NCT06348199Active, not recruitingPhase 3
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
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
Source: ClinicalTrials.gov · Last updated 26 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 555 (actual)
- First submitted
- 28 Mar 2024
- Start date
- 12 Mar 2024
- Primary completion date
- 10 Mar 2026
- Lead sponsor
- Samsung Bioepis Co., Ltd.
- Diseases
- Lung cancer
- NCT number
- NCT06348199
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 555
- From 12 Mar 2024 to the primary completion date, 10 Mar 2026
- 93 sites in 14 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Severe hypersensitivity to treatment with another monoclonal antibody, any ingredient contained in SB27 or Keytruda, or any component of platinum-containing compounds or pemetrexed.
Other
- Unable or unwilling to take folic acid and vitamin B12 supplementation
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (93)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| SB Investigative Site Coordinator of this site? Confirm its status | Curitiba | Brazil | Unknown status |
| SB Investigative Site Coordinator of this site? Confirm its status | Florianópolis | Brazil | Unknown status |
| SB Investigative Site Coordinator of this site? Confirm its status | Ijuí | Brazil | Unknown status |
| SB Investigative Site Coordinator of this site? Confirm its status | Natal | Brazil | Unknown status |
| SB Investigative Site Coordinator of this site? Confirm its status | Pelotas | Brazil | Unknown status |
| SB Investigative Site 1 Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Unknown status |
| SB Investigative Site 2 Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Unknown status |
| SB Investigative Site Coordinator of this site? Confirm its status | Rio de Janeiro | Brazil | Unknown status |
| SB Investigative Site Coordinator of this site? Confirm its status | Santo André | Brazil | Unknown status |
| SB Investigative Site Coordinator of this site? Confirm its status | Düsseldorf | Germany | Unknown status |
| SB Investigative Site Coordinator of this site? Confirm its status | Halle | Germany | Unknown status |
| SB Investigative Site Coordinator of this site? Confirm its status | Moers | Germany | Unknown status |
| SB Investigative Site Coordinator of this site? Confirm its status | Neuss | Germany | Unknown status |
| SB Investigative Site Coordinator of this site? Confirm its status | Leganés | Spain | Unknown status |
| SB Investigative Site Coordinator of this site? Confirm its status | Málaga | Spain | Unknown status |
| SB Investigative Site Coordinator of this site? Confirm its status | Ourense | Spain | Unknown status |
| SB Investigative Site Coordinator of this site? Confirm its status | Oviedo | Spain | Unknown status |
| SB Investigative Site Coordinator of this site? Confirm its status | Santiago de Compostela | Spain | Unknown status |
| SB Investigative Site Coordinator of this site? Confirm its status | Seville | Spain | Unknown status |
| SB Investigative Site Coordinator of this site? Confirm its status | Valencia | Spain | Unknown status |
| SB Investigative Site Coordinator of this site? Confirm its status | Batumi | Georgia | Unknown status |
| SB Investigative Site 1 Coordinator of this site? Confirm its status | Tbilisi | Georgia | Unknown status |
| SB Investigative Site 5 Coordinator of this site? Confirm its status | Tbilisi | Georgia | Unknown status |
| SB Investigative Site 6 Coordinator of this site? Confirm its status | Tbilisi | Georgia | Unknown status |
| SB Investigative Site 4 Coordinator of this site? Confirm its status | Tbilisi | Georgia | Unknown status |
| SB Investigative Site 2 Coordinator of this site? Confirm its status | Tbilisi | Georgia | Unknown status |
| SB Investigative Site 3 Coordinator of this site? Confirm its status | Tbilisi | Georgia | Unknown status |
| SB Investigative Site Coordinator of this site? Confirm its status | Bangalore | India | Unknown status |
| SB Investigative Site Coordinator of this site? Confirm its status | Bhubaneswar | India | Unknown status |
| SB Investigative Site Coordinator of this site? Confirm its status | Erandwane | India | Unknown status |
| SB Investigative Site Coordinator of this site? Confirm its status | Hyderabad | India | Unknown status |
| SB Investigative Site 1 Coordinator of this site? Confirm its status | Jaipur | India | Unknown status |
| SB Investigative Site 2 Coordinator of this site? Confirm its status | Jaipur | India | Unknown status |
| SB Investigative Site Coordinator of this site? Confirm its status | Mumbai | India | Unknown status |
| SB Investigative Site Coordinator of this site? Confirm its status | Sūrat | India | Unknown status |
| SB Investigative Site Coordinator of this site? Confirm its status | Udaipur | India | Unknown status |
| SB Investigative Site Coordinator of this site? Confirm its status | Himeji | Japan | Unknown status |
| SB Investigative Site Coordinator of this site? Confirm its status | Iwakuni | Japan | Unknown status |
| SB Investigative Site Coordinator of this site? Confirm its status | Izumi | Japan | Unknown status |
| SB Investigative Site Coordinator of this site? Confirm its status | Kawachi-Nagano | Japan | Unknown status |
| SB Investigative Site Coordinator of this site? Confirm its status | Kobe | Japan | Unknown status |
| SB Investigative Site Coordinator of this site? Confirm its status | Kochi | Japan | Unknown status |
| SB Investigative Site Coordinator of this site? Confirm its status | Sagamihara | Japan | Unknown status |
