PePS2: A phase II trial of pembrolizumab in patients with non-small cell lung cancer and a performance status of 2

Trial Overview and Summary

 Chief Investigator:  Professor Gary Middleton
 Sponsor:  University of Birmingham
 Funder:  Merck, Sharp and Dohme
 Disease Site:  Non-Small Cell Lung Cancer with a Performance Status of 2
 Trial Type:  Clinical Trial of an Investigational Medicinal Product
 Status:  Follow Up
 UKCRN Study ID (if applicable):  31307
 Open to New Sites?  No
 Recruitment End Date:  February 2018
 CRCTU Trial Management Team:  Early Drug Development Team
 Trial Email Address:

Many patients with lung cancer have impaired performance status (PS), a measure of a patient’s general well-being and daily activity. This means that they are ineligible for trials of new therapies including pembrolizumab (anti PD-1): all of the trials of this drug reported thus far have been in patients with PS 0-1.

The favourable safety profile of pembrolizumab suggests that it may represent an excellent choice for PS2 patients.

In this trial, PS2 patients with non-small cell lung cancer will be treated with the anti-PD1 antibody, to assess toxicity, safety, response rate and duration of response.

Please note that the trials team cannot give individuals clinical advice. Patients and their families should contact their treating physician to discuss trials for which they may be eligible.

Trial Summary

View Trial Summary Document [.pdf]

Trial Protocol

View Trial Protocol Document [.pdf]

Please Note:

  • Clinical trial protocols are complex technical documents which should only be used for the treatment of subjects taking part in the trial.
  • Patients who are interested in taking part in the trial are advised to talk to their health care professional and refer to the  CancerHelp website.
  • Investigators please ensure you have R&D approval for this specific version of the protocol before using as a reference. 


Latest Publications
Middleton, G., Brock, K., Savage, J., Mant, R., Summers, Y., Connibear, J., Shah, R., Ottensmeier, C., Shaw, P., Lee, S. M., Popat, S., Barrie, C., Barone, G., & Billingham, L. (2020). Pembrolizumab in patients with non-small-cell lung cancer of performance status 2 (PePS2): a single arm, phase 2 trial. The Lancet. Respiratory medicine8(9), 895–904.

Latest News
'Study finds new group of lung cancer patients could benefit from immunotherapy treatment' - University of Birmingham Press (12 May 2020)