Docetaxel and Gemcitabine With Filgrastim-SD/01 Support in Patients With Advanced Non-Small Cell Lung Carcinoma

Docetaxel and Gemcitabine given on day 1 and 8 of a 21-day schedule has substantial activity
in non-small cell lung cancer. Both first and second-line patients have response rates
comparable to or better than other standard combination regimens. Grade 3/4 neutropenia
occurs in up to half of patients not given growth factor support.

Studies demonstrate that a single dose of Filgrastim-SF/01 at 100 mg/kg effectively enhances
post chemotherapy neutrophil recovery in a manner similar to that of daily Filgrastim. This
current study is designed to characterize the incidence of grade 3/4 neutropenia when a
fixed dose of Filgrastim-SD/01 is added to a well-studied myelosuppressive chemotherapy
regimen consisting of Gemcitabine and Docetaxel.

- Histologically or cytologically documented non-small cell lung cancer

- Subjects must have stage IV or IIIB NSCLC

- 0-1 prior treatment regimens of chemotherapy

- Subjects must have bi-dimensionally measurable disease or evaluable disease by
physical exam or radiological studies

- Age > 18 years

- 1st Line - ECOG 0-2

- 2nd Line - ECOG 0-1

- Absolute neutrophil count > or = 1.5 x 10 to the 9th power/L

- Platelet count > or = 100 x 10 to the 9th power/L

- Adequate renal function with screening serum creatinine < or = 2.0 mg/dL

- Adequate AST and ALT no more than 1.5 x the upper limit of normal and serum bilirubin
< or = upper limit of normal

- Subjects must be at least two weeks from prior major thoracic or abdominal surgery
and at least two weeks from completion of radiation therapy, and recovered from all
toxicities associated with these treatments

- Negative HCG by urine or blood test in subject of child-bearing potential

- Life expectancy > 2 months

- Ethical - Before any study specific procedure is done or before study medication is
administered, the subject or legally acceptable representative must give informed
consent for participation in the study