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Pembrolizumab in Patients With Non-Small Cell Lung Cancer and a Performance Status 2 (PePS2)

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ClinicalTrials.gov Identifier: NCT02733159
Recruitment Status : Recruiting
First Posted : April 11, 2016
Last Update Posted : November 7, 2017
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
University of Birmingham

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.

Condition or disease Intervention/treatment Phase
Carcinoma, Non-Small-Cell Lung Drug: pembrolizumab Phase 2

Detailed Description:

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 with pembrolizumab 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. Clinical trials of standard-of-care therapy have been successfully performed in the PS=2 only population demonstrating the feasibility of performing clinical trials in this population.

In this trial, the investigators 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. The investigators 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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial of Pembrolizumab in Patients With Non-small Cell Lung Cancer and a Performance Status of 2
Actual Study Start Date : November 7, 2016
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Pembrolizumab
Pembrolizumab: 200 mg Q3W, intravenous administration for a maximum of 2 years, or until progression or unacceptable toxicity.
Drug: pembrolizumab
anti PD-1
Other Name: MK-3475




Primary Outcome Measures :
  1. Toxicity [ Time Frame: Through study completion, a maximum of 2 years and 6 months after end of treatment ]
    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.

  2. Efficacy - Durable Clinical Benefit [ Time Frame: ≥18 weeks, up to maximum of 2 years ]
    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 for 18 weeks or greater.


Secondary Outcome Measures :
  1. Objective Response [ Time Frame: ≥18 weeks, up to maximum of 2 years ]
    Objective response (OR) is the occurrence of CR or PR as the best overall response. OR will be based on responses confirmed using the subsequent 9-weekly scan but OR based on unconfirmed responses will also be reported.

  2. Health Related Quality of Life [ Time Frame: Through study completion, up to a maximum of 2 years ]
    This is defined as the functional effect of a medical condition and/or its consequent treatment upon a patient. The purpose of Health Related Quality of Life (HRQoL) measurement is to quantify the degree to which the medical condition or its treatment impacts the individual's life in a valid and reproducible way. HRQoL will be assessed over time using FACT-L questionnaire and EQ-5D questionnaire.treatment upon a patient. The purpose of HRQoL measurement is to quantify the degree to which the medical condition or its treatment impacts the individual's life in a valid and reproducible way.

  3. Time to Progression [ Time Frame: Time to progression up to 2 years ]
    This is defined as the time from commencement of trial treatment to the date of CT scan when progressive disease first recorded. Patients with no recorded progression at the time of analysis or who die without recorded progression will be censored at the date of the CT scan when they were last recorded with an evaluable measure that was not progression.

  4. Progression-free Survival Time [ Time Frame: Progression-free survival time up to 2 years ]
    This is defined as the time from commencement of trial treatment to the date of CT scan when progressive disease first recorded or date of death without previously recorded progression. Patients who are alive with no recorded progression at the time of analysis will be censored at the date of the CT scan when they were last recorded with an evaluable measure that was not progression.

  5. Overall Survival Time [ Time Frame: Survival time up to 2 years or date of death ]
    This is defined as the time from commencement of trial treatment to the date of death. Patients who are alive at the time of analysis will be censored at the date last seen alive.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Core Inclusion Criteria:

  • Histologically confirmed PD-L1 status defined NSCLC. Biopsy must be within 70 days of first treatment with pembrolizumab.
  • 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.

Core Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02733159


Contacts
Contact: Rhys Mant 0121 414 6788 PePS2@trials.bham.ac.uk

Locations
United Kingdom
The Christie Nhs Foundation Trust Recruiting
Manchester, Greater Manchester, United Kingdom, M20 4BX
Contact: Yvonne Summers         
Southampton University Hospitals Nhs Trust Recruiting
Southampton, Hampshire, United Kingdom, SO16 6YD
Contact: Christian Ottensmeier         
Maidstone and Tunbridge Wells NHS Trust Recruiting
Maidstone, Kent, United Kingdom, ME16 9QQ
Contact: Riyaz Shah, Dr         
University Hospital Birmingham Nhs Foundation Trust Active, not recruiting
Birmingham, West Midlands, United Kingdom, B15 2TH
Velindre Cancer Centre Recruiting
Cardiff, United Kingdom, CF14 2TL
Contact: Alison Brewster         
Western General Hospital Recruiting
Edinburgh, United Kingdom
Contact: Melanie Mackean         
United Lincolnshire Hospitals NHS Trust Recruiting
Lincoln, United Kingdom, LN2 5QY
Contact: Gloria Barone, Dr         
Barts Health NHS Trust Recruiting
London, United Kingdom, E1 1BB
Contact: John Connibear, Dr         
University College London Hospitals Recruiting
London, United Kingdom, NW1 2BU
Contact: Siow-Ming Lee         
The Royal Marsden Recruiting
London, United Kingdom, SW3 6JJ
Contact: Sanjay Popat         
Sponsors and Collaborators
University of Birmingham
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Gary Middleton, Professor University of Birmingham

Responsible Party: University of Birmingham
ClinicalTrials.gov Identifier: NCT02733159     History of Changes
Other Study ID Numbers: RG_14-172
First Posted: April 11, 2016    Key Record Dates
Last Update Posted: November 7, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by University of Birmingham:
Performance Status 2
Pembrolizumab
MK-3475

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Pembrolizumab
Antineoplastic Agents