A Randomized Phase II, Multi-Center, Open-Label Trial of PR104 and Docetaxel in Patients With Advanced Non-Small Cell Lung Cancer

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