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

NCT06348199 ↗

Phase 3 Active not recruiting 555 enrolled Samsung Bioepis Co., Ltd.
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

EvaluationDrugModalityDoseRoute
Comparator Pembrolizumab Monoclonal antibody 200 mg Intravenous
Subject SB27 Unknown 200 mg Intravenous