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局所進行切除不能ステージ III 非小細胞肺癌（NSCLC）の参加者を対象に、アテゾリズマブとティラゴルマブをデュルバルマブと比較した研究 (SKYSCRAPER-03)

2026年5月7日 更新者：Hoffmann-La Roche

プラチナベースの同時化学放射線療法後に進行していない局所進行切除不能ステージ III 非小細胞肺癌患者におけるアテゾリズマブとティラゴルマブのデュルバルマブと比較した第 III 相非盲検ランダム化試験

この研究の目的は、少なくとも 2 サイクルの同時プラチナ治療を受けた切除不能な局所進行 III 期非小細胞肺癌 (NSCLC) の参加者を対象に、アテゾリズマブとチラゴルマブの併用の有効性と安全性をデュルバルマブと比較して評価することです。ベースの化学放射線療法（CRT）を受けており、放射線による疾患の進行はありません。

調査の概要

状態

完了

条件

介入・治療

研究の種類

介入

入学 (実際)

829

段階

  • フェーズ 3

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

  • アメリカ
    • California
      • Palo Alto、California、アメリカ、94305
        • Stanford University
    • Colorado
      • Greeley、Colorado、アメリカ、80631
        • Banner MD Anderson Cancer Center
    • Florida
      • Fort Myers、Florida、アメリカ、33901-8101
        • Florida Cancer Specialists
      • Palm Bay、Florida、アメリカ、32901
        • Cancer Care Centers of Brevard
      • Pensacola、Florida、アメリカ、32503
        • Woodlands Medical Specialists, P.A.
      • St. Petersburg、Florida、アメリカ、33705
        • Florida Cancer Specialist, North Region
    • Georgia
      • Marietta、Georgia、アメリカ、30060
        • Northwest Georgia Oncology Centers PC - Marietta
    • Illinois
      • Peoria、Illinois、アメリカ、61615
        • Illinois Cancer Care
    • Maine
      • Brunswick、Maine、アメリカ、04011
        • New England Cancer Specialists
    • Massachusetts
      • Fairhaven、Massachusetts、アメリカ、02719
        • Southcoast Health System
    • Minnesota
      • Minneapolis、Minnesota、アメリカ、55404
        • Minnesota Oncology Hematology
    • Missouri
      • Kansas City、Missouri、アメリカ、64132
        • HCA Midwest Health
      • Springfield、Missouri、アメリカ、65807
        • Cox Health Systems
    • Nevada
      • Las Vegas、Nevada、アメリカ、89128
        • Comprehensive Cancer Centers of Nevada
      • Las Vegas、Nevada、アメリカ、89106
        • Optum Health Care
    • New Jersey
      • East Brunswick、New Jersey、アメリカ、08816
        • Titan Health Partners LLC, d/b/a Astera Cancer Care
    • New Mexico
      • Farmington、New Mexico、アメリカ、87401
        • San Juan Oncology Associates
    • New York
      • Albany、New York、アメリカ、12208
        • New York Oncology Hematology,P.C.-Albany
      • New York、New York、アメリカ、10029
        • Mount Sinai Medical Center
      • The Bronx、New York、アメリカ、10461
        • Montefiore Medical Center
    • South Carolina
      • Greenville、South Carolina、アメリカ、29615
        • Prisma Health ? Upstate
    • Tennessee
      • Chattanooga、Tennessee、アメリカ、37403
        • Tennessee Oncology Chattanooga
      • Nashville、Tennessee、アメリカ、37203
        • Sarah Cannon Research Institute / Tennessee Oncology
    • Virginia
      • Fairfax、Virginia、アメリカ、22031
        • Virginia Cancer Specialists
      • Norfolk、Virginia、アメリカ、23502
        • Virginia Oncology Associates
  • アルゼンチン
      • Buenos Aires、アルゼンチン、C1431FWO
        • CEMIC
      • Ciudad Autonoma Buenos Aires、アルゼンチン、C1284AEB
        • Hospital Británico de Buenos Aires
      • Córdoba、アルゼンチン、X5004FHP
        • Clínica Universitaria Reina Fabiola
      • Rosario、アルゼンチン、S2000QGB
        • Sanatorio Parque S.A.
  • イギリス
      • Birmingham、イギリス、B9 5SS
        • Birmingham Heartlands Hospital
      • Cambridge、イギリス、CB2 0QQ
        • Addenbrooke's NHS Trust
      • Glasgow、イギリス、G12 0YN
        • Beatson West of Scotland Cancer Centre
      • Huddersfield、イギリス、HD3 3EA
        • Calderdale & Huddersfield Nhs Trust
      • Leicester、イギリス、LE1 5WW
        • Leicester Royal Infirmary
      • Maidstone、イギリス、ME16 9QQ
        • Maidstone & Tonbridge Wells Hospital
      • Manchester、イギリス、M20 4BX
        • Christie Foundation Trust
      • Sheffield、イギリス、S10 2SJ
        • Weston Park Hospital
  • イスラエル
      • Beersheba、イスラエル、8410100
        • Soroka Medical Center
      • Haifa、イスラエル、3109601
        • Rambam Medical Center
      • Jerusalem、イスラエル、9103102
        • Shaare Zedek Medical Center
      • Petah Tikva、イスラエル、4941492
        • Rabin Medical Center
  • イタリア
    • Campania
      • Naples、Campania、イタリア、80131
        • Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione G. Pascale
    • Emilia-Romagna
      • Meldola、Emilia-Romagna、イタリア、47014
        • IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola
      • Parma、Emilia-Romagna、イタリア、43100
        • Azienda Ospedaliero Universitaria di Parma
    • Lazio
      • Rome、Lazio、イタリア、00128
        • Policlinico Universitario Campus Biomedico
      • Rome、Lazio、イタリア、00144
        • IRCCS Istituto Regina Elena (IFO)
    • Liguria
      • Genoa、Liguria、イタリア、16132
        • IRCCS AOU San Martino - IST
    • Lombardy
      • Brescia、Lombardy、イタリア、25123
        • A.O. Spedali Civili Di Brescia-P.O. Spedali Civili
      • Milan、Lombardy、イタリア、DUMMY_VALUE
        • Azienda Socio Sanitaria Territoriale Niguarda (Ospedale Niguarda Ca' Granda)
      • Pavia、Lombardy、イタリア、27100
        • Fondazione IRCCS Policlinico San Matteo
    • Tuscany
      • Pisa、Tuscany、イタリア、56124
        • Azienda Ospedaliera Universitaria Pisana - Ospedale Cisanello
    • Veneto
      • Vicenza、Veneto、イタリア、36100
        • Azienda ULSS 8 Berica
  • オランダ
      • Amersfoort、オランダ、3813 TZ
        • Meander Medisch Centrum
      • Breda、オランダ、4819 EV
