Open-Label Single-Arm Phase 2 Study of ALIMTA in Patients With Advanced Non-Small Cell Lung Cancer Who Have Had Prior Chemotherapy
- diagnosis of NSCLC
- Locally advanced or metastatic disease (Stage IIIB or IV).
- Patients must have previously received one chemotherapy regimen for palliative
therapy of locally advanced or metastatic disease.
- Disease status must be that of measurable disease as defined by RECIST criteria
- Performance status of 0 to 1 on the Eastern Cooperative Oncology Group (ECOG) Scale;
and adequate organ function.
- Known or suspected brain metastasis, or Second primary malignancy that is clinically
detectable at the time of consideration for study enrollment
- Concurrent administration of any other tumor therapy.
- History of significant neurological or mental disorder, including seizures or
dementia; or any other serious concomitant disorders that would compromise the safety
of the patient or compromise the patient's ability to complete the study
- Inability to interrupt aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs)
2 days before, the day of, and 2 days after the dose of pemetrexed.
- Inability or unwillingness to take folic acid, vitamin B12 supplementation, or