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肺がん患者における化学療法後の最善の支持療法と比較したアテゾリズマブ (MPDL3280A) の安全性と有効性を評価する研究 [IMpower010]

2026年9月7日更新者：Hoffmann-La Roche

IB-IIIA期の非小細胞細胞を完全切除した患者を対象に、アテゾリズマブ（抗PD-L1抗体）の有効性と安全性を、補助シスプラチンベースの化学療法後の最良の支持療法と比較して調査する第III相、非盲検、無作為化試験肺癌

This is a Phase III, global, multicenter, open-label, randomized study to compare the efficacy and safety of 16 cycles (1 cycle duration=21 days) of atezolizumab (MPDL3280A) treatment compared with best supportive care (BSC) in participants with Stage IB-Stage IIIA non-small cell lung cancer (NSCLC) following resection and adjuvant chemotherapy, as measured by disease-free survival (DFS) as assessed by the investigator and overall survival (OS). Participants, after completing up to 4 cycles of adjuvant cisplatin-based chemotherapy, will be randomized in a 1:1 ratio to receive atezolizumab for 16 cycles or BSC.

調査の概要

状態

完了

条件

非小細胞肺がん

介入・治療

研究の種類

介入

入学 (実際)

1280

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
- Arkansas
  - Fayetteville、Arkansas、アメリカ、72703
    - Highlands Oncology Group
- California
  - Encinitas、California、アメリカ、92024
    - California Cancer Associates for Research & Excellence, Inc.
  - Fountain Valley、California、アメリカ、92708
    - Compassionate Cancer Care Medical Group, Inc
  - Los Angeles、California、アメリカ、90024
    - University of California Los Angeles
  - Los Angeles、California、アメリカ、90027
    - Southern California Permanente Medical Group Bellflower
  - Stanford、California、アメリカ、94305
    - Stanford University
  - Vallejo、California、アメリカ、94589
    - Kaiser Permanente
  - Walnut Creek、California、アメリカ、94596
    - Kaiser Permanente - Walnut Creek
- Connecticut
  - Norwich、Connecticut、アメリカ、06360
    - Eastern Connecticut Hematology and Oncology Associates
- Florida
  - Boca Raton、Florida、アメリカ、33486
    - Lynn Cancer Institute - West
  - Deerfield Beach、Florida、アメリカ、33442
    - University of Miami School of Medicine - Sylvester at Deerfield
  - Fort Lauderdale、Florida、アメリカ、33308
    - Holy Cross Hospital Inc
  - Fort Myers、Florida、アメリカ、33916
    - Florida Cancer Specialists-Broadway, Fort Myers
  - St. Petersburg、Florida、アメリカ、33705
    - SCRI Florida Cancer Specialists North
- Georgia
  - Marietta、Georgia、アメリカ、30060
    - Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital
  - Thomasville、Georgia、アメリカ、31792
    - Lewis Hall Singletary Oncology Center
- Illinois
  - Chicago、Illinois、アメリカ、60612
    - University of Illinois at Chicago
  - Chicago、Illinois、アメリカ、60612
    - Rush University Medical Center
  - Peoria、Illinois、アメリカ、61615
    - Illinois Cancer Care
  - Springfield、Illinois、アメリカ、62794
    - Southern Illinois University, Simmons Cancer Institute
- Kentucky
  - Louisville、Kentucky、アメリカ、40402
    - Norton Cancer Institute
- Missouri
  - Kansas City、Missouri、アメリカ、64111
    - St. Luke's Cancer Institute
- Nevada
  - Henderson、Nevada、アメリカ、89052
    - Comprehensive Cancer Centers of Nevada
- New Jersey
  - Florham Park、New Jersey、アメリカ、07932
    - Hematology Oncology Associates of Northern New Jersey
  - Livingston、New Jersey、アメリカ、07039
    - Saint Barnabas Medical Center
  - Paramus、New Jersey、アメリカ、07652
    - Valley Hospital
  - Summit、New Jersey、アメリカ、07901
    - Overlook Medical Center
- New York
  - Lake Success、New York、アメリカ、11042
    - Clinical Research Alliance
  - New York、New York、アメリカ、10065
    - Weill Cornell Medical College
- North Carolina
  - Charlotte、North Carolina、アメリカ、28204
    - Presbyterian Hospital
- Ohio
  - Cincinnati、Ohio、アメリカ、45219
    - University of Cincinnati
