The purposes of this study are to determine: 1) The safety of ALIMTA plus Gemcitabine and any side effects that might be associated with the combination of these two drugs. 2) Whether ALIMTA plus Gemcitabine can help patients with non-small cell lung cancer live longer. 3) Whether ALIMTA plus Gemcitabine can make the tumor smaller or disappear, and for how long. 4) To see if patients feel better while taking ALIMTA plus Gemcitabine.

Condition	Treatment or Intervention	Phase
Carcinoma, Non-Small-Cell Lung	Drug: ALIMTA Plus Gemcitabine	Phase II

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

Criteria

Inclusion Criteria:

• Diagnosis of Non-Small Cell Lung Cancer that can be treated with chemotherapy.
• Have received no prior chemotherapy for Non-Small Cell Lung Cancer.
• Have at least one measurable lesion.
• Have an adequate performance status.
• Sign an informed consent.

Exclusion Criteria:

• A female who is pregnant or breastfeeding.
• Treatment with an investigational drug within the last 30 days, previously completed or withdrawn from this study or any other study investigating ALIMTA.
• Treatment with radiation therapy within the last 1-2 weeks.
• Brain metastasis that is uncontrolled.
• Active infection or other serious condition.

"There may be multiple sites in this clinical trial."      1-877-CTLILLY (1-877-285-4559) 

Arkansas
      "For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.", Springdale,  Arkansas,  United States; Recruiting
California
      "For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.", Oxnard,  California,  United States; Recruiting
      "For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.", Palo Alto,  California,  United States; Recruiting
Iowa
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Iowa City,  Iowa,  United States; Recruiting
Missouri
      "For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.", Columbia,  Missouri,  United States; Recruiting
      "For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.", Kansas City,  Missouri,  United States; Recruiting
Montana
      "For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.", Great Falls,  Montana,  United States; Recruiting
Washington
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Seattle,  Washington,  United States; Recruiting

Study ID Numbers:  7213
Record last reviewed:  March 2004
Record first received:  May 28, 2003
ClinicalTrials.gov Identifier:  NCT00061451
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-10-29