Lung Non-Small Cell CarcinomaPhase 2NCT05242965

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

A Phase 2 study testing CD105/Yb-1/SOX2/CDH3/MDM2-polyepitope Plasmid DNA Vaccine, Sargramostim and Computed Tomography in people with Lung Non-Small Cell Carcinoma and Stage IV Lung Cancer AJCC v8, run by University of Washington at 2 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Lung Non-Small Cell Carcinoma, Stage IV Lung Cancer AJCC v8
What is being tested?: CD105/Yb-1/SOX2/CDH3/MDM2-polyepitope Plasmid DNA Vaccine, Sargramostim and Computed Tomography
Type of treatment: Vaccines, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 2 sitesUnited States
Study dates: 24 Mar 2023to 21 Nov 2032
Phase: Phase 2

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Histologically-confirmed diagnosis of stage IV non-squamous or squamous NSCLC.
Have measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 within one month of first vaccine. Target lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
Have completed 3-4 cycles of chemoimmunotherapy, without evidence of progressive disease. Pembrolizumab has to be included in at least 3 of these cycles.
Have not received more than 2 cycles of maintenance pembrolizumab and/or pemetrexed and be a candidate for continuation of this therapy.
At least 1 site of disease that could be biopsied during treatment. This site should not be a site that is used to determine measurable disease for efficacy purposes. Lesions that will be biopsied should not be on a previously irradiated area unless progression has been demonstrated in such lesions.
Patients must be at least 28 days post systemic steroids prior to enrollment, unless this is a steroid administered concurrently with chemotherapy or used as part of prophylaxis to prevent intravenous (IV) contrast reactions.

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Patients must have Eastern Cooperative Oncology Group (ECOG) Performance Status Score of 0 or 1.
Patients must have recovered from major infections and/or surgical procedures, and in the opinion of a principle investigator (PI)/co-PI/study physician/physician extender, not have any significant active concurrent medical illnesses precluding protocol treatment.
Willing to undergo up to two serial biopsies while on study.
Estimated life expectancy of more than 6 months.
White blood cells (WBC) >= 3000/mm^3 (within 60 days of first vaccination).
Lymphocyte count >= 800/mm^3 (within 60 days of first vaccination).
Platelet count >= 75,000/mm^3 (within 60 days of first vaccination).
Hemoglobin (Hgb) >= 9 g/dl (within 60 days of first vaccination).
Serum creatinine =< 1.2 mg/dl or creatinine clearance > 50 ml/min (within 60 days of first vaccination).
Total bilirubin =< 1.5 mg/dl (within 60 days of first vaccination).
Aspartate aminotransferase/serum glutamic oxaloacetic transaminase (AST/SGOT) =< 2 times upper limit of normal (ULN) or SGOT =< 5 times upper limit of normal (ULN) in the presence of liver metastasis (within 60 days of first vaccination).
If female of childbearing potential has a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study medication.
All patients who are having sex that can lead to pregnancy must agree to contraception for the duration of study.
Patients must be at least 18 years of age.

Who cannot join

Patients with any of the following cardiac conditions:
Symptomatic restrictive cardiomyopathy
Unstable angina within 4 months prior to enrollment
New York Heart Association functional class III-IV heart failure on active treatment
Symptomatic pericardial effusion
Patients with central nervous system (CNS) metastasis that have not been treated. Patients with previously treated brain metastases may participate provided they are clinically stable for at least 4 weeks and, have no evidence of new or enlarging brain metastases and also are off steroids for 2 weeks prior to dosing with study medication.

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Patients with any contraindication to receiving recombinant human granulocyte-macrophage colony stimulating factor (rhuGM-CSF) based products.
Patients with any clinically significant autoimmune disease that requires active treatment with immunosuppressants. Replacement therapy (e.g., thyroxine, insulin) is not considered a form of systemic treatment. Administration of systemic steroids (i.e., for allergic reactions, computed tomography (CT) scans, or the management of immune related adverse events [irAEs]) is allowed.
Has a known history of another prior invasive malignancy within 2 years, except subjects with early stage cancer that has undergone potentially curative therapy with no evidence of that disease recurrence for 2 years since initiation of that therapy.
Patients who are simultaneously enrolled in any other treatment study.
Patients who are pregnant or breastfeeding.
Patients with genetic driver alterations (e.g EGFR, ALK, ROS1, BRAF, MET ex 14, RET) for which targeted treatment exist and are Food and Drug Association (FDA) approved, except if the subject is not eligible or has progressed through those therapies.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Jennifer Childs contact

866-932-8588

CVICoordinators@medicine.washington.edu

United States2 sites, 1 recruiting

University of Nebraska Medical Center
Omaha, Nebraska, 98198
Jennifer S Childs, MPH, 206-616-2305, childj@uw.edu
Apar Ganti
Recruiting
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109
Active, not recruiting

Other trials in United States

About this study

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

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.

Read the 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.

This study previously closed to accrual in 2025. The study reopened at the University of Nebraska in 2026.

