A Phase 3 clinical trial evaluating pembrolizumab (Keytruda) in participants with metastatic non-squamous non-small cell lung cancer completed its primary stage on March 10, 2026. The study, which enrolled 555 participants, aims to compare the efficacy, safety, pharmacokinetics, and immunogenicity of investigational product SB27 against Keytruda.
Background
Pembrolizumab, marketed as Keytruda, is a widely used immunotherapy. In this trial, it serves as the reference drug against which the investigational product SB27 is being compared for the treatment of metastatic non-squamous non-small cell lung cancer.
Trial design
The study, identified as NCT06348199, is a Phase 3 trial with an enrollment of 555 participants. The trial focuses on subjects with metastatic non-squamous non-small cell lung cancer (NSCLC). Participants receive either the investigational product SB27 or Keytruda, along with chemotherapy every 3 weeks. The trial's goal is to confirm that SB27 works in the same way as Keytruda, specifically comparing their efficacy, safety, pharmacokinetics, and immunogenicity.
What this means
The primary completion of this Phase 3 trial signifies that data collection for the study's main objectives has concluded. While specific efficacy and safety results are not yet available, this milestone indicates progress towards evaluating SB27 as a potential alternative to pembrolizumab (Keytruda) for patients with metastatic non-squamous non-small cell lung cancer. The trial's design to compare efficacy, safety, pharmacokinetics, and immunogenicity suggests an aim to establish similarity between the two treatments.
Source
This information is based on the trial record for NCT06348199 on ClinicalTrials.gov, which reported the primary completion date as March 10, 2026. Further details on the study are available on clinicaltrials.gov.