Primary

Inclusion Criteria:

- Relapsed or refractory histologically or cytologically confirmed Stage IIIB, IV, or
recurrent NSCLC

- Previously treated and failed to respond to standard therapy or progressed after
standard therapy

- 18 years of age or older

Primary Exclusion Criteria:

- Received a non-FDA approved investigational agent within the last 4 weeks.

- Previous cancer therapies (chemotherapy, hormonal therapy, monoclonal antibodies or
radiation therapy) within the last 3 weeks, 8 weeks for fully human or humanized
monoclonal antibodies

- Infection requiring antibiotics or hospitalization within the last 2 weeks

- HIV, Hepatitis-B, Hepatitis-C

- Pregnant or breast-feeding women

- Major surgery within the last 4 weeks

- History of other cancers within the past 5 years