New vaccine aims to train immune system against lung cancer
NCT ID NCT01720836
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 1/2 trial is testing a vaccine made from a piece of the MUC1 protein, which is found on many lung cancer cells. The vaccine is mixed with an adjuvant called Poly-ICLC to boost the immune response. Thirty patients with early or locally advanced non-small cell lung cancer will receive the vaccine every three weeks for three doses, with optional yearly boosters. The goal is to see if the vaccine triggers the body to produce antibodies against MUC1, potentially helping the immune system fight the cancer.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- MUC1 peptide vaccine with Poly-ICLC (Hiltonol) adjuvant
- What this could lead to
- If successful, this vaccine could train the immune system to recognize and attack lung cancer cells, potentially preventing recurrence in early-stage patients.
- What could go wrong
- This is an early phase 1/2 trial with only 30 participants, so it is too small to prove effectiveness. The vaccine may not produce a strong enough immune response or could cause side effects.
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 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Start date
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Nov 2012
- Expected to finish
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Oct 2032
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
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: * Subjects must have histologically or cytologically confirmed non-small cell lung cancer (NSCLC) or neuroendocrine carcinoid tumor * All subjects must have one of the following stages: Stage IA(T1NO); IB (T2NO), II \& IIIA (N2 negative); IIIA (N2+), IIIB (N3+) * Patients must have stable disease at the time of enrollment * Women and men at least 18 years of age * ECOG performance status 0-1(Appendix A) * Subjects must be within 4 to 24 weeks of standard of care treatment for their particular stage of disease * Subjects must have acceptable organ and marrow function as defined below: * Leukocytes \> 3,000/µL * Absolute Neutrophils \> 1,500/µL * Hemoglobin \> 10 g/dL * Platelets \> 100,000/µL * Total Bilirubin within normal institutional limits * Creatinine within normal institutional limits OR * Creatinine clearance \> 60 mL/min/1.73 m2 for subjects with above normal AST and ALT with alkaline phosphatase within \< 1.5 times upper limit of normal * The effects of a MUC1vaccine on the developing human fetus at the recommended therapeutic dose are unknown. For this reason, men and women of childbearing potential must be willing to use effective contraception (hormonal barrier method of birth control; abstinence) while on study treatment and for at least 3 months thereafter. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately Exclusion Criteria: * Subjects may not be receiving any other investigational agents \- No history of prior malignancy, except for non-melanoma skin cancer * Any positive 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. * Known Hepatitis B on immunomodulators (i.e. interferon) * Known Hepatitis C on immunomodulators (i.e. interferon) * No prior vaccine therapy * Patients may not be receiving any steroids or other anti-immune therapy at the time of registration. * Subjects must not be more than 24 weeks from standard of care treatment for their particular stage of disease * Subjects must not have post-obstructive pneumonia or other serious infection at the time of registration or other serious underlying medical condition that would impair the ability of the subjects to receive protocol treatment * Prior resection of lung cancer is allowed, if at least five years have elapsed between previous resection and registration * 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 * Pregnant women are excluded from this study. Women of childbearing potential must have a negative pregnancy test * Subjects with immune deficiency are not expected to respond to the vaccine. Therefore, known HIV-positive patients are excluded from the study * Subjects with a history of known autoimmune disease are excluded from this study
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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
1 site. 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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UPMC Hillman Cancer Center
RECRUITINGPittsburgh, Pennsylvania, 15232, United States
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