臨床研究等提出・公開システム

Date of registration	Nov. 13, 2019
Last modified on	Feb. 28, 2024
Trial ID	jRCT2080224946

Scientific Title	A Phase III, double blind, randomized study of Bevacizumab in combination with Carboplatin or Cisplatin + Etoposide + Atezolizumab compared with Carboplatin or Cisplatin + Etoposide + Atezolizumab in patients with untreated ES-SCLC
Public Title	Tecentriq_SCLC(1L)_Bev_comb[BEAT-SC]

Contact for Scientific Queries	Name
	Contact Name for Scientific Queries	Chugai Pharmaceutical Co., Ltd.
	Address	1-1 NIHONBASHI-MUROMACHI 2-CHOME, CHUO-KU, Tokyo
	Phone Number	+81-120189706
	E-mail Address	clinical-trials@chugai-pharm.co.jp

Contact for Public Queries	Name
	Contact Name for Public Queries	Chugai Pharmaceutical Co., Ltd.
	Address	1-1 NIHONBASHI-MUROMACHI 2-CHOME, CHUO-KU, Tokyo
	Phone Number	+81-120189706
	E-mail Address	clinical-trials@chugai-pharm.co.jp

Recruitment Status	completed

Date of First Enrolment		Jan. 17, 2020
Target Sample Size		330
Study Type		Interventional
Study Design	Study Design	multicenter, double blind, randomized study
Study Design	Objective	treatment purpose
Phase		3
Key inclusion & exclusion criteria	Inclusion Criteria	- Histologically or cytologically confirmed ES-SCLC - No prior treatment for ES-SCLC - ECOG performance status of 0 or 1 - Measurable disease, as defined by RECIST v1.1 - Adequate hematologic and end organ function
	Exclusion Criteria	- Malignancies other than SCLC within the last 5 years - Pregnant or lactating women - History of autoimmune disease - History of idiopathic pulmonary fibrosis, organizing pneumonia, drug induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan. - Positive test for Human Immunodeficiency Virus (HIV) - Active hepatitis B or hepatitis C - Severe infections at the time of enrollment - Significant cardiovascular disease - Prior treatment with immune checkpoint blockade therapies, anti-PD1 and anti-PD-L1 therapeutic antibody
	Minimum Age	20age old over
	Maximum Age	No limit
	Gender	Both
Health Condition or Problem Studied		Extensive-stage Small Cell Lung Cancer
Intervention(s)		investigational material(s) Generic name etc : atezolizumab INN of investigational material : atezolizumab Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : 1,200 mg every 21 days by infusion Generic name etc : bevacizumab INN of investigational material : bevacizumab Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : 15 mg/kg every 21 days by infusion control material(s) Generic name etc : - INN of investigational material : - Therapeutic category code : Dosage and Administration for Investigational material : -
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		efficacy RECIST v1.1
Secondary Outcome		safety efficacy pharmacokinetics Observation, RECIST v1.1, Inspection

Primary Sponsor	Chugai Pharmaceutical Co., Ltd.
Secondary Sponsor	-

Name of Funding Organization	-
Name of Research Funding	-

Name of IRB	Matsusaka City Hospital IRB
Address of IRB	1550, Tonomachi, Matsusaka-shi, Mie
Phone Number of IRB
E-mail Address of IRB
Status of IRB Review	approved
Date of Approval by IRB	Nov. 01, 2019

Secondary ID No.	JapicCTI-195034
Name of Other Registries

Countries / Regions of Recruitment	Japan/Asia except Japan

History of Changes

No	Publication date
5	Feb. 28, 2024	(this page)	Changes
4	July. 07, 2023	Detail	Changes
3	Jan. 19, 2021	Detail	Changes
2	Jan. 21, 2020	Detail	Changes
1	Nov. 18, 2019	Detail

List of change history