A phase II trial of pembrolizumab in NSCLC PS2 patients

• Research type

  Research Study

• Full title

  A phase II trial of pembrolizumab in patients with non-small cell lung cancer and a performance status of 2

• IRAS ID

  169512

• Contact name

  Gary Middleton

• Contact email

  G.Middleton@bham.ac.uk

• Eudract number

  2015-002241-55

• Duration of Study in the UK

  4 years, 0 months, 0 days

• Research summary

  Research Summary

  Non-small cell lung cancer (NSCLC) is the most common type of lung cancer. There are several studies which demonstrate a role for the immune system in fighting lung cancer. However, there are multiple mechanisms by which cancer dampens this response. The PD-1 receptor-ligand interaction is one of the major pathways hijacked by tumours to help evade detection and elimination by the cells of the immune system. A number of compounds which block this pathway, including the drug pembrolizumab, have shown impressive results in some patients.

  At present all of the trials reported thus far have been in patients with a good Performance Status of 0-1, a measure of daily activity. Unfortunately many patients with lung cancer have impaired performance status, making them ineligible for trials of new therapies including anti PD-1.

  In this trial we would like to determine whether this drug can be used to treat Performance status 2 patients with a lower general daily activity. The purpose of this trial is to determine that pembrolizumab is safe and tolerable.
  We would also like to see how well the treatment works, find out more information about tumour shrinkage, and learn more about the disease and how it changes over time. This trial will use Computed Tomography (CT) scans to track the size of the tumours, optional biopsies to look at how the tumour changes, and results from blood tests to look at tumour cell DNA and immune cells to see how the drug is acting on the body.

  This is a single arm phase II trial, with a total trial duration of 4 years (1 year recruitment, 2 years trial treatment and follow-up of patients).

  Summary of Results

  The lay summary of the study results can be found on the Cancer Research UK website:
  https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fu2790089.ct.sendgrid.net%2Fls%2Fclick%3Fupn%3DXv3JSvJ-2B3M71ppf7N9agbZ0oYz60WoglvPkqIfU1HPHTUfauCq2ZPvNtWjz0kGXSOCiSOfyPyipJY7AGHLby83CxCKkzl39Br4eiOAMc6C5AFgSnc5-2BHZZeQgYi3oDRmlk7JrlvIjAxq2KXECuQXkXneEwN8q7XMEMR3OVrgYXVjz8223Hu1TiewOykVh3NzdQxbjWo7-2BntzWDPwqOW3NA-3D-3D9txn_E1aO2-2BZlVOSJJV-2FajQqskegTd6IRomHYTi-2Fbt8SH3YLeDOrGV0jJXnFIlsaDHlx98z3BuUSVgnqCDZ5gLiP4SJKqx133BO0qkDBbzXGlG9cmtYnEV-2FnzRZcKhtnW0askrp7pKzgxQJVqykSz0etzEgDPFVoY8cXht9t3BQy8F-2FjvvRgm8vG40mjYTTb-2BvuE2RF6Xc1esT-2BGwfkxlA-2BC6dQ-3D-3D&data=05%7C02%7Cedgbaston.rec%40hra.nhs.uk%7C9ad5c4cc648f4753a89e08dc240abd4e%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638424875743216617%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=I0MKXH%2Ben6o%2FQqo94eAbzEkMszBI63%2BedOz%2BtvpLjVQ%3D&reserved=0

• REC name

  West Midlands - Edgbaston Research Ethics Committee

• REC reference

  16/WM/0010

• Date of REC Opinion

  2 Feb 2016

• REC opinion

  Favourable Opinion