REFINE-Lung

• Research type

  Research Study

• Full title

  A randomised open-label phase III trial of REduced Frequency pembrolizumab immuNothErapy for first-line treatment of patients with advanced non-small cell lung cancer (NSCLC) utilising a novel multi-arm frequency-response optimisation design

• IRAS ID

  1004165

• Contact name

  Philip Badman

• Contact email

  p.badman@imperial.ac.uk

• Sponsor organisation

  Imperial College London

• Eudract number

  2021-004908-18

• ISRCTN Number

  ISRCTN70247820

• Clinicaltrials.gov Identifier

  NCT05085028

• Research summary

  Lung cancer is the most common cause of cancer death. Things have improved with the use of drugs like pembrolizumab, which is often used following diagnosis of advanced non-small cell lung cancer (NSCLC). Pembrolizumab uses the immune system, the body’s natural defence. The immune system sends cells called T cells to fight infections and diseases. Cancer cells hide in the ‘PD-1/PD-L1 pathway’, allowing them to grow and spread. Pembrolizumab blocks the pathway. This prevents cancer cells from hiding, meaning they can be killed by T cells. The cancer may shrink or disappear as a result.

  Treatment is usually every 6 weeks, sometimes with chemotherapy. Treatment can last 2 years, and this may be too much. Research has not shown that length increases benefit, and many people who stop before 2 years continue to benefit from pembrolizumab after it has finished.

  There is a possibility that researchers can reduce treatment frequency without effectiveness being reduced. This is the main aim of REFINE-Lung, and has the potential to bring a number of positive consequences:

  • Similar effectiveness but less side effects
  • Improved quality of life
  • Less visits to and savings by hospitals

  Eligible participants will be about to or already receiving pembrolizumab as first treatment for NSCLC. After 6 months, they will be randomly allocated to one of the following with or without chemotherapy until the cancer grows significantly:

  • Pembrolizumab 6 weekly – the ‘control’ group, or standard treatment;
  • Pembrolizumab 12 weekly.

  After 150 participants are recruited, the researchers will see if 12 weekly is similar to 6 weekly, and if so 3 further groups will be opened:

  • Pembrolizumab 9 weekly;
  • Pembrolizumab 15 weekly;
  • Pembrolizumab 18 weekly.

  Up to 350 participants will be recruited into each group from 27-35 participating UK hospitals, 1750 in total. Each participant will be followed up for 18 months.

• REC name

  North West - Haydock Research Ethics Committee

• REC reference

  22/NW/0037

• Date of REC Opinion

  16 Feb 2022

• REC opinion

  Favourable Opinion