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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

NCT06348199 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 555

Last updated 2025-11-17

No results posted yet for this study

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.

Conditions

  • Non-small Cell Lung Cancer Stage IV

Interventions

DRUG

SB27

Will be administered intravenously at a fixed dose of 200 mg every 3 weeks

DRUG

Keytruda

Will be administered intravenously at a fixed dose of 200 mg every 3 weeks

Sponsors & Collaborators

  • Samsung Bioepis Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-12
Primary Completion
2026-03-31
Completion
2026-09-30

Countries

  • Bosnia and Herzegovina
  • Brazil
  • Georgia
  • Germany
  • India
  • Japan
  • Malaysia
  • Mexico
  • Philippines
  • Romania
  • Serbia
  • Spain
  • Thailand
  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06348199 on ClinicalTrials.gov