UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040194 |
|---|---|
| Receipt number | R000045833 |
| Scientific Title | Durvalmab plus platinum-etoposide versus atezolizumab plus platinum-etoposide in extensive- stage small cell lung cancer: a systematic review. |
| Date of disclosure of the study information | 2020/04/20 |
| Last modified on | 2020/06/07 07:40:52 |
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Basic information
Public title
Durvalmab plus platinum-etoposide versus atezolizumab plus platinum-etoposide in extensive- stage small cell lung cancer: a systematic review.
Acronym
Durvalmab plus platinum-etoposide versus atezolizumab plus platinum-etoposide in extensive- stage small cell lung cancer
Scientific Title
Durvalmab plus platinum-etoposide versus atezolizumab plus platinum-etoposide in extensive- stage small cell lung cancer: a systematic review.
Scientific Title:Acronym
Durvalmab plus platinum-etoposide versus atezolizumab plus platinum-etoposide in extensive- stage small cell lung cancer
Region
| Japan |
Condition
Condition
extensive-stage (ES) small-cell lung cancer (SCLC) (ES-SCLC)
Classification by specialty
| Pneumology | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to compare the efficacy and safety of durvalumab + platinum-etoposide and atezolizumab + platinum-etoposide with platinum etoposide alone as a common comparator and to rank the efficacy and safety of these therapeutic regimens by using statistical methods of Bayesian network meta-analysis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Overall survival(OS)
Key secondary outcomes
Progression free survival(PFS)
Grade3-5 Any adverse events(G3-5AAEs)
Grade3-5 neutropenia, anemia, 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
Phase 3 studies of duvalumab+platinu-etoposide or atezolizumab+platinum-etoposide
Patiets with aged 18 years or more, histological or cytological confirmation of previously untreated advanced extensive disease small cell ling cancer, with performance status of 0 to 1
Key exclusion criteria
Case report
Observational studies
non-randomized controlled trials
Target sample size
Research contact person
Name of lead principal investigator
| 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
142-8666
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo, 142-8666, Japan
TEL
+81-3-37848532
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
142-8666
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo, 142-8666, Japan
TEL
+81-3-37848532
Homepage URL
koichi-a@med.showa-u.ac.jp
Sponsor or person
Institute
Showa University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Showa University School of Medicine
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
Showa University School of Medicine
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo, 142-8666, Japan
Tel
+81-3-37848532
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 | 04 | Month | 20 | 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
940
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
Completed
Date of protocol fixation
| 2020 | Year | 04 | Month | 18 | Day |
Date of IRB
| 2019 | Year | 04 | Month | 18 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 20 | Day |
Last follow-up date
| 2020 | Year | 05 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To date, no head-to-head trials have compared the efficacy and safety of atezolizumab (ATZ) plus platinum-etoposide (EP) versus durvalumab (DUR) plus EP (DUR+EP) as first line treatment for extensive-stage (ES) small-cell lung cancer (SCLC) (ES-SCLC). The purpose of this study was to compare the efficacy and safety of DUP + EP and ATZ + EP with EP as a common comparator and to rank the efficacy and safety of these therapeutic regimens by using statistical methods of Bayesian network meta-analysis.
Management information
Registered date
| 2020 | Year | 04 | Month | 18 | Day |
Last modified on
| 2020 | Year | 06 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045833