        • Amphia Ziekenhuis
      • Leidschendam、オランダ、2262 BA
        • Medisch Centrum Haaglanden, locatie Antoniushove
      • Sittard-Geleen、オランダ、6162 BG
        • Zuyderland Medisch Centrum - Sittard Geleen
  • オーストラリア
    • New South Wales
      • Blacktown、New South Wales、オーストラリア、2148
        • Blacktown Hospital
      • Campbelltown、New South Wales、オーストラリア、2560
        • Macarthur Cancer Therapy Centre
      • Kogarah、New South Wales、オーストラリア、2217
        • St George Hospital
    • South Australia
      • Bedford Park、South Australia、オーストラリア、5042
        • Flinders Medical Centre
    • Victoria
      • Victoria、Victoria、オーストラリア、3168
        • Monash Health Translational Precinct
    • Western Australia
      • Bull Creek、Western Australia、オーストラリア、6149
        • Fiona Stanley Hospital
  • オーストリア
      • Innsbruck、オーストリア、6020
        • Tiroler Landeskrankenanstalten Ges.M.B.H.
      • Linz、オーストリア、4020
        • Kepler Universitätskliniken GmbH - Med Campus III
      • Vienna、オーストリア、1140
        • Klinik Penzing
  • カナダ
    • British Columbia
      • Abbotsford British Columbia、British Columbia、カナダ、V2S 0C2
        • BC Cancer ? Abbotsford
      • Victoria、British Columbia、カナダ、V8R 6V5
        • BC Cancer - Victoria
    • Ontario
      • Barrie、Ontario、カナダ、L4M 6M2
        • Royal Victoria Regional Health Centre
      • Brampton、Ontario、カナダ、L6R 3J7
        • William Osler Health System Brampton Civic Hospital
      • Ottawa、Ontario、カナダ、K1H 8L6
        • Ottawa Hospital Research Institute
  • ギリシャ
      • Asvestochóri、ギリシャ、570 10
        • General Hospital "G.Papanikolaou"
      • Athens、ギリシャ、11527
        • Sotiria Hospital
      • Kifissia、ギリシャ、145 64
        • Agioi Anargyroi Cancer Hospital
  • スペイン
      • A Coruña、スペイン、15006
        • Complejo Hospitalario Universitario A Coruña (CHUAC)
      • Barcelona、スペイン、08035
        • Hospital Universitari Vall d'Hebron
      • Madrid、スペイン、28041
        • Hospital Universitario 12 de Octubre
      • Madrid、スペイン、28046
        • Hospital Universitario La Paz
      • Madrid、スペイン、28009
        • Hospital General Universitario Gregorio Marañón
      • Málaga、スペイン、29010
        • Hospital Regional Universitario Carlos Haya
      • Seville、スペイン、41013
        • Hospital Universitario Virgen del Rocío
      • Seville、スペイン、41014
        • Hospital Univ. Nuestra Señora de Valme
    • Balearic Islands
      • Palma de Mallorca、Balearic Islands、スペイン、07198
        • Hospital Son Llatzer
    • Barcelona
      • Badalona、Barcelona、スペイン、08916
        • Hospital Universitari Germans Trias i Pujol
    • Castellon
      • Castellon、Castellon、スペイン、12002
        • Hospital Provincial de Castellon
  • タイ
      • Bangkok、タイ、10400
        • Rajavithi Hospital
      • Bangkok、タイ、10300
        • Vajira Hospital
      • Bangkok、タイ、10400
        • Ramathibodi Hospital;Medicine/Oncology
      • Songkhla、タイ、90110
        • Songklanagarind Hospital
  • トルコ（Türkiye）
      • Adana、トルコ（Türkiye）、01220
        • Adana Baskent University Medical Faculty
      • Ankara、トルコ（Türkiye）、06500
        • Gazi University Medical Faculty, Oncology Hospital
      • Ankara、トルコ（Türkiye）、06100
        • Ankara University Medical Faculty
      • Ankara、トルコ（Türkiye）、06100
        • Hacettepe Universitesi Tip Fakultesi Hastanesi
      • Bornova, ?zm?r、トルコ（Türkiye）、35100
        • Ege University Medical Faculty
      • Diyarbakır、トルコ（Türkiye）、21280
        • Dicle University Faculty of Medicine
      • Edirne、トルコ（Türkiye）、22030
        • Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi
      • Istanbul、トルコ（Türkiye）、34098
        • Istanbul University Cerrahpasa Faculty of Medicine
      • Istanbul、トルコ（Türkiye）、34214
        • Medipol University Medical Faculty
      • Malatya、トルコ（Türkiye）、44280
        • Inonu University Faculty of Medicine Turgut Ozal Medical Center
  • ドイツ
      • Braunschweig、ドイツ、38114
        • Klinikum Braunschweig
      • Cologne、ドイツ、51109
        • Klinikum Koeln-Merheim
      • Göttingen、ドイツ、37075
        • Universitaetsmedizin Goettingen
      • Heidelberg、ドイツ、69126
        • Thoraxklinik Heidelberg gGmbH
      • München、ドイツ、81925
        • Klinikum Bogenhausen
      • Regensburg、ドイツ、93053
        • Universitätsklinikum Regensburg
  • ニュージーランド
      • Auckland、ニュージーランド、1023
        • Auckland City Hospital, Cancer and Blood Research
  • ハンガリー
      • Pécs、ハンガリー、7623
        • Pecsi Tudomanyegyetem
      • Tatabánya、ハンガリー、2800
        • Szent Borbala Korhaz
      • Törökbálint、ハンガリー、2045
        • Tudogyogyintezet Torokbalint
  • フランス
      • Angers、フランス、49933
        • CHU Angers
      • Caen、フランス、14000
        • Centre François Baclesse
      • Marseille、フランス、13015
        • Hopital Nord AP-HM
      • Montpellier、フランス、34070
        • Clinique Clementville
      • Vantoux、フランス、57070
        • Hôpital Robert Schuman
      • Villejuif、フランス、94805
        • Institut Gustave Roussy
  • ブラジル
    • Ceará
      • Fortaleza、Ceará、ブラジル、60336-550
        • CRIO - Centro Regional Integrado de Oncologia
    • Paraná
      • Curitiba、Paraná、ブラジル、80810-050
        • Centro Integrado de Oncologia de Curitiba
    • Rio Grande do Sul
      • Ijuí、Rio Grande do Sul、ブラジル、98700-000
        • Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda
