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NCT05242965 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Stage IV Lung Cancer AJCC v8 and Lung Non-Small Cell Carcinoma, sponsored by University of Washington.

Active
Registry status
Phase 2
Development phase
5
Enrollment target
2
Study locations

NCT05242965: Active Phase 2 study of Stage IV Lung Cancer AJCC v8 and Lung Non-Small Cell Carcinoma, sponsored by University of Washington.

NCT05242965 is a Phase 2 study of Stage IV Lung Cancer AJCC v8 and Lung Non-Small Cell Carcinoma that is active but no longer recruiting, run by University of Washington. The registered enrollment target is 5 participants, below the 98-participant average among 81 other Stage IV Lung Cancer AJCC v8 trials with a reported enrollment target (95% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05242965, a Phase 2 study of Stage IV Lung Cancer AJCC v8 and Lung Non-Small Cell Carcinoma, is active but no longer recruiting, sponsored by University of Washington.

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
5 participants
Enrollment target
2
Study locations

Study 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.

Primary Outcome

Immunohistochemical (IHC) staining for CD8+ CD3+ will be performed on the biopsies collected pre-treatment and post 3rd vaccine administration.

Conditions Studied

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

Interventions

  • PROCEDURE Biospecimen Collection
  • PROCEDURE Computed Tomography
  • PROCEDURE Biopsy
  • BIOLOGICAL CD105/Yb-1/SOX2/CDH3/MDM2-polyepitope Plasmid DNA Vaccine
  • BIOLOGICAL Sargramostim

Study Locations (2)

Washington

  • VA Puget Sound Health Care System - Seattle
  • Fred Hutch/University of Washington Cancer Consortium - Seattle

Trial Details

FieldValue
Enrollment Target 5 participants
Start Date 2023-03-24
Est. Completion 2026-12-31
Phase Phase 2
University of Washington

1,048 total trials

What the registry record for NCT05242965 still lists

NCT05242965 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 98-participant average among 81 other Stage IV Lung Cancer AJCC v8 trials with a reported enrollment target (95% lower).

The record links to 2 conditions, with Stage IV Lung Cancer AJCC v8 appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.

NCT05242965 reports a single indexed study location in Washington.

Frequently Asked Questions

What is clinical trial NCT05242965 about?

NCT05242965 is a clinical study titled "A Multiple Antigen Vaccine (STEMVAC) for the Treatment of Patients With Stage IV Non-Small Cell Lung Cancer". 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...

What is the current status of trial NCT05242965?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 5 participants. The study started on 2023-03-24. Estimated completion is 2026-12-31.

What conditions does trial NCT05242965 study?

This clinical trial studies the following conditions: Stage IV Lung Cancer AJCC v8, Lung Non-Small Cell Carcinoma.

What interventions are being tested in trial NCT05242965?

The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Biopsy (PROCEDURE), CD105/Yb-1/SOX2/CDH3/MDM2-polyepitope Plasmid DNA Vaccine (BIOLOGICAL), Sargramostim (BIOLOGICAL).

Who is sponsoring clinical trial NCT05242965?

This trial is sponsored by University of Washington, which has 1,048 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05242965 being conducted?

This trial has 2 study locations across Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Stage IV Lung Cancer AJCC v8

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT05242965's enrollment target sits among peer trials

5 78th of 81 higher than 1 of 81 other Stage IV Lung Cancer AJCC v8 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Stage IV Lung Cancer AJCC v8 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT05242965, the US trial registry maintained by the National Library of Medicine. NCT05242965 (small enrollment · single site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.