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

NCT ID: NCT02733159

Last Updated: 2025-02-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-04
• Study Completion Date: 2024-02-05

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.

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 (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.

Conditions

Carcinoma, Non-Small-Cell Lung

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pembrolizumab

Pembrolizumab: 200 mg Q3W, intravenous administration for a maximum of 2 years, or until progression or unacceptable toxicity.

Group Type: EXPERIMENTAL

pembrolizumab

Intervention Type: DRUG

anti PD-1

Interventions

pembrolizumab

anti PD-1

Intervention Type: DRUG

Other Intervention Names

MK-3475

Eligibility Criteria

Inclusion Criteria

• 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.

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

University of Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gary Middleton, Professor

Role: PRINCIPAL_INVESTIGATOR

University of Birmingham

Locations

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

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

Countries

United Kingdom

References

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.

Reference Type: RESULT

PMID: 32199466 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Study Documents

Document Type: Trial Website

View Document

Related Links

https://doi.org/10.1093/annonc/mdy292.007

Pembrolizumab in performance status 2 patients with non-small cell lung cancer (NSCLC): Results of the PePS2 trial

Other Identifiers

2015-002241-55

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

ISRCTN10047797

Identifier Type: REGISTRY

Identifier Source: secondary_id

RG_14-172

Identifier Type: -

Identifier Source: org_study_id