A Multiple Antigen Vaccine (STEMVAC) for the Treatment of Patients With Stage IV Non-Small Cell Lung Cancer
Active, enrolledPhase 2Results postedLast updated 3 April 2026
What this trial tests
Phase 2 trial testing CD105/Yb-1/SOX2/CDH3/MDM2-polyepitope Plasmid DNA Vaccine in Lung Non-Small Cell Carcinoma in 5 participants. Participants enrolled and being followed up; not accepting new ones.
18 and older, any sex, with Lung Non-Small Cell Carcinoma or Stage IV Lung Cancer AJCC v8. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
CD8 is Reported as a Fraction of CD3+ Tumor Infiltrating Lymphocytes (TIL) in 4 High-power Field (HPF)Primary· Baseline and after the third vaccine (at approximately 12 weeks)
Immunohistochemical (IHC) staining for CD8+ CD3+ will be performed on the biopsies collected pre-treatment and post 3rd vaccine administration.
Baseline % of CD8+ of CD3+ TIL
Group
Value
95% CI
Arm I (STEMVAC, Sargramostim)
32
32 – 32
Arm II (Sargramostim)
32
14 – 51
Post Vaccine % of CD8+ of CD3+ TIL
Group
Value
95% CI
Arm I (STEMVAC, Sargramostim)
49
49 – 49
Arm II (Sargramostim)
41
26 – 56
Number of Participants With Recorded Adverse Event(s)Primary· Up to 20 weeks
Will be evaluated using the modified National Cancer Institute (NCI) toxicity criteria. Toxicity evaluation will be based on Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Group
Value
95% CI
Arm I (STEMVAC, Sargramostim)
2
Arm II (Sargramostim)
3
Adverse events — posted to ClinicalTrials.gov
Time frame: Systemic adverse events (AE) will be recorded from the time of confirmed eligibility through End of Treatment (up to 20 weeks). Patients are monitored for the development of vaccine toxicities with clinical lab results and physical exams. Clinically significant AEs are graded on a scale of 1-5. We will record AEs reported to us by the patient, caregivers, and clinical support staff. All-cause mortality will be assessed up to 5 years. Serious and other AEs were assessed up to 20 weeks..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
Other trials of CD105/Yb-1/SOX2/CDH3/MDM2-polyepitope Plasmid DNA Vaccine
Trials testing the same drug.
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Washington
Last refreshed: 3 April 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05242965.