Conditions: Lung Non-Small Cell Carcinoma, Stage IV Lung Cancer AJCC v8
Being tested: CD105/Yb-1/SOX2/CDH3/MDM2-polyepitope Plasmid DNA Vaccine, Sargramostim, Computed Tomography, Biopsy, Biospecimen Collection
Medical subject headings: Carcinoma, Non-Small-Cell Lung, Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CD105/Yb-1/SOX2/CDH3/MDM2-polyepitope Plasmid DNA VaccineBiological
Also called CD105/Yb-1/SOX2/CDH3/MDM2 Plasmid Vaccine, STEMVAC, STEMVAC Th1 Polyepitope Plasmid-based Vaccine
Given ID
SargramostimBiological
Also called 23-L-Leucinecolony-Stimulating Factor 2, DRG-0012, Leukine, Prokine
Given ID
Computed TomographyProcedure or surgery
Also called CAT Scan, Computed Axial Tomography, CT Scan
Undergo CT
BiopsyProcedure or surgery
Also called Bx
Undergo biopsy
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection
Undergo blood sample collection

Study groups in NCT05242965
Study group	Role	What they receive
Arm I (STEMVAC, sargramostim)	Experimental	Patients receive STEMVAC ID and sargramostim ID on day 14 (+3 days) 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. Receives: Biological: CD105/Yb-1/SOX2/CDH3/MDM2-polyepitope Plasmid DNA Vaccine; Biological: Sargramostim; Procedure: Computed Tomography; Procedure: Biopsy; Procedure: Biospecimen Collection
Arm II (sargramostim)	Active comparator	Patients receive sargramostim ID on day 14 (+3 days) 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. Receives: Biological: Sargramostim; Procedure: Computed Tomography; Procedure: Biopsy; Procedure: Biospecimen Collection

What is being measured

The primary outcome is the main question the study is designed to answer.

CD8 is Reported as a Fraction of CD3+ Tumor Infiltrating Lymphocytes (TIL) in 4 High-power Field (HPF)
Immunohistochemical (IHC) staining for CD8+ CD3+ will be performed on the biopsies collected pre-treatment and post 3rd vaccine administration.
Measured: Baseline and after the third vaccine (at approximately 12 weeks)
Number of Participants With Recorded Adverse Event(s)
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
Measured: Up to 20 weeks

Secondary outcomes (6)

Magnitude of the Immune Response to CD105/Yb-1/SOX2/CDH3/MDM2-polyepitope Plasmid DNA Vaccine (STEMVAC)
Will measure the magnitude of the Th1 STEMVAC specific immune response using IFN-gamma enzyme-linked immunosorbent spot (ELISPOT). T-test among the 2 groups (vaccine and adjuvant alone) will be conducted to evaluate immune response if skewness is not observed.
Measured: Up to 1 year
Vaccine Induced T-cells Traffic to Tumor
Will evaluate if vaccine induced T-cells traffic to tumor and eliminate cancer cells which have undergone epithelial to mesenchymal transformation (EMT). Will assess TCR-beta (TCRb) gene usage in both T-cell lines expanded from peripheral blood and in the tumor biopsy, and the expression of EMT related genes in the tumor after vaccination with STMEVAC+GM-CSF or GM-CSF alone. Shannon diversity index will be summarized and the Clopper-Pearson confidence interval will be computed for the rate of T-cell trafficking among the 10 patients subject to TCRb sequencing.
Measured: Up to 1 year
Overall Response Rate (ORR)
Will evaluate potential clinical response approximately one month after the 3rd vaccine using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. An informal comparison will be conducted to compare the ORR between the two arms, with the Fisher exact test to account for small sample size.
Measured: 1 month after the 3rd vaccine (Up to 6 months)
Progression Free Survival (PFS)
Kaplan-Meier estimates of the survival function with 95% confidence intervals (CIs) at specific time points (using Greenwood's formula for the standard error) will be computed.
Measured: Up to 5 years
Overall Survival (OS)
Kaplan-Meier estimates of the survival function with 95% CIs at specific time points (using Greenwood's formula for the standard error) will be computed. Comparisons of OS in the two arms will be conducted by the log-rank test.
Measured: Up to 5 years
T-cell Activation and Type I Lymphocyte Markers
Two-sample T-tests or the Wilcoxon test will be utilized to compare the absolute change of T-cell activation markers and the Type I immune cells from baseline based on the normality of the data.
Measured: Up to 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Mar 202321 Nov 2032

First posted16 Feb 2022
Study start24 Mar 2023
Primary completion21 Nov 2027 (estimated)
Study completion21 Nov 2032 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Lung Non-Small Cell CarcinomaStudies of the same condition, open and under way.
More trials run by University of WashingtonThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 40 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05242965
Sponsor's protocol ID: RG1013946
Other IDs: NCI-2021-14159, 10726, W81XWH2110271
Status last verified: Jul 2026
First submitted: 18 Jan 2022
Last updated: 27 Jul 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No