A Phase III randomised, double-blind, multicentre study to compare the efficacy, safety, pharmacokinetics, and immunogenicity between SB27 (proposed pembrolizumab biosimilar) and Keytruda in subjects with metastatic non-squamous non-small cell lung cancer

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-507448-36-00

Acronym

SB27-3004

Enrollment

103

Registered

2024-01-16

Start date

2024-02-16

Completion date

Unknown

Last updated

2025-10-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-small Cell Lung Cancer

Brief summary

objective response rate (ORR)

Interventions

DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion

DRUGPEMETREXED

DRUGCARBOPLATIN

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
objective response rate (ORR)	—

Countries

Germany, Romania, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026