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

Condition(s) studied

Investigational drug(s) / intervention(s)

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

Study 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

Primary outcome measure(s)

• 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
• 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

Trial sites (24)

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