The purposes of this study are to determine:

• the safety of ALIMTA and any side effects that might be associated with it
• how much ALIMTA should be given to patients.

It is possible that information collected during this study will be analyzed by the Sponsor in the future to evaluate ALIMTA for other possible uses or for other medical or scientific purposes other than those currently proposed. Although ALIMTA has been shown to be effective in some patients with non-small-cell lung cancer, ALIMTA might not have beneficial effects for all patients.

Condition	Treatment or Intervention	Phase
Non-Small-Cell Lung Carcinoma	Drug: pemetrexed	Phase III

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

Criteria

Inclusion Criteria:

• Diagnosis of locally advanced or metastatic (Stage III or IV at entry) non-small cell lung cancer (NSCLC) that is not amenable to curative therapy.
• Patients must have been previously treated with one platinum-containing chemotherapy regimen for locally advanced or metastatic disease. Patients are also eligible if they have received one platinum-based chemotherapy regimen as neoadjuvant or adjuvant chemotherapy, but must have received an additional chemotherapy regimen upon recurrence.
• No more than two prior systemic anti-cancer therapies will be allowed.
• Prior radiation therapy is allowed to <25% of the bone marrow. Prior radiation to the whole pelvis is not allowed. Prior radiotherapy must be completed at least 2 weeks before study enrollment, and the patient must have recovered from the acute toxic effects of the treatment prior to study enrollment.

Exclusion Criteria:

• Pregnancy.
• Breast-feeding.
• Second primary malignancy that is clinically detectable at the time of consideration for study enrollment.
• Inability to interrupt aspirin, or other nonsteroidal anti-inflammatory agents for a 5-day period.
• Inability or unwillingness to take folic acid or vitamin B12 supplementation.

"There may be multiple sites for 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., Torrance,  California,  United States; Recruiting

Study ID Numbers:  8433
Record last reviewed:  March 2004
Record first received:  February 20, 2004
ClinicalTrials.gov Identifier:  NCT00078260
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-10-29