  - Cincinnati、Ohio、アメリカ、45242
    - Oncology Hematology Care - SCRI
- Oregon
  - Portland、Oregon、アメリカ、97239
    - Oregon Health and Science University
- Pennsylvania
  - Harrisburg、Pennsylvania、アメリカ、17109
    - Pinnacle Health
  - Pittsburgh、Pennsylvania、アメリカ、15212
    - AHN Cancer Institute ? Allegheny General Hospital
- Rhode Island
  - Providence、Rhode Island、アメリカ、02903
    - Rhode Island Hospital
- Tennessee
  - Chattanooga、Tennessee、アメリカ、37403
    - University Oncology Associates
  - Chattanooga、Tennessee、アメリカ、37403
    - Sarah Cannon Research Institute / Tennessee Oncology
  - Nashville、Tennessee、アメリカ、37203
    - Sarah Cannon Cancer Center
- Texas
  - Houston、Texas、アメリカ、77030
    - Houston Methodist Cancer Center
- Virginia
  - Bristol、Virginia、アメリカ、24201
    - Wellmont Medical Associates
  - Fredericksburg、Virginia、アメリカ、22408
    - Hematology Oncology Associates of Fredericksburg, Inc.
- Washington
  - Auburn、Washington、アメリカ、98002-4117
    - MultiCare Regional Cancer Center - Auburn
  - Everett、Washington、アメリカ、98201
    - Providence Everett Med Ctr
  - Seattle、Washington、アメリカ、98122
    - Swedish Medical Center
イギリス
- - Birmingham、イギリス、B9 5SS
    - Birmingham Heartlands Hospital
  - Colchester, Essex、イギリス、CO4 5JL
    - Colchester General Hospital
  - London、イギリス、EC1A 7BE
    - St Bartholomew's Hospital
イスラエル
- - Haifa、イスラエル、31096
    - Rambam Medical Center
  - Holon、イスラエル、58100
    - Edith Wolfson Medical Center
  - Kfar Saba、イスラエル、44281
    - Meir Medical Center
  - Petah Tikva、イスラエル、49100
    - Rabin Medical Center
  - Tel Aviv、イスラエル、64239
    - Tel Aviv Sourasky Medical Ctr
  - Tel HaShomer、イスラエル、52621
    - Chaim Sheba Medical Center
イタリア
- Abruzzo
  - Chieti、Abruzzo、イタリア、66013
    - Ospedale Clinicizzato SS Annunziata
- Friuli Venezia Giulia
  - Pordenone、Friuli Venezia Giulia、イタリア、33170
    - Azienda per l'Assistenza Sanitaria N° 5 - Friuli Occidentale
- Lazio
  - Rome、Lazio、イタリア、00128
    - Policlinico Universitario Campus Biomedico Di Roma
- Lombardy
  - Bergamo、Lombardy、イタリア、24127
    - Asst Papa Giovanni XXIII
  - Brescia、Lombardy、イタリア、25123
    - ASST Spedali Civili di Brescia
  - Milan、Lombardy、イタリア、20132
    - Ospedale San Raffaele
- Piedmont
  - Cuneo、Piedmont、イタリア、12100
    - Azienda Sanitaria Ospedaliera s. Croce e Carle
  - Novara、Piedmont、イタリア、28100
    - A.O.U. Maggiore della Carità
  - Orbassano、Piedmont、イタリア、10043
    - Azienda Sanitaria Ospedaliera S Luigi Gonzaga
  - Turin、Piedmont、イタリア、10126
    - Azienda Ospedaliera Città della Salute e della Scienza di Torino
- Sicily
  - Catania、Sicily、イタリア、95122
    - Azienda Ospedaliera Di Rilievo Nazionale E Di Alta Specializzazione Garibaldi
- Trentino-Alto Adige
  - Trento、Trentino-Alto Adige、イタリア、38100
    - Ospedale Santa Chiara
- Tuscany
  - Pisa、Tuscany、イタリア、56124
    - Azienda Ospedaliero Universitaria Pisana
- Umbria
  - Perugia、Umbria、イタリア、06132
    - Ospedale Silvestrini
- Veneto
  - Verona、Veneto、イタリア、37126
    - Azienda Ospedaliera Universitaria Integrata Verona
ウクライナ
- - Kryvyi Rih、ウクライナ、50048
    - CE Kryvyi Rih Oncology Dispensary of Dnipropetrovsk Regional Council
  - Kyiv、ウクライナ、03115
    - Kyiv City Clinical Oncological Center
  - Sumy、ウクライナ、40022
    - Regional Municipal Institution Sumy Regional Clinical Oncology Dispensary
  - Zaporizhzhya、ウクライナ、69040
    - MI Zaporizhzhia Regional Clinical Oncological Dispensary Zaporizhzhia SMU Ch of Oncology
- KIEV Governorate
  - Kropyvnytskyi、KIEV Governorate、ウクライナ、25006
    - Private Enterprise Private Manufacturing Company Acinus
  - Kyiv、KIEV Governorate、ウクライナ、02096
