A7471028 A Phase 2 Trial of PF-00299804 V's Erlotinib for NSCLC

• Research type

  Research Study

• Full title

  A Randomised Phase 2 Trial of PF-00299804 Versus Erlotinib for the Treatment of Advanced Non-Small Cell Lung Cancer After Failure of at Least One Prior Chemotherapy Regimen

• IRAS ID

  6885

• Contact name

  Kirsty Stirling

• Sponsor organisation

  ICON Clinical Research (UK) Ltd

• Eudract number

  2008-005235-14

• ISRCTN Number

  N/A

• Research summary

  This study is being done to evaluate the clinical activity of a drug that is not yet approved to treat Non-Small Cell Lung Cancer. The drug is called PF-00299804 and it will be compared with a drug that is approved for the treatment of non-small cell lung cancer, erlotinib (Tarceva) in this study.PF-00299804 has been given to about 115 people in other studies. PF-00299804 is a new type of research drug that targets proteins in cells called ??HER? (this stands for Human Epidermal Growth Factor Receptor). The main side effects are similar to those for erlotinib Tarceva - rash, diarrhoea, mouth sores and fatigue. In 42 patients with Non-Small Cell Lung Cancer a clinical benefit (response or disease stabilisation) was observed in 45% of patients.The main purpose of this study is to now compare the effects of PF-00299804 with erlotinib (Tarceva) when administered as treatment to patients with advanced Non-Small Cell Lung Cancer (NSCLC) who have had at least one prior chemotherapy regimen.There will be 160 people in this study from the US, Europe and Asia. The study will run for a total of 3 years and each patient will spend approximately 1-2 years in the study.Patients will either get PF-00299804 or erlotinib (Tarceva). Patients have a 50% chance of getting PF-00299804. The doctor will know if the patient is on PF-00299804 or erlotinib (Tarceva).

• REC name

  East of Scotland Research Ethics Service REC 2

• REC reference

  08/S0501/92

• Date of REC Opinion

  21 Jan 2009

• REC opinion

  Further Information Favourable Opinion