Trial of Pemetrexed or Pemetrexed With Gemcitabine for Patients With Advanced Lung Cancer Who Are Not Eligible for Platinum-Based Chemotherapy and Have Not Previously Been Treated With Chemotherapy

Inclusion Criteria: * histologically or cytologically confirmed NSCLC not amenable to surgery or radiotherapy of curative intent * locally advanced or metastatic Stage IIIb (with N3 supraclavicular or T4 for pleural effusion) or IV NSCLC * no prior chemotherapy * measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria (Therasse et al. 2000) * men and women greater than or equal to 70 years of age or patients who, in the investigator's opinion, are not eligible for platinum-based chemotherapy Exclusion Criteria: * have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry * have symptomatic brain metastases * have a history or presence of other malignancy except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin or prior malignancy treated more than 5 years before without recurrence (excluding melanoma, breast cancer and hypernephroma) * are unable to interrupt therapy with aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs) such as naproxen, piroxicam, diflunisal, or nabumetone around each dose of pemetrexed (5 days for short-acting or 8 days for long acting preparations) * are unable or unwilling to take steroids * are unable or unwilling to take folic acid or vitamin B12 supplementation * have clinically detectable (by physical examination) third-space fluid collections; for example, ascites or pleural effusions that cannot be controlled by drainage or other procedures prior to study entry * have other serious concomitant illness or medical conditions according to investigator criteria, including but not limited to the following: * congestive heart failure or angina pectoris, except if it is medically controlled * previous history of myocardial infarction within 1 year from study entry, uncontrolled hypertension, or arrhythmias * active infection requiring iv antibiotics * active ulcer, unstable diabetes mellitus, or other contra-indication to corticotherapy * superior vena cava syndrome