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NCT06348199 Clinical Trial

A Study to Compare the Efficacy, Safety, Pharmacokinetics, and Immunogenicity Between SB27 and Keytruda in Subjects With Metastatic Non-squamous Non-small Cell Lung Cancer

Non-small Cell Lung Cancer Stage IV Clinical Trial

Official title:
A Phase III Randomised, Double-blind, Multicentre Study to Compare the Efficacy, Safety, Pharmacokinetics, and Immunogenicity Between SB27 (Proposed Pembrolizumab Biosimilar) and Keytruda in Subjects With Metastatic Non-squamous Non-small Cell Lung Cancer

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06348199
Other study ID # SB27-3004
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date March 12, 2024
Est. completion date March 2027

Study information
Verified date June 2024
Source Samsung Bioepis Co., Ltd.
Contact Samsung Bioepis
Phone +82-32-728-0371
Email sbregistry@samsung.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this clinical trial is to confirm that SB27 works in the same way as Keytruda in metastatic non-squamous non-small cell lung cancer (NSCLC) patients. The main question it aims to answer is: • How effective the study drug is Participants will receive either investigational product (SB27 or Keytruda) and chemotherapy every 3 weeks. Researchers will compare SB27 and Keytruda to see if SB27 works in the same way as Keytruda.

Recruitment information / eligibility
Status Recruiting
Enrollment 616
Est. completion date March 2027
Est. primary completion date September 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Male or female = 18 years of age - Have been diagnosed with stage IV non-squamous NSCLC - Have not received any prior systemic anti-cancer therapy for metastatic NSCLC - Agree to use adequate methods of contraception Exclusion Criteria: - Unable or unwilling to take folic acid and vitamin B12 supplementation - Severe hypersensitivity to treatment with another monoclonal antibody, any ingredient contained in SB27 or Keytruda, or any component of platinum-containing compounds or pemetrexed.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• SB27
Will be administered intravenously at a fixed dose of 200 mg every 3 weeks
• Keytruda
Will be administered intravenously at a fixed dose of 200 mg every 3 weeks

Locations
Country Name City State
Georgia SB Investigative Site Batumi
Georgia SB Investigative Site Tbilisi
Germany SB Investigative Site Hessen
Germany SB Investigative Site North Rhine-Westphalia
Germany SB Investigative Site North Rhine-Westphalia
Germany SB Investigative Site Saxony-Anhalt
India SB Investigative Site Jaipur
India SB Investigative Site Karnataka
India SB Investigative Site Odisha
India SB Investigative Site Rajasthan
India SB Investigative Site Surat
Japan SB Investigative Site Hyogo
Japan SB Investigative Site Kanagawa
Japan SB Investigative Site Kochi
Japan SB Investigative Site Okayama
Japan SB Investigative Site Osaka
Japan SB Investigative Site Tokyo
Japan SB Investigative Site Yamaguchi
Malaysia SB Investigative Site Johor
Malaysia SB Investigative Site Kelantan
Malaysia SB Investigative Site Pulau Pinang
Malaysia SB Investigative Site Wilayah Persekutuan Putrajaya
Romania SB Investigative Site Bihor
Romania SB Investigative Site Cluj-Napoca
Romania SB Investigative Site Craiova
Romania SB Investigative Site Iasi
Romania SB Investigative Site Mures
Romania SB Investigative Site Sibiu
Romania SB Investigative Site Suceava
Romania SB Investigative Site Timis
Spain SB Investigative Site A Coruña
Spain SB Investigative Site Madrid
Spain SB Investigative Site Ourense
Spain SB Investigative Site Valencia

Sponsors (1)
Lead Sponsor Collaborator
Samsung Bioepis Co., Ltd.

Countries where clinical trial is conducted

Georgia,  Germany,  India,  Japan,  Malaysia,  Romania,  Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary Objective response rate (ORR) at Week 24 Defined as the proportion of subjects achieving a complete response (CR) or partial response (PR) at Week 24 according to RECIST v1.1 At Week 24
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