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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000026258
Receipt No. R000029323
Scientific Title Accompanying research of Phase II study for efficacy and safety of pembrolizumab for the cytotoxic chemotherapy unfit previously untreated patients highly expressing PD-L1 positive advanced non-small cell lung cancer (1888)
Date of disclosure of the study information 2017/03/27
Last modified on 2019/03/22

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Basic information
Public title Accompanying research of Phase II study for efficacy and safety of pembrolizumab for the cytotoxic chemotherapy unfit previously untreated patients highly expressing PD-L1 positive advanced non-small cell lung cancer (1888)
Acronym 1888-A
Scientific Title Accompanying research of Phase II study for efficacy and safety of pembrolizumab for the cytotoxic chemotherapy unfit previously untreated patients highly expressing PD-L1 positive advanced non-small cell lung cancer (1888)
Scientific Title:Acronym 1888-A
Region
Japan

Condition
Condition lung cancer
Classification by specialty
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 untreated with advanced NSCLC who enrolled onto pembrolizumab trial (1693 trial). 1693 trial is a Phase II safety and efficacy study of pembrolizumab in poor performance status patients with previously untreated advanced NSCLC in Tokyo Metropolitan Komagome Hospital. The UMIN ID of XXXX trial is UMIN0000XXXXX.
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 pembrolizumab 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 untreated advanced NSCLC highly expressing PD-L1 (1888, UMIN000020855)
2) Patients providing written informed consent.
Key exclusion criteria None
Target sample size 20

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 yhosomi@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 Hospita
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
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
2017 Year 03 Month 27 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 Enrolling by invitation
Date of protocol fixation
2017 Year 02 Month 22 Day
Date of IRB
2017 Year 06 Month 01 Day
Anticipated trial start date
2017 Year 06 Month 01 Day
Last follow-up date
2022 Year 03 Month 31 Day
Date of closure to data entry
2022 Year 03 Month 31 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information Accompanying research of Phase II study for efficacy and safety of pembrolizumab for the cytotoxic chemotherapy unfit previously untreated patients highly expressing PD-L1 positive advanced non-small cell lung cancer (1888)(UMIN000026259)

Management information
Registered date
2017 Year 02 Month 21 Day
Last modified on
2019 Year 03 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029323

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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