BO21563 Bevacizumab with chemoradiation in non small cell lung cancer

• Research type

  Research Study

• Full title

  A single-arm, open-label, multicentre phase 1b feasibility trial of bevacizumab given in combination with concomitant chemoradiation (cisplatin and etoposide) in locally advanced unresectable non-squamous non-small cell lung cancer

• IRAS ID

  3917

• Sponsor organisation

  F Hoffmann-La Roche AG

• Eudract number

  2008-002279-28

• Research summary

  Lung cancer is the mostfrequent type of cancer, as well as the leading cause of cancer-related deathsin the world. In 2002, there were 1.35 million new cases of lung cancer and1.18 million deaths worldwide. Lung cancer remains a highly lethal disease witha 5 year survival rate on not more than 15% in industrialised countries.Cigarette smoking is the principal underlying cause, and non small cell lungcancer (NSCLC) accounts for 80% of all lung cancer cases. Although significantprogress and advances in treatments has been made over the last few years withcure rates of between 10 and 20%, the majority of patients with advanced nonsmall cell lung cancer will experience either a local or distant progression oftheir disease and die within 5 years of diagnosis. In this clinical trial, weare looking to investigate both the feasibility and safety profile of theinvestigational drug bevacizumab when this is given at two different doselevels (7.5mg/Kg and 15mg/Kg) in combination with chemotherapy (Cisplatin andEtoposide) and radiotherapy (chemoradiation) in locally advanced inoperable(unresectable) non-small cell lung cancer and to then establish a preferreddose of bevacizumab when this is given in combination with chemoradiation inthe treatment of locally advanced inoperable (unresectable) non small cell lungcancer. A total of 16 evaluable patients are expected to be enrolled across thestudy in 3 treatment cohorts. Cohort 1 three patients are expected to beenrolled to the 7.5mg dose of bevacizumab for 3 treatment cycles. Cohort 2three patients are expected to be to enrolled to the 5mg dose of bevacizumabfor 3 treatment cycles. In the third cohort, a total of ten patients willreceive the preferred dose of bevacizumab as determined by the safety andfeasibility profile of the cohort 1 and cohort 2 bevacizumab dose to receive atotal 9 cycles of bevacizumab in this cohort. For the UK, a total of8 patients are expected to be enrolled across the two participating studycentres.

• REC name

  North West - Liverpool Central Research Ethics Committee

• REC reference

  08/H1005/95

• Date of REC Opinion

  30 Oct 2008

• REC opinion

  Further Information Favourable Opinion