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 |
Biomarker study of immunological response in Japanese patients with stage III non-small cell lung cancer receiving chemoradiotherapy followed by durvalumab
Dual-Bio study
Biomarker study of immunological response in Japanese patients with stage III non-small cell lung cancer receiving chemoradiotherapy followed by durvalumab
Dual-Bio study
Japan |
Non-small cell lung cancer
Pneumology | Hematology and clinical oncology |
Malignancy
NO
To evaluate the association between mmunological factors in PBMC and the efficacy of durvalumab in patients with stgae III NSCLC
Safety,Efficacy
Exploratory
Not applicable
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
Observational
20 | years-old | <= |
Not applicable |
Male and Female
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
1) previously treated with PD-1/PD-L1 inhibitors or anti CTLA-4 antibody
150
1st name | Nobuyuki |
Middle name | |
Last name | Yamamoto |
Wakayama Medical University
Internal Medicine III
641-8509
811-1 Kimiidera, Wakayama City
073-441-0619
nbyamamo@wakayama-med.ac.jp
1st name | Hirotsugu |
Middle name | |
Last name | Kemmotsu |
Shizuoka Cancer Center
Division of Thoracic Oncology
411-8777
1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun
055-989-5222
h.kenmotsu@scchr.jp
Wakayama Medical University
AstraZeneca K.K.
Profit organization
Japan Lung Cancer Society
Shizuoka Cancer Center IRB
1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun
+81559895222
tansaku_office@scchr.jp
NO
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)
2020 | Year | 01 | Month | 16 | Day |
Unpublished
Open public recruiting
2019 | Year | 10 | Month | 07 | Day |
2020 | Year | 02 | Month | 14 | Day |
2020 | Year | 02 | Month | 27 | Day |
2025 | Year | 02 | Month | 26 | Day |
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.
2020 | Year | 01 | Month | 15 | Day |
2020 | Year | 07 | Month | 16 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044671
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