Phase II Randomized Trial of STEMVAC Vaccine with Sargramostim in Treating Patients with Stage IV Non-Small Cell Lung Cancer

What this Trial Is About

Researchers are evaluating a DNA vaccine called STEMVAC in patients with stage IV non-small cell lung cancer NSCLC. This phase II trial studies whether STEMVAC, which targets five specific proteins that help lung cancer grow, can shrink tumors when given with a drug called sargramostim GM-CSF. The vaccine is designed to activate the immune system to recognize and attack lung cancer cells during maintenance therapy. Participants are randomly assigned to one of two treatment groups. One group receives the STEMVAC vaccine plus sargramostim injected into the skin on day 14 of a 21-day maintenance therapy cycle for three doses, followed by a booster dose nine weeks after the third. The other group receives sargramostim alone on the same schedule. Both groups undergo CT scans and biopsies during screening and treatment, along with blood sample collections during the trial and follow-up. Throughout the study, participants are monitored for immune responses, tumor changes, and safety outcomes for up to 20 weeks, with some immune markers followed for up to a year. After treatment ends, follow-up occurs twice yearly for up to five years. Researchers measure tumor-infiltrating immune cells, vaccine-induced immune activity, overall cancer response, and survival outcomes to understand the vaccines effects and safety.

A Multiple Antigen Vaccine (STEMVAC) for the Treatment of Patients With Stage IV Non-Small Cell Lung Cancer