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
Launched by SAMSUNG BIOEPIS CO., LTD. · Mar 28, 2024
Trial Information
Current as of August 24, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new medication called SB27 to see if it works as well as an existing treatment called Keytruda for patients with stage IV non-squamous non-small cell lung cancer (NSCLC). The main goal is to find out how effective SB27 is in treating this type of cancer. Participants in the trial will receive either SB27 or Keytruda along with chemotherapy every three weeks. By comparing the two treatments, researchers hope to understand if SB27 can provide similar benefits to patients.
To be eligible for this study, participants must be at least 18 years old and have been diagnosed with stage IV non-squamous NSCLC without having received any prior cancer treatments. They should also agree to use reliable contraception during the study. Participants can expect regular visits and treatments over the course of the trial. It's important to note that individuals with severe allergies to similar treatments or certain supplements may not be able to join the study. This trial is currently recruiting participants, and all genders are welcome to apply.
Gender
ALL
Eligibility criteria
- 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.
About Samsung Bioepis Co., Ltd.
Samsung Bioepis Co., Ltd. is a leading biopharmaceutical company dedicated to developing high-quality biosimilars and innovative therapeutics. A subsidiary of Samsung, the company leverages advanced biotechnology and extensive research capabilities to enhance patient access to affordable treatments. Committed to rigorous scientific standards and regulatory compliance, Samsung Bioepis collaborates with healthcare professionals and stakeholders to deliver effective solutions for various chronic and complex diseases. With a focus on sustainability and patient-centric care, the company aims to contribute significantly to the global healthcare landscape.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Osaka, , Japan
Tokyo, , Japan
Madrid, , Spain
Tbilisi, , Georgia
Jaipur, , India
Surat, , India
Cluj Napoca, , Romania
Craiova, , Romania
Sibiu, , Romania
Málaga, , Spain
Batumi, , Georgia
Hessen, , Germany
North Rhine Westphalia, , Germany
Odisha, , India
Hyogo, , Japan
Kanagawa, , Japan
Kochi, , Japan
Okayama, , Japan
Yamaguchi, , Japan
Bihor, , Romania
Iaşi, , Romania
Suceava, , Romania
Timis, , Romania
A Coruña, , Spain
Ankara, , Turkey
Istanbul, , Turkey
Saxony Anhalt, , Germany
Karnataka, , India
Rajasthan, , India
Johor, , Malaysia
Kelantan, , Malaysia
Pulau Pinang, , Malaysia
Wilayah Persekutuan Putrajaya, , Malaysia
Mures, , Romania
Ourense, , Spain
Valencia, , Spain
Gujarat, , India
Odissa, , India
Pune, , India
Hyogo Ken, , Japan
Kanagawa Ken, , Japan
Kochi Ken, , Japan
Osaka Fu, , Japan
Yamaguchi Ken, , Japan
Pahang, , Malaysia
Dolj, , Romania
Navarre, , Spain
Khon Kaen, , Thailand
Banja Luka, , Bosnia And Herzegovina
Mostar, , Bosnia And Herzegovina
Sarajevo, , Bosnia And Herzegovina
Düsseldorf, , Germany
Halle, , Germany
Kassel, , Germany
Moers, , Germany
Neuss, , Germany
Bangalore, , India
Bhubaneshwar, , India
Bhubaneswar, , India
Erandwane, , India
Sūrat, , India
Udaipur, , India
Himeji, , Japan
Iwakuni, , Japan
Izumi, , Japan
Kawachi Nagano, , Japan
Kobe, , Japan
Sagamihara, , Japan
Tachikawa, , Japan
Takarazuka, , Japan
Toyonaka, , Japan
George Town, , Malaysia
Johor Bahru, , Malaysia
Kota Bharu, , Malaysia
Kuantan, , Malaysia
Lembah Pantai, , Malaysia
Putrajaya, , Malaysia
Quezon City, , Philippines
Oradea, , Romania
Timişoara, , Romania
Târgu Mureş, , Romania
Leganés, , Spain
Oviedo, , Spain
Pamplona, , Spain
Santiago De Compostela, , Spain
Bangkok Noi, , Thailand
Bangkok, , Thailand
Hyderabad, , India
Makati City, , Philippines
San Juan City, , Philippines
Belgrade, , Serbia
Kragujevac, , Serbia
Nis, , Serbia
Sremska Kamenica, , Serbia
Florianópolis, , Brazil
Porto Alegre, , Brazil
Giessen, , Germany
Manila, , Philippines
Sevilla, , Spain
Kavaklıdere, , Turkey
Curitiba, , Brazil
Ijui, , Brazil
Natal, , Brazil
Pelotas, , Brazil
Rio De Janeiro, , Brazil
Santo André, , Brazil
Mumbai, , India
Aguascalientes, , Mexico
Ciudad De México, , Mexico
Guadalajara, , Mexico
Davao City, , Philippines
Adapazarı, , Turkey
Izmit, , Turkey
Maltepe, , Turkey
Sivas, , Turkey
Balgat, , Turkey
Cubuk, , Turkey
Konak, , Turkey
Seyhan, , Turkey
Bağcılar, , Turkey
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported