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Clinical trial

A Phase I, Randomised, Double-blind, Three-arm, Parallel Group, Multicentre Study to Compare the Pharmacokinetics (PK), Efficacy, Safety, and Immunogenicity of Pembrolizumab (SB27, European Union [EU] Sourced Keytruda, and the United States of America [US] Sourced Keytruda) in Subjects With Stage II-IIIA Non-small Cell Lung Cancer Following Complete Resection and Adjuvant Platinum-based Chemotherapy

NCT06268613 is registered in ClinicalTrials.gov with Samsung Bioepis Co., Ltd. as lead sponsor.

NCT NCT06268613
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Registry record

As filed in ClinicalTrials.gov.

Title
A Phase I, Randomised, Double-blind, Three-arm, Parallel Group, Multicentre Study to Compare the Pharmacokinetics (PK), Efficacy, Safety, and Immunogenicity of Pembrolizumab (SB27, European Union [EU] Sourced Keytruda, and the United States of America [US] Sourced Keytruda) in Subjects With Stage II-IIIA Non-small Cell Lung Cancer Following Complete Resection and Adjuvant Platinum-based Chemotherapy
Lead sponsor
Samsung Bioepis Co., Ltd.
Phase
Phase 1
Overall status
Active, not recruiting
Start date
January 16, 2024
Completion date
November 30, 2026
Enrollment
163 (actual)
Sites
24

Conditions

As the registry lists them; a condition with its own page is linked.

non-small cell lung cancer stage ii, non-small cell lung cancer stage iiia