Vaccination of Stage IV NSCLC Patients With a Carbohydrate Mimotope Vaccine
Lung Neoplasms
Conditions: official terms
Lung Neoplasms
Study Type
Study Phase
Phase 2
Study Design
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Name: P10s-PADRE vaccine Type: Biological
Name: Placebo Type: Biological
Overall Status
Not yet recruiting
The purpose of this study is to evaluate the clinical efficacy of an investigational agent, P10s-PADRE, a peptide mimotope-based vaccine, in patients of all races with stage IV Non-Small Cell Lung Cancer who have completed their primary chemotherapy without progressing, and who still have measurable residual disease.

A randomized double-blind placebo-controlled trial is designed with the goal being to evaluate the efficacy of the vaccine. Efficacy will be based primarily on the tumor response, and secondarily on progression-free survival. Information on safety and tolerability will be collected. Humoral and cellular immune responses will be analyzed.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- stage IV Non-Small Cell Lung Cancer

- completed their primary chemotherapy

- achieved either stable disease or partial response with measurable residual disease

Exclusion Criteria:

- Women who are pregnant or breast-feeding.

- Patients who have autoimmune disease or are immunosuppressed or receiving systemic corticosteroids
Highlands Oncology Group
Fayetteville, Arkansas, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Status: Not yet recruiting
Contact: Konstantinos Arnaoutakis, MD -
Start Date
June 2015
Completion Date
June 2017
University of Arkansas
University of Arkansas
Record processing date processed this data on July 28, 2015 page