Type and Grade of Toxicities, Demographic and Background CharacteristicsPhase 2NCT07859592

Labyrinthin Vaccination in Veterans With Lung Adenocarcinoma

A Phase 2 study testing LabVax 3(22)-23 and GM-CSF (adjuvant) in combination with pembrolizumab in people with Type and Grade of Toxicities, Demographic and Background Characteristics and Advanced, Metastatic, Recurrent Adenocarcinoma and Malignant Solid Neoplasm, run by VA Office of Research and Development 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

Who is it for?: Ages 18 years and older
Conditions the study is for: Type and Grade of Toxicities, Demographic and Background Characteristics, Advanced, Metastatic, Recurrent Adenocarcinoma and Malignant Solid Neoplasm
What is being tested?: LabVax 3(22)-23 and GM-CSF (adjuvant) in combination with pembrolizumab
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 4 sitesUnited States
Study dates: 1 Dec 2026to 1 Dec 2035
Phase: Phase 2

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

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)

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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)

Who cannot join

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

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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 exclusion criteria for participants entering Phase 2:
Is receiving systemic steroid therapy (> 10 mg prednisone oral daily or equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment
Has a known history of active TB (Bacillus Tuberculosis)
Hypersensitivity to pembrolizumab or any of its excipients
Has had a prior anti-cancer monoclonal antibody (mAb) within 3 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 3 weeks earlier
Has had prior chemotherapy, targeted therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent
Note: Subjects with ≤ Grade 2 neuropathy are an exception to this criterion and may qualify for the study.
Note: If subjects received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
Has known untreated, symptomatic central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases requiring treatment, and are not using steroids (> 10 mg prednisone oral daily or equivalent) for at least 7 days prior to trial treatment. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability.
Has known history of ≥ grade 3 pneumonitis or interstitial lung disease related to radiation, immunotherapy, chemotherapy, or targeted therapy
Has an active infection requiring systemic therapy
Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator
Has known active Hepatitis B (e.g., Hepatitis B Surface Antigen (HBsAg) reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected)
Has received a live vaccine within 30 days of planned start of study therapy
Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed. Corona Virus Disease (COVID) vaccines are allowed.

Trial locations and contacts

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

Tianhong Li, MD contact

(707) 437-1802

tianhong.Li@va.gov

Manuel Alcazar, RN contact

(916) 843-2776

manuel.alcazar@va.gov

United States4 sites

Kansas City VA Medical Center, Kansas City, MO
Kansas City, Missouri, 64128-2226
Chao Huang, 650-493-5000, Chao.Huang@va.gov
VA Long Beach Healthcare System, Long Beach, CA
Long Beach, California, 90822
Pankaj Gupta, 562-826-8000 ext. 12243, Pankaj.Gupta@va.gov
VA Northern California Health Care System, Mather, CA
Sacramento, California, 95655-4200
Jerry L Nadler, MD, (916) 843-2776, Jerry.Nadler@va.gov
Jefferson Lee, (916) 843-2769, Jefferson.Lee2@va.gov
San Francisco VA Medical Center, San Francisco, CA
San Francisco, California, 94121-1563
Sunny Wang, 415-221-4810 ext. 23380, Sunny.wang@va.gov

Other trials in United States

About this study

Official title: Labyrinthin Vaccination for Patients With Lung Adenocarcinomas

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.

Read the detailed description

Phase 2: Up to 30 participants with advanced/ metastatic or recurrent lung adenocarcinoma. Pembrolizumab will be given intravenously every 3 weeks for up to 12 cycles on Day 1 of Weeks 1, 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, and 34. Subjects will be given LabVax 3(22)-23 (intradermally) and adjuvant GM-CSF (subcutaneously) on weeks 7, 8, 10, 13, and 19. Participants will receive study treatment over 34 weeks if tolerating the treatment without tumor progression; a safety follow-up visit will occur 30 days post-last dose of study treatment. The participant's chart will be reviewed for up to 12 months post-last dose of study treatment. The study will be terminated if safety is insufficient or if response is insufficient in the first expansion.

