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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000033142
Receipt No. R000037040
Official scientific title of the study Accompanying research of Phase II study of atezolizumab for advanced non-small-cell lung cancer patients not indicative of cytotoxic chemotherapy
Date of disclosure of the study information 2018/07/07
Last modified on 2018/06/25

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Basic information
Official scientific title of the study Accompanying research of Phase II study of atezolizumab for advanced non-small-cell lung cancer patients not indicative of cytotoxic chemotherapy
Title of the study (Brief title) 2130-A
Region
Japan

Condition
Condition advanced non-small cell lung cancer
Classification by specialty
Pneumology
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 (XXXX trial). XXXX trial is a Phase II safety and efficacy study of atezolizumab in poor performance status patients with previously treated advanced NSCLC in Tokyo Metropolitan Komagome Hospital. The UMIN ID of XXXX trial is UMINXXXXX.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase II

Assessment
Primary outcomes To explore the relationship between immunological state of atezolizumab 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 atezolizumab in poor performance status patients with previously treated advanced NSCLC (UMIN000032585)
2) Patients providing written informed consent.
Key exclusion criteria None
Target sample size 64

Research contact person
Name of lead principal investigator Yukio Hosomi
Organization Tokyo Metropolitan Komagome Hospital
Division name Department of Thoracic Oncology and Respiratory Medicine
Address 3-18-22, Honkomagome, Bunkyo, Tokyo, JAPAN
TEL +81-03-3823-2101
Email yhosomi@cick.jp

Public contact
Name of contact person Yusuke Okuma
Organization Tokyo Metropolitan Komagome Hospital
Division name Department of Thoracic Oncology and Respiratory Medicine
Address 3-18-22, Honkomagome, Bunkyo, Tokyo, JAPAN
TEL +81-03-3823-2101
Homepage URL
Email y-okuma@cick.jp

Sponsor
Institute partment of Thoracic Oncology and Respiratory Medicine, Tokyo Metropolitan Komagome Hospital
Institute
Department

Funding Source
Organization Self funding
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor National Cancer Center Hospital
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
2018 Year 07 Month 07 Day

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2018 Year 06 Month 25 Day
Anticipated trial start date
2018 Year 06 Month 25 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 None

Management information
Registered date
2018 Year 06 Month 25 Day
Last modified on
2018 Year 06 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037040

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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