      • Porto Alegre、Rio Grande do Sul、ブラジル、90610-000
        • Hospital Sao Lucas - PUCRS
    • São Paulo
      • Barretos、São Paulo、ブラジル、14784-400
        • Hospital de Cancer de Barretos
      • São José do Rio Preto、São Paulo、ブラジル、15090-000
        • Hospital de Base de Sao Jose do Rio Preto
      • São Paulo、São Paulo、ブラジル、01246-000
        • Instituto do Câncer do Estado de São Paulo - ICESP
  • ベルギー
      • Charleroi、ベルギー、6000
        • GHdC Site Les Viviers
      • Ghent、ベルギー、9000
        • AZ Maria Middelares
      • Hasselt、ベルギー、3500
        • Jessa Zkh (Campus Virga Jesse)
  • ポルトガル
      • Coimbra、ポルトガル、3000-075
        • IPO de Coimbra
      • Lisbon、ポルトガル、1500-650
        • Hospital da Luz
      • Porto、ポルトガル、4100-180
        • Hospital CUF Porto
      • Porto、ポルトガル、4200-072
        • IPO do Porto
  • ポーランド
      • Gda?sk、ポーランド、80-214
        • Uniwersyteckie Centrum Kliniczne
      • Olsztyn、ポーランド、10-228
        • Szpital Kliniczny MSWiA z Warmi?sko-Mazurskim Centrum Onkologii
      • Otwock、ポーランド、05-400
        • Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy
      • Warsaw、ポーランド、02-781
        • Narod.Inst.Onkol. im. M.Sklodowskiej - Curie-Panst.Inst.Bad
      • Wroc?aw、ポーランド、53-413
        • Dolnośląskie Centrum Onkologii, Pulmonologii i Hematologii
  • 中国
      • Beijing、中国、101149
        • Beijing Chest Hospital
      • Beijing、中国、100142
        • Beijing Cancer Center
      • Changchun、中国、132013
        • Jilin cancer hospital
      • Changsha、中国、410008
        • Xiangya Hospital Central South University
      • Chengdu、中国、610041
        • Sichuan Provincial Cancer Hospital
      • Chongqing、中国、400030
        • Chongqing Cancer Hospital
      • Fujian、中国、350001
        • Fujian Medical University Union Hospital
      • Fuzhou、中国、350014
        • Fujian Provincial Cancer Hospital
      • Guangzhou、中国、510060
        • Cancer Center, Sun Yat-sen University of Medical Sciences
      • Hangzhou、中国、310002
        • Hangzhou Cancer Hospital
      • Jinan、中国、250117
        • Shandong Cancer Hospital
      • Nanjing、中国、210009
        • Zhongda Hospital Affiliated to Southeast University
      • Qingdao、中国、266042
        • The Affiliated Hospital of Qingdao University
      • Shanghai、中国、200000
        • Shanghai Chest Hospital
      • Shantou、中国、515041
        • Cancer Hospital of Shantou University Medical College
      • Taiyuan、中国、030013
        • Shanxi Provincial Cancer Hospital
      • Tianjin、中国、300060
        • Tianjin Cancer Hospital
      • Wenzhou、中国、325000
        • The 2nd School of Medicine, WMU
      • Xiamen、中国、361003
        • The First Affiliated Hospital of Xiamen University
      • Xuzhou、中国、221000
        • The Affiliated Hospital of Xuzhou Medical College
      • Zhengzhou、中国、450008
        • Henan Cancer Hospital
  • 台湾
      • Taichung、台湾、40447
        • China Medical University Hospital
      • Taipei、台湾、112
        • Taipei Veterans General Hospital
  • 日本
      • Aichi、日本、464-8681
        • Aichi Cancer Center
      • Chiba、日本、277-8577
        • National Cancer Center East
      • Hyōgo、日本、670-8520
        • National Hospital Organization Himeji Medical Center
      • Kanagawa、日本、252-0375
        • Kitasato University Hospital
      • Kyoto、日本、606-8507
        • Kyoto University Hospital
      • Miyagi、日本、981-0914
        • Sendai Kousei Hospital
      • Niigata、日本、951-8566
        • Niigata Cancer Center Hospital
      • Osaka、日本、589-8511
        • Kindai University Hospital
      • Saitama、日本、362-0806
        • Saitama Cancer Center
      • Shizuoka、日本、411-8777
        • Shizuoka Cancer Center
      • Tokyo、日本、104-0045
        • National Cancer Center Hospital
      • Tokyo、日本、135-8550
        • The Cancer Institute Hospital of JFCR
      • Wakayama、日本、641-8510
        • Wakayama Medical University Hospital
  • 韓国
      • Cheongju-si、韓国、28644
        • Chungbuk National University Hospital
      • Daegu、韓国、41404
        • Kyungpook National University Chilgok Hospital
      • Gyeonggi-do、韓国、13620
        • Seoul National University Bundang Hospital
      • Gyeonggi-do、韓国、16247
        • St. Vincent's Hospital
      • Gyeonggi-do、韓国、10408
        • National Cancer Center
      • Gyeonggi-do、韓国、16499
        • Ajou University Medical Center
      • Gyeongsangnam-do、韓国、50612
        • Pusan National University Yangsan Hospital
      • Incheon、韓国、21565
        • Gachon University Gil Medical Center
      • Jeollanam-do、韓国、58128
        • Chonnam National University Hwasun Hospital
      • Seoul、韓国、03080
        • Seoul National University Hospital
      • Seoul、韓国、05505
        • Asan Medical Center
      • Seoul、韓国、06351
        • Samsung Medical Center
      • Seoul、韓国、08308
        • Korea University Guro Hospital
      • Seoul、韓国、06591
        • Seoul St Mary's Hospital
      • Ulsan、韓国、44033
        • Ulsan University Hosiptal
  • 香港
      • Hong Kong、香港
        • Tuen Mun Hospital
      • Hong Kong、香港
        • Pamela Youde Nethersole Eastern Hospital
      • Hong Kong、香港、DUMMY_VALUE
        • Queen Elizabeth Hospital
      • Hong Kong、香港、DUMMY_VALUE
        • Princess Margaret Hospital, Oncology
      • Pokfulam、香港、DUMMY_VALUE
        • Queen Mary Hospital

