KRAS変異肺がんの治療歴のある参加者におけるアベマシクリブ（LY2835219）の研究 (JUNIPER)
2026年1月19日 更新者：Eli Lilly and Company
ジュニパー：プラチナベースの化学療法後に進行した検出可能なKRAS変異を有するステージIVのNSCLC患者を対象とした、アベマシクリブ＋最良の支持療法とエルロチニブ＋最良の支持療法のランダム化第3相試験
この研究の主な目的は、アベマシクリブとして知られる治験薬が肺がんの参加者に対してどの程度安全で有効であるかを評価することです。
調査の概要
研究の種類
介入
入学 (実際)
453
段階
- フェーズ 3
アクセスの拡大
承認済み 一般販売用。
拡張アクセス記録をご覧ください。
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Arkansas
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Fayetteville、Arkansas、アメリカ、72703
- Highlands Oncology Group
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Jonesboro、Arkansas、アメリカ、72401
- St. Bernards Medical Center
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California
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Duarte、California、アメリカ、91010
- City of Hope National Medical Center
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La Jolla、California、アメリカ、92037
- University of California - San Diego
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Loma Linda、California、アメリカ、92350
- Loma Linda University School of Medicine
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Los Angeles、California、アメリカ、90024
- SMO TRIO -Translational Research
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Los Angeles、California、アメリカ、90024
- CBCC Global Research, Inc.
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Los Angeles、California、アメリカ、90024
- Central Coast Medical Oncology Corporation
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Los Angeles、California、アメリカ、90024
- Fort Wayne Oncology & Hematology
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Los Angeles、California、アメリカ、90024
- St. Joseph Heritage Medical Group
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Los Angeles、California、アメリカ、90024
- UCLA Department of Medicine-Hematology/Oncology
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Los Angeles、California、アメリカ、90095
- Cancer Care Associates Medical Group
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Sacramento、California、アメリカ、95816
- Dignity Health Care Institute
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Colorado
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Englewood、Colorado、アメリカ、80112
- SMO Catholic Health Initiatives
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Englewood、Colorado、アメリカ、80112
- Alegent Immanuel Cancer Center
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Englewood、Colorado、アメリカ、80112
- Jewish Hospital
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Englewood、Colorado、アメリカ、80112
- Oncology Hematology West
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Englewood、Colorado、アメリカ、80112
- St Joseph Cancer Center
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Englewood、Colorado、アメリカ、80112
- St. Francis Medical Center
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Delaware
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Newark、Delaware、アメリカ、19713
- Medical Oncology Hematology Consultants
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Florida
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Boca Raton、Florida、アメリカ、33486
- Boca Raton Regional Hospital
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Daytona Beach、Florida、アメリカ、32114
- Halifax Medical Center
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Pembroke Pines、Florida、アメリカ、33028
- Memorial Cancer Institute
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Tampa、Florida、アメリカ、33612-9497
- H Lee Moffitt Cancer Center
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Georgia
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Athens、Georgia、アメリカ、30607
- University Cancer & Blood Center, LLC
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Illinois
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Harvey、Illinois、アメリカ、60426
- Ingalls Memorial Hospital
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Indiana
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Indianapolis、Indiana、アメリカ、46202
- Indiana University School of Medicine
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Iowa
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Iowa City、Iowa、アメリカ、52242
- University of Iowa
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Kansas
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Wichita、Kansas、アメリカ、67214
- Cancer Center of Kansas, P.A.
