OncRef

Clinical Trial: NCT06348199

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

Status:

ACTIVE NOT RECRUITING

Phase:

Phase 3

Lead Sponsor:Samsung Bioepis Co., Ltd.
Information Provided By:Samsung Bioepis Co., Ltd.
Last Update Posted:2026-07-07

Study Overview

Brief 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.

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

Conditions

Non-small Cell Lung Cancer Stage IV

Intervention / Treatment

  • Drug: SB27
  • Drug: Keytruda

Other Study ID Numbers

  • SB27-3004

Start Date (Actual)

2024-03-12

Primary Completion Date (Actual)

2026-03-10

Study Completion Date (Estimated)

2026-09

Enrollment (Actual)

555

Study Type

Interventional

Phase

Phase 3