UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026258 |
|---|---|
| Receipt number | 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 12:21:16 |
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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
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
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 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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029323
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
