Could a vaccine stop lung cancer before it starts?
NCT ID NCT07169617
First seen Jun 24, 2026 · Last updated Aug 27, 2026 · Updated 3 times
Summary
This study tests a vaccine called SurVaxM in 80 current or former heavy smokers at high risk for lung cancer. The vaccine trains the immune system to recognize and attack cells that produce a protein called survivin, which is common in cancer cells. The goal is to see if the vaccine can trigger antibodies that may prevent lung cancer from developing.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- SurVaxM (survivin peptide vaccine) with montanide and sargramostim
- What this could lead to
- If it works, this could point toward a vaccine that prevents lung cancer in people at high risk, like heavy smokers.
- What could go wrong
- This is an early phase II trial with only 80 participants, so results may not apply broadly. The vaccine may not trigger a strong enough immune response or prevent cancer.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 80 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2029
An estimate. End dates often move.
- Lead sponsor
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A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Former and current smokers (male and female) with a \>= 20 pack year smoking history * Prostate, Lung, Colorectal and Ovarian (PLCO)m2012 Lung Cancer Risk Prediction Score \> 1.34% * Participants \>= 18 years old will be enrolled. Because no dosing or adverse event (AE) data are currently available on the use of SurVaxM in participants \< 18 years of age, children and adolescents are excluded from this study but will be eligible for future pediatric trials, if applicable * Eastern Cooperative Oncology Group (ECOG) performance status =\< 1 (Karnofsky \>= 60%) * Platelets \>= 100,000/microliter * Total bilirubin =\< 1.5 x institutional upper limit of normal (ULN) * Note: Higher total bilirubin levels (=\< 3 mg/dL) can be allowed if due to known benign liver condition, i.e. Gilbert's * Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 1.5 x institutional upper limit of normal * Serum creatinine =\< 1.5 x institutional upper limit of normal * The effects of SurVaxM plus montanide on the developing human fetus at the recommended therapeutic dose are unknown. For this reason women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately * Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: * History of autoimmune disease necessitating systemic immunosuppression, immunodeficiency, and/or organ allograft * Participants may not be receiving any other chemotherapy (except hormonal agents), immunotherapy or investigational agent, or any immunosuppressive agent, including systemic steroids, including those given after organ transplant * Participants with current or prior malignancy except for the following: * Malignancy treated with curative intent and with no evidence of active disease present for more than 3 years before screening and felt to be at low risk for recurrence by treating physician * Adequately treated carcinoma-in-situ or basal cell carcinoma of the skin without current evidence of disease * Adequately treated lentigo maligna melanoma without current evidence of disease or adequately controlled nonmelanomatous skin cancer * Prior or current malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen (e.g., localized prostate cancer) may be included * History of allergic reactions attributed to compounds of similar chemical or biologic composition to montanide or granulocyte-macrophage colony-stimulating factor (GM-CSF) * Uncontrolled intercurrent illness, or psychiatric illness/social situations that would limit compliance with study requirements * Pregnant women are excluded from this study because of the unknown effects of SurVaxM plus montanide on the fetus. Because there is an unknown but potential risk for AEs in nursing infants secondary to treatment of the mother with SurVaxM plus montanide, breastfeeding should be discontinued if the mother is treated with SurVaxM plus montanide * Individuals participating in another interception trial with an immunomodulatory agent will be excluded from participation in this trial for a washout period of 6 months
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
4 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Northwestern University
Chicago, Illinois, 60611, United States
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Rocky Mountain Regional VA Medical Center
Aurora, Colorado, 80045, United States
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Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
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University of Tennessee - Knoxville
Knoxville, Tennessee, 37920, United States
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