Randomized, Multi-center, Open-label, Study of PR104 Versus PR104/Docetaxel in Non-Small Cell Lung Cancer (NSCLC)

Inclusion Criteria:

Subjects with locally advanced or metastatic NSCLC (stage IIIb/IV) who have relapsed following adjuvant or first line therapy with a platinum containing regimen, and are appropriate candidates for treatment with single agent docetaxel
Confirmed NSCLC by prior pathological analysis (tissue aspirate or biopsy)
At least 21 days from prior chemotherapy
At least 30 days from prior irradiation therapy
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
Life expectancy of 12 weeks or more
Adequate hematologic function [Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L; platelet count ≥100x10^9/L; hemoglobin ≥8.5 g /dL maintained in the absence of red blood cell transfusions; and prothrombin time international normalized ratio ≤1.7; or prothrombin time ≤2 seconds above control)
Adequate hepatic function (albumin ≥2.8 g/dL; total bilirubin ≤2 mg/dL [51.3 μmol/L]; and alanine aminotransferase and aspartate aminotransferase ≤1.5 times the upper limit of the normal range)
Adequate renal function (serum creatinine ≤2.0 times the upper limit of the normal range or creatinine clearance ≥60 mL/min).
At least one untreated target lesion that could be measured in one dimension, according to the Response Evaluation Criteria in Solid Tumors (RECIST)

Exclusion Criteria:

Previous treatment with docetaxel (prior treatment with paclitaxel permitted)
Receipt of more than one prior systemic chemotherapy regimen
Active concomitant malignancy likely to effect any of the primary or secondary outcome measures in the current study
Women who are pregnant, breast-feeding or planning to become pregnant during the study
Men or women of reproductive-potential who are unwilling to use an effective method of contraception during the study and for 30 days following the last dose
Evidence of a significant medical disorder or laboratory finding that, in the opinion of the Investigator, compromises the subject's safety during study participation
Active Central Nervous System (CNS) metastatic disease requiring intervention
Less than 4 weeks since major surgery
Known human immunodeficiency virus (HIV) positivity