NCT05242965

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

A Phase II Randomized Study of Safety and Efficacy of a Multiple Antigen Vaccine (STEMVAC) in Non-Small-Cell Lung Cancer Patients

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: University of Washington · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial tests whether CD105/Yb-1/SOX2/CDH3/MDM2-polyepitope plasmid DNA vaccine (STEMVAC) works to shrink tumors in patients with stage IV non-small cell lung cancer. STEMVAC targets specific immunogenic proteins that help lung cancer cells to grow. STEMVAC is made up of deoxyribonucleic acid (DNA), which is a natural substance in every living organism. DNA acts like a blueprint that tells all the cells in your body how to function. The DNA used in this study contains instructions for your body to produce parts of the 5 proteins the investigators identified (CDH3, CD105, YB-1, MDM2 and SOX2). STEMVAC is given with granulocyte-macrophage colony stimulating factor (GM-CSF) which is being used as an adjuvant to help create a stronger immune response. Giving STEMVAC with GM-CSF to patients while on maintenance therapy for non-small cell lung cancer (NSCLC) may help activate certain immune cells to recognize and kill lung cancer cells.

Detailed description

OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive STEMVAC intradermally (ID) and sargramostim ID on day 14 of the 21-day maintenance therapy cycle for a series of 3 vaccine doses and a booster vaccine 9 weeks after the third vaccine dose. Patients also undergo computed tomography (CT) and biopsy during screening and on the trial, as well as blood sample collection on trial and during follow-up. ARM II: Patients receive sargramostim ID on day 14 of the 21-day maintenance therapy cycle for a series of 3 vaccine doses and a booster vaccine 9 weeks after the third vaccine dose. Patients also undergo CT and biopsy during screening and on the trial, as well as blood sample collection on trial and during follow-up. After completion of study treatment, patients are followed up twice yearly for up to 5 years.

Conditions

• Lung Non-Small Cell Carcinoma
• Stage IV Lung Cancer AJCC v8

Interventions

Type	Name	Description
BIOLOGICAL	CD105/Yb-1/SOX2/CDH3/MDM2-polyepitope Plasmid DNA Vaccine	Given ID
BIOLOGICAL	Sargramostim	Given ID
PROCEDURE	Computed Tomography	Undergo CT
PROCEDURE	Biopsy	Undergo biopsy
PROCEDURE	Biospecimen Collection	Undergo blood sample collection

Timeline

• Start date: 2023-03-24
• Primary completion: 2024-08-13
• Completion: 2026-12-31
• First posted: 2022-02-16
• Last updated: 2026-04-03
• Results posted: 2026-04-03

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study