# A Study to Compare the Pharmacokinetics, Efficacy, Safety, and Immunogenicity of Pembrolizumab (SB27, EU Sourced Keytruda, and US Sourced Keytruda) in Subjects With Stage II-IIIA NSCLC Following Complete Resection and Adjuvant Platinum-based Chemotherapy

> **NCT06268613** · PHASE1 · ACTIVE_NOT_RECRUITING · sponsor: **Samsung Bioepis Co., Ltd.** · enrollment: 163 (actual)

## Conditions studied

- Non-small Cell Lung Cancer Stage II
- Non-small Cell Lung Cancer Stage IIIA

## Interventions

- **DRUG:** SB27
- **DRUG:** EU sourced Keytruda
- **DRUG:** US sourced Keytruda

## Key facts

- **NCT ID:** NCT06268613
- **Lead sponsor:** Samsung Bioepis Co., Ltd.
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE1
- **Study type:** INTERVENTIONAL
- **Status:** ACTIVE_NOT_RECRUITING
- **Start date:** 2024-01-16
- **Primary completion:** 2026-02-19
- **Final completion:** 2026-11
- **Target enrollment:** 163 (ACTUAL)
- **Last updated:** 2026-05-05


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT06268613

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT06268613, "A Study to Compare the Pharmacokinetics, Efficacy, Safety, and Immunogenicity of Pembrolizumab (SB27, EU Sourced Keytruda, and US Sourced Keytruda) in Subjects With Stage II-IIIA NSCLC Following Complete Resection and Adjuvant Platinum-based Chemotherapy". Retrieved via AI Analytics 2026-06-08 from https://api.ai-analytics.org/clinical/NCT06268613. Licensed CC0.

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