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:

  • -Eastern Cooperative Oncology Group (ECOG) Performance Status 0 または 1
  • -組織学的または細胞学的に文書化されたNSCLCで、組織学的に扁平上皮または非扁平上皮の局所進行で切除不能なステージIIIのNSCLC
  • -全身陽電子放出断層撮影-コンピューター断層撮影（PET-CT）スキャン、同時化学放射線療法（cCRT）の初回投与前および42日以内に実行
  • -放射線療法（RT）と同時に投与されたプラチナベースの化学療法の少なくとも2つの前のサイクル。これは、研究で無作為化される前の1〜42日以内に完了する必要があります（cCRTの1サイクルは21または28日と定義されます）
  • cCRT の放射線療法 (RT) コンポーネントは、強度変調 RT (推奨) または 3D-適合技術
  • 同時プラチナベースの CRT 中または後に進行なし
  • 既知の PD-L1 結果
  • 平均余命 >/= 12 週間
  • -適切な血液学的および末端器官の機能
  • -女性の参加者は、ティラゴルマブの最終投与後90日間、アテゾリズマブの最終投与の5か月後、またはデュルバルマブの最終投与の3か月後、妊娠を避ける意思がある必要があります
  • 男性参加者は、治療期間中およびチラゴルマブの最終投与後90日間、禁欲を続けるか、コンドームを使用する必要があります
  • 男性参加者は、治療期間中およびチラゴルマブの最終投与後90日間は精子を提供してはなりません

除外基準:

  • -以前のNSCLCの病歴および/またはNSCLCの以前の治療歴（参加者は、切除不能なステージIII疾患と新たに診断されなければなりません）
  • 上皮成長因子受容体（EGFR）遺伝子または未分化リンパ腫キナーゼ（ALK）融合がん遺伝子に変異があることが知られているNSCLC
  • ステージ IV 疾患の証拠
  • 局所進行NSCLCに対する逐次CRTによる治療
  • -無作為化前の決定的なcCRT中または後に進行した局所進行NSCLCの参加者
  • 以前の CRT からのグレード 2 を超える未解決の毒性
  • 以前のCRTによるグレード2以上の肺炎
  • -自己免疫疾患または免疫不全の活動性または病歴
  • -特発性肺線維症、組織化肺炎、薬物誘発性肺炎、または特発性肺炎の病歴または活動性肺炎の証拠
  • -スクリーニング前の5年以内のNSCLC以外の悪性腫瘍の病歴 転移または死亡のリスクが無視できる程度の悪性腫瘍を除く
  • -以前の同種幹細胞または固形臓器移植
  • -アクティブなエプスタイン-バーウイルス（EBV）感染症、またはスクリーニング時の既知または疑われる慢性活動性EBV感染症
  • -研究治療の開始前28日以内の治験療法による治療
  • -抗細胞傷害性Tリンパ球関連タンパク質4、IgおよびITIMドメインを含む抗T細胞免疫受容体（抗TIGIT）、抗PD-1および抗PD-L1を含む、CD137アゴニストまたは免疫チェックポイント遮断療法による以前の治療
  • -以前のグレード>/= 3の免疫介在性有害事象または未解決のグレード> 1の免疫介在性有害事象 免疫チェックポイント阻害剤以外の以前の免疫療法剤を受けている
  • 全身性免疫抑制薬による治療
  • 妊娠中または授乳中の女性

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
実験的：アテゾリズマブ + ティラゴルマブ
参加者は、各 28 日サイクルの 1 日目にアテゾリズマブを静脈内 (IV) 投与され、続いて各 28 日サイクルの 1 日目にチラゴルマブが最大 13 サイクルにわたって IV 投与されます。
薬：アテゾリズマブ
アテゾリズマブ 1680 mg を 4 週間ごと (Q4W) に、各 28 日サイクルの 1 日目に IV 投与します。
他の名前：
  • テセントリク; RO5541267
薬：ティラゴルマブ
チラゴルマブ 840 mg Q4W は、各 28 日サイクルの 1 日目に IV 投与されます。
他の名前：
  • MTIG7192A; RO7092284
アクティブコンパレータ：デュルバルマブ
参加者は、最大 13 サイクルの各 28 日サイクル中に IV 投与されたデュルバルマブを受け取ります。
薬：デュルバルマブ
デュルバルマブは、体重に基づいて 10 mg/kg を 2 週間ごとに IV (Q2W)、各 28 日サイクルの 1 日目と 15 日目に投与するか、4 週間ごとに 1500 mg IV の固定用量で投与します (Q4W) (参加者の体重 >/= 30 kg) 各 28 日サイクルの 1 日目。

