- Histologically or cytologically documented diagnosis of progressive or recurrent,
locally advanced or metastatic NSCLC; a tumor that expresses at least one member of
the erbB family of receptors; failed or relapsed after receiving a platinum-containing
regimen as therapy; at least one measurable target lesion as defined by RECIST that
has not been irradiated.
- Prior exposure to agents that target the erbB receptor family; unknown response to
prior platinum-containing chemotherapy regimen; cytotoxic chemotherapy within 3 weeks
prior to baseline disease assessments (6 weeks for nitrosoureas or mitomycin); more
than 2 prior chemotherapy regimens: immunotherapy or other biologic therapy within 2
weeks prior to baseline disease assessment; prior irradiation to areas encompassing
greater than 30% of marrow-bearing bone; brain metastases.