JRCT ID: jRCT2080220796
Registered date:04/08/2009
Basic Information
Recruitment status | |
---|---|
Health condition(s) or Problem(s) studied | Unresectable stage III non-small cell lung cancer |
Date of first enrollment | 04/08/2009 |
Target sample size | 39 |
Countries of recruitment | |
Study type | Interventional |
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 |
Outcome(s)
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) |
Key inclusion & exclusion criteria
Age minimum | >= 20age old |
---|---|
Age maximum | <= 74age old |
Gender | Both |
Include criteria | Patients with unresectable stage IIIA or IIIB of NSCLC Patients who are judged to be suitable for radical radiotherapy |
Exclude 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 |
Related Information
Primary Sponsor | DAIICHISANKYO Co.,Ltd. |
---|---|
Secondary Sponsor | |
Source(s) of Monetary Support | |
Secondary ID(s) | JapicCTI-090825 |
Contact
Public contact | |
Name | |
Address | http://www.daiichisankyo.co.jp/corporate/rd/measure/clinical/index.html |
Telephone | |
Affiliation | DAIICHI SANKYO COMPANY, LIMITED |
Scientific contact | |
Name | |
Address | |
Telephone | |
Affiliation |