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
Progression-free Survival (PFS), as Assessed by an Independent Review Facility (IRF) in Programmed Death-ligand 1 (PD-L1) Positive Analysis Set (PPAS)
時間枠：From randomization to first occurrence of PD or death from any cause, whichever occurred first (up to approximately 57 months)
PFS was defined as the time from randomization to the first occurrence of PD, as determined by an IRF according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1), or death from any cause, whichever occurred first. PD was defined as at least a 20% increase in the sum of diameters (SOD) of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline). Additionally, the SOD must also demonstrate an absolute increase of ≥ 5 millimeters (mm) or unequivocal progression of existing non-target lesions. Kaplan-Meier (K-M) method was used to estimate median PFS.
From randomization to first occurrence of PD or death from any cause, whichever occurred first (up to approximately 57 months)
PFS, as Assessed by an IRF in FAS
時間枠：From randomization to first occurrence of PD or death from any cause, whichever occurred first (up to approximately 57 months)
PFS was defined as the time from randomization to the first occurrence of PD, as determined by an IRF according to RECIST v1.1, or death from any cause, whichever occurred first. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline). Additionally, the SOD must also demonstrate an absolute increase of ≥ 5 mm or unequivocal progression of existing non-target lesions. K-M method was used to estimate median PFS.
From randomization to first occurrence of PD or death from any cause, whichever occurred first (up to approximately 57 months)

