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 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: SB27-1005
• Study Type: interventional
• Target: 163
• Locations: 4 countries
• Sites: 24

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Area Under the Concentration-time Curve (AUC) over the Dosing Interval at Cycle 1

  Defined as AUC calculated in Cycle 1 based on intensive PK assessment

  At the end of Cycle 1 (each cycle is 21 days)

• Area Under the Concentration-time Curve (AUC) over the Dosing Interval at Cycle 6

  Defined as AUC calculated in Cycle 6 based on intensive PK assessment

  At the end of Cycle 6 (each cycle is 21 days)

Secondary Outcomes (2)

• 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

• Overall Survival

  From the date of randomization until the date of death of any cause, assessed up to Week 55

Study Arms (3)

SB27

EXPERIMENTAL

SB27 will be administered intravenously at a fixed dose of 200 mg every 3 weeks, maximum 18 cycles over about 51 weeks

Drug: SB27

EU sourced Keytruda

ACTIVE COMPARATOR

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

Drug: EU sourced Keytruda

US sourced Keytruda

ACTIVE COMPARATOR

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

Drug: US sourced Keytruda

Interventions

US sourced Keytruda DRUG

Will be administered intravenously at a fixed dose of 200 mg every 3 weeks, maximum 18 cycles over about 51 weeks

US sourced Keytruda

SB27 DRUG

Will be administered intravenously at a fixed dose of 200 mg every 3 weeks, maximum 18 cycles over about 51 weeks

SB27

EU sourced Keytruda DRUG

Will be administered intravenously at a fixed dose of 200 mg every 3 weeks, maximum 18 cycles over about 51 weeks

EU sourced Keytruda

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Samsung Bioepis Co., Ltd.: lead

Study Sites (24)

SB Investigative Site

Gdansk, Poland

Location

SB Investigative Site

Otwock, Poland

Location

SB Investigative Site

Ansan, South Korea

Location

SB Investigative Site

Busan, South Korea

Location

SB Investigative Site

Daegu, South Korea

Location

SB Investigative Site

Hwasun, South Korea

Location

SB Investigative Site

Incheon, South Korea

Location

SB Investigative Site

Jinju, South Korea

Location

SB Investigative Site

Seongnam, South Korea

Location

SB Investigative Site 3

Seoul, South Korea

Location

SB Investigative Site 4

Seoul, South Korea

Location

SB Investigative Site 5

Seoul, South Korea

Location

SB Investigative Site 6

Seoul, South Korea

Location

SB Investigative Site 1

Suwon, South Korea

Location

SB Investigative Site 2

Suwon, South Korea

Location

SB Investigative Site

Ulsan, South Korea

Location

SB Investigative Site

Jaén, Jaén, Spain

Location

SB Investigative Site

A Coruña, Santiago de Compostela, Spain

Location

SB Investigative Site

Málaga, Spain

Location

SB Investigative Site

Adana, Turkey (Türkiye)

Location

SB Investigative Site 1

Ankara, Turkey (Türkiye)

Location

SB Investigative Site 2

Ankara, Turkey (Türkiye)

Location

SB Investigative Site

Istanbul, Turkey (Türkiye)

Location

SB Investigative Site

Izmir, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2024
• First Posted: February 20, 2024
• Study Start: January 16, 2024
• Primary Completion: February 19, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: May 5, 2026

Record last verified: 2026-05

Locations

KR (14); TU (5); PL (2); ES (3)