PEARLS (pembrolizumab as adjuvant treatment for lung cancer)
Research type
Research Study
Full title
A randomized, phase 3 trial with anti-PD-1 monoclonal antibody pembrolizumab (MK-3475) versus placebo for patients with early stage NSCLC after resection and completion of standard adjuvant therapy (PEARLS)
IRAS ID
183975
Contact name
Mary O’Brien
Contact email
Sponsor organisation
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Eudract number
2015-000575-27
Duration of Study in the UK
7 years, 11 months, 28 days
Research summary
This is a phase III, triple-blinded, placebo-controlled, randomised study to compare the efficacy of Pembrolizumab against placebo in patients who have had have had surgery, in which their Non Small Cell Lung Cancer (NSCLC) was removed.
The purpose of the study is to test if the study drug is safe and effective at reducing the chances of NSCLC coming back after surgical resection, followed or not by chemotherapy.
About 1380 people will participate in the study. Eligible patients will be randomly assigned receive treatment with either placebo or pembrolizumab. Patients who participate will be administered the treatment by IV every 3 weeks for one year. After the treatment ends, patients will be evaluated regularly for five years or until there is evidence of cancer recurrence.
Pembrolizumab is one of a new group of drugs that will enhance the immune system is active in advanced lung cancer. This drug or placebo will be given in this trial after standard therapies have been completed i.e. after surgery or after surgery and chemotherapy.
A number of assessments and procedures will be performed during the study including physical examinations, blood sample assessments, quality of life questionnaires, urine sample assessments, electrocardiograms (ECG) and CT/MRI scans to determine disease status. These assessments are performed as part of the evaluation to determine if the study drug is effective and safe.The study will be run at approximately 9 centres in the UK and is sponsored by MSD Ltd.
REC name
London - Riverside Research Ethics Committee
REC reference
15/LO/1419
Date of REC Opinion
12 Nov 2015
REC opinion
Further Information Favourable Opinion