二次結果の測定

結果測定
メジャーの説明
時間枠
Overall Survival (OS) in PPAS
時間枠：From randomization to death from any cause (up to approximately 57 months)
OS was defined as the time from randomization to death from any cause. K-M method was used to estimate median OS.
From randomization to death from any cause (up to approximately 57 months)
PFS, as Assessed by the Investigator in PPAS
時間枠：From randomization to first occurrence of PD or death from any cause, whichever occurred first (up to approximately 57 months)
PFS was defined as the time from randomization to the first occurrence of PD, as determined by the investigator according to RECIST v1.1, or death from any cause, whichever occurred first. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline). Additionally, the SOD must also demonstrate an absolute increase of ≥ 5 mm or unequivocal progression of existing non-target lesions. K-M method was used to estimate median PFS.
From randomization to first occurrence of PD or death from any cause, whichever occurred first (up to approximately 57 months)
Confirmed Objective Response Rate (ORR), as Assessed by an IRF in PPAS
時間枠：Up to approximately 57 months
ORR was defined as the percentage of participants who achieved an objective response (OR), characterized by a complete response (CR) or partial response (PR) on two consecutive occasions ≥ 4 weeks apart, as determined by an IRF according to RECIST v1.1. CR was defined as disappearance of all target and non-target lesion & normalization of tumor marker level. Additionally, any lymph nodes (whether target or non-target) must have a reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR. Percentages have been rounded off.
Up to approximately 57 months
Confirmed ORR, as Assessed by the Investigator in PPAS
時間枠：Up to approximately 57 months
ORR was defined as the percentage of participants who achieved an OR, characterized by CR or PR on two consecutive occasions ≥ 4 weeks apart, as determined by the investigator according to RECIST v1.1. CR was defined as disappearance of all target and non-target lesions & normalization of tumor marker level. Additionally, any lymph nodes (whether target or non-target) must have a reduction in short axis to < 10 mm. PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR. Percentages have been rounded off.
Up to approximately 57 months
Duration of Response (DOR), as Assessed by an IRF in PPAS
時間枠：From first occurrence of a confirmed OR until the first date of PD or death from any cause, whichever occurred first (up to approximately 57 months)
DOR was defined as the time from the first occurrence of a confirmed OR, characterized by CR or PR, until the first date of PD, as determined by an IRF according to RECIST v1.1, or death from any cause, whichever occurred first. CR was defined as disappearance of all target and non-target lesions & normalization of tumor marker level. Additionally, any lymph nodes (whether target or non-target) must have a reduction in short axis to < 10 mm. PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline). Additionally, the SOD must also demonstrate an absolute increase of ≥ 5 mm or unequivocal progression of existing non-target lesions. Median DOR was estimated using the K-M method.
From first occurrence of a confirmed OR until the first date of PD or death from any cause, whichever occurred first (up to approximately 57 months)
DOR, as Assessed by the Investigator in PPAS
時間枠：From first occurrence of a confirmed OR until the first date of PD or death from any cause, whichever occurred first (up to approximately 57 months)
DOR was defined as the time from the first occurrence of a confirmed OR, characterized by CR or PR, until the first date of PD, as determined by the investigator according to RECIST v1.1, or death from any cause, whichever occurred first. CR was defined as disappearance of all target and non-target lesions, normalization of tumor marker level. Additionally, any lymph nodes (whether target or non-target) must have a reduction in short axis to < 10 mm. PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline). Additionally, the SOD must also demonstrate an absolute increase of ≥ 5 mm or unequivocal progression of existing non-target lesions. Median DOR was estimated using the K-M method.
From first occurrence of a confirmed OR until the first date of PD or death from any cause, whichever occurred first (up to approximately 57 months)
Time to Confirmed Deterioration (TTCD) in Cough, as Assessed Using European Organisation for Research and Treatment of Cancer Quality-of-life Questionnaire Lung Cancer Module (EORTC QLQ-LC13) in PPAS
時間枠：Up to approximately 57 months
TTCD=time from randomization until first confirmed clinically meaningful deterioration (CCMD) on each respective score. EORTC QLQ-LC13 is a lung cancer-specific instrument consisting of 13 questions: one multiple-item scale assessing dyspnoea (3 items), and 10 single items assessing cough, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts, pain medication. Cough scored on a 4-point scale: 1=Not at all, 2=A little, 3=Quite a bit, 4=Very much. Scores were linearly transformed to score range of 0-100. High symptom score=high level of symptom severity. CCMD=increase from baseline (≥10 points) in a symptom score, held for at least two consecutive assessments or an initial clinically meaningful increase above baseline followed by death from any cause within 6 weeks. K-M method was used to estimate median TTCD.
Up to approximately 57 months
TTCD in Dyspnoea, as Assessed Using EORTC QLQ-LC13 in PPAS
時間枠：Up to approximately 57 months
TTCD=time from randomization until first CCMD on each respective score. EORTC QLQ-LC13 is a lung cancer-specific instrument consisting of 13 questions: one multiple-item scale assessing dyspnoea (3 items), and 10 single items assessing cough, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts, pain medication. Dyspnoea was scored on a 4-point scale: 1=Not at all, 2=A little, 3=Quite a bit, 4=Very much. Scores were linearly transformed to score range of 0-100. High symptom score=high level of symptom severity. CCMD=increase from baseline (≥10 points) in a symptom score, held for at least two consecutive assessments or an initial clinically meaningful increase above baseline followed by death from any cause within 6 weeks. K-M method was used to estimate median TTCD.
Up to approximately 57 months
TTCD in Chest Pain, as Assessed Using EORTC QLQ-LC13 in PPAS
時間枠：Up to approximately 57 months
TTCD=time from randomization until first CCMD on each respective score. EORTC QLQ-LC13 is a lung cancer-specific instrument consisting of 13 questions: one multiple-item scale assessing dyspnoea (3 items), and 10 single items assessing cough, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts, pain medication. Chest pain was scored on a 4-point scale: 1=Not at all, 2=A little, 3=Quite a bit, 4=Very much. Scores were linearly transformed to score range of 0-100. High symptom score=high level of symptom severity. CCMD=increase from baseline (≥10 points) in a symptom score, held for at least two consecutive assessments or an initial clinically meaningful increase above baseline followed by death from any cause within 6 weeks. K-M method was used to estimate median TTCD.
Up to approximately 57 months
TTCD in Global Health Status (GHS)/Quality-of-life (QoL), as Assessed Using European Organisation for Research and Treatment of Cancer Quality-of-life Core-30 (EORTC QLQ-C30) in PPAS
時間枠：Up to approximately 57 months
TTCD=time from randomization until first CCMD on each respective score. EORTC QLQ-C30 is cancer-specific instrument consisting of 30 questions to evaluate 5 aspects of participant functioning (physical, emotional, role, cognitive, & social), 3 symptom scales (fatigue, nausea, vomiting, & pain), GHS/QoL, & 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea & financial difficulties). GHS/QoL questions were scored on 7-point scale with scores ranging from 1=Very poor to 7=Excellent. Scores were linearly transformed to a score range of 0-100. High score for GHS/QoL scale=better health-related quality-of-life (HRQoL). CCMD=decrease from baseline (≥10 points) in GHS/QoL scale score, held for at least 2 consecutive assessments/initial clinically meaningful decrease above baseline followed by death within 6 weeks. K-M method was used to estimate median TTCD.
