Universal Immunization to Fortify Immunotherapy Efficacy and Response

Although immune checkpoint inhibitors (ICIs) have substantially extended survival in many patients, most patients do not achieve durable responses on these treatments. There is a substantial unmet need for methods to sensitize more patients to ICIs. Studies have shown that personalized mRNA lipid nanoparticle vaccines enhance antitumor immunity in combination with PD1 inhibition, under the assumption that these vaccines generate T cells reactive against the targets encoded by the mRNA in the vaccines. However, it was recently found that mRNA vaccines targeting non-tumor antigens are also powerful adjuvants to immune checkpoint blockade. Retrospective clinical data strongly suggests that receipt of COVID mRNA vaccines with ICIs is responsible for significant improvements in three-year overall survival in multiple large cohorts of patients with non-small cell lung cancer (NSCLC). Patients treated with these vaccines also have increased expression of programmed death ligand 1 (PD-L1) on their tumors. This trial is designed to evaluate whether the Pfizer-BioNTech COVID mRNA vaccine improves responses to ICIs in patients with stage IV non-small cell lung cancer.

NCT Number	NCT07597070
Lead Sponsor	University of Florida Collaborators: M.D. Anderson Cancer Center
Conditions	Stage 4 NSCLC
Enrollment	500 participants
Start Date	2026-09
Primary Completion	2035-03 (estimated)
Study Completion	2035-03 (estimated)
Updated on ClinicalTrials.gov	2026-06-08