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
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Samsung Bioepis Co., Ltd.
- Enrollment
- 163
- Locations
- 24
- Primary Endpoint
- Area Under the Concentration-time Curve (AUC) over the Dosing Interval at Cycle 6
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
SB27
SB27 will be administered intravenously at a fixed dose of 200 mg every 3 weeks, maximum 18 cycles over about 51 weeks
Intervention: SB27 (Drug)
EU sourced Keytruda
EU sourced Keytruda will be administered intravenously at a fixed dose of 200 mg every 3 weeks, maximum 18 cycles over about 51 weeks
Intervention: EU sourced Keytruda (Drug)
US sourced Keytruda
EU sourced Keytruda will be administered intravenously at a fixed dose of 200 mg every 3 weeks, maximum 18 cycles over about 51 weeks
Intervention: US sourced Keytruda (Drug)
Outcomes
Primary Outcomes
Area Under the Concentration-time Curve (AUC) over the Dosing Interval at Cycle 6
Time Frame: At the end of Cycle 6 (each cycle is 21 days)
Defined as AUC calculated in Cycle 6 based on intensive PK assessment
Area Under the Concentration-time Curve (AUC) over the Dosing Interval at Cycle 1
Time Frame: At the end of Cycle 1 (each cycle is 21 days)
Defined as AUC calculated in Cycle 1 based on intensive PK assessment
Secondary Outcomes
- Overall Survival(From the date of randomization until the date of death of any cause, assessed up to Week 55)
- 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)