UMIN-CTR Clinical Trial

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
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	142-8666
Address	1-5-8 Hatanodai, Shinagawa-ku, Tokyo, 142-8666, Japan
TEL	+81-3-37848532
Homepage URL
Email	koichi-a@med.showa-u.ac.jp

Sponsor
Institute	Showa University School of Medicine
Institute
Department

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
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 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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045833