Feasibility of cetuximab in combination with gemcitabine or docetaxel or carboplatin/gemcitabine for chemonaïve patients with advanced non-small cell lung cancer (NSCLC): Observations from an ongoing randomized phase II/III trial (GemTax IV)

19005 Background: The novel therapeutic agent cetuximab, a monoclonal antibody that specifically targets the epidermal growth factor receptor, is currently registered for colorectal and head and neck cancer and is undergoing broad clinical investigations in advanced NSCLC. This randomized trial assesses the feasibility of cetuximab in combination with two common chemotherapeutic regimens in patients with locally advanced or metastatic NSCLC. Early phase II results are reported. Methods: Patients with histologically confirmed stage IIIB or IV NSCLC, WHO performance status 0–2, and no prior chemotherapy received cetuximab 400 mg/m2 as initial dose then 250 mg/m2 weekly either in combination with gemcitabine 1,000 mg/m2 days 1 and 8 for two 3-weekly cycles followed by docetaxel 75 mg/m2 day 1 for 2 cycles (q3w) or gemcitabine 1200 mg/m2 days 1 and 8 and carboplatin AUC5 day 1 for a maximum of 4 cycles (q3w). Cetuximab was administered until disease progression or unacceptable toxicity. Results: 142 patients ...