A Phase 2 interventional study of Biospecimen Collection and Montanide ISA 51 VG in Lung Carcinoma, sponsored by National Cancer Institute (NCI). Not yet recruiting at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-26.
Sponsored by National Cancer Institute (NCI) · Phase 2, Interventional, and Prevention
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.
PRIMARY OBJECTIVE:
I. 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:
I. 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:
I. 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.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
This study's planned enrollment of 80 is above the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →National Cancer Institute (NCI) is the lead sponsor of 3,506 studies on the registry; 334 are open to participants now.
Of its 402 completed or terminated interventional studies of FDA-regulated products, 365 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
Total bilirubin =\< 1.5 x institutional upper limit of normal (ULN)
Exclusion Criteria:
Participants with current or prior malignancy except for the following:
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.
Procedure: Biospecimen Collection · Drug: Montanide ISA 51 VG · Other: Questionnaire Administration · Biological: Sargramostim · Biological: SVN53-67/M57-KLH Peptide Vaccine
Undergo collection of blood samples
Also known as: Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection
Given SC
Ancillary studies
Given SC
Also known as: 23-L-Leucinecolony-Stimulating Factor 2, DRG-0012, Leukine, Prokine, rhu GM-CFS, Sagramostim, Sargramostatin
Given SC
Also known as: SurVaxM
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%.
Time frame: Up to week 20
Proportion of participants who require a 3-month booster to achieve seroconversion
Proportions will be reported with the corresponding confidence intervals.
Time frame: At week 18
Proportion of participants who achieve seroconversion
Proportions will be reported with the corresponding confidence intervals.
Time frame: By 3 months
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.
Time frame: Up to week 20
Proportion of participants who do not achieve seroconversion
Proportions will be reported with the corresponding confidence intervals.
Time frame: Up to week 20
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.
Time frame: 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
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.
Time frame: Up to week 24
Seroconversion rate
Will perform exploratory analyses associating participants' demographic and clinical characteristics with outcomes using Wilcoxon ranksum tests to compare continuous variables between responders and non-responders using Fisher's exact test or chi-squared test to compare categorical variables between responders and non-responders. Multivariable logistic regression models will be used to examine the effects of multiple risk factors simultaneously.
Time frame: Up to week 20
Proportion of participants who require a 3-month booster to achieve seroconversion
Will perform exploratory analyses associating participants' demographic and clinical characteristics with outcomes using Wilcoxon ranksum tests to compare continuous variables between responders and non-responders using Fisher's exact test or chi-squared test to compare categorical variables between responders and non-responders. Multivariable logistic regression models will be used to examine the effects of multiple risk factors simultaneously.
Time frame: At week 18
Plan to share: 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.
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
National Cancer Institute (NCI)