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Kentucky
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Lexington、Kentucky、アメリカ、40503
- Central Baptist Hospital
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Louisville、Kentucky、アメリカ、40202
- University of Louisville
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Maryland
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Bethesda、Maryland、アメリカ、20889
- Walter Reed National Military Medical Center
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Massachusetts
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Framingham、Massachusetts、アメリカ、01701
- Metro-West and Greater Boston CNS Research
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Michigan
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Detroit、Michigan、アメリカ、48201
- Karmanos Cancer Institute
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Missouri
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Springfield、Missouri、アメリカ、65807
- Mercy Medical Research Institute
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Montana
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Billings、Montana、アメリカ、59101
- Billings Clinic Research Center
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New Hampshire
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Lebanon、New Hampshire、アメリカ、03756
- Dartmouth Hitchcock Medical Center
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New York
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Johnson City、New York、アメリカ、13790
- Broome Oncology
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New York、New York、アメリカ、10065
- Weill Cornell Medical College
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Ohio
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Cincinnati、Ohio、アメリカ、45242
- Oncology Hematology Care Inc
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Oklahoma
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Tulsa、Oklahoma、アメリカ、74146
- Oklahoma Cancer Specialists & Research Institute, LLC
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Oregon
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Portland、Oregon、アメリカ、97213
- Providence Cancer Center Oncology Hematology Care
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Pennsylvania
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Pittsburgh、Pennsylvania、アメリカ、15213
- UPMC Hillman Cancer Center
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South Carolina
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Charleston、South Carolina、アメリカ、29401
- Roper St. Francis Healthcare
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Tennessee
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Chattanooga、Tennessee、アメリカ、37404
- Chattanooga Oncology Hematology Associates
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Nashville、Tennessee、アメリカ、37203
- Tennessee Oncology PLLC
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Nashville、Tennessee、アメリカ、37203
- Chattanooga Oncology Hematology Associates
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Texas
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Dallas、Texas、アメリカ、75230
- Mary Crowley Cancer Research Center
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Utah
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Salt Lake City、Utah、アメリカ、84106
- Utah Cancer Specialists
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Vermont
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Burlington、Vermont、アメリカ、05401
- University of Vermont Medical Center
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Virginia
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Richmond、Virginia、アメリカ、23298
- Virginia Commonwealth University
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Washington
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Kennewick、Washington、アメリカ、99336
- Kadlec Clinical Hematology & Oncology
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Seattle、Washington、アメリカ、98104
- Swedish Medical Center
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Valley、Washington、アメリカ、99216
- Cancer Care Northwest
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Berazategui、アルゼンチン、B1884BBF
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
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Ciudad Autonoma Buenos Aires、アルゼンチン、1093
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Ciudad Autonoma Buenos Aires、アルゼンチン、1025
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Ciudad Autonoma Buenos Aires、アルゼンチン、C1181AAX
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Rosario、アルゼンチン、2000
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Rosario、アルゼンチン、S2000DSV
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Viedma、アルゼンチン、8500
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Beersheba、イスラエル、8410101
- Soroka Medical Center
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Holon、イスラエル、5822012
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Jerusalem、イスラエル、9112001
- Hadassah Medical Center - Ein Karem
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Kfar Saba、イスラエル、4428164
- Meir Medical Center
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Petah Tikva、イスラエル、4941492
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Tel Litwinsky、イスラエル、5265601
- Sheba medical center
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Catania、イタリア、95125
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Genova、イタリア、16132
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Livorno、イタリア、57124
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Parma、イタリア、43100
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Rome、イタリア、00152
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Dnipropetrovsk、ウクライナ、49102
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Kharkiv、ウクライナ、61070
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Kryvyi Rih、ウクライナ、50048
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Kyiv、ウクライナ、04107
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Lutsk、ウクライナ、63000
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Poltava、ウクライナ、36011
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Sumy、ウクライナ、40005
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Uzhhorod、ウクライナ、88000
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Vinnitsa、ウクライナ、21029
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Graz、オーストリア、8036
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Linz、オーストリア、4020
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
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Linz、オーストリア、4021
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Salzburg、オーストリア、5020
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Calgary、カナダ、T2N 4N2
- For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.
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Edmonton、カナダ、T6G 1Z2
- For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.
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Montreal、カナダ、H2L 4M1
- For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.
