Phase II Study of Cabazitaxel-XRP6258 in Advanced Non-Small Cell Lung Cancer

Inclusion Criteria

• •Histologic or cytologic diagnosis of NSCLC (squamous or non-squamous or NSCLC-not specified)
• •Subjects who have failed first line chemotherapy (platinum doublets or non- platinum doublets \[previous taxane exposure is allowed\]) for Stage IV NSCLC.
• •Measurable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST)
• •Eastern Cooperative Oncology Group (ECOG) performance status 0-2
• •Age \> 18 years old
• •Adequate bone marrow, liver and renal function, defined as:
• •* Absolute neutrophil count (ANC) greater than or equal to 1500/ul
• •* Hemoglobin greater than or equal to 10 g/dl
• •* Platelet count greater than or equal to 100,000/ul
• •* Total bilirubin less than or equal to 1.5 x upper limit of normal (except in subjects with documented Gilbert's syndrome)
• •* AST/ALT less than or equal to 1.5 x upper limit of normal
• •* Serum creatinine less than or equal to 1.8 mg/dl
• •Fully recovered from any previous surgery (at least 4 weeks since major surgery)
• •Fully recovered from previous radiation therapy (at least 2 weeks)
• •All subjects must agree to practice approved methods of birth control (if applicable). A negative pregnancy test must be documented during the screening period for women of childbearing potential.
• •Written informed consent and authorization to use and disclose health information (HIPAA) must be signed by the subject.
• •Subjects with symptomatic brain metastases should be adequately treated and controlled prior to the initiation of the study. Subjects with asymptomatic brain metastases will be allowed in the study without any prior therapy for brain metastases.