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

Phase 3

Recruiting

• Conditions: Non-small Cell Lung Cancer Stage IV
• Interventions: Drug: SB27; Drug: Keytruda

• Registration Number: NCT06348199
• Lead Sponsor: Samsung Bioepis Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-12
• Study First Submitted: 2024-03-28
• Study First Submitted QC: 2024-03-28
• Study First Posted: 2024-04-04
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-30
• Last Update Posted: 2025-05-01
• Primary Completion: 2025-09
• Study Completion: 2027-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 616

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SB27	SB27	SB27 will be administered followed by Pemetrexed and Carboplatin (Carboplatin will be administered for the first 4 cycles).
Keytruda	Keytruda	Keytruda will be administered followed by Pemetrexed and Carboplatin (Carboplatin will be administered for the first 4 cycles).

Primary Outcome Measures

Name	Time	Method
Objective response rate (ORR) at Week 24	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

Trial Locations

Locations (1)

SB Investigative Site; 🇹🇷 Sivas, Turkey