A Study of Ramucirumab (IMC-1121B) With Paclitaxel and Carboplatin in Non-small Cell Lung Cancer

Inclusion Criteria:

Histologically or cytologically confirmed NSCLC
Advanced NSCLC
Measurable disease (as defined by Response Evaluation Criteria in Solid Tumors [RECIST 1.0])
Eastern Cooperative Oncology Group (ECOG) Performance Status is ≤ 1
Age ≥ 18 years
Adequate hematologic function = an absolute neutrophil count (ANC) ≥ 1500/μL, hemoglobin ≥ 9 g/dL, and a platelet count ≥ 100,000/microliter (μL)
Adequate hepatic function = a total bilirubin ≤ 1.5 mg/dL transaminases and alkaline phosphatase ≤ 5 x the upper limit of normal (ULN)
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)
Adequate coagulation function, INR ≤ 1.5 and a partial thromboplastin time (PTT) ≤ 5 seconds above ULN
Adequate contraception
Signed informed consent

Exclusion Criteria:

Untreated CNS metastases
Prior bevacizumab therapy
Radiologically documented evidence of major blood vessel invasion or encasement by cancer
Prior systemic chemotherapy for Stage IIIB/IV NSCLC
Prior systemic chemotherapy or radiation therapy for Stage I-IIIA NSCLC < 1 year prior
Any concurrent malignancy other than basal cell skin cancer, or carcinoma in situ of the cervix
Concurrent treatment with other anticancer therapy, including other chemotherapy, immunotherapy, hormonal therapy, radiotherapy, chemoembolization, or targeted therapy
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
Uncontrolled thrombotic or hemorrhagic disorders
Poorly-controlled hypertension
Chronic daily treatment with aspirin (> 325 mg/day) or other known inhibitors of platelet function
History of gross hemoptysis (defined as bright red blood or ≥ 1/2 teaspoon)
Serious non-healing wound, ulcer, or bone fracture
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
Elective or a planned major surgery to be performed during the course of the trial
Peripheral neuropathy ≥ Grade 2 (National Cancer Institute Common Toxicity Criteria for Adverse Events, Version 3.0 [NCI-CTCAE v 3.0])
If female, is pregnant or lactating
Radiographic evidence of intratumor cavitation
Grade 3-4 gastrointestinal bleeding within 3 months prior to study entry