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