臨床研究等提出・公開システム

Date of registration	Aug. 04, 2009
Last modified on	Dec. 17, 2018
Trial ID	jRCT2080220796

Scientific Title	A Phase II Study of Nimotuzumab in Patients with Unresectable Stage III Non-small Cell Lung Cancer
Public Title

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	DAIICHI SANKYO COMPANY, LIMITED
	Address	http://www.daiichisankyo.co.jp/corporate/rd/measure/clinical/index.html
	Phone Number
	E-mail Address

Recruitment Status

Date of First Enrolment
Target Sample Size		39
Study Type		Interventional
Study Design	Study Design	Open-label, multi-center
Study Design	Objective
Phase		2
Key inclusion & exclusion criteria	Inclusion Criteria	Patients with unresectable stage IIIA or IIIB of NSCLC Patients who are judged to be suitable for radical radiotherapy
	Exclusion Criteria	Patients with another active malignancy Patients who have obvious pulmonary fibrosis or interstitial pneumonia by chest CT-scans Patients with severe or uncontrolled complications
	Minimum Age	20age old over
	Maximum Age	74age old under
	Gender	Both
Health Condition or Problem Studied		Unresectable stage III non-small cell lung cancer
Intervention(s)		investigational material(s) Generic name etc : DE-766 INN of investigational material : Nimotuzumab Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : Intravenous drip infusion
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		Tolerability The proportion of patients who have completed all of the protocol-stipulated treatments
Secondary Outcome		Safety, response rate, progression-free survival , progression-free survival rate, and survival rate NCI-CTC (ver.3.0), RECIST (ver. 1.1)

Primary Sponsor	DAIICHISANKYO Co.,Ltd.
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-090825
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
13	Dec. 17, 2018	(this page)	Changes
12	Oct. 21, 2015	Detail	Changes
11	Oct. 21, 2015	Detail	Changes
10	Dec. 25, 2014	Detail	Changes
9	Dec. 25, 2014	Detail	Changes
8	Oct. 16, 2012	Detail	Changes
7	Oct. 16, 2012	Detail	Changes
6	Sept. 16, 2011	Detail	Changes
5	Jan. 27, 2011	Detail	Changes
4	Aug. 30, 2010	Detail	Changes
3	Aug. 30, 2010	Detail	Changes
2	Aug. 04, 2009	Detail	Changes
1	Aug. 04, 2009	Detail

List of change history