Efficacy and Safety Study of Imprime PGG® Injection in Combination With Cetuximab and Concomitant Paclitaxel and Carboplatin Therapy in Patients With Previously Untreated Advanced (Stage IIIB or IV) Non-Small Cell Lung Cancer

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.