The purpose of this research study is to evaluate the safety and effectiveness of Neulasta® (pegfilgrastim) in reducing infection when given on the same day versus one day after the completion of chemotherapy (docetaxel and carboplatin) in patients with advanced or metastatic non-small cell lung cancer (NSCLC). This study is considered to be "investigational" because previous studies with Neulasta® used next day dosing and not same day dosing.

Condition	Treatment or Intervention	Phase
Lung Cancer Carcinoma, Non-Small-Cell Lung	Drug: pegfilgrastim	Phase II

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Eligibility Criteria:

• Age 18 years or older
• Diagnosis of advanced or metastatic non-small cell lung cancer (NSCLC)
• Have not received any prior chemotherapy
• Have not received radiation therapy or undergone major surgery within the past 2 weeks

Arizona
      Research Site, Tucson,  Arizona,  United States
Florida
      Research Site, Miami,  Florida,  United States
Indiana
      Research Site, South Bend,  Indiana,  United States
Michigan
      Research Site, Clinton Township,  Michigan,  United States
Ohio
      Research Site, Sylvania,  Ohio,  United States
Pennsylvania
      Research Site, Kingston,  Pennsylvania,  United States
South Carolina
      Research Site, Florence,  South Carolina,  United States
Tennessee
      Research Site, Knoxville,  Tennessee,  United States

Study ID Numbers:  20030123
Record last reviewed:  February 2005
Last Updated:  February 23, 2005
Record first received:  October 27, 2004
ClinicalTrials.gov Identifier:  NCT00094822
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08