drugset / Trial / NCT06348199
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
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2024-03-12
- Primary completion
- 2026-03-10
- Completion
- 2026-09
Outcome
Met primary endpoint
release “프로젝트명 SB27)의 글로벌 임상 1상 및 3상 데이터 분석 결과, 각각의 1차 평가 변수(primary endpoint)에서 동등성을 입증한 것으로 확인” samsungbioepis.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Pembrolizumab | Monoclonal antibody | 200 mg | Intravenous |
| Subject | SB27 | Unknown | 200 mg | Intravenous |