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Toronto、カナダ、M4N 3M5
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Vancouver、カナダ、V5Z 4E6
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Winnipeg、カナダ、R3A 1M3
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Athens、ギリシャ、11527
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Athens、ギリシャ、11522
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Athens、ギリシャ、18537
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Heraklion、ギリシャ、71110
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Pátrai、ギリシャ、26504
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A Coruña、スペイン、15006
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Barcelona、スペイン、08003
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L'Hospitalet de Llobregat、スペイン、08907
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Madrid、スペイン、28041
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Madrid、スペイン、28040
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Madrid、スペイン、28050
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Málaga、スペイン、29010
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Seville、スペイン、41013
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Valencia、スペイン、46026
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Ankara、トルコ（Türkiye）、06100
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Ankara、トルコ（Türkiye）、06490
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Antalya、トルコ（Türkiye）、07059
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Edirne、トルコ（Türkiye）、22030
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Istanbul、トルコ（Türkiye）、34020
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Istanbul、トルコ（Türkiye）、34098
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Istanbul、トルコ（Türkiye）、34890
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Izmir、トルコ（Türkiye）、35100
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Berlin、ドイツ、14165
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Gera、ドイツ、07548
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Großhansdorf、ドイツ、22927
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Hamburg、ドイツ、21075
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Hanover、ドイツ、30459
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Heidelberg、ドイツ、69126
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Immenhausen、ドイツ、34376
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Nuremberg、ドイツ、90419
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Regensburg、ドイツ、93053
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Rosenheim、ドイツ、83022
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Tübingen、ドイツ、72076
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Ulm、ドイツ、89081
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Bron、フランス、69677
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Dijon、フランス、21034
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
-
Grenoble、フランス、38043
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Lille、フランス、59037
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Marseille、フランス、13015
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Poitiers、フランス、86021
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Rennes、フランス、35033
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Saint-Brieuc、フランス、22027
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
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Saint-Priest-en-Jarez、フランス、42270
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Toulouse、フランス、31059
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Vantoux、フランス、57070
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Ijuí、ブラジル、98700 000
- Associacao Hospital de Caridade Ijui
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Lajeados、ブラジル、95900-000
- Hospital Bruno Born
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Porto Alegre、ブラジル、90610-970
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Rio de Janeiro、ブラジル、20231-050
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Salvador、ブラジル、41253-190
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Sao Jose Rio Preto、ブラジル、15090-000
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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São Paulo、ブラジル、01246000
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
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São Paulo、ブラジル、01509-010
- Fundação Antonio Prudente - Hospital do Câncer A.C Camargo
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San Juan、プエルトリコ、00921-3201
- VA Caribbean Healthcare System
