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
| Registry | NCT06348199 |
|---|---|
| Status | Active not recruiting |
| Phase | Phase 3 |
| Study type | Interventional; randomized, parallel, masking: quadruple, treatment |
| Enrollment | 555 (Actual) |
| Sponsor | Samsung Bioepis Co., Ltd. (Industry) |
| Conditions | Non-small Cell Lung Cancer Stage IV |
| Interventions | SB27, Keytruda (Drug) |
| Dates | start 2024-03-12, primary completion 2026-03-10, completion 2026-09-01 (estimated), first posted 2024-04-04, last updated 2026-07-07 |
| Locations | 93 sites in Bosnia and Herzegovina, Brazil, Georgia, Germany, India, Japan, Malaysia, Mexico and 6 more countries |
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All trials for Non-small Cell Lung Cancer Stage IV All trials of SB27 All trials of Keytruda
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| SB27 | Experimental | Drug: SB27 | SB27 will be administered followed by Pemetrexed and Carboplatin (Carboplatin will be administered for the first 4 cycles). |
| Keytruda | Active comparator | Drug: Keytruda | Keytruda will be administered followed by Pemetrexed and Carboplatin (Carboplatin will be administered for the first 4 cycles). |
Sex: All, ages: 18 Years to any
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.
| Facility | City | Country | Status |
|---|---|---|---|
| SB Investigative Site | Banja Luka | Bosnia and Herzegovina | |
| SB Investigative Site | Mostar | Bosnia and Herzegovina | |
| SB Investigative Site | Sarajevo | Bosnia and Herzegovina | |
| SB Investigative Site | Curitiba | Brazil | |
| SB Investigative Site | Florianópolis | Brazil | |
| SB Investigative Site | Ijuí | Brazil | |
| SB Investigative Site | Natal | Brazil | |
| SB Investigative Site | Pelotas | Brazil | |
| SB Investigative Site 1 | Porto Alegre | Brazil | |
| SB Investigative Site 2 | Porto Alegre | Brazil | |
| SB Investigative Site | Rio de Janeiro | Brazil | |
| SB Investigative Site | Santo André | Brazil | |
| SB Investigative Site | Batumi | Georgia | |
| SB Investigative Site 1 | Tbilisi | Georgia | |
| SB Investigative Site 2 | Tbilisi | Georgia | |
| SB Investigative Site 3 | Tbilisi | Georgia | |
| SB Investigative Site 4 | Tbilisi | Georgia | |
| SB Investigative Site 5 | Tbilisi | Georgia | |
| SB Investigative Site 6 | Tbilisi | Georgia | |
| SB Investigative Site | Düsseldorf | Germany | |
| SB Investigative Site | Halle | Germany | |
| SB Investigative Site | Moers | Germany | |
| SB Investigative Site | Neuss | Germany | |
| SB Investigative Site | Bangalore | India | |
| SB Investigative Site | Bhubaneswar | India | |
| SB Investigative Site | Erandwane | India | |
| SB Investigative Site | Hyderabad | India | |
| SB Investigative Site 1 | Jaipur | India | |
| SB Investigative Site 2 | Jaipur | India | |
| SB Investigative Site | Mumbai | India | |
| SB Investigative Site | Sūrat | India | |
| SB Investigative Site | Udaipur | India | |
| SB Investigative Site | Himeji | Japan | |
| SB Investigative Site | Iwakuni | Japan | |
| SB Investigative Site | Izumi | Japan | |
| SB Investigative Site | Kawachi-Nagano | Japan | |
| SB Investigative Site | Kobe | Japan | |
| SB Investigative Site | Kochi | Japan | |
| SB Investigative Site | Sagamihara | Japan | |
| SB Investigative Site | Tachikawa | Japan | |
| SB Investigative Site | Takarazuka | Japan | |
| SB Investigative Site | Toyonaka | Japan | |
| SB Investigative Site | George Town | Malaysia | |
| SB Investigative Site | Johor Bahru | Malaysia | |
| SB Investigative Site | Kota Bharu | Malaysia | |
| SB Investigative Site | Kuantan | Malaysia | |
| SB Investigative Site | Lembah Pantai | Malaysia | |
| SB Investigative Site | Putrajaya | Malaysia | |
| SB Investigative Site | Aguascalientes | Mexico | |
| SB Investigative Site | Guadalajara | Mexico | |
| SB Investigative Site | Mexico City | Mexico | |
| SB Investigative Site | Davao City | Philippines | |
| SB Investigative Site | Makati City | Philippines | |
| SB Investigative Site | Manila | Philippines | |
| SB Investigative Site | Quezon City | Philippines | |
| SB Investigative Site | San Juan City | Philippines | |
| SB Investigative Site | Cluj-Napoca | Romania | |
| SB Investigative Site 1 | Craiova | Romania | |
| SB Investigative Site 2 | Craiova | Romania | |
| SB Investigative Site | Craiova | Romania | |
| SB Investigative Site | Iași | Romania | |
| SB Investigative Site | Oradea | Romania | |
| SB Investigative Site | Sibiu | Romania | |
| SB Investigative Site | Suceava | Romania | |
| SB Investigative Site 1 | Belgrade | Serbia | |
| SB Investigative Site 2 | Belgrade | Serbia | |
| SB Investigative Site | Kamenitz | Serbia | |
| SB Investigative Site | Kragujevac | Serbia | |
| SB Investigative Site | Niš | Serbia | |
| SB Investigative Site | Leganés | Spain | |
| SB Investigative Site | Málaga | Spain | |
| SB Investigative Site | Ourense | Spain | |
| SB Investigative Site | Oviedo | Spain | |
| SB Investigative Site | Santiago de Compostela | Spain | |
| SB Investigative Site | Seville | Spain | |
| SB Investigative Site | Valencia | Spain | |
| SB Investigative Site 1 | Bangkok | Thailand | |
| SB Investigative Site 2 | Bangkok | Thailand | |
| SB Investigative Site | Bangkok Noi | Thailand | |
| SB Investigative Site | Khon Kaen | Thailand | |
| SB Investigative Site | Adapazarı | Turkey (Türkiye) | |
| SB Investigative Site 1 | Ankara | Turkey (Türkiye) | |
| SB Investigative Site 2 | Ankara | Turkey (Türkiye) | |
| SB Investigative Site | Bağcılar | Turkey (Türkiye) | |
| SB Investigative Site | Balgat | Turkey (Türkiye) | |
| SB Investigative Site | Çubuk | Turkey (Türkiye) | |
| SB Investigative Site | Istanbul | Turkey (Türkiye) | |
| SB Investigative Site | İzmit | Turkey (Türkiye) | |
| SB Investigative Site | Kavaklıdere | Turkey (Türkiye) | |
| SB Investigative Site | Konak | Turkey (Türkiye) | |
| SB Investigative Site | Maltepe | Turkey (Türkiye) | |
| SB Investigative Site | Seyhan | Turkey (Türkiye) | |
| SB Investigative Site | Sivas | Turkey (Türkiye) |