ABLE Trial – Afatinib Before Lung surgEry

• Research type

  Research Study

• Full title

  An Open Label Multi-Centre Preoperative Window of Opportunity Study of Afatinib in Stage Ia to IIb Non-Small Cell Lung Cancer

• IRAS ID

  113983

• Contact name

  Clive Mulatero

• Sponsor organisation

  University of Leeds

• Eudract number

  2012-004537-16

• ISRCTN Number

  ISRCTN16279802

• Duration of Study in the UK

  2 years, 0 months, 0 days

• Research summary

  There are many new, targeted drugs available to treat lung cancer patients. The way that each patient’s lung cancer responds to these new treatments is very variable. If we understood the important cellular pathways for each cancer it might allow doctors to predict which drug would be beneficial for each patient.

  PET/CT scanners take pictures that show how metabolically active cancers are (how much energy they are using). All patients who are going to have lung surgery have a PET/CT scan as part of their routine preoperative investigations.

  There is almost always a few weeks between each patient completing their investigations and their date of surgery and the researchers plan to offer a drug (a daily tablet) called afatinib to patients during this ‘window of opportunity’.

  Each patient in the study will have a repeat the PET/CT scan after having taken afatinib for a fortnight to see whether there has been any change in the amount of energy that the cancer is using as a result of taking the drug. A reduction in the amount of energy used by cancers might be an early sign of slowing down or stopping the growth of the cancer as dividing cells use more energy that other cells. If this is seen it might provide a signal to show whether a particular cancer is responding to afatinib or not.

  The researchers will also analyse the tumour removed at surgery together with 'before' and 'after' samples of blood and tumour to look for differences between patients whose cancers respond and those that do not.

  The researchers hope that this study will help future patients to be able to know with more certainty, and sooner, whether their cancer will respond to afatinib or not.

• REC name

  Yorkshire & The Humber - Leeds East Research Ethics Committee

• REC reference

  12/YH/0539

• Date of REC Opinion

  8 Jan 2013

• REC opinion

  Further Information Favourable Opinion