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Gdansk、ポーランド、80-219
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Lodz、ポーランド、90-242
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Olsztyn、ポーランド、10-357
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Radom、ポーランド、26-617
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Szczecin、ポーランド、70-891
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Baia Mare、ルーマニア、430031
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Bucharest、ルーマニア、022328
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Cluj-Napoca、ルーマニア、400015
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Cluj-Napoca、ルーマニア、400058
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Craiova、ルーマニア、200347
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Arkhangelsk、ロシア、163045
- Arkhangelsk Regional Clinical Oncology Dispensary
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Chelyabinsk、ロシア、454048
- Private clinic "Evimed"
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Krasnodar、ロシア、350086
- Krasnodar regional clinical hospital # 1 n. a. S. V. Ochapovskogo
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Kursk、ロシア、305035
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Moscow、ロシア、115478
- Russian oncological scientific centre n.a. N.N. Blokhin of RAMS
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Saint Petersburg、ロシア、198255
- Saint-Petersburg City Clinical Oncology Dispensary
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Saint Petersburg、ロシア、197758
- St-Petersburg scientifical practical center of specialized kinds of medical care (oncological)
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Ufa、ロシア、450054
- Republic clinical oncology dispensary of MoH of Bashkortostan Republic
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Volzhskiy、ロシア、404130
- Volgograd Regional Clinical Oncology Dispensary
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Beijing、中国、100071
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Beijing、中国、100021
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
-
Beijing、中国、100730
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
-
Changchun、中国、130012
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Changzhou、中国、213000
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Chengdu、中国、610041
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Haikou、中国、570311
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Hangzhou、中国、310022
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Hefei、中国、230001
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Nanning、中国、530021
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Shanghai、中国、200030
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Shenyang、中国、100042
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Chiayi City、台湾、613
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Kaohsiung City、台湾、83301
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Kaohsiung City、台湾、82445
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Taichung、台湾、40447
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Taichung、台湾、404
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Tainan、台湾、70403
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Taipei、台湾、10449
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Taipei、台湾、11217
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Taipei、台湾、10002
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Zhonghe、台湾、235
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Amagasaki、日本、660-0892
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Asahikawa、日本、070-8644
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Bunkyō City、日本、113-8431
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Bunkyō City、日本、113-8677
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Fukuoka、日本、811-1395
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Habikino、日本、583-8588
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Hirakata、日本、573-1191
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Hiroshima、日本、734-8551
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Hyōgo、日本、6608550
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Kanazawa、日本、920-8641
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Kashiwa、日本、277 8577
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Kishiwada、日本、596-8501
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Kitaadachi-Gun、日本、362-0806
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Kobe、日本、650-0047
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Kurashiki、日本、710-8602
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Kōtoku、日本、135-8550
