Pembrolizumab in Patients With Non-Small Cell Lung Cancer and a Performance Status 2
PePS2
A Phase II Trial of Pembrolizumab in Patients With Non-small Cell Lung Cancer and a Performance Status of 2
3 other identifiers
interventional
62
1 country
10
Brief Summary
This study is to determine that pembrolizumab is safe and tolerable at the selected dose for the treatment of Non-Small Cell Lung Cancer (NSCLC) in patients with a performance status of 2. All patients will receive pembrolizumab.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jan 2017
Longer than P75 for phase_2
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 1, 2016
CompletedFirst Posted
Study publicly available on registry
April 11, 2016
CompletedStudy Start
First participant enrolled
January 4, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 7, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
February 5, 2024
CompletedResults Posted
Study results publicly available
February 10, 2025
CompletedFebruary 10, 2025
January 1, 2025
6.1 years
March 1, 2016
July 26, 2024
January 16, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Toxicity Rate
Adverse events will be recorded in relation to each cycle of treatment and graded according to CTCAE criteria. The toxicity co-primary outcome measure for the trial is defined as the occurrence of a treatment-related dose delay or treatment discontinuation due to toxicity.
Date of patient registration until 6 months after the administration of the last treatment (a maximum of 2 years treatment and 6 months followup after end of treatment)
Durable Clinical Benefit
Patients will have CT scans every 9 weeks from baseline until disease progression. On each occasion, overall tumour burden will be assessed using RECIST version 1.1. The efficacy co-primary outcome measure for the trial is durable clinical benefit defined as the occurrence of CR, PR or SD without prior progressive disease at or after the second scheduled CT scan (scheduled to occur at 18 weeks).
≥18 weeks, up to maximum of 2 years
Secondary Outcomes (7)
Objective Response
≥18 weeks, up to maximum of 2 years
Health Related Quality of Life
Through study completion, up to a maximum of 2 years
Time to Progression
Time to progression up to 2 years
Progression-free Survival Time
Progression-free survival time up to 2 years
Overall Survival Time
Survival time up to 2 years or date of death
- +2 more secondary outcomes
Study Arms (1)
Pembrolizumab
EXPERIMENTALPembrolizumab: 200 mg Q3W, intravenous administration for a maximum of 2 years, or until progression or unacceptable toxicity.
Interventions
Eligibility Criteria
You may qualify if:
- Histologically confirmed PD-L1 status defined NSCLC. Biopsy must be within 70 days of first treatment with pembrolizumab.
- Eastern Cooperative Oncology Group (ECOG) performance status 2.
- Life expectancy \> 12 weeks.
- Uni-dimensionally measurable disease according to Response Evaluation Criteria in Solid Tumours (RECIST) v1.1
- Computerised Tomography (CT) scan of chest and abdomen within 28 days of starting pembrolizumab.
- Adequate haematological function:
- Platelet count ≥100 x 109 /L.
- Neutrophils ≥1.5 x 109/L.
- Haemoglobin ≥ 90 g/L.
- Adequate hepatic function:
- Serum bilirubin ≤1.5 x upper limit of normal (ULN).
- Serum transaminases ≤2.5 x ULN.
- Adequate renal function: Creatinine clearance \<1.5 times ULN concurrent with creatinine clearance \>50 ml/min.
- Provision of signed and dated, written informed consent prior to any trial specific procedures, sampling and analyses.
You may not qualify if:
- Patients who do not meet the criteria of performance status = 2 on the ECOG Performance scale.
- Untreated symptomatic brain or leptomeningeal metastatic disease.
- Medical or psychiatric conditions compromising informed consent.
- Any medical condition which in the opinion of the investigator would compromise the ability of the patient to participate in the trial or which would jeopardise compliance with the protocol.
- Radiotherapy within 28 days of trial treatment.
- Active autoimmune disease that has required systemic treatment in past 2 years
- Chronic usage of steroids or other immunosuppressant medication.
- Previous history of pneumonitis.
- Any evidence of clinical autoimmunity.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Birminghamlead
- Merck Sharp & Dohme LLCcollaborator
Study Sites (10)
The Christie NHS Foundation Trust
Manchester, Greater Manchester, M20 4BX, United Kingdom
Southampton University Hospitals NHS Trust
Southampton, Hampshire, SO16 6YD, United Kingdom
Maidstone and Tunbridge Wells NHS Trust
Maidstone, Kent, ME16 9QQ, United Kingdom
University Hospital Birmingham NHS Foundation Trust
Birmingham, West Midlands, B15 2TH, United Kingdom
Velindre Cancer Centre
Cardiff, CF14 2TL, United Kingdom
Western General Hospital
Edinburgh, United Kingdom
United Lincolnshire Hospitals NHS Trust
Lincoln, LN2 5QY, United Kingdom
Barts Health NHS Trust
London, E1 1BB, United Kingdom
University College London Hospitals
London, NW1 2BU, United Kingdom
The Royal Marsden Hospital
London, SW3 6JJ, United Kingdom
Related Publications (1)
Middleton G, Brock K, Savage J, Mant R, Summers Y, Connibear J, Shah R, Ottensmeier C, Shaw P, Lee SM, Popat S, Barrie C, Barone G, Billingham L. Pembrolizumab in patients with non-small-cell lung cancer of performance status 2 (PePS2): a single arm, phase 2 trial. Lancet Respir Med. 2020 Sep;8(9):895-904. doi: 10.1016/S2213-2600(20)30033-3. Epub 2020 Mar 19.
PMID: 32199466RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- PePS2 Trial Coordinator
- Organization
- Cancer Research UK Clincial Trials Unit, University of Birmingham
Study Officials
- PRINCIPAL INVESTIGATOR
Gary Middleton, Professor
University of Birmingham
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 1, 2016
First Posted
April 11, 2016
Study Start
January 4, 2017
Primary Completion
February 7, 2023
Study Completion
February 5, 2024
Last Updated
February 10, 2025
Results First Posted
February 10, 2025
Record last verified: 2025-01
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- Data will be available within 6 months of the primary publication.
- Access Criteria
- See Plan Description above.
The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request. The Cancer Research UK Clinical Trials Unit (CRCTU) is committed to responsible and controlled sharing of anonymised clinical trial data with the wider research community to maximise potential patient benefit while protecting the privacy and confidentiality of trial participants. Data anonymised in compliance with the Information Commissioners Office requirements, using a procedure based on guidelines from the Medical Research Council (MRC) Methodology Hubs, will be available for sharing with researchers outside of the trials team within 6 months of the primary publication. More detailed information on the CRCTU's Data Sharing Policy and the mechanism for obtaining data can be found on the CRCTU website: https://www.birmingham.ac.uk/research/activity/mds/trials/crctu/index.aspx.