Labyrinthin Vaccination in Veterans With Lung Adenocarcinoma
This phase 2 trial tests the safety and effectiveness of a cancer vaccine called LabVax 3(22)-23 and GM-CSF in combination with pembrolizumab in treating adenocarcinoma that has spread to other places in the body (advanced stage). LabVax 3(22)-23 is designed to target a specific antigen (labyrinthin), which is a protein found on the surface of adenocarcinoma tumor cells. Labyrinthin is a protein that is not expressed on normal cells in the skin, lungs, salivary glands, pancreas, nor other tissues. In adenocarcinoma, the tumor cells produce too much labyrinthin causing them to express this protein on the surface of the tumor cells. One way to control the growth of these tumor cells is to teach the immune system to generate an immune response against the labyrinthin protein by vaccination against labyrinthin. GM-CSF, or sargramostim, is a protein that acts as a white blood cell growth factor. It has also been shown to stimulate immune system. Thus, administration of GM-CSF may help to boost the immune system response when given together with the vaccine. This study may improve the general knowledge about LabVax 3(22)-23 and how the body may generate an immune response to kill adenocarcinoma tumor cells. In the second phase of the study, participants will also receive pembrolizumab, which may improve anti-cancer activity when given with LabVax 3(22)-23 and GM-CSF.
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This describes the study’s primary purpose.
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These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Oct 6, 2026 · Source: ClinicalTrials.gov
The study is not accepting participants yet.
Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 2
- Sponsor
- VA Office of Research and Development
- Interventions being studied
- Combination Product: LabVax 3(22)-23 and GM-CSF (adjuvant) in combination with pembrolizumab
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- Ability to understand and willingness to sign an informed consent form
- Histologically confirmed diagnosis of lung adenocarcinoma
- Subjects with advanced/metastatic or recurrent solid tumors, with measurable or non-measurable disease as determined by Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 are eligible for participation.
- Histologically confirmed diagnosis of labyrinthin-positive lung adenocarcinoma
- Received at least one line of anti-PD-1 or anti-PD-L1 therapy for any stage of non-Small Cell Lung Cancer (NSCLC). Anti-PD-1 or anti-PD-L1 may have been given alone or in combination with other therapy
- Progressed on at least one line of therapy if participant has a known sensitizing mutation for which an FDA-approved targeted therapy for NSCLC exists (e.g., EGFR, ALK, ROS1, BRAF, RET, NTRK, and MET sensitizing mutations)
- All subjects must be candidates for pembrolizumab therapy
- Subjects can either have progressed, had no response, or intolerance to prior cancer therapy. Patients must have recovered from all clinically significant treatment-related toxicities to grade 1 or less, except chemotherapy-associated peripheral neuropathy (motor or sensory), or endocrine-related AE, in which recovery to ≤ Grade 2 is allowed. For endocrine-related AEs, physiological doses of replacement therapy (e.g., levothyroxine, insulin, hydrocortisone, or other replacement therapy for adrenal or pituitary insufficiency, etc.) are allowed.
- No limit on prior lines of therapy for metastatic disease. Prior chemotherapy, immunotherapy (including pembrolizumab) or molecularly targeted therapy must have been completed at least 3 weeks prior to initiating study treatment. Prior palliative radiation must have been completed at least 2 weeks prior to initiating study treatment.
- Subjects with known untreated, active brain and/or leptomeningeal metastases are excluded. Subjects with treated brain metastasis who are neurologically stable and off steroids for at least one week are eligible.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Life expectancy of ≥ 6 months at the time of initiating study treatment
- Subjects must demonstrate adequate organ function as defined below:
- Absolute neutrophil count (ANC) greater than or equal to 1,000 cells /Liter (L)
- Absolute lymphocyte counts (ALCs) greater than or equal to 600 cells per microliter
- Platelets greater than or equal to 75,000 cells/L
- Creatinine clearance as calculated per Cockcroft-Gault or Modification of Diet in Renal Disease (MDRD) formula ≥30 milliliters(mL)/minute (min)
- Total bilirubin ≤ 1.5 times the upper limit of normal (ULN), OR direct bilirubin ≤ ULN for participants with total bilirubin levels \>1.5 times the ULN
- Aspartate aminotransferase or serum glutamic-oxaloacetic transaminase (AST or SGOT) and alanine aminotransferase or serum glutamic-pyruvic transaminase (ALT or SGPT) ≤2.5 times the ULN, OR ≤5 times the ULN for participants with liver metastases
- Because the effects of the study treatment on the unborn fetus or nursing infant are unknown, pregnant and nursing women are ineligible. Women of childbearing age must have a negative urine or serum pregnancy test-Human Chorionic Gonadotropin(HCG) within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
- Confirmation of adequate archival tumor specimens (i.e., sufficient specimens for ten, 5-7 micrometer (µm) thick, unstained sections)
- Subjects who have autoimmune diseases that require immunosuppressive medications other than prednisone ≤ 10 milligram (mg) daily or equivalent. Physiological doses of replacement therapy (e.g., levothyroxine, insulin, hydrocortisone, or other replacement therapy for adrenal or pituitary insufficiency, etc.) are not considered a form of immunosuppressant and are allowed.
- Prior splenectomy
- Pregnant or nursing women
- Any medical condition including additional malignancies, laboratory abnormalities, or psychiatric illness that in the opinion of the investigator would prevent the subject from participating and adhering to study related procedures.
- Uncontrolled concomitant disease that in the opinion of the investigator would interfere with the subject's safety or compliance on trial
- Severe infection that in the opinion of the investigator would interfere with subject safety or compliance on trial within 4 weeks prior to enrollment
- Subjects who have contraindications to GM-CSF injections according to the package insert (e.g., subjects with excessive leukemic myeloid blasts in the bone marrow or peripheral blood (≥ 10%); known hypersensitivity to GM-CSF, yeast-derived products or any component of the product) Additional
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- VA Long Beach Healthcare System, Long Beach, CALong Beach, California
- VA Northern California Health Care System, Mather, CASacramento, California
- San Francisco VA Medical Center, San Francisco, CASan Francisco, California
- Kansas City VA Medical Center, Kansas City, MOKansas City, Missouri
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 6, 2026. Always confirm current availability with the study team.