UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025261
Receipt number R000029032
Scientific 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.
Date of disclosure of the study information 2016/12/31
Last modified on 2016/12/14 19:17:36

* 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

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.

Acronym

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.

Scientific 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.

Scientific Title:Acronym

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

1st name
Middle name
Last name Masahide Mori

Organization

Toneyama National Hospital

Division name

Department of Thoracic Oncology

Zip code


Address

5-1-1,Toneyama, Toyonaka-city, Osaka

TEL

06-6853-2001

Email

mmori@toneyama.go.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yuki Akazawa

Organization

Toneyama National Hospital

Division name

Department of Thoracic Oncology

Zip code


Address

5-1-1,Toneyama, Toyonaka-city, Osaka

TEL

06-6853-2001

Homepage URL


Email

akazaway@toneyama.go.jp


Sponsor or person

Institute

HANSHIN Oncology Group

Institute

Department

Personal name



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)



IRB Contact (For public release)

Organization


Address


Tel


Email



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


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

2016 Year 09 Month 07 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029032


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name