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Lung CarcinomaPhase 2NCT07169617

Testing the SurVaxM Vaccine for Lung Cancer Prevention

A Phase 2 study testing Biospecimen Collection, Montanide ISA 51 VG and Questionnaire Administration in people with Lung Carcinoma, run by National Cancer Institute (NCI) at 4 sites in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This phase II trial tests how well a survivin peptide vaccine called SurVaxM works in preventing lung cancer in high risk patients. Upon administration, the SurVaxM vaccine activates the immune system to produce an immune cell response against cancer cells that express a protein called survivin. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lung Carcinoma
What is being tested?
Biospecimen Collection, Montanide ISA 51 VG and Questionnaire Administration
Type of treatment
Vaccines, Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
4 sitesUnited States
Study dates
1 Oct 2026to 31 Dec 2029
Phase
Phase 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

  • 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)
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

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

United States4 sites

  • Rocky Mountain Regional VA Medical Center

    Aurora, Colorado, 80045

    Robert L. Keith, 720-857-5120, Robert.keith@cuanschutz.edu

    Robert L. Keith

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

    Saikrishna S. Yendamuri, 716-845-1228, sai.yendamuri@roswellpark.org

    Saikrishna S. Yendamuri

  • Northwestern University

    Chicago, Illinois, 60611

    Seema A. Khan, 312-503-4236, s-khan2@northwestern.edu

    Seema A. Khan

  • University of Tennessee - Knoxville

    Knoxville, Tennessee, 37920

    Sean Jordan, 865-305-6955, SAJordan@utmck.edu

    Sean Jordan

Other trials in United States

About this study

Official title: Evaluating the Feasibility of a Survivin Peptide Vaccine (SurVaxM) as an Interception Agent in Patients at High Risk for Lung Cancer

This phase II trial tests how well a survivin peptide vaccine called SurVaxM works in preventing lung cancer in high risk patients. Upon administration, the SurVaxM vaccine activates the immune system to produce an immune cell response against cancer cells that express a protein called survivin. This may result in decreased tumor cell proliferation and lead to tumor cell death. SurVaxM is given with montanide, a substance that helps the immune system respond to the SurVaxM vaccine, followed by sargramostim, which is given to increase the number of white blood cells in the body. The SurVaxM vaccine may help the body make special proteins called antibodies, which may be helpful in preventing the development of lung cancer.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To evaluate the effect of SVN53-67/M57-KLH peptide vaccine (SurVaxM) administration on the generation of a systemic anti-survivin immune response.

SECONDARY OBJECTIVES:

  1. To assess the proportion of participants needing a 3-month booster dose to achieve seroconversion.

II. To assess the proportion of participants mounting a cellular immune response to SurVaxM vaccination.

III. To assess the safety profile of SurVaxM administration in this population.

EXPLORATORY OBJECTIVES:

  1. To associate participants' demographic and clinical characteristics with outcomes (seroconversion or needing the 3-month booster).

II. Correlation of human leukocyte antigen (HLA) typing and the association of HLA types to humoral and/or cellular responses.

OUTLINE:

Patients receive SurVaxM with montanide ISA 51 VG (montanide) subcutaneously (SC) followed by sargramostim SC on day 0, week 2, week 4, and week 6. Patients then receive a booster dose of SurVaxM with montanide SC followed by sargramostim SC on week 18. Patients also undergo collection of blood samples throughout the trial.

After completion of study intervention, patients are followed up at weeks 20 and 24.

Conditions
Lung Carcinoma
Being tested
Biospecimen Collection, Montanide ISA 51 VG, Questionnaire Administration, Sargramostim, SVN53-67/M57-KLH Peptide Vaccine
Medical subject headings
Lung Neoplasms

What participants receive

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

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection

    Undergo collection of blood samples

  • Montanide ISA 51 VGDrug

    Given SC

  • Questionnaire AdministrationOther

    Ancillary studies

  • SargramostimBiological

    Also called 23-L-Leucinecolony-Stimulating Factor 2, DRG-0012, Leukine, Prokine

    Given SC

  • SVN53-67/M57-KLH Peptide VaccineBiological

    Also called SurVaxM

    Given SC

Study groups in NCT07169617
Study groupRoleWhat they receive
Prevention (SurVaxM, montanide, sargramostim)ExperimentalPatients receive SurVaxM with montanide SC followed by sargramostim SC on day 0, week 2, week 4, and week 6. Patients then receive a booster dose of SurVaxM with montanide SC followed by sargramostim SC on week 18. Patients also undergo collection of blood samples throughout the trial.
Receives: Procedure: Biospecimen Collection; Drug: Montanide ISA 51 VG; Other: Questionnaire Administration; Biological: Sargramostim; Biological: SVN53-67/M57-KLH Peptide Vaccine

What is being measured

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

  1. Seroconversion rate

    Seroconversion rate will be summarized as the frequency and proportion of participants who achieved sufficient seroconversion, which will be reported with the corresponding 95% confidence intervals. A one-sample exact test for one proportion will be used to test whether seroconversion rate exceeds the unacceptably low rate of 50%.

    Measured: Up to week 20

Secondary outcomes (6)

  1. Proportion of participants who require a 3-month booster to achieve seroconversion

    Proportions will be reported with the corresponding confidence intervals.

    Measured: At week 18

  2. Proportion of participants who achieve seroconversion

    Proportions will be reported with the corresponding confidence intervals.

    Measured: By 3 months

  3. Proportion of participants who do not achieve seroconversion at 3 months but achieve seroconversion 2-4 weeks after receiving a 3-month booster

    Proportions will be reported with the corresponding confidence intervals.

    Measured: Up to week 20

  4. Proportion of participants who do not achieve seroconversion

    Proportions will be reported with the corresponding confidence intervals.

    Measured: Up to week 20

  5. Cellular responses to the administration of SVN53-67/M57-KLH peptide vaccine

    Will be measured on peripheral blood mononuclear cells. Will tabulate the proportion of participants mounting a cellular response using flow cytometry.

    Measured: Before the administration of the first dose, 2-4 weeks after completion of the four priming doses, prior to receiving the booster, and 2-4 weeks after completion of the booster

  6. Incidence of adverse events

    Participants will also be provided with a participant diary, thermometer, and injection site reaction measuring tools to assist in collection and documentation of adverse events post-injection. All adverse events attributable to the vaccine as well as their severity will be reported in a descriptive format. The incidence rate and severity of each attributable adverse event will be tabulated and reported. Adverse events will be assessed using Common Terminology Criteria for Adverse Events version 5.0.

    Measured: Up to week 24

Timeline

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

  1. First posted12 Sep 2025
  2. Study start1 Oct 2026 (estimated)
  3. Primary completion30 Mar 2029 (estimated)
  4. Study completion31 Dec 2029 (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 2
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07169617
Sponsor's protocol ID
NCI-2025-06377
Other IDs
NCI-2025-06377, NCI24-19-01, NWU24-19-01, P30CA060553, UG1CA242643
Status last verified
Aug 2026
First submitted
11 Sep 2025
Last updated
26 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Biospecimen Collection, Montanide ISA 51 VG and Questionnaire Administration in people with Lung Carcinoma, run by National Cancer Institute (NCI) at 4 sites 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 11 inclusion and 11 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: opening soon, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites 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 phase mean?

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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Seroconversion rate (time frame: Up to week 20). 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 NCT07169617.

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 Aug 2026.

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