Window Trial of AZD8931 in resectable non-small cell lung cancer

• Research type

  Research Study

• Full title

  A signal seeking window trial of AZD8931 in patients with resectable non-small cell lung cancer

• IRAS ID

  63162

• Contact name

  paul taylor

• Sponsor organisation

  University Hospital of South Manchester NHS Foundation Trust

• Eudract number

  2011-001518-33

• Research summary

  Non-small cell lung cancer (NSCLC) is the commonest cause of cancer related morbidity and mortality worldwide. One way to control growth of cancer is to block the signalling activity of receptors called EGFR-1, HER2 and HER3 that are present on the surface of cancer cells. Two drugs that block the EGFR-1 receptor are licensed for NSCLC. AZD8931 is a new agent, taken orally, that is designed to block HER2 and HER3 receptors in addition to EGFR-1. The expectation is that blockade of EGFR-1, HER-2 and HER-3 will be more clinically effective than blockade of EGFR-1 alone. In phase I testing this agent was well tolerated. The main side effects were skin rash and diarrhoea. These side effects increased in frequency with higher doses up to 200mg daily. A dose of 40mg, orally, twice daily is recommended for further testing. The aim of this study is to determine whether this dose is biologically active in NSCLC. Patients who consent to participate will receive a 10-14 day course of AZD8931 at 40mg twice daily during the interval that they would normally be required to wait for surgery. (If surgery has to be rescheduled patients may receive up to a maximum of 18 days treatment). Following surgery the cancer cells in the resected tumour will be examined for signs (biomarkers) of suppression of growth and growth factor receptor signaling. If the dose of 40mg twice daily is demonstrated to have biological activity (ie suppress cancer cell growth and growth factor receptor signalling) this will be the dose appropriate for further clinical testing in patients with lung cancer.

• REC name

  North West - Haydock Research Ethics Committee

• REC reference

  12/NW/0162

• Date of REC Opinion

  6 Jul 2012

• REC opinion

  Further Information Favourable Opinion