Could a vaccine stop lung cancer in smokers? early trial launches
NCT ID NCT03300817
First seen Jun 27, 2026 · Last updated Jul 31, 2026 · Updated 1 time
Summary
This early-phase trial tests a MUC1 peptide vaccine in 50 current or former smokers at high risk for lung cancer. The vaccine aims to train the immune system to recognize and attack precancerous cells before they become cancer. The study focuses on safety and whether the vaccine triggers a strong immune response.
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 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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50 people
The number who actually took part.
- Started
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Dec 2017
- Expected to finish
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Dec 2026
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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55 to 80 years
- 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: * PRE-REGISTRATION INCLUSION CRITERIA * Smoking history of \>= 30 pack-years AND either current smoker (still smoking or quit \< 1 year prior to pre-registration) OR former smoker (quit 1-15 years prior to pre-registration); Note: Pack years is determined by multiplying the number of packs smoked per day by the number of years smoked * Eastern Cooperative Oncology Group (ECOG) performance status =\< 1 * Computed tomography (CT) scan of the chest done =\< 6 months prior to pre-registration showing either negative findings (no nodules) or solid or part-solid nodules \< 6 mm in size (consistent with \< 1% probability of malignancy, Lung-Reporting and Data Systems \[RADs\] version 1.0) * Willingness to employ adequate contraception, if applicable; Note: 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 * REGISTRATION INCLUSION CRITERIA * Leukocytes (white blood cell \[WBC\]) \>= 3,000/microliter * Neutrophils (absolute neutrophil count \[ANC\]) \>= 1,500/microliter * 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 \[SGOT\]) =\< 1.5 x institutional upper limit of normal (ULN) * Alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 1.5 x institutional upper limit of normal (ULN) * Creatinine =\< institutional upper limit of normal (ULN) Exclusion Criteria: * PRE-REGISTRATION EXCLUSION CRITERIA * History of any malignancy; exceptions: non-melanoma skin cancer or carcinoma in situ (CIS) of the cervix * Known hepatitis B or C * Receiving any other investigational agents * Any prior investigational immune therapy, such as for lung cancer prevention or treatment or for CIS of the cervix * Use of oral or systemic steroids or other systemic anti-immune therapy =\< 90 days prior to pre-registration; Note: Use of inhaled/nasal steroids and local steroid injections for pain control are not exclusionary * Known human immunodeficiency virus (HIV) * Known autoimmune disease * Known non-alcoholic steatohepatitis (NASH) or non-alcoholic fatty liver disease (NAFLD) * History of allergic reactions attributed to compounds of similar chemical or biologic composition to MUC1/Poly-ICLC * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * REGISTRATION EXCLUSION CRITERIA * Any positive antinuclear antibody (ANA) titer above 1:160, even in an asymptomatic individual. Note: Weakly positive ANA defined as ANA titers up to 1:160 maximum (=\< 1:160) will be acceptable in an asymptomatic individual who is otherwise eligible for the study * Pregnant or breast feeding; Note: Pregnant women are excluded from this study because the MUC1/Poly-ICLC vaccine may have the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events (AEs) in nursing infants secondary to treatment of the mother with MUC1/Poly-ICLC vaccine, breastfeeding should be discontinued if the mother is treated with the vaccine
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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.
Contacts and locations
Locations
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Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
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UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232, United States
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Other studies related to the condition(s) this trial covers.
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