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

Phase 1

Recruiting

• Conditions: 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

• Registration Number: NCT06268613
• Lead Sponsor: Samsung Bioepis Co., Ltd.

Brief Summary

The goal of this clinical trial is to compare the amount of study drug in patients' blood to confirm that SB27 works in the same way as EU and US sourced Keytruda in early or locally advanced non-small cell lung cancer (NSCLC) patients who underwent surgery and adjuvant chemotherapy. The main question it aims to answer is:

• What the body does to the study drug, which is called "pharmacokinetic"

Participants will receive investigational product (IP) administration every 3 weeks, maximum 18 cycles over about 51 weeks and blood sample will be collected.

Researchers will compare 3 medicines (SB27, EU sourced Keytruda, and US sourced Keytruda) to see if SB27 works in the same way as EU and US sourced Keytruda.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-16
• Study First Submitted: 2024-02-02
• Study First Submitted QC: 2024-02-12
• Study First Posted: 2024-02-20
• Status Verified: 2024-08
• Last Update Submitted: 2024-11-28
• Last Update Posted: 2024-12-02
• Primary Completion: 2025-05
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 135

Inclusion Criteria

• Male or female aged 18 years or older
• Diagnosed as NSCLC stage II-IIIA (staging should be confirmed after surgery)
• Have completely removed all of the cancer from the body surgically
• Have been received 3 or 4 cycles of platinum-based chemotherapy after surgery

Exclusion Criteria

• Have received anti-cancer therapy before surgery
• Have or had autoimmune disease in past 5 years

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SB27	SB27	SB27 will be administered intravenously at a fixed dose of 200 mg every 3 weeks, maximum 18 cycles over about 51 weeks
EU sourced Keytruda	EU sourced Keytruda	EU sourced Keytruda will be administered intravenously at a fixed dose of 200 mg every 3 weeks, maximum 18 cycles over about 51 weeks
US sourced Keytruda	US sourced Keytruda	EU sourced Keytruda will be administered intravenously at a fixed dose of 200 mg every 3 weeks, maximum 18 cycles over about 51 weeks

Primary Outcome Measures

Name	Time	Method
Area Under the Concentration-time Curve (AUC) over the Dosing Interval at Cycle 6	At the end of Cycle 6 (each cycle is 21 days)	Defined as AUC calculated in Cycle 6 based on intensive PK assessment
Area Under the Concentration-time Curve (AUC) over the Dosing Interval at Cycle 1	At the end of Cycle 1 (each cycle is 21 days)	Defined as AUC calculated in Cycle 1 based on intensive PK assessment

Secondary Outcome Measures

Name	Time	Method
Overall Survival	From the date of randomization until the date of death of any cause, assessed up to Week 55	Defined as the time from the date of randomization until the date of death of any cause.
Disease-free Survival	From the date of randomization until the date of disease recurrence, occurrence of new primary NSCLC, or death of any cause, whichever occurs first, assessed up to Week 55	Defined as the time from the date of randomization until the date of disease recurrence, occurrence of new primary NSCLC, or death of any cause, whichever occurs first.

Trial Locations

Locations (1)

SB Investigative Site; 🇹🇷 Istanbul, Turkey