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

Non-small Cell Lung Cancer Stage II Clinical Trial

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06268613
• Other study ID #: SB27-1005
• Status: Recruiting
• Phase: Phase 1
• Start date: January 16, 2024
• Est. completion date: December 2025

Study information

• Verified date: May 2024
• Source: Samsung Bioepis Co., Ltd.
• Contact: Samsung Bioepis
• Phone: +82-32-728-0371
• Email: sbregistry[@]samsung.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 135
• Est. completion date: December 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer Stage II
• Non-small Cell Lung Cancer Stage IIIA

Intervention

Drug:
• 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
Will be administered intravenously at a fixed dose of 200 mg every 3 weeks, maximum 18 cycles over about 51 weeks
• US sourced Keytruda
Will be administered intravenously at a fixed dose of 200 mg every 3 weeks, maximum 18 cycles over about 51 weeks

Locations

Country	Name	City	State
Korea, Republic of	SB Investigative Site	Busan
Korea, Republic of	SB Investigative Site	Daegu
Korea, Republic of	SB Investigative Site	Hwasun
Korea, Republic of	SB Investigative Site	Jinju
Korea, Republic of	SB Investigative Site	Seongnam
Korea, Republic of	SB Investigative Site	Seoul
Korea, Republic of	SB Investigative Site	Suwon
Poland	SB Investigative Site	Szczecin
Spain	SB Investigative Site	A Coruña	Santiago De Compostela
Spain	SB Investigative Site	Jaén
Spain	SB Investigative Site	Leganés	Madrid
Spain	SB Investigative Site	Málaga
Turkey	SB Investigative Site	Adana
Turkey	SB Investigative Site	Ankara
Turkey	SB Investigative Site	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Bioepis Co., Ltd.

Countries where clinical trial is conducted

Korea, Republic of,  Poland,  Spain,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	Disease-free Survival	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.	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
Secondary	Overall Survival	Defined as the time from the date of randomization until the date of death of any cause.	From the date of randomization until the date of death of any cause, assessed up to Week 55