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

Last updated: March 17, 2025
Sponsor: Samsung Bioepis Co., Ltd.
Overall Status: Active - Recruiting

Phase

3

Condition

N/A

Treatment

SB27

Keytruda

Clinical Study ID

NCT06348199
SB27-3004
  • Ages > 18
  • All Genders

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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Unable or unwilling to take folic acid and vitamin B12 supplementation

  • Severe hypersensitivity to treatment with another monoclonal antibody, anyingredient contained in SB27 or Keytruda, or any component of platinum-containingcompounds or pemetrexed.

Study Design

Total Participants: 616
Treatment Group(s): 2
Primary Treatment: SB27
Phase: 3
Study Start date:
March 12, 2024
Estimated Completion Date:
March 31, 2027

Connect with a study center

  • SB Investigative Site

    Banja Luka,
    Bosnia and Herzegovina

    Active - Recruiting

  • SB Investigative Site

    Mostar,
    Bosnia and Herzegovina

    Active - Recruiting

  • SB Investigative Site

    Sarajevo,
    Bosnia and Herzegovina

    Active - Recruiting

  • SB Investigative Site

    Curitiba,
    Brazil

    Active - Recruiting

  • SB Investigative Site

    Florianópolis,
    Brazil

    Active - Recruiting

  • SB Investigative Site

    Ijui,
    Brazil

    Active - Recruiting

  • SB Investigative Site

    Natal,
    Brazil

    Active - Recruiting

  • SB Investigative Site

    Pelotas,
    Brazil

    Active - Recruiting

  • SB Investigative Site

    Porto Alegre,
    Brazil

    Active - Recruiting

  • SB Investigative Site

    Rio De Janeiro,
    Brazil

    Active - Recruiting

  • SB Investigative Site

    Santo André,
    Brazil

    Active - Recruiting

  • SB Investigative Site

    Batumi,
    Georgia

    Active - Recruiting

  • SB Investigative Site

    Tbilisi,
    Georgia

    Active - Recruiting

  • SB Investigative Site

    Düsseldorf,
    Germany

    Active - Recruiting

  • SB Investigative Site

    Giessen,
    Germany

    Active - Recruiting

  • SB Investigative Site

    Halle,
    Germany

    Active - Recruiting

  • SB Investigative Site

    Hessen,
    Germany

    Site Not Available

  • SB Investigative Site

    Kassel,
    Germany

    Site Not Available

  • SB Investigative Site

    Moers,
    Germany

    Active - Recruiting

  • SB Investigative Site

    Neuss,
    Germany

    Active - Recruiting

  • SB Investigative Site

    North Rhine-Westphalia,
    Germany

    Site Not Available

  • SB Investigative Site

    Saxony-Anhalt,
    Germany

    Site Not Available

  • SB Investigative Site

    Bangalore,
    India

    Active - Recruiting

  • SB Investigative Site

    Bhubaneshwar,
    India

    Active - Recruiting

  • SB Investigative Site

    Bhubaneswar,
    India

    Active - Recruiting

  • SB Investigative Site

    Erandwane,
    India

    Active - Recruiting

  • SB Investigative Site

    Gujarat,
    India

    Site Not Available

  • SB Investigative Site

    Hyderabad,
    India

    Active - Recruiting

  • SB Investigative Site

    Jaipur,
    India

    Active - Recruiting

  • SB Investigative Site

    Karnataka,
    India

    Site Not Available

  • SB Investigative Site

    Mumbai,
    India

    Active - Recruiting

  • SB Investigative Site

    Odisha,
    India

    Site Not Available

  • SB Investigative Site

    Odissa,
    India

    Site Not Available

  • SB Investigative Site

    Pune,
    India

    Site Not Available

  • SB Investigative Site

    Rajasthan,
    India

    Site Not Available

  • SB Investigative Site

    Surat,
    India

    Site Not Available

  • SB Investigative Site

    Sūrat,
    India

    Active - Recruiting

  • SB Investigative Site

    Udaipur,
    India

    Active - Recruiting

  • SB Investigative Site

    Himeji,
    Japan

    Active - Recruiting

  • SB Investigative Site

    Hyogo,
    Japan

    Site Not Available

  • SB Investigative Site

    Hyogo-Ken,
    Japan

    Site Not Available

  • SB Investigative Site

    Iwakuni,
    Japan

    Active - Recruiting

  • SB Investigative Site

    Izumi,
    Japan

    Active - Recruiting

  • SB Investigative Site

    Kanagawa,
    Japan

    Site Not Available

  • SB Investigative Site

    Kanagawa-Ken,
    Japan

    Site Not Available

  • SB Investigative Site

    Kawachi-Nagano,
    Japan

    Active - Recruiting

  • SB Investigative Site

    Kobe,
    Japan

    Active - Recruiting

  • SB Investigative Site

    Kochi,
    Japan

    Active - Recruiting

  • SB Investigative Site

    Kochi-Ken,
    Japan

    Site Not Available

  • SB Investigative Site

    Okayama,
    Japan

    Site Not Available

  • SB Investigative Site

    Osaka,
    Japan

    Site Not Available

  • SB Investigative Site

    Osaka-Fu,
    Japan

    Site Not Available

  • SB Investigative Site

    Sagamihara,
    Japan

    Active - Recruiting

  • SB Investigative Site

    Tachikawa,
    Japan

    Active - Recruiting

  • SB Investigative Site

    Takarazuka,
    Japan

    Active - Recruiting

  • SB Investigative Site

