Selumetinib or Placebo + Docetaxel for KRAS positive NSCLC

• Research type

  Research Study

• Full title

  A Phase III, Double-Blind, Randomised, Placebo-Controlled Study to Assess the Efficacy and Safety of Selumetinib (AZD6244; ARRY-142886) (Hyd-Sulfate) in Combination with Docetaxel, in Patients receiving second line treatment for KRAS Mutation-Positive Locally Advanced or Metastatic Non Small Cell Lung Cancer (Stage IIIB – IV) (SELECT-1)

• IRAS ID

  136253

• Contact name

  Fiona Blackhall

• Contact email

  fiona.blackhall@christie.nhs.uk

• Sponsor organisation

  AstraZeneca UK Ltd

• Eudract number

  2013-001676-38

• Research summary

  Selumetinib is an experimental treatment for patients who have advanced non small cell lung cancer (NSCLC) and harbour a mutation of the KRAS gene (approximately 10 to 30% patients). An earlier run study has shown selumetinib to provide clinical benefit when given in combination with docetaxel in patients with KRAS positive advanced NSCLC.
  This study will investigate the safety and efficacy of selumetinib/placebo with docetaxel for patients who have previously received chemotherapy for KRAS positive advanced NSCLC.
  Combination of selumetinib/placebo and docetaxel may cause additional side effects or make other side effects more intense. Patients will be closely monitored by means of blood tests, physical examination, eye tests, heart tests (ECG and echocardiogram / MUGA) throughout the study, and will have regular scans to look for effects on the tumour.
  To be eligible for the study, male and female patients must be at least 18 years old with advanced NSCLC.
  Pre screening of patients will be required to assess the archival tumour (taken at time of diagnosis of cancer) for the KRAS mutation.
  Female patients must not be pregnant or breastfeeding. Male patients and female patients of childbearing potential must use adequate birth control methods.
  During the study patients will receive docetaxel in a 3weekly cycle (usually up to 6 cycles), and selumetinib/placebo twice daily until the end of the study. Patients will have clinic visits every week in the first cycle, then once per cycle, until they are no longer achieving clinical benefit in the opinion of the treating investigator.
  Expected that five hospital sites in the UK will participate. Approximately 25 patients will be recruited

• REC name

  North West - Haydock Research Ethics Committee

• REC reference

  13/NW/0641

• Date of REC Opinion

  24 Sep 2013

• REC opinion

  Favourable Opinion