臨床研究等提出・公開システム

Date of registration	July. 08, 2013
Last modified on	Dec. 17, 2018
Trial ID	jRCT2080222136

Scientific Title	Randomized, Multicenter, Double-Blind, Phase 3 Trial Comparing the Efficacy of Ipilimumab Plus Etoposide/Platinum Versus Etoposide/Platinum in Subjects With Newly Diagnosed Extensive-Stage Disease Small Cell Lung Cancer (ED-SCLC)
Public Title	Trial in Extensive-Disease Small Cell Lung Cancer (ED-SCLC) Subjects Comparing Ipilimumab Plus Etoposide and Platinum Therapy to Etoposide and Platinum Therapy Alone

Completion Date or Terminated date
Actual Enrolled Number
Baseline Characteristics
Participant flow
Adverse events
Primary Outcome Measures
Secondary Outcome Measures
Brief summary
Posting of journal publication
Date of the first journal publication of results
URL hyperlink(s) related to results and publications

Plan to share IPD
Plan description
URL link to protocol file(s)
Version of protocol file(s)	version: date:

Contact for Scientific Queries	Name
	Contact Name for Scientific Queries
	Address
	Phone Number
	E-mail Address

Contact for Public Queries	Name
	Contact Name for Public Queries	Bristol-Myers Squibb K.K.
	Address	mg-jp-clinical_trial@bms.com
	Phone Number
	E-mail Address

Recruitment Status

Date of First Enrolment
Target Sample Size		1100
Study Type		Interventional
Study Design	Study Design	Randomized, Double Blind, Placebo Control, Parallel Assignment Study
Study Design	Objective
Phase		3
Key inclusion & exclusion criteria	Inclusion Criteria	Extensive-Stage Disease Small Cell Lung Cancer (ED-SCLC) Eastern Cooperative Oncology Group (ECOG) of 0 or 1
	Exclusion Criteria	Prior systemic therapy for lung cancer Symptomatic Central Nervous System (CNS) metastases History of autoimmune disease
	Minimum Age	20age old over
	Maximum Age	No limit
	Gender	Both
Health Condition or Problem Studied		Small Cell Lung Carcinoma
Intervention(s)		investigational material(s) Generic name etc : Ipilimumab (BMS-734016) INN of investigational material : Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : Inravenrous (IV), 90 minute infusion, Once every 3 weeks for 4 doses and then every 12 weeks until PD
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		Overall Survival (OS) of subjects who received blinded study therapy
Secondary Outcome		Overall Survival Immune-related Progression Free Survival (irPFS)

Primary Sponsor	Bristol-Myers Squibb K.K.
Secondary Sponsor

Name of Funding Organization
Name of Research Funding

Name of IRB
Address of IRB
Phone Number of IRB
E-mail Address of IRB
Status of IRB Review
Date of Approval by IRB

Secondary ID No.	JapicCTI-132182
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
13	Dec. 17, 2018	(this page)	Changes
12	May. 18, 2017	Detail	Changes
11	May. 18, 2017	Detail	Changes
10	Jan. 04, 2017	Detail	Changes
9	Jan. 04, 2017	Detail	Changes
8	April. 11, 2016	Detail	Changes
7	April. 11, 2016	Detail	Changes
6	Mar. 24, 2015	Detail	Changes
5	Mar. 24, 2015	Detail	Changes
4	Oct. 10, 2014	Detail	Changes
3	Oct. 10, 2014	Detail	Changes
2	July. 08, 2013	Detail	Changes
1	July. 08, 2013	Detail

List of change history