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

S

Samsung

Status and phase

Enrolling
Phase 1

Conditions

Non-small Cell Lung Cancer Stage II
Non-small Cell Lung Cancer Stage IIIA

Treatments

Drug: US sourced Keytruda
Drug: SB27
Drug: EU sourced Keytruda

Study type

Interventional

Funder types

Industry

Identifiers

NCT06268613
SB27-1005

Details and patient eligibility

About

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.

Enrollment

135 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

135 participants in 3 patient groups

SB27
Experimental group
Description:
SB27 will be administered intravenously at a fixed dose of 200 mg every 3 weeks, maximum 18 cycles over about 51 weeks
Treatment:
Drug: SB27
EU sourced Keytruda
Active Comparator group
Description:
EU sourced Keytruda will be administered intravenously at a fixed dose of 200 mg every 3 weeks, maximum 18 cycles over about 51 weeks
Treatment:
Drug: EU sourced Keytruda
US sourced Keytruda
Active Comparator group
Description:
EU sourced Keytruda will be administered intravenously at a fixed dose of 200 mg every 3 weeks, maximum 18 cycles over about 51 weeks
Treatment:
Drug: US sourced Keytruda

Trial contacts and locations

15

Loading...

Central trial contact

Samsung Bioepis

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems