臨床研究等提出・公開システム

Japanese

Date of registration	Mar. 14, 2024
Last modified on	Oct. 10, 2024
Trial ID	jRCT2061230110

Scientific Title	A Phase III, Randomized, Double-blind Study of Tiragolumab Plus Atezolizumab Compared With Placebo Plus Atezolizumab in Participants With Completely Resected Stage IIB, IIIA, or Select IIIB, PD-L1 Positive, Non-small Cell Lung Cancer Who Have Received Adjuvant Platinum-based Chemotherapy
Public Title	A Study of Tiragolumab Plus Atezolizumab Compared With Placebo Plus Atezolizumab in Participants With Completely Resected Non-small Cell Lung Cancer Who Have Received Adjuvant Platinum-based Chemotherapy (SKYSCRAPER-15)

Contact for Scientific Queries	Name	Raymond Meng
	Affiliation	F. Hoffmann-La Roche Ltd
	Address	1-1 NIHONBASHI-MUROMACHI 2-CHOME, CHUO-KU, Tokyo
	Telephone	+81-120189706
	E-mail	clinical-trials@chugai-pharm.co.jp
Contact for Public Queries	Name	Clinical trials information
	Affiliation	Chugai Pharmaceutical Co., Ltd.
	Address	1-1 NIHONBASHI-MUROMACHI 2-CHOME, CHUO-KU, Tokyo
	Telephone	+81-120189706
	E-mail	clinical-trials@chugai-pharm.co.jp

Recruitment status	Not Recruiting

Anticipated date of first enrollment		July. 01, 2024
Actual date of first enrollment		July. 01, 2024
Target sample size		1150
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	double blind
	control	placebo control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	Eastern Cooperative Oncology Group performance status of 0 or 1 Histological or cytological diagnosis of Stage IIB, IIIA, and select IIIB NSCLC of either non-squamous or squamous histology Participants must have had complete resection of NSCLC Participants must have received between one to four cycles of adjuvant histology-based platinum doublet chemotherapy Participants must have recovered adequately from surgery and from adjuvant chemotherapy Tumor cell PD-L1 expression at >/= 1% Adequate hematologic and end-organ function
	Exclusion Criteria	Any history of prior NSCLC within the last 5 years Any evidence of residual disease or disease recurrence following surgical resection of NSCLC, or during or following adjuvant chemotherapy NSCLC known to have mutation in the EGFR gene or an ALK fusion oncogene
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Non-small Cell Lung Cancer (NSCLC)
Intervention(s)		Tiragolumab: Tiragolumab will be administered IV Atezolizumab: Atezolizumab will be administered IV
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		efficacy Observation/Inspection
Secondary Outcome(s)		safety, efficacy, phamacokinetics Observation/Inspection

Primary Sponsor	Chugai Pharmaceutical Co., Ltd.

Primary Sponsor	F. Hoffmann-La Roche Ltd

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	Hiroshima University Hospital IRB
Address	1-2-3, Kasumi, Minami-ku, Hiroshima, Hiroshima
Telephone	+81-82-257-5596
E-Mail	hugcp@hiroshima-u.ac.jp
Approval Status	Approval
Date of approval	Mar. 05, 2024

Plan to share IPD	Yes
Plan description	Qualified researchers may request access to individual patient level data through the clinical study data request platform. For further details on Chugai's Data Sharing Policy and how to request access to related clinical study documents, see here (www.chugai-pharm.co.jp/english/profile/rd/ctds_request.html).

Secondary ID(s)	NCT06267001
Issuing Authority	ClinicalTrials.gov

Countries of Recruitment（Except Japan）	United States/Argentina/Australia/Belgium/Brazil/China/France/Greece/Hong Kong/Italy/Republic of Korea/Mexico/Peru/Poland/Romania/Slovakia/Spain/Taiwan/Thailand/Turkey

History of Changes

No	Publication date
4	Oct. 10, 2024	(this page)	Changes
3	Sept. 19, 2024	Detail	Changes
2	July. 16, 2024	Detail	Changes
1	Mar. 14, 2024	Detail

List of change history