Phase 1/2 study of radium-223 dichloride + pembrolizumab in NSCLC
Research type
Research Study
Full title
An open-label, multicenter, Phase 1/2 study of radium-223 dichloride in combination with pembrolizumab in participants with stage IV non-small cell lung cancer
IRAS ID
275800
Contact name
Alastair Greystoke
Contact email
Sponsor organisation
Bayer Consumer Care AG
Eudract number
2018-003704-39
Duration of Study in the UK
4 years, 5 months, 29 days
Research summary
Patients with a specific type of lung cancer , known as “non-small cell lung cancer”, which has spread to the bone will be invited to participate in this study.
The purpose of the study is to evaluate the combination of radium-223 dichloride and pembrolizumab in these patients.
Radium-223 dichloride is a radiopharmaceutical, that is infused through the vein and that is taken up by bones. It is approved for prostate cancer patients where it has spread to the bones.
Pembrolizumab belongs to a class of medicines known as immunotherapy and it works by helping the immune system to fight the cancer. It is approved for lung cancer patients.
Available data suggest the combination of radiotherapy and pembrolizumab may improve the activity against the tumour in patients with lung cancer with an expected clinically acceptable safety profile.
This study consists of two parts.
The first part of the study is being conducted outside of the UK and aims to determine the most appropriate dose of radium-223 dichloride in combination with the standard dose of pembrolizumab. The main purpose of the second part of the study is to evaluate the effectiveness of the combination of radium-223 dichloride and pembrolizumab. The second part of the study will consist of 2 groups. The first group will include approximately 104 patients who have not been treated before for their advanced lung cancer. Patients in group 1 will have a 50% chance of receiving either radium-223 plus pembrolizumab or pembrolizumab alone. The second group of patients will consist of approximately 40 patients who have progressed on prior treatment. Patients in group 2 will receive radium-223 dichloride plus pembrolizumab. This second part of the study will be conducted in US, Japan and Europe, including NHS sites in the UK and will last for approximately 5 years.
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
20/NE/0091
Date of REC Opinion
26 Mar 2020
REC opinion
Favourable Opinion