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Matsuyama、日本、791-0280
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Nagasaki、日本、852-8501
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Nagoya、日本、464-8681
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Nagoya、日本、466-8560
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Natori、日本、981-1293
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Okayama、日本、700-8558
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Osaka、日本、545-8586
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Osaka、日本、534-0021
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Osaka、日本、537-8511
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Sakai、日本、5918555
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Sayama、日本、589-8511
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Sendai、日本、980-0873
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Shinjuku-ku、日本、160-0023
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Sunto-Gun、日本、411-8777
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Ube、日本、755-0241
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Utsunomiya、日本、320-0834
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Wakayama、日本、641-8510
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Yokohama、日本、236-0004
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Yonago、日本、683-0826
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Yufu-shi、日本、8795593
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Goyang-si、韓国、10408
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Incheon、韓国、21565
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Seoul、韓国、03722
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Seoul、韓国、05505
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Seoul、韓国、06351
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Seoul、韓国、06591
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Seowon-Gu、韓国、28644
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Suwon、韓国、16247
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Ulsan、韓国、44033
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
説明
包含基準:
- 米国癌病期分類ハンドブックに関する合同委員会によるステージ IV の非小細胞肺癌 (NSCLC) の診断が確認されている。
- 研究中央研究所での研究アッセイにより、キルステンラット肉腫（KRAS）癌遺伝子のコドン12または13に検出可能な変異があることが確認された。 地域の検査機関による腫瘍組織由来の KRAS 癌遺伝子のコドン 12 または 13 における KRAS 陽性突然変異は、無作為化された参加者の 10% までに許可されます。
- プラチナベースの化学療法（維持療法の有無にかかわらず）後に進行があり、かつ進行性および/または転移性疾患に対する免疫チェックポイント阻害剤またはその他の抗がん療法を含む追加療法を受けている、または医師がさらなる治療を受ける不適格と判断した標準的な二次化学療法。 プラチナベースの化学療法と免疫チェックポイント阻害剤（免疫療法）後に進行した参加者。 ペムブロリズマブまたはニボルマブの単独または他の薬剤との併用が対象となります。
- 固形腫瘍における反応評価基準（RECIST 1.1）で定義されている測定可能な疾患を患っている。
- Eastern Cooperative Oncology Group (ECOG) スケールでパフォーマンス ステータス (PS) が 0 ～ 1 である。
- -治験薬の投与前に、骨髄抑制剤の場合は少なくとも21日間、または非骨髄抑制剤の場合は14日間、以前のすべてのがん治療（化学療法、放射線療法、免疫療法、および治験療法を含む）を中止している。
除外基準:
- -非骨髄抑制剤または骨髄抑制剤の治験薬の初回投与からそれぞれ14日または21日以内に、適応症について規制当局の承認を受けていない薬剤による治療を受けている。
- 以下の症状のいずれかの既往歴がある：失神前または原因不明または心血管病因による失神、心室不整脈（心室頻拍および心室細動を含むがこれらに限定されない）、または突然の心停止。
- 不安定な中枢神経系（CNS）転移がある。 CNS転移の病歴または安定したCNS転移の病歴は許可されます（ステロイド薬などの積極的な治療はもはや必要ありません）。 CNS転移の既往歴のある参加者は、たとえ症状に変化がなかったとしても、安定性を証明するために無作為化後28日以内に脳スキャン（磁気共鳴画像法（MRI）など）を受けなければならない。
- -以前にこの研究またはサイクリン依存性キナーゼ4（CDK4）およびサイクリン依存性キナーゼ6（CDK6）阻害剤を研究する他の研究を完了または中止したことがある、または以前のCDK4およびCDK6阻害剤による治療を受けている。
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：アベマシクリブ
アベマシクリブ 200 ミリグラム (mg) を 12 時間ごとに経口投与し、1 日目から 28 日目まで最善の支持療法 (BSC) を加えます (28 日サイクル)。
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経口投与
他の名前：
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アクティブコンパレータ：エルロチニブ
エルロチニブ 150 mg を 24 時間ごとに経口投与し、さらに BSC を 1 日目から 28 日目まで投与しました (28 日サイクル)。
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経口投与
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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全体的な生存 (OS)
時間枠：ランダム化日から何らかの原因による死亡日まで（最長 32 か月）
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OS は、ランダム化日から何らかの原因による死亡日までと定義されます。
全生存期間分析のデータ包含カットオフ日の時点で死亡がわかっていない各参加者について、OS 時間は、参加者が生存していることがわかっている最後の日付で打ち切られました。
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ランダム化日から何らかの原因による死亡日まで（最長 32 か月）
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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完全奏効（CR）または部分奏効（PR）を示した参加者の割合（客観的奏効率[ORR]）
時間枠：ランダム化日から目標進行まで（最大 32 か月）
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ORR は、固形腫瘍における奏効評価基準 (RECIST) v1.1 に従って、完全奏効 (CR) または部分奏効 (PR) の最良の全奏効 (BOR) を達成した参加者の割合でした。
CR は、すべての標的病変および非標的病変が消失し、新たな病変が出現しないことと定義されます。
PR は、標的病変の最長直径 (LD) の合計 (基準値として LD の合計を考慮) が少なくとも 30% 減少し、非標的病変が進行せず、新たな病変が出現しないことと定義されます。
