008-Lung Cancer PET Imaging phase1b study using Erlotinib & MK-0646

• Research type

  Research Study

• Full title

  A Phase Ib, Multicenter Trial to Evaluate Molecular Determinants of Response to Erlotinib and MK-0646 in Advanced Non-Small- Cell Lung Cancer

• IRAS ID

  9073

• Sponsor organisation

  Merck & Co, Inc

• Eudract number

  2008-000074-21

• ISRCTN Number

  unknown

• Research summary

  The study is a phase 1b study which is in two parts (I & II). Part I primarily aims to investigate whether FDG-PET scans (type of imaging scans) of the primary tumour(s) is a fast indicator of treatment response in patients with Non-Small Cell Lung Cancer (NSCLC) treated with the study drug Erlotinib (alone).Part II: based on pre-clinical studies, part II primarily aims to investigate whether a molecular responder biomarker taken at the beginning of the study can predict an FDG-PET response at week 3 following combination treatment of Erlotinib and MK-0646 in the patients failing to achieve a response to 1 week of erlotinib only treatment. A molecular biomarker is a chemical feature in the blood or tumour tissue that can be used to measure the progress of disease or the effects of treatment.

• REC name

  South West - Cornwall & Plymouth Research Ethics Committee

• REC reference

  09/H0206/5

• Date of REC Opinion

  26 Feb 2009

• REC opinion

  Further Information Favourable Opinion