    - Kyiv Railway Clinical Hospital #3 of Branch Health Center of the PJSC Ukrainian Railway
  - Odesa、KIEV Governorate、ウクライナ、65055
    - Municipal Institution Odesa Regional Oncology Dispensary
- Katerynoslav Governorate
  - Dnipropetrovsk、Katerynoslav Governorate、ウクライナ、49102
    - MI Dnipropetrovsk City Multifield Clinical Hospital 4 of Dnipropetrovsk Regional Council
- Kharkiv Governorate
  - Kharkiv、Kharkiv Governorate、ウクライナ、61070
    - Communal Non profit Enterprise Regional Center of Oncology
- Poltava Governorate
  - Ivano-Frankivsk、Poltava Governorate、ウクライナ、76018
    - Municipal Institution SubCarpathian ClinicalOncological Centre
- Vinnytsia Oblast
  - Vinnytsia、Vinnytsia Oblast、ウクライナ、21018
    - Communal Nonprofit Enterprise Podilsky Regional Center Of Oncology OfTheVinnytsia Regional Council
オランダ
- - Groningen、オランダ、9728 NT
    - Martini Ziekenhuis
  - Nieuwegein、オランダ、3430 EM
    - St. Antonius Ziekenhuis Nieuwegein
- North Brabant
  - 's-Hertogenbosch、North Brabant、オランダ、5223 GZ
    - Jeroen Bosch Ziekenhuis
オーストラリア
- Queensland
  - Douglas、Queensland、オーストラリア、4814
    - Townsville Hospital
- Victoria
  - Malvern、Victoria、オーストラリア、3144
    - Cabrini Hospital Malvern
カナダ
- Ontario
  - Brampton、Ontario、カナダ、L6R 3J7
    - William Osler Health Centre
- Quebec
  - Laval、Quebec、カナダ、H7M 3L9
    - Cite de La Sante de Laval
スペイン
- - Barcelona、スペイン、08025
    - Hospital Santa Creu i Sant Pau
  - Barcelona、スペイン、08916
    - Hospital Universitari Germans Trias i Pujol
  - Barcelona、スペイン、08035
    - Vall d'Hebron Institute of Oncology (VHIO), Barcelona
  - Barcelona、スペイン、08003
    - Hospital del Mar
  - Córdoba、スペイン、14004
    - C.H. Regional Reina Sofia
  - Jaén、スペイン、23007
    - Complejo Hospitalario de Jaen
  - Lugo、スペイン、27003
    - Hospital Lucus Augusti
  - Madrid、スペイン、28046
    - Hospital Universitario La Paz
  - Madrid、スペイン、28034
    - Hospital Ramon y Cajal
  - Madrid、スペイン、28040
    - Hosp. Clinico San Carlos
  - Madrid、スペイン、28050
    - Hospital Universitario HM Sanchinarro-CIOCC
  - Valencia、スペイン、46026
    - Hospital Universitari i Politecnic La Fe de Valencia
  - Valencia、スペイン、46010
    - Hospital Clinico Universitario de Valencia
  - Zaragoza、スペイン、50009
    - Hosp Clinico Univ Lozano Blesa
- Balearic Islands
  - Palma de Mallorca、Balearic Islands、スペイン、07010
    - Hospital Universitario Son Espases
- Cantabria
  - Santander、Cantabria、スペイン、39008
    - Hospital Universitario Marques de Valdecilla
- Castellon
  - Castellon、Castellon、スペイン、12002
    - Consorcio Hospitalario Provincial de Castellon
- LA Coruna
  - A Coruña、LA Coruna、スペイン、15009
    - Centro Oncologico de Galicia COG
- Murcia
  - El Palmar、Murcia、スペイン、30120
    - Hospital Universitario Virgen de La Arrixaca
- Tenerife
  - San Cristóbal de La Laguna、Tenerife、スペイン、3820
    - Hospital Universitario de Canarias
ドイツ
- - Berlin、ドイツ、13125
    - Evang. Lungenklinik Berlin Klinik für Pneumologie
  - Braunschweig、ドイツ、38114
    - Stadtisches Klinikum Braunschweig
  - Chemnitz、ドイツ、09113
    - Klinikum Chemnitz gGmbH
  - Cologne、ドイツ、51109
    - Kliniken der Stadt Koln gGmbH
  - Frankfurt am Main、ドイツ、60488
    - Krankenhaus Nordwest
  - Großhansdorf、ドイツ、22927
    - LungenClinic Grosshansdorf GmbH
  - Halle、ドイツ、06120
    - Krankenhaus Martha-Maria
  - Hamburg、ドイツ、20246
    - Universitätsklinikum Hamburg-Eppendorf
  - Hamburg、ドイツ、21075
    - Asklepios Klinik Harburg
  - Heidelberg、ドイツ、69126
    - Thoraxklinik Heidelberg gGmbH
  - Hemer、ドイツ、58675
    - Lungenklinik Hemer
  - Homburg、ドイツ、66421
    - Universität Des Saarlandes
  - Immenhausen、ドイツ、34376