Up to approximately 57 months
TTCD in Physical Functioning (PF), as Assessed Using EORTC QLQ-C30 in PPAS
時間枠：Up to approximately 57 months
TTCD=time from randomization until first CCMD on each respective score. EORTC QLQ-C30 is cancer-specific instrument consisting of 30 questions to evaluate 5 aspects of participant functioning (physical, emotional, role, cognitive, & social), 3 symptom scales (fatigue, nausea, vomiting, & pain), GHS/QoL, and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea & financial difficulties). PF was scored on a 4-point scale: 1=Not at all, 2=A little, 3=Quite a bit, 4=Very much. Scores were linearly transformed to a score range of 0-100. High score for PF=high/healthy level of functioning. CCMD=decrease from baseline (≥10 points) in PF score, held for at least 2 consecutive assessments or initial clinically meaningful decrease above baseline followed by death within 6 weeks. K-M method was used to estimate median TTCD.
Up to approximately 57 months
OS in FAS
時間枠：From randomization to death from any cause (up to approximately 57 months)
OS was defined as the time from randomization to death from any cause. K-M method was used to estimate median OS.
From randomization to death from any cause (up to approximately 57 months)
PFS, as Assessed by the Investigator in FAS
時間枠：From randomization to first occurrence of PD or death from any cause, whichever occurred first (up to approximately 57 months)
PFS was defined as the time from randomization to the first occurrence of PD, as determined by the investigator according to RECIST v1.1, or death from any cause, whichever occurred first. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline). Additionally, the SOD must also demonstrate an absolute increase of ≥ 5 mm or unequivocal progression of existing non-target lesions. K-M method was used to estimate median PFS.
From randomization to first occurrence of PD or death from any cause, whichever occurred first (up to approximately 57 months)
Confirmed ORR, as Assessed by an IRF in FAS
時間枠：Up to approximately 57 months
ORR was defined as the percentage of participants who achieved an OR, characterized by CR or PR on two consecutive occasions ≥ 4 weeks apart, as determined by an IRF according to RECIST v1.1. CR was defined as disappearance of all target and non-target lesions, normalization of tumor marker level. Additionally, any lymph nodes (whether target or non-target) must have a reduction in short axis to < 10 mm. PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR. Percentages have been rounded off.
Up to approximately 57 months
Confirmed ORR, as Assessed by the Investigator in FAS
時間枠：Up to approximately 57 months
ORR was defined as the percentage of participants who achieved an OR, characterized by a CR or PR on two consecutive occasions ≥ 4 weeks apart, as determined by the investigator according to RECIST v1.1. CR was defined as disappearance of all target and non-target lesions, normalization of tumor marker level. Additionally, any lymph nodes (whether target or non-target) must have a reduction in short axis to < 10 mm. PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR. Percentages have been rounded off.
Up to approximately 57 months
DOR, as Assessed by an IRF in FAS
時間枠：From first occurrence of a confirmed OR until the first date of PD or death from any cause, whichever occurred first (up to approximately 57 months)
DOR was defined as the time from the first occurrence of a confirmed OR, characterized by CR or PR, until the first date of PD, as determined by an IRF according to RECIST v1.1, or death from any cause, whichever occurred first. CR was defined as disappearance of all target and non-target lesions, normalization of tumor marker level. Additionally, any lymph nodes (whether target or non-target) must have a reduction in short axis to < 10 mm. PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline). Additionally, the SOD must also demonstrate an absolute increase of ≥ 5 mm or unequivocal progression of existing non-target lesions. Median DOR was estimated using the K-M method.
From first occurrence of a confirmed OR until the first date of PD or death from any cause, whichever occurred first (up to approximately 57 months)
DOR, as Assessed by the Investigator in FAS
時間枠：From first occurrence of a confirmed OR until the first date of PD or death from any cause, whichever occurred first (up to approximately 57 months)
DOR was defined as the time from the first occurrence of a confirmed OR, characterized by CR or PR, until the first date of PD, as determined by the investigator according to RECIST v1.1, or death from any cause, whichever occurred first. CR was defined as disappearance of all target and non-target lesions, normalization of tumor marker level. Additionally, any lymph nodes (whether target or non-target) must have a reduction in short axis to < 10 mm. PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline). Additionally, the SOD must also demonstrate an absolute increase of ≥ 5 mm or unequivocal progression of existing non-target lesions. Median DOR was estimated using the K-M method.
From first occurrence of a confirmed OR until the first date of PD or death from any cause, whichever occurred first (up to approximately 57 months)
TTCD in Cough, as Assessed Using EORTC QLQ-LC13 in FAS
時間枠：Up to approximately 57 months
TTCD=time from randomization until first CCMD on each respective score. EORTC QLQ-LC13 is a lung cancer-specific instrument consisting of 13 questions: one multiple-item scale assessing dyspnoea (3 items), and 10 single items assessing cough, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts, pain medication. Cough was scored on a 4-point scale: 1=Not at all, 2=A little, 3=Quite a bit, 4=Very much. Scores were linearly transformed to score range of 0-100. High symptom score=high level of symptom severity. CCMD=increase from baseline (≥10 points) in a symptom score, held for at least two consecutive assessments or an initial clinically meaningful increase above baseline followed by death from any cause within 6 weeks. K-M method was used to estimate median TTCD.
Up to approximately 57 months
TTCD in Dyspnoea, as Assessed Using EORTC QLQ-LC13 in FAS
時間枠：Up to approximately 57 months
TTCD=time from randomization until first CCMD on each respective score. EORTC QLQ-LC13 is a lung cancer-specific instrument consisting of 13 questions: one multiple-item scale assessing dyspnoea (3 items), and 10 single items assessing cough, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts, pain medication. Dyspnoea was scored on a 4-point scale: 1=Not at all, 2=A little, 3=Quite a bit, 4=Very much. Scores were linearly transformed to score range of 0-100. High symptom score=high level of symptom severity. CCMD=increase from baseline (≥10 points) in a symptom score, held for at least two consecutive assessments or an initial clinically meaningful increase above baseline followed by death from any cause within 6 weeks. K-M method was used to estimate median TTCD.
Up to approximately 57 months
TTCD in Chest Pain, as Assessed Using EORTC QLQ-LC13 in FAS
時間枠：Up to approximately 57 months
TTCD=time from randomization until first CCMD on each respective score. EORTC QLQ-LC13 is a lung cancer-specific instrument consisting of 13 questions: one multiple-item scale assessing dyspnoea (3 items), and 10 single items assessing cough, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts, pain medication. Chest pain was scored on a 4-point scale: 1=Not at all, 2=A little, 3=Quite a bit, 4=Very much. Scores were linearly transformed to score range of 0-100. High symptom score=high level of symptom severity. CCMD=increase from baseline (≥10 points) in a symptom score, held for at least two consecutive assessments or an initial clinically meaningful increase above baseline followed by death from any cause within 6 weeks. K-M method was used to estimate median TTCD.
Up to approximately 57 months
TTCD in GHS/QoL, as Assessed Using EORTC QLQ-C30 in FAS
時間枠：Up to approximately 57 months
