Phase I Open-Label Dose Escalation Trial Evaluating The Safety And Immunogenicity Of Sequential Administration Of Recombinant DNA And Adenovirus Expressing L523S Protein In Patients With Early Stage Non-Small Cell Lung Cancer

Inclusion Criteria

INCLUSION CRITERIA:

- Histologically and surgical confirmed diagnosis and stage of IB, IIA, or IIB
non-small cell lung cancer (NSCLC) according to the Revised International System for
Staging Lung Cancer

- Primary surgical resection of lung cancer greater than or equal to 4 weeks and less
than or equal to 3 years prior to the Day 0 visit

- No evidence of disease by standard diagnostic tests

- Chest X-ray and physical examination showing no active disease

- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

- WBC count greater than or equal to 3,000 cells/mm3 and ANC greater than or equal to
1,500 cells/mm3

- Hemoglobin value greater than or equal to 10.0 g/dL and a platelet count greater than
or equal to 125,000 cells/mm3

- Adequate renal function (defined as serum creatinine <1.5 times the upper limit of
normal for females and males)

- Normal hepatic function (defined as serum bilirubin <1.5 times the upper limit of
normal, AST <2.5 times the upper limit of normal and alkaline phosphatase <1.5 times
the upper limit of normal)

- Ability to understand and willingness to sign an IRB-approved written consent prior
to study enrollment

- Female patients must be greater than or equal to 60 years of age, or greater than or
equal to 5 years amenorrhea or surgically sterile

- Male patients who are capable of fathering a child and whose partners are capable of
having a child must agree to use adequate contraception for 6 months after enrollment
(for men or women-surgical sterilization; for women-hormonal contraceptives, vaginal
ring or IUD)

- Absolute CD4+ cell count of >200 cells/mm3

EXCLUSION CRITERIA:

- Received pre- or post-operative radiotherapy

- Received prior biologic, immunologic, or gene therapy for cancer

- Received an investigational drug (new chemical entity) within three months of study
entry

- Received antibiotics within 2 weeks of Day 0 visit

- Received systemic or inhaled corticosteroids or immunosuppressive therapy within 4
weeks of Day 0 visit (Use of topical corticosteroids and/or eye drops containing
glucocorticosteroids is acceptable)

- History of active autoimmune diseases such as, but not limited to, systemic lupus
erythematosis, sarcoidosis, rheumatoid arthritis, glomerulonephritis, vasculitis, or
inflammatory bowel disease

- History of bleeding in stools and/or diarrhea within 4 weeks of Day 0 visit

- History of anaphylaxis or severe allergic reaction to vaccines or unknown allergens

- Received any commercial vaccine within 2 weeks of Day 0 visit

- Received a major organ allograft

- Current or previous diagnosis of paraneoplastic syndrome

- Evidence of a clinically significant active pulmonary infection, emphysema, FeV1 less
than or equal to 50% predicted, DLCO less than or equal to 50% predicted, pulse
oximetry less than or equal to 92% at the time of study entry

- Known to be HIV positive

- Results of virology screening indicate positive serology for HCV (hepatitis C virus)
and/or HBsAG (hepatitis B surface antigen). Positive serology for HBV antibodies is
allowed.

- History of other malignancies at other sites, except effectively treated non-melanoma
skin cancers, superficial bladder cancer or carcinoma in situ of the cervix or an
effectively treated malignancy that has been in remission for greater than 5 years
and is highly likely to have been cured

- Uncontrolled medical problems (neurological, cardiovascular, gastrointestinal,
genitourinary or other illness) considered as unwarranted high risk for
investigational new drug treatment

- Patient is lactating

- Staging classification of TX or NX or MX

- Prior adjuvant chemotherapy within 8 weeks prior to the Day 0 visit