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SurVaxM Vaccine for High-Risk Lung Cancer Prevention

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What is being tested

Biospecimen Collection

+ Montanide ISA 51 VG

+ Questionnaire Administration

ProcedureDrugOtherBiological
Who is being recruted

Lung Diseases+4

+ Lung Neoplasms

+ Neoplasms

Over 18 Years
+17 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Phase 2
Interventional
Study Start: February 2026
See protocol details

Summary

Principal SponsorNational Cancer Institute (NCI)
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: February 25, 2026

Actual date on which the first participant was enrolled.

This study aims to explore how a specific vaccine called SurVaxM can potentially help prevent lung cancer in people who are at a high risk of developing the disease. SurVaxM is designed to stimulate the body's immune system to target survivin, a protein often found in cancer cells. By encouraging an immune response against this protein, the study hopes to reduce the chances of cancer developing. Understanding how well this vaccine works could lead to new prevention strategies for people who face a high risk of lung cancer, offering a proactive approach to cancer care. Participants in the study receive the SurVaxM vaccine through a series of injections just under the skin, along with another substance called montanide, and a medication named sargramostim to boost the immune response. These injections are given on a schedule over several weeks, with an additional booster shot later on. The study monitors the participants' immune responses by regularly collecting blood samples and checking whether the vaccine is prompting the desired immune reactions. Safety and any side effects are closely watched to ensure the well-being of participants. Following the treatment phase, participants continue to be monitored to assess the long-term effects and benefits of the vaccine.

Official TitleEvaluating the Feasibility of a Survivin Peptide Vaccine (SurVaxM) as an Interception Agent in Patients at High Risk for Lung Cancer 
NCT07169617
Principal SponsorNational Cancer Institute (NCI)
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

80 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Lung DiseasesLung NeoplasmsNeoplasmsNeoplasms by SiteRespiratory Tract DiseasesRespiratory Tract NeoplasmsThoracic Neoplasms

Criteria

10 inclusion criteria required to participate
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

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

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7 exclusion criteria prevent from participating
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

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

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Patients 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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 4 locations

Suspended

Rocky Mountain Regional VA Medical Center

Aurora, United StatesSee the location
Suspended

Northwestern University

Chicago, United States
Suspended

Roswell Park Cancer Institute

Buffalo, United States
Suspended

University of Tennessee - Knoxville

Knoxville, United States
Recruiting soon4 Study Centers