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Non-small Cell Lung Cancer (NSCLC)Phase 1/2NCT01720836

Study of the Immune Response of MUC1 (Mucin1) Peptide Vaccine for Non-small Cell Lung Cancer

A Phase 1/2 study testing Vaccine + PolyICLC in people with Non-small Cell Lung Cancer (NSCLC), run by Olivera Finn at 1 site 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

All subjects will receive the vaccine subcutaneously every 3 weeks x 3 with optional yearly booster vaccines up to and including 10 years post last vaccine for those patients who are confirmed responders to the vaccine . Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-small Cell Lung Cancer (NSCLC)
What is being tested?
Vaccine + PolyICLC
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited States
Study dates
Nov 2012to Oct 2032
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

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

  • 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
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  • 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

Who cannot join

  • 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)
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  • 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

Trial locations and contacts

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

Research Coordinator contact

412-647-8583

wardj@upmc.edu

United States1 site, 1 recruiting

  • UPMC Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232

    Recruiting

Other trials in United States

About this study

Official title: Study of the Immunogenicity of the MUC1 Peptide - Poly-ICLC (Polyinosinic-polycytidylic Acid Stabilized With Polylysine and Carboxymethylcellulose) OR HILTONOL™ Adjuvant Vaccine in Patients With Localized and Locally Advanced Non-Small Cell Lung Cancer

All subjects will receive the vaccine subcutaneously every 3 weeks x 3 with optional yearly booster vaccines up to and including 10 years post last vaccine for those patients who are confirmed responders to the vaccine . The rationale for using Poly-ICLC as an adjuvant are two ongoing trials at University of Pittsburgh Cancer Institute (UPCI) of the MUC1 100mer peptide vaccine - one as a therapeutic vaccine in subjects with metastatic castrate resistant prostate cancer and the other in subjects with advanced colonic adenomas at risk for developing colon cancer. The same formulation, MUC1 100mer peptide admixed with Poly-ICLC, is used in both trials. There has been no toxicity observed and the vaccine is highly immunogenic in early disease. In the proposed NSCLC trial the anti-MUC1 immune response will be thoroughly characterized.

Being tested
Vaccine + PolyICLC
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

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

  • Vaccine + PolyICLCBiological

    The vaccine will consist of 100 micrograms of MUC1 100mer peptide dissolved in 50 micro-liters of sterile saline, admixed with 500 micrograms of Hiltonol® in 250 microliters volume, for a total injection volume of 300 microliters.

Study groups in NCT01720836
Study groupRoleWhat they receive
Stage IA or I/II NSCLC or neuroendocrine carcinoid tumorExperimentalResection or radiotherapy without adjuvant chemotherapy followed by 3 cycles of vaccine + PolyICLC.
Receives: Biological: Vaccine + PolyICLC
Stage IB/II/IIIAExperimentalResection and neoadjuvant and/or adjuvant chemotherapy followed by 3 cycles of vaccine + PolyICLC.
Receives: Biological: Vaccine + PolyICLC
Stage IIIA or IIIBExperimentalInoperable, concomitant chemo-irradiation followed by 3 cycles of vaccine + PolyICLC.
Receives: Biological: Vaccine + PolyICLC

What is being measured

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

  1. Immunologic response

    Immunologic response will be measured by increases in anti MUC1 antibody titers post vaccination at different stages of disease: localized (Stage I, II) or locally advanced (Stage III) non-small cell lung cancer and neuroendocrine carcinoid tumors.

    Measured: 2 years

Secondary outcomes (6)

  1. Anti-MUC1 immunity

    To assess spontaneous anti- MUC1 immunity in response to cancer prior to administration of the MUC1 vaccine

    Measured: 2 years

  2. Association between baseline MUC1 immunity and vaccine

    To assess the association between baseline MUC1 immunity and vaccine - induced increases in anti MUC1 antibodies

    Measured: 2 years

  3. Immunocompetence versus immunosuppression

    To characterize the change in the balance between immunocompetence (response of T cells to polyclonal stimulation) versus immunosuppression at different stages of disease {check for increased numbers of regulatory T cells (Treg) and Myeloid-Derived Suppressor Cells (MDSC)}

    Measured: 2 years

  4. MUC1 associated safety

    To monitor adverse events associated with the study agents

    Measured: 2 years

  5. survival

    To monitor for progression free survival

    Measured: 2 years

  6. survival

    To monitor for progression of overall survival

    Measured: 2 years

Timeline

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

  1. First posted2 Nov 2012 (estimated)
  2. Study startNov 2012
  3. Primary completionOct 2028 (estimated)
  4. Study completionOct 2032 (estimated)

Resources

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 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01720836
Sponsor's protocol ID
11-094
Other IDs
902168
Status last verified
Oct 2026
First submitted
31 Oct 2012
Last updated
26 Oct 2026
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Vaccine + PolyICLC in people with Non-small Cell Lung Cancer (NSCLC), run by Olivera Finn at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Research Coordinator (412-647-8583, wardj@upmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Immunologic response (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01720836.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.

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