrolling)
• FirstHealth of the Carolinas, Inc. — Pinehurst, North Carolina, United States (enrolling)
• Baptist Clinical Research Institute — Memphis, Tennessee, United States (enrolling)
• Nashville General Hospital — Nashville, Tennessee, United States (enrolling)

Full record on ClinicalTrials.gov

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