Efficacy and Safety of Cetuximab in Combination With Cisplatin Gemcitabine as First-Line Therapy in Advanced NSCLC

• Status: Unknown status
• Trial end date: 1969-12-31

Summary

Lung cancer is the leading cause of cancer deaths worldwide. It is estimated that, in 2004, 173,700 new cases of lung cancer will be diagnosed in the United States alone and 164,440 deaths due to this disease will occur(13) . NSCLC accounts for approximately 80% of all lung cancers. Among NSCLC cases approximately 30% present with locally advanced and 40% with metastatic disease (14,15) . In metastatic disease, chemotherapy is the treatment of choice, but benefits obtained in survival have been modest. Five-year survival is less than 15%, probably due to diagnosis at late stages. Surgical results in earlier stages are poor compared to other tumor types (about 40% of recurrence in stages I-II). Results of chemotherapy in advanced stages are also poor (one-year survival of 40%) (15,17). It is commonly accepted that the standard treatment for advanced disease (stage IV and IIIb with malignant pleural effusion) consists of platinum-based chemotherapy(15,16) . However, there are many open questions in the management of these patients, such as the role of 3-drugs combinations, non-platinum-based therapies, and new biologic therapeutics' approaches. Currently, in the treatment of advanced NSCLC response rates of about 20%-30% and median survival times of 6 to 11 months have been achieved (16, 17, 18, 19, 20, 21, 22,). Several combinations of drugs are used and show similar efficacy. Cisplatin plus vinorelbine or Cisplatin plus Gemcitabine are among the most commonly used regimens in the first-line therapy of NSCLC.

• Phase: Phase 2

Details

• Lead Sponsor: Grupo Portugues de Estudo do Cancro do Pulmao
• Treatments: Cetuximab; Cisplatin; Gemcitabine