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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041702
Receipt No. R000047602
Scientific Title Comparative efficacy and safety of Immune Checkpoint Inhibitors plus Platinum Etoposide versus Platinum Irinotecan for Extensive Stage-Small Cell Lung Cancer. A Systematic Review and Network Meta-analysis
Date of disclosure of the study information 2020/09/07
Last modified on 2020/09/06

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Basic information
Public title Comparative efficacy and safety of Immune Checkpoint Inhibitors plus Platinum Etoposide versus Platinum Irinotecan for Extensive Stage-Small Cell Lung Cancer. A Systematic Review and Network Meta-analysis
Acronym Immune Checkpoint Inhibitors plus Platinum Etoposide versus Platinum Irinotecan for Extensive Stage-Small Cell Lung Cancer
Scientific Title Comparative efficacy and safety of Immune Checkpoint Inhibitors plus Platinum Etoposide versus Platinum Irinotecan for Extensive Stage-Small Cell Lung Cancer. A Systematic Review and Network Meta-analysis
Scientific Title:Acronym Immune Checkpoint Inhibitors plus Platinum Etoposide versus Platinum Irinotecan for Extensive Stage Small Cell Lung Cancer
Region
Japan

Condition
Condition Extensive stage small cell lung cancer
Classification by specialty
Medicine in general Pneumology Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To compare the efficacy and safety of immune checkpoint inhibitors and platinum-irinotecan combination therapy for extensive stage small cell lung cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes overall survival
Key secondary outcomes progression free survival
Incidence of Grade 3 or higher any adverse events
Incidence of Grade 3 or higher neutropenia, anemia, and thrombocytopenia

Base
Study type Others,meta-analysis etc

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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with cytologically or histologically confirmed advanced small cell lung cancer.
Performance status 0 to 2
Not received previous systemic anti-cancer treatment.
Key exclusion criteria non-small cell lung cancer patients
Poor performance status (3 or more)
Patients previously treated with systemic anticancer therapy
Target sample size 2000

Research contact person
Name of lead principal investigator
1st name Koichi
Middle name
Last name Ando
Organization Showa University
Division name Department of Medicine, Division of Respiratory Medicine and Allergology,
Zip code 142-8666
Address 1-5-8 Hatanodai, Shinagawa-ku, Tokyo, 142-8666, Japan
TEL +81-3-3784-8532
Email koichi-a@med.showa-u.ac.jp

Public contact
Name of contact person
1st name Koichi
Middle name
Last name Ando
Organization Showa University School of Medicine
Division name Department of Medicine, Division of Respiratory Medicine and Allergology,
Zip code 1428666
Address 1-5-8 Hatanodai, Shinagawa-ku, Tokyo, 142-8666, Japan
TEL +81-3-3784-8532
Homepage URL
Email koichi-a@med.showa-u.ac.jp

Sponsor
Institute Showa University
Institute
Department

Funding Source
Organization Showa University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Showa University
Address 1-5-8 Hatanodai, Shinagawa-ku, Tokyo, 142-8555, Japan
Tel +81-3-3784-8532
Email koichi-a@med.showa-u.ac.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
2020 Year 09 Month 07 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 Preinitiation
Date of protocol fixation
2020 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2020 Year 09 Month 01 Day
Last follow-up date
2020 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information In this study, the following six treatment groups are included as a comparison group

Pembrolizumab plus platinum etoposide
Durvalmab plus platinum etoposide
Atezolizumab plus platinum etoposide
platinum amrubicin
Platinum irinotecan
platinum etoposide

Comparisons between all two groups in each of these treatment groups can be evaluated.

Management information
Registered date
2020 Year 09 Month 06 Day
Last modified on
2020 Year 09 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047602

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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