Efficacy/Safety of Imprime PGG® Injection With Cetuximab and Paclitaxel/Carboplatin Therapy in Patients With Untreated Advanced Non-Small Cell Lung Cancer (NSCLC)

Inclusion Criteria:

1. Has read, understood and signed the informed consent form (ICF) approved by the Independent Review Board/Ethics Committee (IRB/EC)
2. Is between the ages of 18 and 75 years old, inclusive
3. Has histologically or cytologically confirmed stage IIIB (malignant pericardial or pleural effusion) or stage IV non-small cell lung cancer
4. Has measurable disease, defined as at least one tumor that fulfills the criteria for a target lesion according to RECIST
5. Has an ECOG performance status of 0 or 1
6. Has a life expectancy of > 3 months

7. Has adequate hematologic function as evidenced by:

   • ANC ≥ 1,500/μL
   • PLT ≥ 100,000/μL
   • HGB ≥ 9 g/dL obtained within 1 week prior to the first dose of study medication;

8. Has adequate renal function as evidenced by:

   • Serum creatinine ≤ 1.5 X the upper limit of normal (ULN) for the reference lab
   • Urine dipstick for proteinuria of < 1+ (i.e., either 0 or trace) within 2 weeks of Day 1 If urine dipstick is ≥ 1+, then urine protein excretion must be ≤ 500 mg over a 24 hour collection obtained within 1 week prior to the first dose of study medication;

9. Has adequate hepatic function as evidenced by:

   • Serum total bilirubin ≤ 1.0 mg/dL
   • AST ≤ 2.5X ULN for the reference lab (≤ 5X ULN for subjects with known hepatic metastases)
   • ALT ≤ 2.5X ULN for the reference lab (≤ 5X ULN for subjects with known hepatic metastases) obtained within 1 week prior to the first dose of study medication;
10. If a woman of childbearing potential or a fertile man (and his partners), must agree to use an effective form of contraception (hormonal contraceptive, double-barrier method or abstinence) during the study.

Exclusion Criteria:

1. Has received prior systemic chemotherapy at any time for lung cancer;
2. Has received previous radiation therapy to >30% of active bone marrow or any radiation therapy within 3 weeks of Day 1
3. Has a known hypersensitivity to baker's yeast, or has an active yeast infection
4. Has had previous exposure to Betafectin® or Imprime PGG
5. Has an active infection

6. Presents with any of the following medical diagnoses/conditions at the time of screening:

   • Central nervous system (CNS) metastases
   • Peripheral neuropathy ≥ grade 2 from any cause
   • Fever of >38.5° C within 3 days prior to screening or Day 1, initial dosing
   • Known HIV/AIDs, Hepatitis B, Hepatitis C, connective tissue or autoimmune disease, or other clinical diagnosis, ongoing or intercurrent illness that in the physician's opinion could interfere with participation

7. Has a history of any of the following medical diagnoses/conditions:

   • Myocardial infarction or an unstable or uncontrolled disease or condition related to or impacting cardiac function (e.g., unstable angina, congestive heart failure) within the previous 6 months
   • Second malignancy within the previous 5 years, other than basal cell carcinoma, cervical intra-epithelial neoplasia or curatively treated prostate cancer with a PSA of <2.0 ng/mL
8. Has a known hypersensitivity to cetuximab, murine proteins, or any component of cetuximab
9. Has a know sensitivity to Cremophor EL
10. Has previously received treatment with cetuximab
11. If female, is pregnant or breast-feeding
12. Is receiving concurrent investigational therapy or has received investigational therapy within a period of 30 days prior to the first scheduled day of dosing (investigational therapy is defined as treatment for which there is currently no regulatory-authority-approved indication)
13. Has previously received an organ or progenitor/stem cell transplant.