TTCD=time from randomization until first CCMD on each respective score. EORTC QLQ-C30 is cancer-specific instrument consisting of 30 questions to evaluate 5 aspects of participant functioning (physical, emotional, role, cognitive, & social), 3 symptom scales (fatigue, nausea, vomiting, & pain), GHS/QoL, and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea & financial difficulties). GHS/QoL questions were scored on 7-point scale with scores ranging from 1=Very poor to 7=Excellent. Scores were linearly transformed to a score range of 0-100. High score for GHS/QoL scale=better HRQoL. CCMD=decrease from baseline (≥10 points) in GHS/QoL scale score, held for at least 2 consecutive assessments or initial clinically meaningful decrease above baseline followed by death within 6 weeks. K-M method was used to estimate median TTCD.
Up to approximately 57 months
TTCD in PF, as Assessed Using EORTC QLQ-C30 in FAS
時間枠：Up to approximately 57 months
TTCD=time from randomization until first CCMD on each respective score. EORTC QLQ-C30 is cancer-specific instrument consisting of 30 questions to evaluate 5 aspects of participant functioning (physical, emotional, role, cognitive, & social), 3 symptom scales (fatigue, nausea, vomiting, & pain), GHS/QoL, and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea & financial difficulties). PF was scored on a 4-point scale: 1=Not at all, 2=A little, 3=Quite a bit, 4=Very much. Scores were linearly transformed to a score range of 0-100. High score for PF=high/healthy level of functioning. CCMD=decrease from baseline (≥10 points) in PF score, held for at least 2 consecutive assessments or initial clinically meaningful decrease above baseline followed by death within 6 weeks. K-M method was used to estimate median TTCD.
Up to approximately 57 months
PFS Rate at 12, 18, and 24 Months, as Assessed by an IRF in PPAS
時間枠：At Months 12, 18, and 24
PFS rate at 12, 18, and 24 months was defined as the percentage of participants who did not experience PD or death from any cause, as determined by an IRF, at 12, 18, and 24 months. PFS was defined as the time from randomization to the first occurrence of PD, as determined by an IRF according to RECIST v1.1, or death from any cause, whichever occurred first. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline). Additionally, the SOD must also demonstrate an absolute increase of ≥ 5 mm or unequivocal progression of existing non-target lesions. K-M method was used to estimate median PFS rate. Percentages have been rounded off.
At Months 12, 18, and 24
PFS Rate at 12, 18, and 24 Months, as Assessed by the Investigator in PPAS
時間枠：At Months 12, 18, and 24
PFS rate at 12, 18, and 24 months was defined as the percentage of participants who did not experience PD or death from any cause, as determined by the investigator, at 12, 18, and 24 months. PFS was defined as the time from randomization to the first occurrence of PD, as determined by the investigator according to RECIST v1.1, or death from any cause, whichever occurred first. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline). Additionally, the SOD must also demonstrate an absolute increase of ≥ 5 mm or unequivocal progression of existing non-target lesions. K-M method was used to estimate median PFS rate. Percentages have been rounded off.
At Months 12, 18, and 24
OS Rate at 12, 24, 36, and 48 Months in PPAS
時間枠：At Months 12, 24, 36, and 48
OS rate at months 12, 24, 36 and 48 was defined as percentage of participants who did not experience death from any cause at the specified timepoints. OS was defined as the time from randomization to death from any cause. K-M method was used to estimate OS rate. Percentages have been rounded off.
At Months 12, 24, 36, and 48
Time-to-distant Metastasis (TTDM), as Assessed by the Investigator in PPAS
時間枠：Up to approximately 57 months
TTDM was defined as the time from the date of randomization until the date of first documented distant metastasis, as assessed by investigator according to RECIST v1.1, or death, whichever occurred first. Distant metastasis was defined as any new lesion that was outside of the radiation field. K-M method was used to estimate median TTDM.
Up to approximately 57 months
PFS Rate at 12, 18, and 24 Months, as Assessed by an IRF in FAS
時間枠：At Months 12, 18, and 24
PFS rate at 12, 18, and 24 months was defined as the percentage of participants who did not experience PD or death from any cause, as determined by an IRF, at 12, 18, and 24 months. PFS was defined as the time from randomization to the first occurrence of PD, as determined by an IRF according to RECIST v1.1, or death from any cause, whichever occurred first. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline). Additionally, the SOD must also demonstrate an absolute increase of ≥ 5 mm or unequivocal progression of existing non-target lesions. K-M method was used to estimate PFS rate. Percentages have been rounded off.
At Months 12, 18, and 24
PFS Rate at 12, 18, and 24 Months, as Assessed by the Investigator in FAS
時間枠：At Months 12, 18, and 24
PFS rate at 12, 18, and 24 months was defined as the percentage of participants who did not experience PD or death from any cause, as determined by the investigator, at 12, 18, and 24 months. PFS was defined as the time from randomization to the first occurrence of PD, as determined by the investigator according to RECIST v1.1, or death from any cause, whichever occurred first. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline). Additionally, the SOD must also demonstrate an absolute increase of ≥ 5 mm or unequivocal progression of existing non-target lesions. K-M method was used to estimate PFS rate. Percentages have been rounded off.
At Months 12, 18, and 24
OS Rate at 12, 24, 36, and 48 Months in FAS
時間枠：At Months 12, 24, 36, and 48
OS rate at months 12, 24, 36 and 48 was defined as percentage of participants who did not experience death from any cause at the specified timepoints. OS was defined as the time from randomization to death from any cause. K-M method was used to estimate OS rate. Percentages have been rounded off.
At Months 12, 24, 36, and 48
TTDM, as Assessed by the Investigator in FAS
時間枠：Up to approximately 57 months
TTDM was defined as the time from the date of randomization until the date of first documented distant metastasis, as assessed by investigator according to RECIST v1.1, or death, whichever occurred first. Distant metastasis was defined as any new lesion that was outside of the radiation field. K-M method was used to estimate median TTDM.
Up to approximately 57 months
Number of Participants With Adverse Events (AEs)
時間枠：Up to approximately 24.7 months
An AE was defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product.
Up to approximately 24.7 months
Number of Participants With Cytokine Release Syndrome (CRS)
時間枠：Up to approximately 24.7 months
CRS=supraphysiologic response following administration of any immune therapy that results in activation/engagement of endogenous or infused T cells and/or other immune effector cells. Symptoms may be progressive, including fever at onset, and may also include hypotension, capillary leak (hypoxia), and end-organ dysfunction.
Up to approximately 24.7 months

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

Hoffmann-La Roche

捜査官

  • スタディディレクター：Clinical Trials、Hoffmann-La Roche

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)

2020年8月24日

一次修了 (実際)

2025年5月27日

研究の完了 (実際)

2025年7月31日

試験登録日

最初に提出

2020年8月13日

QC基準を満たした最初の提出物

2020年8月13日

最初の投稿 (実際)

2020年8月14日

学習記録の更新

投稿された最後の更新 (実際)

2026年6月3日

QC基準を満たした最後の更新が送信されました

2026年5月7日

最終確認日

2026年5月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

  • GO41854
  • 2019-004773-29 (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

有資格の研究者は、臨床研究データ要求プラットフォーム (www.vivli.org) を通じて、個々の患者レベルのデータへのアクセスを要求できます。 適格な研究に関するロシュの基準の詳細については、こちら (https://vivli.org/members/ourmembers/) をご覧ください。臨床情報の共有に関するロシュのグローバル ポリシーおよび関連する臨床研究文書へのアクセスを要求する方法の詳細については、こちら (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm) を参照してください。

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

はい

米国FDA規制機器製品の研究

いいえ

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。

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