LCI-LUN-ABR-001: Carbo With Nab-Paclitaxel in Patients With Advanced NSCL Cancer

Inclusion Criteria

• Histologically confirmed stage IV non-small cell lung cancer with predominantly squamous histology
• No prior systemic treatment for metastatic disease. Patients who have received prior adjuvant chemotherapy for early-stage lung cancer are eligible if at least 12 months have elapsed between the date of final chemotherapy administration and the date of consent
• Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as >20 mm with conventional techniques or as >10 mm with CT scan, MRI, or calipers by clinical exam
• Biopsy accessible disease
• Patients with previous radiotherapy as definitive therapy for locally advanced non-small cell lung cancer are eligible, as long as the recurrence is outside the original radiation therapy port. Definitive radiation therapy must have been completed >4 weeks prior to the date the informed consent is signed
• Age >18 years
• ECOG performance status less than or equal to 1
• If patient has brain metastasis, the disease must be stable (treated and/or asymptomatic) for at least 4 weeks prior to first dose of study treatment
• Bilirubin 100, 000 cells/mm3, Hemoglobin > 9.0g/dL and ANC > 1,500 cells/mm3
• Adequate renal function with creatinine = 30% bone marrow was irradiated
• Receiving any other investigational agents
• Known hypersensitivity to either carboplatin or ABRAXANE
• Uncontrolled and current illness including, but not limited to, 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
• Pregnant or breast feeding
• Other active malignancies
• Neuropathy greater than or equal to grade 2