Phase II Study in Patients With Recurrent Non-Small-Cell Lung Cancer

Inclusion Criteria

Subjects with recurrent or progressive NSCLC with either present or prior histologic confirmation or pathologic confirmation of NSCLC
Subjects receiving 1 or more prior chemotherapy regimens for the treatment of recurrent/metastatic disease, including at least 1 platinum-based combination
Unidimensionally measurable NSCLC
Subjects with tumor tissue available for EGFR assessment
ECOG performance status of 0 or 1
Subjects with asymptomatic brain metastasis were eligible; however, they must have completed radiotherapy/radiosurgery at least 3 weeks prior to enrollment and have been off steroids

Exclusion Criteria

Women of childbearing potential who were unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 4 weeks after the study. Male subjects must also have agreed to use effective contraception
Women of childbearing potential using a prohibited contraceptive method
Women who were pregnant or breastfeeding
Women with a positive pregnancy test on enrollment or prior to study drug administration.