Comparison between ABP 234 and Keytruda® (Pembrolizumab)
Research type
Research Study
Full title
A Randomized, Double-Blind Study to Compare Efficacy, Pharmacokinetics, Safety, and Immunogenicity Between ABP 234 and Keytruda® (Pembrolizumab) in Subjects with Advanced or Metastatic Non-squamous Non-Small Cell Lung Cancer.
IRAS ID
1009553
Contact name
Amgen Inc. Amgen Inc.
Contact email
Sponsor organisation
Amgen Inc.
Clinicaltrials.gov Identifier
Research summary
Lung cancer is one of the most frequently diagnosed cancers and the leading cause of cancer related deaths worldwide with an estimated 2 million new cases and 1.76 million deaths per year. Non-small cell lung cancer (NSCLC) accounts for the majority of all lung cancer cases. Options for treatment include chemotherapy, targeted therapy and immunotherapy. Immunotherapies use the bodies immune system to fight cancer.
The study drug in this study is an immunotherapy called ABP 234. This new therapy is being developed to be a biosimilar product to an approved immunotherapy called pembrolizumab (brand name - Keytruda®). A biosimilar product is generally defined as a product that is similar to another approved biological medicine with no meaningful clinical differences in terms of safety, purity, and strength from the approved medicine. In addition to the overall comparison of ABP 234 to pembrolizumab, this study will also compare US-sourced pembrolizumab to EU-sourced pembrolizumab. Participants in the study will receive either the study drug ABP 234, US-sourced pembrolizumab or EU-sourced pembrolizumab. This study is the first time ABP 234 will be tested in humans.
Participants will be in the study for around 28 months and have at least 38 study visits.
The study will be split into the following phases:
Screening
Treatment period (split into Induction and Maintenance - during the induction period participants will also receive either cisplatin or carboplatin chemotherapy alongside the study drug and pemetrexed may also be offered )
Follow-Up Phase
To participate patients must be over 18 and have a diagnosis of stage IV metastatic (cancer that has spread) non-squamous NSCLC.REC name
South Central - Hampshire B Research Ethics Committee
REC reference
25/SC/0010
Date of REC Opinion
5 Feb 2025
REC opinion
Favourable Opinion