    - Fachklinik für Lungenerkrankungen
  - Karlsruhe、ドイツ、76137
    - Vincentius-Diakonissen-Kliniken gAG
  - Koblenz Am Rhein、ドイツ、56073
    - Katholisches Klinikum Marienhof
  - München、ドイツ、81925
    - Klinikum Bogenhausen
  - Münster、ドイツ、48149
    - Gemeinschaftspraxis für Hämatologie und Onkologie
  - Oldenburg、ドイツ、26121
    - Pius-Hospital Oldenburg
  - Regensburg、ドイツ、93049
    - Krankenhaus Barmherzige Bruder Regensburg
  - Velbert、ドイツ、42551
    - Praxis fur Hamatologie und internistische Onkologie
- Baden-Wurttemberg
  - Löwenstein、Baden-Wurttemberg、ドイツ、74245
    - SLK Kliniken Heilbronn GmbH, Standort Fachklinik Löwenstein
- North Rhine-Westphalia
  - Bielefeld、North Rhine-Westphalia、ドイツ、33611
    - Ev.Krankenhaus Bielefeld gGmbH
ハンガリー
- - Budapest、ハンガリー、1125
    - Semmelweis Egyetem
  - Pécs、ハンガリー、7624
    - University of Pecs, I st Dept of Internal Medicine
  - Szolnok、ハンガリー、5004
    - Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rend.Int.
  - Törökbálint、ハンガリー、2045
    - Reformatus Pulmonologiai Centrum
フランス
- - Limoges、フランス、87042
    - Hôpital Universitaire Dupuytren
  - Lyon、フランス、69373
    - Centre Léon Bérard Centre Régional de Lutte Contre Le Cancer Rhône Alpes
  - Marseille、フランス、13008
    - Hôpital Saint Joseph
  - Mont-de-Marsan、フランス、40000
    - Centre Hospitalier de Mont de Marsan - Hopital Layne
  - Montpellier、フランス、34298
    - Centre Regional de Lutte contre le Cancer Val d Aurelle - Paul Lamarque
  - Montpellier、フランス、34070
    - Clinique Clémentville
  - Nantes、フランス、44093
    - Centre René Gauducheau Centre de Lutte Contre Le Cancer Nantes Atlantique
  - Saint-Mandé、フランス、94160
    - Hopital d'Instruction des Armees de Begin
  - Saint-Pierre、フランス、97448
    - Centre Hospitalier Regional Sud Reunion
  - Saint-Quentin、フランス、02321
    - Centre Hospitalier de Saint-Quentin
  - Toulon、フランス、83000
    - Centre Hospitalier Intercommunal Toulon - La Seyne sur Mer
  - Toulon、フランス、83041
    - Hopital d Instruction des Armees de Sainte Anne
ベルギー
- - Brussels、ベルギー、1200
    - Cliniques Universitaires St-Luc
  - Liège、ベルギー、4000
    - CHU de Liège (Sart Tilman)
ポルトガル
- - Coimbra、ポルトガル、3000-602
    - Centro Hospitalar E Universitário de Coimbra EPE
  - Lisbon、ポルトガル、1769-001
    - Centro Hospitalar de Lisboa Norte E.P.E ? Hospital Pulido Valente
  - Porto、ポルトガル、4200-319
    - Hospital de Sao Joao
  - Porto、ポルトガル、4200-072
    - Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe
ポーランド
- - Otwock、ポーランド、05-400
    - Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy
  - Poznan、ポーランド、60569
    - Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu
ルーマニア
- - Craiova、ルーマニア、200542
    - Oncology Center Sf. Nectarie
ロシア
- - Novosibirsk、ロシア、630047
    - City Clinical Hospital #1
  - Volgograd、ロシア、400138
    - Volgograd Regional Clinical Oncology Dispensary
  - Yaroslavl、ロシア、150040
    - Regional Clinical Oncology Hospital
- Moscow Oblast
  - Moscovskaya Oblast、Moscow Oblast、ロシア、143423
    - Moscow City Oncology Hospital #62
  - Moscow、Moscow Oblast、ロシア、105229
    - Principal Military Clinical Hospital n.a. N.N. Burdenko
  - Moscow、Moscow Oblast、ロシア、115478
    - Russian Oncology Research Center n a N N Blokhin
- Respublika Mordoviya
  - Saransk、Respublika Mordoviya、ロシア、430032
    - Mordovia State University
- Sankt-Peterburg
  - Pushkin、Sankt-Peterburg、ロシア、196603
    - Evromedservis LCC
  - Saint Petersburg、Sankt-Peterburg、ロシア、194291
    - Leningrad Regional Clinical Hospital
  - Saint Petersburg、Sankt-Peterburg、ロシア、197758
    - GBUZ Saint Petersburg Clinical Research Center of Specialized Types of Care (Oncology)
