Cetuximab maintenance therapy in advanced NSCLC (NEXT)

• Research type

  Research Study

• Full title

  Open, randomized, multinational phase IIIb trial evaluating the activity and safety of cetuximab as 250 mg/m² weekly and 500 mg/m² every two weeks maintenance therapy after platinum-based chemotherapy in combination with cetuximab as first-line treatment for subjects with advanced non-small cell lung cancer (NSCLC)

• IRAS ID

  8698

• Sponsor organisation

  Merck KGaA

• Eudract number

  2008-004454-33

• ISRCTN Number

  N/A

• Research summary

  The standard treatment for patients with advanced non small cell lung cancer (NSCLC) is platinum-based chemotherapy. Several studies have suggested that improved results can be obtained when Cetuximab is given in addition to this chemotherapy. When used in combination with chemotherapy, cetuximab has also been used as a maintenance therapy if subjects no longer tolerate chemotherapy. In a previous trial patients received maintenance therapy of 250 mg/mý of cetuximab every week. Based on the results, there is a need to further investigate the options for maintenance therapy with an every 2 weeks schedule of cetuximab at a dose of 500 mg/mý that would be more convenient for subjects suffering from NSCLC at this stage of disease. To date, a comparative trial of treatment with cetuximab once weekly and every 2 weeks regimen has not been reported, however, there is evidence from non-comparative studies that an every 2 weeks regimen is efficacious and safe.The aim of this study is to compare the effectiveness and safety of having cetuximab every week at a dose of 250 mg/mý versus cetuximab every 2 weeks at a dose of 500 mg/mý. This will be analysed in terms of overall survival time, especially overall survival rate at one year, time to treatment failure, tumour response and disease control, and safety. In addition, the compliance to maintenance therapy and subject satisfaction will be evaluated.

• REC name

  West Midlands - Coventry & Warwickshire Research Ethics Committee

• REC reference

  08/H1211/174

• Date of REC Opinion

  2 Mar 2009

• REC opinion

  Further Information Favourable Opinion