UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Multi-institutional retrospective observational study of effectiveness and safety of treatment with Nivolmab for advanced or recurrent non-small cell lung cancer harboring EGFR mutation.
Title of the study (Brief title)	Multi-institutional retrospective observational study of effectiveness and safety of treatment with Nivolmab for advanced or recurrent non-small cell lung cancer harboring EGFR mutation.
Region	Japan

Condition
Condition	Non-small cell Lung Cancer
Classification by specialty	Pneumology Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To investigate the effectiveness and safety of the treatment with Nivolmab for the advanced or recurrent non-small cell lung cancer patients harboring EGFR mutation.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	effectiveness and safety
Key secondary outcomes	Response rate Progression free survival Overall survival Adverse events

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

Eligibility
Age-lower limit	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	NSCLC patients harboring EGFR gene mutation, who were treated with Nivolmab by the end of December 2016, are eligible for this study.
Key exclusion criteria	Nothing
Target sample size	100

Research contact person
Name of lead principal investigator	Masahide Mori
Organization	Toneyama National Hospital
Division name	Department of Thoracic Oncology
Address	5-1-1,Toneyama, Toyonaka-city, Osaka
TEL	06-6853-2001
Email	mmori@toneyama.go.jp

Public contact
Name of contact person	Yuki Akazawa
Organization	Toneyama National Hospital
Division name	Department of Thoracic Oncology
Address	5-1-1,Toneyama, Toyonaka-city, Osaka
TEL	06-6853-2001
Homepage URL
Email	akazaway@toneyama.go.jp

Sponsor
Institute	HANSHIN Oncology Group
Institute
Department

Funding Source
Organization	HANSHIN Oncology Group
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

Secondary IDs
Secondary IDs	YES
Study ID_1	HANSHIN 0416
Org. issuing International ID_1	HANSHIN Oncology Group
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	国立病院機構刀根山病院(大阪府)、先端医療センター(兵庫県)、兵庫県立がんセンター(兵庫県)、大阪府立成人病センター(兵庫県)、神戸大学医学部附属病院(兵庫県)、宝塚市立病院(兵庫県)、京都桂病院(京都府)、関西医科大学枚方病院(大阪府)を予定

Other administrative information
Date of disclosure of the study information	2016 Year 12 Month 31 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2016 Year 09 Month 07 Day
Anticipated trial start date	2016 Year 12 Month 31 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	This retrospective study will be performed based on the patient's clinical records.

Management information
Registered date	2016 Year 12 Month 13 Day
Last modified on	2016 Year 12 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029032