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Vaccination of Advanced-Stage Lung Cancer Patients | Clinical Trials | Clareo Health

WITHDRAWNPHASE1/PHASE2

Vaccination of Advanced-Stage Lung Cancer Patients

"Vaccination of Advanced-Stage Lung Cancer Patients" A Phase I/II Study of a Carbohydrate Mimotope Based Vaccine With MONTANIDETM ISA 51 VG ST Adjuvant

NCT02264236•University of Arkansas

View on ClinicalTrials.gov

Summary

The overarching purpose of this study is to evaluate the clinical efficacy of an investigational agent, P10s-PADRE, a peptide mimotope-based vaccine, in combination with standard-of-care (SoC) treatment in subjects with advanced-stage (i.e., metastatic) Lung Cancer. Vaccine will consist of P10s-PADRE admixed with an adjuvant, MONTANIDETM ISA 51 VG. Up to one hundred fifty (150) subjects with advanced-stage Lung Cancer of any histologic type will be enrolled for this vaccine trial. This single-arm, multi-site trial is designed to evaluate the therapeutic benefits of the vaccine in subjects with advanced-stage lung cancer. The primary objectives of the study are: (1) to monitor the safety and tolerability of the vaccine when it is administered in combination with SoC therapy; and (2) to determine whether immunization with vaccine can successfully elicit a robust immune response in subjects with advanced-stage lung cancer.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Advanced-stage (i.e., metastatic) Lung Cancer of any histologic type
•2. (Computed Tomography) CT scans were completed within 4 weeks prior to registration
•3. Age 18 years and older
•4. ECOG Performance Status 0 to 2
•5. White blood cell (WBC) count ≥ 3,000/mm3 within 3 weeks prior to registration
•6. Platelet count ≥ 100,000/mm3 within 3 weeks prior to registration
•7. Serum glutamic-pyruvic transaminase (SGPT) or alanine aminotransferase test (ALT) ≤ 2 x institutional upper limit (IUL) of normal obtained within 3 weeks prior to registration
•8. Serum glutamic-oxaloacetic transaminase (SGOT) or aspartate aminotransferase test (AST) ≤ 2 x institutional upper limit (IUL) of normal obtained within 3 weeks prior to registration
•9. Serum creatinine ≤ 1.8 mg/dL obtained within 3 weeks prior to registration
•10. Radiation is allowed
+1 more criteria

Exclusion Criteria

•1. Active infection requiring treatment with antibiotics
•2. Any other significant medical or psychiatric conditions which, in the opinion of the enrolling investigator, may interfere with consent or compliance of the treatment regimen
•3. Existing diagnosis or evidence of organic brain syndrome that might preclude participation in the full protocol
•4. Existing diagnosis or history of significant impairment of basal cognitive function that might preclude participation in the full protocol
•5. Existing diagnosis or history of leptomeningeal disease, spinal cord compression or brain metastases unless: (a) metastases have been locally treated and have remained clinically controlled and asymptomatic for at least 14 days following treatment, AND (b) subject has no residual neurological dysfunction and has been off corticosteroids for at least 14 days prior to registration

Locations (1)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Key Dates

Start Date

October 1, 2015

Primary Completion Date

June 1, 2021

Completion Date

June 1, 2021

Last Updated

July 20, 2025

Conditions

Lung Neoplasms

Interventions

P10s-PADRE vaccine

BIOLOGICAL

LUNG-ROLL: Treatment Patterns and Cost of Illness of Lung Cancer in Canada

NCT07143110

Lung Neoplasms

View study

RECRUITINGPHASE1

Anti-Mesothelin TNaive/SCM hYP218 (TNhYP218) CAR T Cells in Participants With Mesothelin-Expressing Solid Tumors Including Mesothelioma

NCT06885697

MesotheliomaNeoplasms+6 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 20, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Vaccination of Advanced-Stage Lung Cancer Patients

Inclusion Criteria

Exclusion Criteria

LUNG-ROLL: Treatment Patterns and Cost of Illness of Lung Cancer in Canada

Anti-Mesothelin TNaive/SCM hYP218 (TNhYP218) CAR T Cells in Participants With Mesothelin-Expressing Solid Tumors Including Mesothelioma

Lung B.A.S.E.S. 4 Life Mobile Low-dose Computed Tomography (LDCT) Screening: Ages 40-54

Preventing Dato-DXd Associated Stomatitis With Dexamethasone Mouthwash, TROPION-DM

Diagnosis of Multiple Cancer and Monitoring of Minimal Residual Tumors After Treatment Using Blood and High-Sensitivity Genetic Analysis Techniques

Mediastinal Lymph Node Dissection Versus Spared Mediastinal Lymph Node Dissection in Stage I GGN NSCLC