AZD9291 in patients with advanced NSCLC, following EGFR TKI therapy

• Research type

  Research Study

• Full title

  A Phase I, open-label, multicentre study to assess the safety, tolerability, pharmacokinetics and preliminary anti-tumour activity of ascending doses of AZD9291 in patients with advanced non small cell lung cancer who have progressed following prior therapy with an epidermal growth factor receptor tyrosine kinase inhibitor agent

• IRAS ID

  120142

• Contact name

  Malcolm Ranson

• Sponsor organisation

  AstraZeneca UK

• Eudract number

  2012-004628-39

• Research summary

  Lung cancer is the most common cancer in the world. In 2008, there were an estimated 1.6 million new cases, 80-85% of which were non-small cell lung cancer (NSCLC). Treatment of patients with advanced NSCLC can be guided by the presence of molecular drivers in the tumours such as EGFR, AnLK and KRAS mutations. Patients with activating mutations in EGFR (i.e. EGFRM) are routinely prescribed EGFR tyrosine-kinase inhibitors (TKIs) such as Iressa or Tarceva. In these patients, the tumours initially respond to treatment but then develop resistance. In approximately 50% of these cases, resistance and disease progression is associated with the emergence of a secondary EGFR mutation, T790M. Pre-clinical studies have shown that a new drug, AZD9291, can block tumour growth in patients with EGFRM and EGFRM T790M tumours.This study will investigate the safety, tolerability and efficacy of this potential new medicine in this patient population who have already received chemotherapy and/or a TKI. It will also involve the taking of additional tumour and blood samples for exploratory research into factors that may influence the development of NSCLC and/or response to AZD9291. All patients on the study will be treated with AZD9291. The study will recruit about 160 patients in total, aged 18 years or over. During the study, patients will be asked to attend hospital visits on a regular basis and will undergo assessments to check their health and to see how the drug is working. Patients can remain on AZD9291 for as long as they are receiving benefit and are not experiencing unacceptable side effects.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  13/NW/0032

• Date of REC Opinion

  11 Mar 2013

• REC opinion

  Further Information Favourable Opinion