UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000023433
Receipt No. R000026982
Scientific Title A single arm confirmatory study of nivolumab in patients with previously treated advanced sarcomatoid carcinoma of the lung
Date of disclosure of the study information 2016/11/01
Last modified on 2019/07/06

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title A single arm confirmatory study of nivolumab in patients with previously treated advanced sarcomatoid carcinoma of the lung
Acronym Nivolumab for advanced sarcomatoid carcinoma of the lung
Scientific Title A single arm confirmatory study of nivolumab in patients with previously treated advanced sarcomatoid carcinoma of the lung
Scientific Title:Acronym Nivolumab for advanced sarcomatoid carcinoma of the lung
Region
Japan

Condition
Condition advanced sarcomatoid carcinoma of the lung
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To confirm effect and safety of nivolumab in patients with advanced sarcomatoid carcinoma of the lung.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Overall response rate by Central review
Key secondary outcomes Overall response rate by investigator, PFS, OS, DCR, Survival rate at 6 months, and toxicity

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Nivolumab 3mg/kg every 2 weeks
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Histologically confirmed sarcomatoid carcinoma of the lung
2. Stage III, IV, and postoperative recurrence
3. Age > 20
4. PS 0-2
5. Measurable lesion
6. Adequate organ function
7. Written informed consent
Key exclusion criteria 1. Active auto-immune disease
2. Interstitial lung disease or pulmonary fibrosis
3. Active infection such as bacteria, HBV, or HCV
Target sample size 42

Research contact person
Name of lead principal investigator
1st name Yuichiro
Middle name
Last name Ohe
Organization National Cancer Center Hospital
Division name Department of Thoracic Oncology
Zip code 104-0045
Address Tsukiji 5-1-1, Chuo-ku, Tokyo
TEL 03-3542-2511
Email yohe@ncc.go.jp

Public contact
Name of contact person
1st name Yutaka
Middle name
Last name Fujiwara
Organization National Cancer Center Hospital
Division name Department of Thoracic Oncology
Zip code 104-0045
Address Tsukiji 5-1-1, Chuo-ku, Tokyo
TEL 03-3542-2511
Homepage URL
Email yutakafu@ncc.go.jp

Sponsor
Institute National Cancer Center Hospital
Institute
Department

Funding Source
Organization National Cancer Center Hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization National Cancer center Hospital
Address Tsukiji 5-1-1, Chuo-ku, Tokyo
Tel 03-3542-2511
Email yutakafu@ncc.go.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2016 Year 11 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2017 Year 02 Month 23 Day
Date of IRB
2017 Year 02 Month 23 Day
Anticipated trial start date
2017 Year 03 Month 27 Day
Last follow-up date
2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 08 Month 01 Day
Last modified on
2019 Year 07 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026982

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.