Conditions: Type and Grade of Toxicities, Demographic and Background Characteristics, Advanced, Metastatic, Recurrent Adenocarcinoma and Malignant Solid Neoplasm
Being tested: LabVax 3(22)-23 and GM-CSF (adjuvant) in combination with pembrolizumab
Keywords: Carcinoma, Neoplasms, Glandular and Epithelial, Neoplasms by Histologic Type, Neoplasms, Neoplastic Processes, Pathologic Processes, Pathological Conditions, Signs and Symptoms, Adenocarcinoma, Neoplasm Metastasis, Vaccines, Biological Products, Complex Mixtures, Glycoprotein, Glycoconjugates, Carbohydrates, Hematopoietic Cell Growth Factors, Cytokines, Intercellular Signaling Peptides and Proteins, Peptides, Amino Acids, Peptides, and Proteins
Medical subject headings: Limb-girdle muscular dystrophy, type 2C, Neoplasm Metastasis, Adenocarcinoma, Carcinoma, Neoplasms, Glandular and Epithelial, Neoplasms by Histologic Type, Neoplasms, Neoplastic Processes

What participants receive

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

LabVax 3(22)-23 and GM-CSF (adjuvant) in combination with pembrolizumabCombination product
LabVax 3(22)-23, and GM-CSF (adjuvant) in combination with pembrolizumab in subjects with advanced/metastatic or recurrent advanced/metastatic or recurrent lung adenocarcinoma.

Study groups in NCT07859592
Study group	Role	What they receive
LabVax 3(22)-23 and GM-CSF (immunoadjuvant) in combination with pembrolizumab	Experimental	LabVax 3(22)-23, and GM-CSF (adjuvant) in combination with pembrolizumab in subjects with advanced/metastatic or recurrent advanced/metastatic or recurrent lung adenocarcinoma. Receives: Combination Product: LabVax 3(22)-23 and GM-CSF (adjuvant) in combination with pembrolizumab

What is being measured

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

Objective Response Rate (ORR) as Assessed According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v 1.1)
To assess antitumor activity per RECIST 1.1 of LabVax 3(22)-23 administered at the Recommended Phase 2 Dose (RP2D) and adjuvant GM-CSF in combination with pembrolizumab in participants with advanced/metastatic or recurrent lung adenocarcinoma who have received at least one line of immune checkpoint inhibitor therapy.
Measured: 7 years

Secondary outcomes (6)

Dose-limiting toxicity (DLTs)
Number of participants with dose-limiting toxicities (DLTs) during the safety lead-in period
Measured: 7 years
Adverse events
Number of participants with treatment-emergent adverse events assessed according to CTCAE v6.0
Measured: 7 years
Median PFS
Median progression-free survival (PFS) in months
Measured: 7 years
6-month PFS
Progression-free survival rate at 6 months in percentage of participants
Measured: 7 years
12-month PFS
Progression-free survival rate at 12 months in percentage of participants
Measured: 7 years
Median OS
Median overall survival (OS) in months
Measured: 7 years

Timeline

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

1 Dec 20261 Dec 2035

First posted6 Oct 2026
Study start1 Dec 2026 (estimated)
Primary completion30 Nov 2030 (estimated)
Study completion1 Dec 2035 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Type and Grade of Toxicities, Demographic and Background CharacteristicsStudies of the same condition, open and under way.
More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Treatment
Allocation: Not applicable
Intervention model: Sequential
Masking: None (open label)
Enrolment: 30 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07859592
Sponsor's protocol ID: ONCB-006-26S
Other IDs: I01RD001080-01A1
Status last verified: Sep 2026
First submitted: 30 Sep 2026
Last updated: 6 Oct 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes

Publications

Ma W, Zeng J, Montoya DJ, Toomey K, Zhou C, Chen S, Liu D, Babich M, Radosevich JA, Li T. Labyrinthin Expression Is Associated with Poor Prognosis in Patients with Non-Small-Cell Lung Cancer. Cancers (Basel). 2023 Feb 1;15(3):924. doi: 10.3390/cancers15030924.
PubMed 36765881