Immune Response and Safety of HS110 Vaccine in Combination With Erlotinib in Patients With Non-Small Cell Lung Cancer

Inclusion Criteria:

• Willing and able to comply with the protocol and sign informed consent.
• Histologically or cytologically confirmed locally advanced or metastatic squamous cell or non-squamous cell NSCLC after at least one but no more than two prior regimens of approved therapy for their disease (not including adjuvant treatment).
• Confirmation that their disease has no known EGFR mutations based on documented prior analysis or study-specific analysis of archival tumor tissue.
• At least one site of bi-dimensionally measurable NSCLC disease.
• Patients with recurrent, resectable disease able to undergo six weeks of vaccine therapy prior to resection.
• Brain metastasis if present and treated must be stable by CT scn or MRI for at least 8 weeks.
• Age ≥ 18 years.
• EGOG performance status of 0-1.
• Lab parameters
• Albumin ≥ 3.5mg/dL
• Total Bilirubin < 1.5mg/dL
• Alanine transaminase (ALT), and aspartate transaminase(AST)≤ 2.5 x upper limits of normal or ≤ x ULN in case of liver metastases.
• Serum creatinine < 1.5mg/dL or calculated creatinine clearance >50 mL/minute per the Cockcroft-Gault formula.

• White blood cell (WBC) count ≥ 4,000/mm3 with an absolute neutrophil count

  • 1,500mm3.
• Hemoglobin ≥ 9g/dL
• Platelet count ≥ 100,000/mm3
• Women of childbearing potential or men of fathering potential must use adequate birth control measures (e.g. abstinence, oral contraceptives, intrauterine device, barrier method with spermicide or surgical sterilization) during the study and for 6 months after receiving the last administration of study medication. Female patients of childbearing potential must test negative for pregnancy prior to enrolling in the trial. Post-menopausal (cessation of menses for more than 6 months) women are eligible for this study.

Exclusion Criteria:

• No prior therapy with EGFR-targeted drugs, including approved and investigational therapies, or prior immunologic or biologic response modifier therapy for treatment of their disease.
• Uncontrolled or untreated brain or spinal cord metastases or meningeal carcinomatosis.
• Known human immunodeficiency virus (HIV), hepatitis B or C, or severe/uncontrolled infections or intercurrent illness, unrelated to the tumor, requiring active therapy.
• Autoimmunity syndromes (primary or acquired) including, but not limited to, the following: rheumatoid arthritis, systemic lupus erythematosus, Sjogren's disease, sarcoidosis, vasculitis, polymyositis, or glomerulonephritis requiring active steroid or other immunosuppressive therapy.
• Known immunodeficiency disorders, either primary or acquired.
• Other malignancies present within the past 3 years, except for cutaneous basal and/or squamous cell carcinoma(s) or in situ cervical cancer.
• History of clinically significant cardiac impairment, congestive heart failure > New York Heart Association (NYHA) cardiac disease classification Class II, unstable angina, or myocardial infarction during the previous 6 months, or serious cardiac arrhythmia.
• Known alcohol or chemical abuse, or mental or psychiatric condition precluding compliance with the protocol.
• Chemotherapy, radiation, or other antitumor therapy during the last 4 weeks.
• Pregnant, nursing, or planning a pregnancy (both men and women) within 12 months of enrollment.
• Known allergy to soy or egg products.
• Patient is anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test.