UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025306
Receipt number R000029111
Scientific Title Accompanying research of Phase II study of nivolumab for advanced non-small-cell lung cancer patients not indicative of cytotoxic chemotherapy
Date of disclosure of the study information 2016/12/17
Last modified on 2020/06/20 11:36:03

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Basic information

Public title

Accompanying research of Phase II study of nivolumab for advanced non-small-cell lung cancer patients not indicative of cytotoxic chemotherapy

Acronym

1693-A

Scientific Title

Accompanying research of Phase II study of nivolumab for advanced non-small-cell lung cancer patients not indicative of cytotoxic chemotherapy

Scientific Title:Acronym

1693-A

Region

Japan


Condition

Condition

advanced non-small cell lung cancer

Classification by specialty

Pneumology Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To explore the relationship between treatment outcome and PBMC or cytokines of previously treated with advanced NSCLC who enrolled onto nivolumab trial (1693 trial). 1693 trial is a Phase II safety and efficacy study of nivolumab in poor performance status patients with previously treated advanced NSCLC in Tokyo Metropolitan Komagome Hospital. The UMIN ID of 1693 trial is UMIN000020855.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

To explore the relationship between immunological state of nivolumab treated patients having NSCLC with poor performance status

Key secondary outcomes



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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1) Patients enrolled onto the Phase II safety and efficacy study of nivolumab in poor performance status patients with previously treated advanced NSCLC (UMIN000020855)
2) Patients providing written informed consent.

Key exclusion criteria

None

Target sample size

32


Research contact person

Name of lead principal investigator

1st name Yukio
Middle name
Last name Hosomi

Organization

Tokyo Metropolitan Cancer and Infectious disease Center Komagome Hospital

Division name

Department of Respiratory Medicine and Thoracic Oncology

Zip code

113-8677

Address

3-18-22, Honkomagome, Bunkyo, Tokyo

TEL

03-3823-2101

Email

y-okuma@cick.jp


Public contact

Name of contact person

1st name Yusuke
Middle name
Last name Okuma

Organization

Tokyo Metropolitan Cancer and Infectious disease Center Komagome Hospital

Division name

Department of Respiratory Medicine and Thoracic Oncology

Zip code

113-8677

Address

3-18-22, Honkomagome, Bunkyo, Tokyo

TEL

03-3823-2101

Homepage URL


Email

y-okuma@cick.jp


Sponsor or person

Institute

Department of Respiratory Medicine and Thoracic Oncology, Tokyo Metropolitan Cancer and Infectious disease Center Komagome Hospita

Institute

Department

Personal name



Funding Source

Organization

Department of Respiratory Medicine and Thoracic Oncology, Tokyo Metropolitan Cancer and Infectious disease Center Komagome 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

Ethics committee of Tokyo Metropolitan Komagome Hospital

Address

3-28-22, Honkomagome, Bunkyo, Tokyo

Tel

03-3823-2101

Email

rinri@cick.jp


Secondary IDs

Secondary IDs

NO

Study ID_1

1732

Org. issuing International ID_1

Tokyo Metropolitan Cancer and Infectious disease Center Komagome Hospital

Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions

がん・感染症センター都立駒込病院(東京都)


Other administrative information

Date of disclosure of the study information

2016 Year 12 Month 17 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

32

Results


Results date posted


Results Delayed

Delay expected

Results Delay Reason

Waiting for biomarker analysis

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

No longer recruiting

Date of protocol fixation

2016 Year 03 Month 31 Day

Date of IRB

2016 Year 03 Month 31 Day

Anticipated trial start date

2016 Year 03 Month 31 Day

Last follow-up date

2020 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

none


Management information

Registered date

2016 Year 12 Month 17 Day

Last modified on

2020 Year 06 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029111


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name