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

Phase
Recruitment status
Active, not recruiting
Participants
Lead sponsor
Samsung Bioepis Co., Ltd.
Start date
Number of sites

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
Recruitment status
Active, not recruiting
Phase
Study type
Interventional

Completion date
First posted
Registry last updated
Primary completion date
Start date

Actual participants
Participants
Participant count basis
Protocol amendments
Number of sites

Registry sponsor category
Lead sponsor
Samsung Bioepis Co., Ltd.
Source registry
ClinicalTrials.gov

Registry ID
ClinicalTrials.gov ID
Registry record
Open registry record

Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Quadruple masking
Masked roles
Participants, Care providers, Investigators, Outcome assessors
Sources for study design

  1. 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

  2. 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

  1. 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.

  2. 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.

Sources for outcomes

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
Sources for eligibility

  • 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)
Sources for sites

Related records

Drugs (2)

Lead sponsors (1)

Conditions (1)

Targets (4)