A Phase II Trial of Cetuximab (C225) as Therapy for Recurrent Non-Small Cell Lung Cancer (NSCLC)

Inclusion Criteria

Inclusion Criteria

1. Subjects with recurrent or progressive NSCLC with either present or prior histologic
confirmation or pathologic confirmation of NSCLC

2. Subjects receiving 1 or more prior chemotherapy regimens for the treatment of
recurrent/metastatic disease, including at least 1 platinum-based combination

3. Unidimensionally measurable NSCLC

4. Subjects with tumor tissue available for EGFR assessment

5. ECOG performance status of 0 or 1

6. 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

1. 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

2. Women of childbearing potential using a prohibited contraceptive method

3. Women who were pregnant or breastfeeding

4. Women with a positive pregnancy test on enrollment or prior to study drug
administration.