| SB Investigative Site Coordinator of this site? Confirm its status | Tachikawa | Japan | Unknown status |
| SB Investigative Site Coordinator of this site? Confirm its status | Takarazuka | Japan | Unknown status |
| SB Investigative Site Coordinator of this site? Confirm its status | Toyonaka | Japan | Unknown status |
| SB Investigative Site Coordinator of this site? Confirm its status | Aguascalientes | Mexico | Unknown status |
| SB Investigative Site Coordinator of this site? Confirm its status | Guadalajara | Mexico | Unknown status |
| SB Investigative Site Coordinator of this site? Confirm its status | Mexico City | Mexico | Unknown status |
| SB Investigative Site Coordinator of this site? Confirm its status | George Town | Malaysia | Unknown status |
| SB Investigative Site Coordinator of this site? Confirm its status | Johor Bahru | Malaysia | Unknown status |
| SB Investigative Site Coordinator of this site? Confirm its status | Kota Bharu | Malaysia | Unknown status |
| SB Investigative Site Coordinator of this site? Confirm its status | Kuantan | Malaysia | Unknown status |
| SB Investigative Site Coordinator of this site? Confirm its status | Lembah Pantai | Malaysia | Unknown status |
| SB Investigative Site Coordinator of this site? Confirm its status | Putrajaya | Malaysia | Unknown status |
| SB Investigative Site Coordinator of this site? Confirm its status | Davao City | Philippines | Unknown status |
| SB Investigative Site Coordinator of this site? Confirm its status | Makati City | Philippines | Unknown status |
| SB Investigative Site Coordinator of this site? Confirm its status | Manila | Philippines | Unknown status |
| SB Investigative Site Coordinator of this site? Confirm its status | Quezon City | Philippines | Unknown status |
| SB Investigative Site Coordinator of this site? Confirm its status | San Juan City | Philippines | Unknown status |
| SB Investigative Site Coordinator of this site? Confirm its status | Cluj-Napoca | Romania | Unknown status |
| SB Investigative Site Coordinator of this site? Confirm its status | Craiova | Romania | Unknown status |
| SB Investigative Site 2 Coordinator of this site? Confirm its status | Craiova | Romania | Unknown status |
| SB Investigative Site 1 Coordinator of this site? Confirm its status | Craiova | Romania | Unknown status |
| SB Investigative Site Coordinator of this site? Confirm its status | Iași | Romania | Unknown status |
| SB Investigative Site Coordinator of this site? Confirm its status | Oradea | Romania | Unknown status |
| SB Investigative Site Coordinator of this site? Confirm its status | Sibiu | Romania | Unknown status |
| SB Investigative Site Coordinator of this site? Confirm its status | Suceava | Romania | Unknown status |
| SB Investigative Site 1 Coordinator of this site? Confirm its status | Belgrade | Serbia | Unknown status |
| SB Investigative Site 2 Coordinator of this site? Confirm its status | Belgrade | Serbia | Unknown status |
| SB Investigative Site Coordinator of this site? Confirm its status | Kamenitz | Serbia | Unknown status |
| SB Investigative Site Coordinator of this site? Confirm its status | Kragujevac | Serbia | Unknown status |
| SB Investigative Site Coordinator of this site? Confirm its status | Niš | Serbia | Unknown status |
| SB Investigative Site 1 Coordinator of this site? Confirm its status | Bangkok | Thailand | Unknown status |
| SB Investigative Site 2 Coordinator of this site? Confirm its status | Bangkok | Thailand | Unknown status |
| SB Investigative Site Coordinator of this site? Confirm its status | Bangkok Noi | Thailand | Unknown status |
| SB Investigative Site Coordinator of this site? Confirm its status | Khon Kaen | Thailand | Unknown status |
| SB Investigative Site Coordinator of this site? Confirm its status | Adapazarı | Turkey (Türkiye) | Unknown status |
| SB Investigative Site 1 Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Unknown status |
| SB Investigative Site 2 Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Unknown status |
| SB Investigative Site Coordinator of this site? Confirm its status | Bağcılar | Turkey (Türkiye) | Unknown status |
| SB Investigative Site Coordinator of this site? Confirm its status | Balgat | Turkey (Türkiye) | Unknown status |
| SB Investigative Site Coordinator of this site? Confirm its status | Banja Luka | Bosnia and Herzegovina | Unknown status |
| SB Investigative Site Coordinator of this site? Confirm its status | Çubuk | Turkey (Türkiye) | Unknown status |
| SB Investigative Site Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Unknown status |
| SB Investigative Site Coordinator of this site? Confirm its status | İzmit | Turkey (Türkiye) | Unknown status |
| SB Investigative Site Coordinator of this site? Confirm its status | Kavaklıdere | Turkey (Türkiye) | Unknown status |
| SB Investigative Site Coordinator of this site? Confirm its status | Konak | Turkey (Türkiye) | Unknown status |
| SB Investigative Site Coordinator of this site? Confirm its status | Maltepe | Turkey (Türkiye) | Unknown status |
| SB Investigative Site Coordinator of this site? Confirm its status | Mostar | Bosnia and Herzegovina | Unknown status |
| SB Investigative Site Coordinator of this site? Confirm its status | Sarajevo | Bosnia and Herzegovina | Unknown status |
| SB Investigative Site Coordinator of this site? Confirm its status | Seyhan | Turkey (Türkiye) | Unknown status |
| SB Investigative Site Coordinator of this site? Confirm its status | Sivas | Turkey (Türkiye) | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.