TRANSCRiPT

• Research type

  Research Study

• Full title

  A study to assess the incidence of mutations in the tyrosine kinase domain of the epidermal growth factor receptor in UK patients with newly diagnosed locally advanced or metastatic non-small cell lung cancer and to investigate the quality of life of these patients undergoing first-line monotherapy with erlotinib (Tarceva®).

• IRAS ID

  55840

• Contact name

  Conrad Lewanski

• Sponsor organisation

  Roche Products Ltd

• Eudract number

  2010-021120-96

• ISRCTN Number

  Not Sent

• Research summary

  Lung cancer is a major cause of cancer-related death in Europe. About 4 out of every 5 cases of lung cancer are non-small cell lung cancer (NSCLC) and by the time of diagnosis approximately two thirds of patients already have advanced disease. Most patients diagnosed with stage III or above disease die within 2 years and for many patients a successful treatment is not available. It is important to find alternative treatments for patients with advanced tumours who are unsuitable for surgery.Erlotinib (Tarceva©) is a medicine that is used to treat NSCLC at an advanced stage. It is licensed for use in the UK when a patient??s previous chemotherapy treatment has not had an effect or has stopped working. Erlotinib is also licensed for first line maintenance treatment in patients with locally advanced or metastatic NSCLC unchanged after receiving 4 cycles of standard chemotherapy. There is some evidence from clinical trials that erlotinib is effective as first-line treatment in selected patients with advanced NSCLC but the drug is not currently licensed in this indication.Erlotinib works by preventing the activity of a protein called epidermal growth factor receptor (EGFR). This protein is known to be involved in the growth and spread of cancer cells. There is some evidence to indicate that people with advanced NSCLC carrying a mutation (a change) in the EGFR have a greater response to drugs, like erlotinib.The incidence of EGFR mutation in patients with advanced NSCLC in the UK is currently unknown, so the objective of this study is to assess the proportion of patients who are newly diagnosed with advanced NSCLC (that has either spread into surrounding structures or around the body) that carry mutations in their EGFR. 1200 patients with newly diagnosed advance NSCLC in the UK will be tested for the presence of EGFR mutations.Patients identified with EGFR mutations will then be further screened for inclusion in the treatment part of the study . Once the study criteria are fulfilled, the patients will receive erlotinib as their first line treatment. They will receive erlotinib for as long as it is controlling their disease.The study will also assess the effect of erlotinib on advanced lung cancer in patients with identified EGFR mutations as well as any side effects of erlotinib and the impact of erlotinib treatment on quality of life.The results of this study will help to provide a targeted treatment option as an alternative to chemotherapy for patients anticipated to benefit most from this class of drug.

• REC name

  London - Bloomsbury Research Ethics Committee

• REC reference

  10/H0713/75

• Date of REC Opinion

  15 Nov 2010

• REC opinion

  Favourable Opinion