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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000025306
Receipt No. 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 2019/06/22

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

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
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 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
2019 Year 06 Month 22 Day


Link to view the page
URL(English) https://upload.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


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