A Randomized Phase II Study of Schedule-Modulated Concomitant Pemetrexed and Erlotinib Versus Single Agent Pemetrexed in Patients With Progressive or Recurrent Non-Small Cell Lung Cancer (NSCLC)

Inclusion Criteria:

- Patients must have histologically or cytologically confirmed advanced (Stage IIIB
with a malignant pleural effusion or Stage IV disease) or recurrent nonsquamous
NSCLC.

- Patients must have at least one measurable disease per RECIST criteria

- Patient must have disease progression after one prior chemotherapy and/or targeted
therapy other than pemetrexed or anti-EGFR therapy for metastatic disease, or relapse
while receiving adjuvant therapy, or within 12 months of completing adjuvant therapy

Exclusion Criteria:

- Patients who have had immunotherapy, hormone, chemotherapy or radiotherapy within 4
weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those
who have not recovered from adverse events due to agents administered more than 4
weeks earlier.

- Patients with uncontrolled brain metastases should be excluded from this clinical
trial because of their poor prognosis.

- Patients with immune deficiency