EORTC 1417-LCG (REACTION)

• Research type

  Research Study

• Full title

  REACTION: A phase II study of etoposide and cis/carboplatin with or without pembrolizumab in untreated extensive small cell lung cancer.

• IRAS ID

  231107

• Contact name

  Raffaele Califano

• Contact email

  Raffaele.califano@christie.nhs.uk

• Sponsor organisation

  European Organisation for Research and Treatment of Cancer (EORTC)

• Eudract number

  2014-003090-42

• Clinicaltrials.gov Identifier

  NCT02580994

• Duration of Study in the UK

  4 years, 2 months, 1 days

• Research summary

  This study is for adults who have extended disease small cell lung cancer (SCLC). This is not curable and there is an urgent need to develop new therapies, which can be added to existing treatments to increase survival without unacceptable toxicity. People are usually treated with combination chemotherapy to control the disease. There is now some early evidence to suggest that immunotherapy (drugs that increase the activity of the body’s immune system to fight cancer cells) may also play a role in treating the disease.

  The purpose of this study is to find out whether adding an immunotherapy drug called pembrolizumab to standard chemotherapy treatment is better than the standard treatment on its own, and is as safe.
  In this study, this is measured by the length of time that participants in each treatment group live with the disease before it gets worse (progression-free survival).
  
  The study will compare the two treatment groups using clinical examinations, regular scans and blood tests. Tumour samples and blood tests will also be used look for certain genes or proteins, including a protein called PD-L1, to learn more about the disease and effects of the drugs.

  This study will take place in NHS sites in the UK as part of a wider international study. The study is sponsored and coordinated by a non-profit organisation called the EORTC (European Organisation for Research and Treatment of Cancer), based in Brussels.

• REC name

  North West - Haydock Research Ethics Committee

• REC reference

  18/NW/0429

• Date of REC Opinion

  18 Jun 2018

• REC opinion

  Favourable Opinion