UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000039167
Receipt number R000044671
Scientific Title Biomarker study of immunological response in Japanese patients with stage III non-small cell lung cancer receiving chemoradiotherapy followed by durvalumab
Date of disclosure of the study information 2020/01/16
Last modified on 2020/07/16 09:14:21

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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 or person

Institute

Wakayama Medical University

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044671


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name