Study which tests 2 medications (SB27, Keytruda) to compare how effective, safe and well tolerated in a large number of metastatic non-squamous non-small cell lung cancer patients
Key facts
- Where
- Leganés, Málaga, Ourense, Oviedo, Santiago de Compostela és Sevilla, SpanyolországSee the 6 sites
- Phase
- 3. fázis
Where in Spanyolország
- Hospital Universitario Severo OchoaLeganés, SpanyolországNo longer taking part
- Hospital Quironsalud MalagaMálaga, SpanyolországNo longer taking part
- Complejo Hospitalario Universitario de OurenseOurense, SpanyolországNo longer taking part
- Hospital Universitario Central De AsturiasOviedo, SpanyolországNo longer taking part
- Complexo Hospitalario Universitario De SantiagoSantiago de Compostela, SpanyolországNo longer taking part
- University Hospital Virgen Del Rocio S.L.Sevilla, SpanyolországNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Samsung Bioepis Co. Ltd.
- Trial code
- EU 2023-507448-36-00
- Record updated
- 2026. október 5.
- Original description
"To demonstrate the equivalence in efficacy of SB27 to Keytruda, in terms of objective response rate (ORR) in subjects with metastatic non-squamous non-small cell lung cancer (NSCLC)"Read full original descriptionShow less
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
"To demonstrate the equivalence in efficacy of SB27 to Keytruda, in terms of objective response rate (ORR) in subjects with metastatic non-squamous non-small cell lung cancer (NSCLC)"
Inclusion: 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: Unable to receive chemotherapy during the study; Unable to take folic acid and vitamin B12 supplementation.