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

Sponsor
Samsung Bioepis Co., Ltd.
Study ID
NCT06348199
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Non-small Cell Lung Cancer Stage IV

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • SB27 — DRUG
    Will be administered intravenously at a fixed dose of 200 mg every 3 weeks
  • Keytruda — DRUG
    Will be administered intravenously at a fixed dose of 200 mg every 3 weeks

Study Details

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.

Key Dates

Start date
Mar 12, 2024
Status verified
Nov 2025
Primary completion
Mar 31, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
555 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: SB27
    SB27 will be administered followed by Pemetrexed and Carboplatin (Carboplatin will be administered for the first 4 cycles).
  • Active Comparator: Keytruda
    Keytruda will be administered followed by Pemetrexed and Carboplatin (Carboplatin will be administered for the first 4 cycles).

Primary Outcome Measure

Objective response rate (ORR) at Week 24 [ Time Frame: At Week 24 ]

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