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

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 - SB27-3004

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2061230106

Enrollment

Registered

2024-03-11

Start date

2024-05-27

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Metastatic non-squamous non-small cell lung cancer

Interventions

SB27 200 mg IV every 3 weeks.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Male or female >= 18 years of age 2. Have been diagnosed with stage IV non-squamous NSCLC 3. Have not received any prior systemic anti-cancer therapy for metastatic NSCLC 4. Agree to use adequate methods of contraception

Exclusion criteria

Exclusion criteria: 1. Unable or unwilling to take folic acid and vitamin B12 supplementation 2. Severe hypersensitivity to treatment with another monoclonal antibody, any ingredient contained in SB27 or Keytruda, or any component of platinum-containing compounds or pemetrexed.

Design outcomes

Primary

Measure	Time frame
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 based on BICR. Confirmation of response will not be considered for the analysis of primary efficacy endpoint.	—

Countries

Bosnia & Herzegovina, Brazil, Georgia, Germany, India, Japan, Malaysia, Mexico, Philippines, Romania, Serbia, Spain, Thailand, Turkey

Contacts

Public ContactDaisuke Umezawa

Fortrea Japan K.K.

Daisuke.Umezawa@fortrea.com+81-90-2705-4005

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026