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
- 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.
- Short title
- 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
- Control arm
- Active comparator
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Active, not recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Completion date
- 2026-11-01
- First posted
- 2024-02-20
- Registry last updated
- 2026-05-05
- Primary completion date
- 2026-02-19
- Start date
- 2024-01-16
- Actual participants
- Participants
- Participant count basis
- Actual
- Protocol amendments
- Number of sites
- Registry sponsor category
- Industry
- Lead sponsor
- Samsung Bioepis Co., Ltd.
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT06268613
- ClinicalTrials.gov ID
- NCT06268613
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- Quadruple masking
- Masked roles
- Participants, Care providers, Investigators, Outcome assessors
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)
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
Timeframe: At the end of Cycle 6 (each cycle is 21 days)
Defined as AUC calculated in Cycle 6 based on intensive PK assessment
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
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.
Overall Survival
Timeframe: From the date of randomization until the date of death of any cause, assessed up to Week 55
Defined as the time from the date of randomization until the date of death of any cause.
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Healthy volunteers
- No
- 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
- Have received anti-cancer therapy before surgery
- Have or had autoimmune disease in past 5 years
- SB Investigative SiteGdansk, Poland
- SB Investigative SiteOtwock, Poland
- SB Investigative SiteAnsan, South Korea
- SB Investigative SiteBusan, South Korea
- SB Investigative SiteDaegu, South Korea
- SB Investigative SiteHwasun, South Korea
- SB Investigative SiteIncheon, South Korea
- SB Investigative SiteJinju, South Korea
- SB Investigative SiteSeongnam, South Korea
- SB Investigative Site 3Seoul, South Korea
- SB Investigative Site 4Seoul, South Korea
- SB Investigative Site 5Seoul, South Korea
- SB Investigative Site 6Seoul, South Korea
- SB Investigative Site 1Suwon, South Korea
- SB Investigative Site 2Suwon, South Korea
- SB Investigative SiteUlsan, South Korea
- SB Investigative SiteJaén, Spain
- SB Investigative SiteA Coruña, Spain
- SB Investigative SiteMálaga, Spain
- SB Investigative SiteAdana, Turkey (Türkiye)
- SB Investigative Site 1Ankara, Turkey (Türkiye)
- SB Investigative Site 2Ankara, Turkey (Türkiye)
- SB Investigative SiteIstanbul, Turkey (Türkiye)
- SB Investigative SiteIzmir, Turkey (Türkiye)
Related records
Drugs (2)
Lead sponsors (1)
Conditions (1)
- Non-small cell lung carcinoma Primary condition