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 | Active Not Recruiting Phase 3

• 1 other identifier: SB27-3004
• Study Type: interventional
• Target: 555
• Locations: 14 countries
• Sites: 94

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.

Conditions

Non-small Cell Lung Cancer Stage IV

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

SB27

EXPERIMENTAL

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

Drug: SB27

Keytruda

ACTIVE COMPARATOR

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

Drug: Keytruda

Interventions

SB27 DRUG

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

SB27

Keytruda DRUG

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

Keytruda

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Samsung Bioepis Co., Ltd.: lead

Study Sites (94)

SB Investigative Site

Banja Luka, Bosnia and Herzegovina

Location

SB Investigative Site

Mostar, Bosnia and Herzegovina

Location

SB Investigative Site

Sarajevo, Bosnia and Herzegovina

Location

SB Investigative Site

Curitiba, Brazil

Location

SB Investigative Site

Florianópolis, Brazil

Location

SB Investigative Site

Ijuí, Brazil

Location

SB Investigative Site

Natal, Brazil

Location

SB Investigative Site

Pelotas, Brazil

Location

SB Investigative Site 1

Porto Alegre, Brazil

Location

SB Investigative Site 2

Porto Alegre, Brazil

Location

SB Investigative Site

Rio de Janeiro, Brazil

Location

SB Investigative Site

Santo André, Brazil

Location

SB Investigative Site

Batumi, Georgia

Location

SB Investigative Site 1

Tbilisi, Georgia

Location

SB Investigative Site 2

Tbilisi, Georgia

Location

SB Investigative Site 3

Tbilisi, Georgia

Location

SB Investigative Site 4

Tbilisi, Georgia

Location

SB Investigative Site 5

Tbilisi, Georgia

Location

SB Investigative Site 6

Tbilisi, Georgia

Location

SB Investigative Site

Düsseldorf, Germany

Location

SB Investigative Site

Halle, Germany

Location

SB Investigative Site

Moers, Germany

Location

SB Investigative Site

Neuss, Germany

Location

SB Investigative Site

Bangalore, India

Location

SB Investigative Site

Bhubaneshwar, India

Location

SB Investigative Site

Bhubaneswar, India

Location

SB Investigative Site

Erandwane, India

Location

SB Investigative Site

Hyderabad, India

Location

SB Investigative Site 1

Jaipur, India

Location

SB Investigative Site 2

Jaipur, India

Location

SB Investigative Site

Mumbai, India

Location

SB Investigative Site

Sūrat, India

Location

SB Investigative Site

Udaipur, India

Location

SB Investigative Site

Himeji, Japan

Location

SB Investigative Site

Iwakuni, Japan

Location

SB Investigative Site

Izumi, Japan

Location

SB Investigative Site

Kawachi-Nagano, Japan

Location

SB Investigative Site

Kobe, Japan

Location

SB Investigative Site

Kochi, Japan

Location

SB Investigative Site

Sagamihara, Japan

Location

SB Investigative Site

Tachikawa, Japan

Location

SB Investigative Site

Takarazuka, Japan

Location

SB Investigative Site

Toyonaka, Japan

Location

SB Investigative Site

George Town, Malaysia

Location

SB Investigative Site

Johor Bahru, Malaysia

Location

SB Investigative Site

Kota Bharu, Malaysia

Location

SB Investigative Site

Kuantan, Malaysia

Location

SB Investigative Site

Lembah Pantai, Malaysia

Location

SB Investigative Site

Putrajaya, Malaysia

Location

SB Investigative Site

Aguascalientes, Mexico

Location

SB Investigative Site

Guadalajara, Mexico

Location

SB Investigative Site

Mexico City, Mexico

Location

SB Investigative Site

Davao City, Philippines

Location

SB Investigative Site

Makati City, Philippines

Location

SB Investigative Site

Manila, Philippines

Location

SB Investigative Site

Quezon City, Philippines

Location

SB Investigative Site

San Juan City, Philippines

Location

SB Investigative Site

Cluj-Napoca, Romania

Location

SB Investigative Site 1

Craiova, Romania

Location

SB Investigative Site 2

Craiova, Romania

Location

SB Investigative Site

Craiova, Romania

Location

SB Investigative Site

Iași, Romania

Location

SB Investigative Site

Oradea, Romania

Location

SB Investigative Site

Sibiu, Romania

Location

SB Investigative Site

Suceava, Romania

Location

SB Investigative Site 1

Belgrade, Serbia

Location

SB Investigative Site 2

Belgrade, Serbia

Location

SB Investigative Site

Kamenitz, Serbia

Location

SB Investigative Site

Kragujevac, Serbia

Location

SB Investigative Site

Niš, Serbia

Location

SB Investigative Site

Leganés, Spain

Location

SB Investigative Site

Málaga, Spain

Location

SB Investigative Site

Ourense, Spain

Location

SB Investigative Site

Oviedo, Spain

Location

SB Investigative Site

Santiago de Compostela, Spain

Location

SB Investigative Site

Seville, Spain

Location

SB Investigative Site

Valencia, Spain

Location

SB Investigative Site 1

Bangkok, Thailand

Location

SB Investigative Site 2

Bangkok, Thailand

Location

SB Investigative Site

Bangkok Noi, Thailand

Location

SB Investigative Site

Khon Kaen, Thailand

Location

SB Investigative Site

Adapazarı, Turkey (Türkiye)

Location

SB Investigative Site 1

Ankara, Turkey (Türkiye)

Location

SB Investigative Site 2

Ankara, Turkey (Türkiye)

Location

SB Investigative Site

Bağcılar, Turkey (Türkiye)

Location

SB Investigative Site

Balgat, Turkey (Türkiye)

Location

SB Investigative Site

Çubuk, Turkey (Türkiye)

Location

SB Investigative Site

Istanbul, Turkey (Türkiye)

Location

SB Investigative Site

İzmit, Turkey (Türkiye)

Location

SB Investigative Site

Kavaklıdere, Turkey (Türkiye)

Location

SB Investigative Site

Konak, Turkey (Türkiye)

Location

SB Investigative Site

Maltepe, Turkey (Türkiye)

Location

SB Investigative Site

Seyhan, Turkey (Türkiye)

Location

SB Investigative Site

Sivas, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

pembrolizumab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2024
• First Posted: April 4, 2024
• Study Start: March 12, 2024
• Primary Completion: March 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: November 17, 2025

Record last verified: 2025-11

Locations

TU (13); DE (4); TH (4); JP (10); RO (8); BO (3); ME (3); IN (10); BR (9); PH (5); GE (7); SE (5); MY (6); ES (7)