UMIN-CTR Clinical Trial

Basic information
Public title	Biomarker study of immunological response in Japanese patients with stage III non-small cell lung cancer receiving chemoradiotherapy followed by durvalumab
Acronym	Dual-Bio study
Scientific Title	Biomarker study of immunological response in Japanese patients with stage III non-small cell lung cancer receiving chemoradiotherapy followed by durvalumab
Scientific Title:Acronym	Dual-Bio study
Region	Japan

Condition
Condition	Non-small cell lung cancer
Classification by specialty	Pneumology Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the association between mmunological factors in PBMC and the efficacy of durvalumab in patients with stgae III NSCLC
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	1) Association between survival and immunological factors in PBMC 2) Association between toxicities and immunological factors in PBMC 3) Association between the efficacy of durvalumab and immunological factors in PBMC 4) Association between the efficacy of durvalumab and proteome analysis
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) Pathologically confirmed non-small cell lung cancer 2) Clinical stage III (8th TNM) including recurrence after surgery 3) Planned to receive chemoradiotherapy with latinum agent 4) Planned to receive durvalumab as consolidation 5) Age >=20 years 6) Written informed consent
Key exclusion criteria	1) previously treated with PD-1/PD-L1 inhibitors or anti CTLA-4 antibody
Target sample size	150

Research contact person
Name of lead principal investigator	1st name Nobuyuki Middle name Last name Yamamoto
Organization	Wakayama Medical University
Division name	Internal Medicine III
Zip code	641-8509
Address	811-1 Kimiidera, Wakayama City
TEL	073-441-0619
Email	nbyamamo@wakayama-med.ac.jp

Public contact
Name of contact person	1st name Hirotsugu Middle name Last name Kemmotsu
Organization	Shizuoka Cancer Center
Division name	Division of Thoracic Oncology
Zip code	411-8777
Address	1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun
TEL	055-989-5222
Homepage URL
Email	h.kenmotsu@scchr.jp

Sponsor
Institute	Wakayama Medical University
Institute
Department

Funding Source
Organization	AstraZeneca K.K.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	Japan Lung Cancer Society
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Shizuoka Cancer Center IRB
Address	1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun
Tel	+81559895222
Email	tansaku_office@scchr.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	和歌山県立医科大学（和歌山県）、久留米大学病院（福岡県）、名古屋大学医学部附属病院（愛知県）、日本医科大学付属病院（東京都）、近畿大学病院（大阪府）、岡山大学病院（岡山県）、島根大学医学部附属病院（島根県）、愛知県がんセンター病院（愛知県）、がん研究会有明病院（東京都）、北里大学病院（東京都）、岩手医科大学（岩手県）、徳島大学病院（徳島県）、国立がん研究センター中央病院（東京都）、埼玉医科大学国際医療センター（埼玉県）、静岡県立静岡がんセンター（静岡県）

Other administrative information
Date of disclosure of the study information	2020 Year 01 Month 16 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	Open public recruiting
Date of protocol fixation	2019 Year 10 Month 07 Day
Date of IRB	2020 Year 02 Month 14 Day
Anticipated trial start date	2020 Year 02 Month 27 Day
Last follow-up date	2025 Year 02 Month 26 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Blood samples will be obtained at pre-CRT, post-CRT, pre-deuvalumab, and 8 weeks after start of durvalumab. Using these blood samples, PBMC analysis and proteome analysis are planned in this study.

Management information
Registered date	2020 Year 01 Month 15 Day
Last modified on	2020 Year 07 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000044671