A Phase 2, Open-label Study of IMC-1121B in Combination With Paclitaxel and Carboplatin as First-line Therapy in Patients With Stage IIIB/IV Non-small Cell Lung Cancer

Inclusion Criteria:

1. Histologically or cytologically confirmed NSCLC

2. Advanced NSCLC

3. Measurable disease (as defined by Response Evaluation Criteria in Solid Tumors
[RECIST]

4. ECOG is ≤ 1

5. Age ≥ 18 years

6. Adequate hematologic function = an absolute neutrophil count (ANC) ≥ 1500/μL,
hemoglobin ≥ 9 g/dL, and a platelet count ≥ 100,000/μL

7. Adequate hepatic function = a total bilirubin ≤ 1.5 mg/dL transaminases and alkaline
phosphatase ≤ 5 x the upper limit of normal (ULN)

8. Adequate renal function serum creatinine ≤ 1.5 x ULN or calculated creatinine
clearance (CrCl) > 60 mL/minute, and urine dipstick for protein < 1+ (ie, either 0 or
trace)

9. Adequate coagulation function, INR ≤ 1.5 and a partial thromboplastin time (PTT) ≤ 5
seconds above ULN

10. Adequate contraception

11. Signed informed consent

Exclusion Criteria:

1. Untreated CNS metastases

2. Prior bevacizumab therapy

3. Radiologically documented evidence of major blood vessel invasion or encasement by
cancer

4. Prior systemic chemotherapy for Stage IIIB/IV NSCLC

5. Prior systemic chemotherapy or radiation therapy for Stage I-IIIA NSCLC < 1 year
prior

6. Any concurrent malignancy other than basal cell skin cancer, or carcinoma in situ of
the cervix

7. Concurrent treatment with other anticancer therapy, including other chemotherapy,
immunotherapy, hormonal therapy, radiotherapy, chemoembolization,or targeted therapy

8. Ongoing or active infection, symptomatic congestive heart failure,unstable angina
pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would
limit compliance with study requirements

9. Uncontrolled thrombotic or hemorrhagic disorders

10. Poorly-controlled hypertension

11. Chronic daily treatment with aspirin (> 325 mg/day) or other known inhibitors of
platelet function

12. History of gross hemoptysis (defined as bright red blood or ≥ 1/2 teaspoon)

13. Serious non-healing wound, ulcer, or bone fracture

14. Undergone major surgery or subcutaneous venous access device placement.
Post-operative bleeding complications or wound complications from a surgical
procedures performed in the last 2 months

15. Elective or a planned major surgery to be performed during the course of the trial

16. Peripheral neuropathy ≥ Grade 2 (National Cancer Institute Common Toxicity Criteria
for Adverse Events, Version 3.0 [NCI-CTCAE v 3.0])

17. If female, is pregnant or lactating

18. Radiographic evidence of intratumor cavitation

19. Grade 3-4 gastrointestinal bleeding within 3 months prior to study entry