Phase 2 Study Of The MEK Inhibitor PD-0325901 In Patients With Advanced Non-Small Cell Lung Cancer

Inclusion Criteria:

- Histologically documented non-small cell lung cancer with metastases (Stage IV or
recurrent disease) or locally advanced (Stage IIIB) with malignant pleural effusion
with no expectation of further effects of prior anticancer therapy, and resolution of
all acute toxic effects

- Adequate renal, liver, and bone marrow function, determined within 2 weeks prior to
the first treatment and an ECOG status of <=1.

- Must have evidence of progression of disease within 6 months of most recent prior
systemic anticancer therapy.

Exclusion Criteria:

- No parathyroid disorder or history of malignancy associated hypercalcemia

- No ongoing radiation therapy or radio-cytotoxic therapy within prior 4 weeks; No
immunotherapy, biologic therapy, hormonal, or molecular targeted therapy within prior
2 weeks

- No concurrent serious infection or life-threatening illness (unrelated to tumor)

- No history of a malignancy (other tha non-small cell lung cancer) except those
treated with curative intent for skin cancer (other than melanoma) or in situ breast
or cervical cancer or those treated with curative intent for any other cancer with no
evidence of disease for 5 years.

- No active seizure disorders or untreated brain metastases.