Clinical trial 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
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Non-small Cell Lung Cancer Stage II
Non-small Cell Lung Cancer Stage IIIA
Lead sponsor: Samsung Bioepis Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-02-20
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Area Under the Concentration-time Curve (AUC) over the Dosing Interval at Cycle 1
timeFrame: At the end of Cycle 1 (each cycle is 21 days)
measure: Area Under the Concentration-time Curve (AUC) over the Dosing Interval at Cycle 6
timeFrame: At the end of Cycle 6 (each cycle is 21 days)
Secondary outcomes:
measure: Disease-free Survival
timeFrame: 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
measure: Overall Survival
timeFrame: From the date of randomization until the date of death of any cause, assessed up to Week 55
Other outcomes:
Locations:
city: Ansan
country: Korea, Republic of
facility: SB Investigative Site
city: Busan
country: Korea, Republic of
facility: SB Investigative Site
city: Daegu
country: Korea, Republic of
facility: SB Investigative Site
city: Hwasun
country: Korea, Republic of
facility: SB Investigative Site
city: Incheon
country: Korea, Republic of
facility: SB Investigative Site
city: Jinju
country: Korea, Republic of
facility: SB Investigative Site
city: Seongnam
country: Korea, Republic of
facility: SB Investigative Site
city: Seoul
country: Korea, Republic of
facility: SB Investigative Site
city: Suwon
country: Korea, Republic of
facility: SB Investigative Site
city: Ulsan
country: Korea, Republic of
facility: SB Investigative Site
city: Gdańsk
country: Poland
facility: SB Investigative Site
city: Otwock
country: Poland
facility: SB Investigative Site
city: Szczecin
country: Poland
facility: SB Investigative Site
city: Leganés
country: Spain
facility: SB Investigative Site
state: Madrid
city: A Coruña
country: Spain
facility: SB Investigative Site
state: Santiago De Compostela
city: Jaén
country: Spain
facility: SB Investigative Site
city: Málaga
country: Spain
facility: SB Investigative Site
city: Adana
country: Turkey
facility: SB Investigative Site
city: Ankara
country: Turkey
facility: SB Investigative Site
city: Istanbul
country: Turkey
facility: SB Investigative Site
Study officials:
References: