臨床研究等提出・公開システム

Date of registration	Mar. 11, 2024
Last modified on	April. 07, 2026
Trial ID	jRCT2061230106

Scientific Title	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)
Public Title	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)

Contact for Scientific Queries	Name	Umezawa Daisuke
	Affiliation	Fortrea Japan K.K.
	Address	Harumi Triton Square Office Tower Y 8F, 1-8-11, Harumi, Chuo-ku, Tokyo
	Telephone	+81-90-2705-4005
	E-mail	Daisuke.Umezawa@fortrea.com
Contact for Public Queries	Name	Umezawa Daisuke
	Affiliation	Fortrea Japan K.K.
	Address	Harumi Triton Square Office Tower Y 8F, 1-8-11, Harumi, Chuo-ku, Tokyo
	Telephone	+81-90-2705-4005
	E-mail	Daisuke.Umezawa@fortrea.com

Recruitment status	Not Recruiting

Anticipated date of first enrollment		Mar. 11, 2024
Actual date of first enrollment		May. 27, 2024
Target sample size		46
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	double blind
	control	active control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion 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	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.
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Metastatic non-squamous non-small cell lung cancer
Intervention(s)		SB27 200 mg IV every 3 weeks.
Primary Outcome(s)		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.

Primary Sponsor	Samsung Bioepis Co., Ltd.

Secondary Sponsor

Name of Certified Review Board	National Hospital Organization Iwakuni Clinical Center IRB
Address	1-1-1 Atagomachi, Iwakuni-Shi, Yamaguchi
Telephone	+81-827-34-1000
Approval Status	Approval
Date of approval	Jan. 04, 2024

Plan to share IPD	No

Secondary ID(s)	NCT06348199
Issuing Authority	ClinicalTrials.gov

Countries of Recruitment（Except Japan）	Bosnia & Herzegovina/Brazil/Georgia/Germany/India/Malaysia/Mexico/Philippines/Romania/Serbia/Spain/Thailand/Turkey

History of Changes

No	Publication date
5	April. 07, 2026	(this page)	Changes
4	April. 10, 2025	Detail	Changes
3	June. 18, 2024	Detail	Changes
2	April. 10, 2024	Detail	Changes
1	Mar. 11, 2024	Detail

List of change history