  - Saint Petersburg、Sankt-Peterburg、ロシア、197758
    - Scientific Research Institute of Oncology n.a. N.N. Petrov
  - Saint Petersburg、Sankt-Peterburg、ロシア、197022
    - St. Petersburg Med Univ
  - Saint Petersburg、Sankt-Peterburg、ロシア、198255
    - City Clinical Oncology Dispensary
- Tatarstan Republic
  - Kazan'、Tatarstan Republic、ロシア、420029
    - Republican Clinical Oncology Dispensary of Ministry of Healthcare of Tatarstan Republic
中国
- - Beijing、中国、100142
    - Beijing Cancer Hospital
  - Beijing、中国、100021
    - Cancer Institute and Hospital Chinese Academy of Medical Sciences
  - Beijing、中国、100853
    - Chinese People's Liberation Army (PLA) General Hospital (301 Hospital)
  - Guangdong、中国、524023
    - Affiliated Hospital of Guangdong Medical University
  - Guangzhou、中国、510120
    - The First Affiliated Hospital of Guangzhou Medical University
  - Hangzhou、中国、310022
    - Zhejiang Cancer Hospital
  - Hefei、中国
    - Anhui Province Cancer Hospital
  - Shanghai、中国、200030
    - Shanghai Chest Hospital
  - Shanghai、中国、200433
    - Shanghai Pulmonary Hospital
  - Shengyang、中国、110042
    - Liaoning Provincial Cancer Hospital
  - Shenyang、中国、110001
    - First Hospital of China Medical University
  - Suzhou、中国、215006
    - First Affiliated Hospital of Soochow University
台湾
- - Changhua、台湾、500
    - Changhua Christian Hospital
  - Kaohsiung City、台湾、807
    - Kaohsiung Medical University Hospital
  - Putzui City、台湾、61363
    - Chang Gung Memorial Hospital Chiayi
  - Taichung、台湾、40705
    - Taichung Veterans General Hospital
  - Tainan、台湾、736
    - Chi Mei Medical Center Liou Ying Campus
  - Taipei、台湾、104
    - Mackay Memorial Hospital
  - Taipei、台湾、00112
    - Taipei Veterans General Hospital
  - Taipei、台湾、10048
    - National Taiwan Uni Hospital
  - Taoyuan City、台湾、333
    - Chang Gung Medical Foundation Linkou Branch
日本
- - Aichi、日本、464-8681
    - Aichi Cancer Center Hospital
  - Akashi、日本、673-0021
    - Hyogo Cancer Center
  - Bunkyō City、日本、113-8431
    - Juntendo University Hospital
  - Bunkyō City、日本、113-8677
    - Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
  - Chiba、日本、277-8577
    - National Cancer Center East
  - Chūō、日本、104-0045
    - National Cancer Center Hospital
  - Fukuoka、日本、812-8582
    - Kyushu University Hospital
  - Hiroshima、日本、734-8551
    - Hiroshima University Hospital
  - Kitaadachi-gun、日本、362-0806
    - Saitama Cancer Center
  - Kitakyushu-shi、日本、807-8555
    - Hospital of the University of Occupational and Environmental Health,Japan
  - Kumamoto、日本、860-8556
    - Kumamoto University Hospital
  - Kyoto、日本、606-8507
    - Kyoto University Hospital
  - Matsuyama、日本、791-0280
    - Shikoku Cancer Center
  - Mitaka-shi、日本、181-0004
    - Kyorin University Hospital
  - Nagoya、日本、466-8560
    - Nagoya University Hospital
  - Niigata、日本、951-8566
    - Niigata Cancer Center Hospital
  - Okayama、日本、700-8558
    - Okayama University Hospital
  - Sapporo、日本、003-0804
    - National Hospital Organization Hokkaido Cancer Center
  - Shizuoka、日本、411-8777
    - Shizuoka Cancer Center
  - Tokyo、日本、160-0023
    - Tokyo Medical University Hospital
  - Tokyo、日本、105-8470
    - Toranomon Hospital
  - Wakayama、日本、641-8510
    - Wakayama Medical University Hospital
  - Yokohama-shi, Asahi-ku、日本、241-8515
    - Kanagawa Cancer Center
- Miyagi
  - Sendai、Miyagi、日本、981-0914
    - Sendai Kousei Hospital
韓国
- - Jeonnam、韓国、519-763
    - Chonnam National University Hwasun Hospital
  - Suwon、韓国、442-723
    - The Catholic University of Korea St. Vincent's Hospital
香港
- - Shatin、香港
    - Prince of Wales Hosp

