Mature Dendritic Cell Vaccination Against Unique Immunogenic Peptides in Patients With Non Small Cell Lung Cancer (NSCLC)

Tumor vaccines represent a promising area of clinical investigation in solid tumors based on
evidence of clinical activity and minimal toxicity. The underlying hypothesis of this
research is that immunization against tumor neoantigens is effectively required to elicit
antigen-reactive T cells capable of recognizing and eliminating cancer. Moreover, both
quantitative and qualitative improvements in CD8 immunity are necessary (but not sufficient)
for clinical response and improved survival. The goal of this study is to build on our prior
clinical trial results in melanoma by studying the immune response to tumor neoantigens in
patients with stage 1 NSCLC.

Inclusion Criteria:

- Patients with completely resected stage I non-small cell lung cancer who are not
considered for adjuvant post operative therapy.

- Age ≥ 18 years.

- ECOG performance status 0-1.

- HLA-A2 positive.

- Required initial laboratory values (submitted within 14 days prior to registration):

- WBC > 3,000/mm3

- Hg ≥ 9.0 gm/dL

- Platelets >75,000/mm3

- Serum bilirubin < 2.0 mg/dL

- Serum creatinine < 2.0 mg/dL

- Sexually active women of childbearing potential must use effective birth control
during the trial and for at least two months following the trial, and sexually active
men must be willing to avoid fathering a new child while receiving therapy.

- Able to understand and willing to sign an IRB-approved written informed consent
document.

Exclusion Criteria:

- Prior treatment with cytotoxic chemotherapy

- Prior treatment with targeted therapy or immunotherapy.

- Active untreated CNS metastasis.

- Active infection.

- Prior malignancy (except non-melanoma skin cancer) within 3 years.

- Pregnant or nursing.

- Concurrent treatment with systemic corticosteroids; local (inhaled or topical)
steroids are permitted.

- Known allergy to eggs.

- Prior history or uveitis or autoimmune inflammatory eye disease.

- Known positivity for hepatitis B sAg, hepatitis C antibody, or HIV antibody.