A Randomized, Double-blind, Parallel-group Study to Compare Efficacy, Safety, and Immunogenicity of GME751 (Proposed Pembrolizumab Biosimilar) and EU-authorized Keytruda in Adult Participants With Untreated Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC)
Latest Information Update: 12 May 2025
At a glance
- Drugs GME 751 (Primary) ; Pembrolizumab
- Indications Non-small cell lung cancer
- Focus Therapeutic Use
- Sponsors Sandoz
Most Recent Events
- 30 Apr 2025 According to Sandoz media release, the company has decided to minimize this study. This decision was partly based on communications with the US FDA, as well as a reflection paper published by the European Medicines Agency.
- 28 May 2024 Status changed from not yet recruiting to recruiting.
- 26 Mar 2024 Planned initiation date changed from 28 Feb 2024 to 26 Apr 2024.