    Tokyo,
    Japan

    Site Not Available

  • SB Investigative Site

    Toyonaka,
    Japan

    Active - Recruiting

  • SB Investigative Site

    Yamaguchi,
    Japan

    Site Not Available

  • SB Investigative Site

    Yamaguchi-Ken,
    Japan

    Site Not Available

  • SB Investigative Site

    George Town,
    Malaysia

    Active - Recruiting

  • SB Investigative Site

    Johor,
    Malaysia

    Site Not Available

  • SB Investigative Site

    Johor Bahru,
    Malaysia

    Active - Recruiting

  • SB Investigative Site

    Kelantan,
    Malaysia

    Site Not Available

  • SB Investigative Site

    Kota Bharu,
    Malaysia

    Active - Recruiting

  • SB Investigative Site

    Kuantan,
    Malaysia

    Active - Recruiting

  • SB Investigative Site

    Lembah Pantai,
    Malaysia

    Active - Recruiting

  • SB Investigative Site

    Pahang,
    Malaysia

    Site Not Available

  • SB Investigative Site

    Pulau Pinang,
    Malaysia

    Site Not Available

  • SB Investigative Site

    Putrajaya,
    Malaysia

    Active - Recruiting

  • SB Investigative Site

    Wilayah Persekutuan Putrajaya,
    Malaysia

    Site Not Available

  • SB Investigative Site

    Aguascalientes,
    Mexico

    Active - Recruiting

  • SB Investigative Site

    Ciudad De México,
    Mexico

    Active - Recruiting

  • SB Investigative Site

    Guadalajara,
    Mexico

    Active - Recruiting

  • SB Investigative Site

    Davao City,
    Philippines

    Active - Recruiting

  • SB Investigative Site

    Makati City,
    Philippines

    Active - Recruiting

  • SB Investigative Site

    Manila,
    Philippines

    Active - Recruiting

  • SB Investigative Site

    Quezon City,
    Philippines

    Active - Recruiting

  • SB Investigative Site

    San Juan City,
    Philippines

    Active - Recruiting

  • SB Investigative Site

    Bihor,
    Romania

    Site Not Available

  • SB Investigative Site

    Cluj-Napoca,
    Romania

    Active - Recruiting

  • SB Investigative Site

    Craiova,
    Romania

    Active - Recruiting

  • SB Investigative Site

    Dolj,
    Romania

    Site Not Available

  • SB Investigative Site

    Iaşi,
    Romania

    Active - Recruiting

  • SB Investigative Site

    Mures,
    Romania

    Site Not Available

  • SB Investigative Site

    Oradea,
    Romania

    Active - Recruiting

  • SB Investigative Site

    Sibiu,
    Romania

    Active - Recruiting

  • SB Investigative Site

    Suceava,
    Romania

    Active - Recruiting

  • SB Investigative Site

    Timis,
    Romania

    Site Not Available

  • SB Investigative Site

    Timişoara,
    Romania

    Active - Recruiting

  • SB Investigative Site

    Târgu-Mureş,
    Romania

    Active - Recruiting

  • SB Investigative Site

    Belgrade,
    Serbia

    Active - Recruiting

  • SB Investigative Site

    Kragujevac,
    Serbia

    Active - Recruiting

  • SB Investigative Site

    Nis,
    Serbia

    Active - Recruiting

  • SB Investigative Site

    Sremska Kamenica,
    Serbia

    Active - Recruiting

  • SB Investigative Site

    A Coruña,
    Spain

    Site Not Available

  • SB Investigative Site

    Leganés,
    Spain

    Active - Recruiting

  • SB Investigative Site

    Madrid,
    Spain

    Active - Recruiting

  • SB Investigative Site

    Málaga,
    Spain

    Active - Recruiting

  • SB Investigative Site

    Navarre,
    Spain

    Site Not Available

  • SB Investigative Site

    Ourense,
    Spain

    Active - Recruiting

  • SB Investigative Site

    Oviedo,
    Spain

    Active - Recruiting

  • SB Investigative Site

    Pamplona,
    Spain

    Active - Recruiting

  • SB Investigative Site

    Santiago De Compostela,
    Spain

    Active - Recruiting

  • SB Investigative Site

    Sevilla,
    Spain

    Active - Recruiting

  • SB Investigative Site

    Valencia,
    Spain

    Active - Recruiting

  • SB Investigative Site

    Bangkok,
    Thailand

    Active - Recruiting

  • SB Investigative Site

    Bangkok Noi,
    Thailand

    Active - Recruiting

  • SB Investigative Site

    Khon Kaen,
    Thailand

    Active - Recruiting

  • SB Investigative Site

    Adapazarı,
    Turkey

    Active - Recruiting

  • SB Investigative Site

    Ankara,
    Turkey

    Active - Recruiting

  • SB Investigative Site

    Balgat,
    Turkey

    Active - Recruiting

  • SB Investigative Site

    Bağcılar,
    Turkey

    Site Not Available

  • SB Investigative Site

    Cubuk,
    Turkey

    Active - Recruiting

  • SB Investigative Site

    Istanbul,
    Turkey

    Site Not Available

  • SB Investigative Site

    Izmit,
    Turkey

    Active - Recruiting

  • SB Investigative Site

    Kavaklıdere,
    Turkey

    Active - Recruiting

  • SB Investigative Site

    Konak,
    Turkey

    Active - Recruiting

  • SB Investigative Site

    Maltepe,
    Turkey

    Active - Recruiting

  • SB Investigative Site

    Seyhan,
    Turkey

    Site Not Available

  • SB Investigative Site

    Sivas,
    Turkey

    Active - Recruiting

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