STEMVAC for Stage IV Non-Small Cell Lung Cancer
This study is testing a vaccine called STEMVAC for people with stage IV non-small cell lung cancer. STEMVAC is designed to help your body's immune system fight cancer cells by targeting specific proteins that help the cancer grow. It's given with another medication called sargramostim, which helps boost your immune response. Researchers want to see if STEMVAC can shrink tumors and how safe it is. To join, you must have stage IV non-small cell lung cancer that can be measured. The study is also looking at how many immune cells (CD8 T cells) are in your tumors before and after treatment. This study is currently open for enrollment at the University of Nebraska.
- Study design
- This is a phase II interventional study with 40 planned participants. It is a randomized study, meaning you would be assigned to one of two groups by chance.
- What's involved
- You would receive STEMVAC and sargramostim, or sargramostim alone, on a schedule for several doses. You would also have CT scans, biopsies, and blood draws during the study and follow-up.
- Compensation
- Not stated in the trial record.
- Follow-up
- After treatment, you would be followed up twice a year for up to 5 years.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT05242965
A Multiple Antigen Vaccine (STEMVAC) for the Treatment of Patients With Stage IV Non-Small Cell Lung Cancer
Recruiting
PHASE2Ages 18+InterventionalTreatmentUniversity of WashingtonInvestigator-initiated
~40 participants
Updated 2026-07-27 on ClinicalTrials.gov
What's tested:CD105/Yb-1/SOX2/CDH3/MDM2-polyepitope Plasmid DNA VaccineSargramostimComputed TomographyBiopsyBiospecimen Collection
At a glance
Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
CD8 is Reported as a Fraction of CD3+ Tumor Infiltrating Lymphocytes (TIL) in 4 High-power Field (HPF)
Measured over Baseline and after the third vaccine (at approximately 12 weeks)
+1 more outcome measured
Conditions
Where it's being run
2 sites across 2 statesNebraska1
Washington1
Study leadership
- Natasha Hunter · PRINCIPAL_INVESTIGATOR · Fred Hutch/University of Washington Cancer Consortium
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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.
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.
Exclusion
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.
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.
What this trial measures
- CD8 is Reported as a Fraction of CD3+ Tumor Infiltrating Lymphocytes (TIL) in 4 High-power Field (HPF)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.
- Number of Participants With Recorded Adverse Event(s)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