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ランダム化日から目標進行まで（最大 32 か月）
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無増悪生存期間 (PFS)
時間枠：ランダム化日から病気の進行または何らかの原因による死亡まで（最長 32 か月）
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PFS は、無作為化日から、RECIST v1.1 で定義される疾患の進行または何らかの原因による死亡の最初の証拠までと定義されます。
進行性疾患（PD）は、対象病変の直径の合計が少なくとも 20% 増加しており、研究上の最小合計と少なくとも 5 mm の絶対増加、または非標的病変の明白な進行を参照します。 1 つ以上の新たな病変。
参加者が完全なベースライン疾患評価を行っていない場合、客観的に決定された疾患の進行または死亡が参加者に観察されたかどうかに関係なく、PFS 時間は初回投与日で打ち切られました。
分析のデータ包含カットオフ日の時点で参加者が死亡または客観的な進行を示していないことがわかっている場合、PFS 時間は最後の適切な腫瘍評価日で打ち切られました。
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ランダム化日から病気の進行または何らかの原因による死亡まで（最長 32 か月）
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MD アンダーソン症状インベントリ肺がん (MDASI-LC) スコアのベースラインからの変化
時間枠：ランダム化日から研究終了まで（最長 32 か月）
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MDASI-LC には 22 項目 + 追加の試験特有の 3 項目が含まれ、その結果、中核症状 (13 項目)、干渉 (6 項目)、肺がん (3 項目)、および頭痛、下痢、発疹に関する試験固有の単一結果。
2 コンストラクト複合コア + 肺がん症状 (16 項目) スコアが計算されました。
7 つのスコアすべてのデータは、0 (存在しない、または干渉しない) と 10 (想像できるほど悪い、または完全に干渉する) に固定された 11 ポイントの数値評価スケールによって収集されました。
測定範囲は１０（最高点－最低点）とした。
治療、来院、治療*来院、およびグループ間で予測されたベースライン スコアの共変量を使用した混合モデル反復測定 (MMRM) 回帰。ベースラインからの最小二乗 (LS) 平均の差。
グループレベルのベースラインからのマイナスの変化は、グループの改善を示しました。
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ランダム化日から研究終了まで（最長 32 か月）
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薬物動態 (PK): 定常状態での 1 回の投与間隔中の濃度対時間曲線の下の面積
時間枠：サイクル 1 からサイクル 3 (28 日サイクル) の 1 日目
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PK は、定常状態での 1 回の投与間隔中の血漿濃度対時間曲線の下の面積によって決定されます。
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サイクル 1 からサイクル 3 (28 日サイクル) の 1 日目
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ヨーロッパの生活の質のベースラインからの変化 - 5 つの次元 - 5 レベル (EQ-5D-5L) スコア
時間枠：ランダム化日から研究終了まで（最長 32 か月）
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1 ～ 5 の良い状態から悪い状態までの 5 つの反応レベルがあり、なし、軽度、中等度、重篤、極度/不可能に相当します。
EuroQol が開発した横断歩道手法を使用して、英国 (UK) の重み付け、健康側面 (可動性、セルフケア、通常の活動、痛み/不快感、不安/うつ病) を使用して EQ-5D-5L を単一の指標に変換しました。価値;寸法は個別にスコア付けされません。
1 つ以上の次元が欠落している場合、インデックスは欠落としてマークされます。
反応パターンのインデックススコアは完全な健康状態から死亡までに固定されており、死亡よりも悪いと考えられる反応パターン/健康状態には負の値が割り当てられました。
最適なパターンにはインデックス値 1.0 が割り当てられます。最悪のパターンには -0.594 のインデックス値が割り当てられます。
ベースラインスコアからの回帰予測変化におけるグループ間の差異を指数について推定しました。
LS 平均値は、治療、来院、治療 * 来院、およびベースラインに対して制御されました。
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ランダム化日から研究終了まで（最長 32 か月）
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リソースの利用率: 入院している参加者の割合
時間枠：ランダム化日から研究終了まで（最長 32 か月）
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リソース使用率は、入院した参加者の割合です。
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ランダム化日から研究終了まで（最長 32 か月）
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- スタディディレクター：Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)、Eli Lilly and Company
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- Goldman JW, Mazieres J, Barlesi F, Dragnev KH, Koczywas M, Goskel T, Cortot AB, Girard N, Wesseler C, Bischoff H, Nadal E, Park K, Lu S, Taus A, Cobo M, Estrem ST, Wijayawardana SR, Turner K, Oakley GJ 3rd, Hurt KC, Chiang AY, Hossain AM, John WJ, Paz-Ares L. A Randomized Phase III Study of Abemaciclib Versus Erlotinib in Patients with Stage IV Non-small Cell Lung Cancer With a Detectable KRAS Mutation Who Failed Prior Platinum-Based Therapy: JUNIPER. Front Oncol. 2020 Oct 26;10:578756. doi: 10.3389/fonc.2020.578756. eCollection 2020.
- Goldman JW, Shi P, Reck M, Paz-Ares L, Koustenis A, Hurt KC. Treatment Rationale and Study Design for the JUNIPER Study: A Randomized Phase III Study of Abemaciclib With Best Supportive Care Versus Erlotinib With Best Supportive Care in Patients With Stage IV Non-Small-Cell Lung Cancer With a Detectable KRAS Mutation Whose Disease Has Progressed After Platinum-Based Chemotherapy. Clin Lung Cancer. 2016 Jan;17(1):80-4. doi: 10.1016/j.cllc.2015.08.003. Epub 2015 Aug 18.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2014年10月3日
一次修了 (実際)
2017年9月15日
研究の完了 (推定)
2026年12月1日
試験登録日
最初に提出
2014年5月23日
QC基準を満たした最初の提出物
2014年5月29日
最初の投稿 (推定)
2014年6月2日
学習記録の更新
投稿された最後の更新 (実際)
2026年2月6日
QC基準を満たした最後の更新が送信されました
2026年1月19日
最終確認日
2026年1月1日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- 15296
- I3Y-MC-JPBK (その他の識別子：Eli Lilly and Company)
- 2013-004662-33 (EudraCT番号)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
はい
IPD プランの説明
匿名化された個々の患者レベルのデータは、研究提案書の承認と署名されたデータ共有契約に基づいて、安全なアクセス環境で提供されます。
IPD 共有時間枠
データは、米国および EU で研究された適応症の一次出版および承認のいずれか遅い方から 6 か月後に入手可能になります。
データは無期限にリクエスト可能です。
IPD 共有アクセス基準
研究提案は独立した審査委員会によって承認され、研究者はデータ共有契約に署名する必要があります。
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- CSR
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。