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

受講資格のある性別

全て

説明

Inclusion Criteria:

Inclusion Criteria for Enrollment Phase

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Histological or cytological diagnosis of Stage IB (tumors greater than or equal to [>/=] 4 centimeters [cm])-IIIA (T2-3 N0, T1-3 N1, T1-3 N2, T4 N0-1) NSCLC (per the Union Internationale Contre le Cancer staging system (UICC)/American Joint Committee on Cancer staging system (AJCC) staging system, 7th edition; Detterbeck et al. 2009)
Participants must have had complete resection of NSCLC 4-12 weeks (>/=28 days and less than or equal to [</=] 84 days) prior to enrollment and must be adequately recovered from surgery
If mediastinoscopy was not performed preoperatively, it is required that, at a minimum, mediastinal lymph node systematic sampling will have occurred. Systematic sampling is defined as removal of at least one representative lymph node at specified levels. MLND entails resection of all lymph nodes at those same levels. For a right thoracotomy, sampling or MLND is required at levels 4 and 7 and for a left thoracotomy, levels 5 and/or 6 and 7. Exceptions will be granted if there is clear documentation in the operative report or in a separately submitted addendum by the surgeon of exploration of the required lymph node areas, the participant will be considered eligible if no lymph nodes are found in those areas; if participants have documented N2 disease in one level (per the UICC/AJCC staging system, 7th edition; Detterbeck et al. 2009), not all levels need to be sampled; if the preoperative staging imaging results (contrast computed tomography [CT] and positron emission tomography [PET] scans) do not suggest evidence of disease in the mediastinum, the participant will be considered eligible if N2 nodal sampling is not performed per surgeon's decision
Eligible to receive a cisplatin-based chemotherapy regimen
Adequate hematologic and end-organ function
Women who are not postmenopausal (>/=12 months of non-therapy-induced amenorrhea) or surgically sterile must have a negative serum pregnancy test result within 14 days prior to initiation of cisplatin-based chemotherapy

