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: Suspended

Phase of Trial: Phase III

Latest Information Update: 21 May 2025

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At a glance

14 May 2025 Planned End Date changed from 28 Aug 2026 to 1 Dec 2025.
14 May 2025 Planned primary completion date changed from 28 Aug 2026 to 1 Dec 2025.
14 May 2025 Status changed from recruiting to suspended in light of the evolving regulatory landscape and growing indications that major Health Authorities will move towards a streamlined clinical development, Sandoz took a strategic decision and is minimizing its CGME751A12301 clinical study.

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