Study of the Telomerase Vaccine GV1001 to Treat Patients With Inoperable Stage III Non-small Cell Lung Cancer

Exclusion Criteria

• •Patients will not be entered in the study for any of the following reasons:
• •1. Prior treatment with gemcitabine, prior targeted therapy (including erlotinib \[Tarceva®\], or gefitinib \[Iressa®\]), or immunological therapy including tumor vaccine therapy intended for the management of NSCLC;
• •2. A minimum of 1 week and a maximum of 4 weeks must have elapsed from the chemo-radiotherapy and patient must have recovered from all treatment-related toxicities to Grade ≤ 1 (CTCAE version 4.03), except for alopecia;
• •3. History of other malignancies except: (1) adequately treated basal or squamous cell carcinoma of the skin; (2) curatively treated, a) in situ carcinoma of the uterine cervix, b) prostate cancer, or c) superficial bladder cancer; or (3) other curatively treated solid tumor with no evidence of disease for ≥ 3 years;
• •4. Received treatment in another clinical study within the 30 days prior to commencing study treatment or patients who have not recovered from side effects of an investigational drug to Grade ≤ 1 (CTCAE version 4.03), except for alopecia;
• •5. Are currently receiving any other cancer treatment, even if given with palliative intent;
• •6. Uncontrolled pleural effusions, ascites, or other third space fluid collections;
• •7. Uncontrolled diabetes mellitus Type 1 or 2;
• •8. Significant cardiovascular impairment (history of congestive heart failure \> New York Heart Association (NYHA) Grade II, unstable angina or myocardial infarction within the past 6 months, or serious cardiac arrhythmia);
• •9. Patients with organ allografts requiring immunosuppression;
• •10. Need for systemic steroid treatment unless chronic daily dose used is ≤ 5mg prednisone or equivalent. Note: Higher dose systemic steroid treatment (≥ 60mg/day of prednisone or equivalent) administered for ≤ 2 weeks in any single episode is permissible if administered for an acute inflammatory condition;
• •11. Known severe adverse reactions to vaccines;
• •12. Known severe adverse events or allergy to GM-CSF;
• •13. Known positive human immunodeficiency virus (HIV), known hepatitis B surface antigen, or hepatitis C positive; and
• •14. Have any medical condition that would interfere with the conduct of the study.