A Phase 3 interventional study of SB27 and Keytruda in Non-small Cell Lung Cancer Stage IV, sponsored by Samsung Bioepis Co., Ltd.. Active, not recruiting at 93 sites in 14 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-07.
Sponsored by Samsung Bioepis Co., Ltd. · Phase 3, Interventional, and Treatment
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:
Researchers will compare SB27 and Keytruda to see if SB27 works in the same way as Keytruda.
Exclusion Criteria:
SB27 will be administered followed by Pemetrexed and Carboplatin (Carboplatin will be administered for the first 4 cycles).
Drug: SB27
Keytruda will be administered followed by Pemetrexed and Carboplatin (Carboplatin will be administered for the first 4 cycles).
Drug: Keytruda
Will be administered intravenously at a fixed dose of 200 mg every 3 weeks
Will be administered intravenously at a fixed dose of 200 mg every 3 weeks
Objective response rate (ORR) at Week 24
Defined as the proportion of subjects achieving a complete response (CR) or partial response (PR) at Week 24 according to RECIST v1.1
Time frame: At Week 24
This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Carcinoma, Non-Small-Cell Lung→
Samsung Bioepis Co., Ltd.