Study E7389-G000-302. Randomized Phase 3 study of Eribulin in NSCLC

• Research type

  Research Study

• Full title

  A Randomized, Open-label, Multicenter, Phase 3 Study to Compare the Efficacy and Safety of Eribulin with Treatment of Physician’s Choice in Subjects with Advanced Non-Small Cell Lung Cancer.

• IRAS ID

  92695

• Contact name

  Paul David Taylor

• Sponsor organisation

  Eisai Ltd

• Eudract number

  2011-000724-15

• Research summary

  This is a clinical trial testing an anti-cancer therapy, called Eribulin Mesylate. Eribulin is already approved in the UK for treating advanced breast cancer. In this multicentre study, which is being conducted in many research sites around the World, Eribulin will be tested in adult patients with an advance form of lung cancer called Non-Small Cell Lung Cancer (NSCLC). This study will look at whether Eribulin is safe, tolerable and effective for the treatment of NSCLC compared with a Treatment of Physician's Choice (TPC). TPC consists of 4 standard treatment options which the Investigator will choose. The participants will be assigned to their treatment group (either Eribulin or TPC) by randomisation (by chance like flipping a coin). This study also involves laboratory testing on blood samples and tissue samples to find out as much as possible on a biochemical/biological level about how Erbulin might affect NSCLC.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  12/NW/0002

• Date of REC Opinion

  13 Feb 2012

• REC opinion

  Further Information Favourable Opinion