Trial Profile

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)

Status: Recruiting

Phase of Trial: Phase III

Latest Information Update: 12 May 2025

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At a glance

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.

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