UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	prospective observational study to assess efficacy and safety of nivolumab in patients with recurrent non-small cell lung cancer
Title of the study (Brief title)	prospective observational study to assess efficacy and safety of nivolumab in patients with recurrent non-small cell lung cancer
Region	Japan

Condition
Condition	non-small cell lung cancer
Classification by specialty	Pneumology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	We will reveal appropriate cases for nivolmab in patients with recurrent non-small cell lung cancer, by verifying a correlation between efficacy and safety of this agent and clinical characteristics.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	response rate and their clinical profiling
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1)adequate patients to administrate nivolmab, after 1st line chemotherapy 2)patients who assent to this study
Key exclusion criteria	1)inadequate patients to administrate nivolmab 2)patients that the investigators identify inadequate for this study
Target sample size	200

Research contact person
Name of lead principal investigator	Kyoichi Kaira
Organization	Gunma University Hospital
Division name	department of translational medicine
Address	3-39-15 Maebashi, Gunma, Japan
TEL	027-220-7111
Email	kkaira1970@yahoo.co.jp

Public contact
Name of contact person	Shinsuke Kitahara
Organization	Gunma University Hospital
Division name	department of respiratory and allergy medicine
Address	3-39-15 Maebashi, Gunma, Japan
TEL	027-220-7111
Homepage URL
Email	shinkita.s50@gmail.com

Sponsor
Institute	Gunma University Hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Gunma University Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

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 07 Month 19 Day

Progress
Recruitment status	Recruiting
Date of protocol fixation	2016 Year 06 Month 23 Day
Anticipated trial start date	2016 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	prospective observational study study duration:01/Jul/2016-30/Jun/2018

Management information
Registered date	2016 Year 07 Month 18 Day
Last modified on	2016 Year 07 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026757