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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
163
Will be administered intravenously at a fixed dose of 200 mg every 3 weeks, maximum 18 cycles over about 51 weeks
Will be administered intravenously at a fixed dose of 200 mg every 3 weeks, maximum 18 cycles over about 51 weeks
Will be administered intravenously at a fixed dose of 200 mg every 3 weeks, maximum 18 cycles over about 51 weeks
SB Investigative Site
Gdansk, Poland
SB Investigative Site
Otwock, Poland
SB Investigative Site
Ansan, South Korea
SB Investigative Site
Busan, South Korea
SB Investigative Site
Daegu, South Korea
SB Investigative Site
Hwasun, South Korea
SB Investigative Site
Incheon, South Korea
SB Investigative Site
Jinju, South Korea
SB Investigative Site
Seongnam, South Korea
SB Investigative Site 3
Seoul, South Korea
...and 14 more locations
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
Time frame: 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
Time frame: At the end of Cycle 6 (each cycle is 21 days)
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.
Time frame: 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
Defined as the time from the date of randomization until the date of death of any cause.
Time frame: From the date of randomization until the date of death of any cause, assessed up to Week 55
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