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.
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 (PS) 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
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
62
anti PD-1
The Christie NHS Foundation Trust
Manchester, Greater Manchester, United Kingdom
Southampton University Hospitals NHS Trust
Southampton, Hampshire, United Kingdom
Maidstone and Tunbridge Wells NHS Trust
Maidstone, Kent, United Kingdom
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.
Time frame: 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).
Time frame: ≥18 weeks, up to maximum of 2 years
Objective Response
Objective response (OR) is the occurrence of Complete Response (CR) or Partial Response (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.
Time frame: ≥18 weeks, up to maximum of 2 years
Health Related Quality of Life
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 Functional Assessment of Cancer Therapy - Lung (FACT-L) questionnaire and EQ-5D questionnaire.
Time frame: Through study completion, up to a maximum of 2 years
Time to Progression
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University Hospital Birmingham NHS Foundation Trust
Birmingham, West Midlands, United Kingdom
Velindre Cancer Centre
Cardiff, United Kingdom
Western General Hospital
Edinburgh, United Kingdom
United Lincolnshire Hospitals NHS Trust
Lincoln, United Kingdom
Barts Health NHS Trust
London, United Kingdom
University College London Hospitals
London, United Kingdom
The Royal Marsden Hospital
London, United Kingdom
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.
Time frame: Time to progression up to 2 years
Progression-free Survival Time
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.
Time frame: Progression-free survival time up to 2 years
Overall Survival Time
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.
Time frame: Survival time up to 2 years or date of death
Duration of Objective Response
This is defined as the time from commencement of trial treatment to the date of the subsequent CT scan when progressive disease is first confirmed or date of death without previously recorded progression. This outcome is calculated and reported separately for patients who achieve an Objective Response (OR) or Stable Disease (SD). Patients experiencing OR or SD 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.
Time frame: Survival time up to 2 years or date of death
Duration of Stable Disease
This is defined as the time from commencement of trial treatment to the date of the subsequent CT scan when progressive disease is first confirmed or date of death without previously recorded progression. This outcome is calculated and reported separately for patients who achieve an Objective Response (OR) or Stable Disease (SD). Patients experiencing OR or SD 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.
Time frame: Survival time up to 2 years or date of death