Inclusion Criteria for Randomized Phase - Women who are not postmenopausal (>/=12 months of non-therapy-induced amenorrhea) or surgically sterile must have a negative serum pregnancy test result within 14 days prior to initiation of atezolizumab or BSC

Exclusion Criteria:

Exclusion Criteria for Enrollment Phase

Illness or condition that may interfere with a participant's capacity to understand, follow, and/or comply with study procedures
Pregnant and lactating women
Treatment with prior systemic chemotherapy: Chemotherapy for early stage of malignancy with curative intent, provided that the last dose received was more than 5 years prior to enrollment and low-dose chemotherapy for non-malignant conditions may be allowed upon approval by the Medical Monitor
Hormonal cancer therapy or radiation therapy as prior cancer treatment within 5 years before enrollment
Treatment with any other investigational agent with therapeutic intent within 28 days prior to enrollment
Participants with hearing impairment
Known sensitivity to any component of the chemotherapy regimen the participant will be assigned to, or to mannitol
Prior treatment with cluster of differentiation (CD) 137 (CD137) agonists or immune checkpoint blockade therapies, anti-programmed death-1 (PD-1), and anti programmed death ligand 1 (PD-L1) therapeutic antibodies
Malignancies other than NSCLC within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death (e.g., expected 5-year OS greater than [>] 90 percent [%]) treated with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated surgically with curative intent, ductal carcinoma in situ treated surgically with curative intent)
History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
Known hypersensitivity to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the atezolizumab formulation
History of autoimmune disease, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis
Positive test for human immunodeficiency virus (HIV)
Participants with active hepatitis B (chronic or acute; defined as having a positive hepatitis B surface antigen [HBsAg] test at screening) or hepatitis C
Active tuberculosis
Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or greater), myocardial infarction, or cerebrovascular accident within the previous 3 months, unstable arrhythmias, or unstable angina
History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan
Prior allogeneic bone marrow transplantation or solid organ transplant
Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the participant at high risk from treatment complications
Known tumor PD-L1 expression status as determined by an immunohistochemistry (IHC) assay from other clinical studies (e.g., participants whose PD-L1 expression status was determined during screening for entry into a study with anti-PD-1 or anti-PD-L1 antibodies but were not eligible are excluded)

Specific Exclusions for Pemetrexed Treatment

- Participants with squamous cell histology

Exclusion Criteria for Randomized Phase

Signs or symptoms of infection within 14 days prior to randomization (severe infection within 28 days prior to randomization), including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia
Received therapeutic oral or intravenous (IV) antibiotics within 14 days prior to randomization
Major surgical procedure within 28 days prior to randomization or anticipation of need for a major surgical procedure during the course of the study
Administration of a live, attenuated vaccine within 4 weeks prior to initiation of study treatment or anticipation that such a live attenuated vaccine will be required during the study
Treatment with systemic immunostimulatory agents (including but not limited to interferons or interleukin-2) within 4 weeks or 5 half-lives of the drug, whichever is longer, prior to randomization: Prior treatment with cancer vaccines is allowed
Treatment with systemic corticosteroids or other immunosuppressive medications (including but not limited to prednisone, dexamethasone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor [anti-TNF] agents) within 14 days prior to randomization

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）

アーム数

武器と介入

参加者グループ / アーム	介入・治療
実験的：Atezolizumab Enrollment Phase: Participants will receive four 21-day cycles of cisplatin-based chemotherapy (cisplatin plus either vinorelbine or docetaxel or gemcitabine or pemetrexed [non-squamous cell NSCLC only]), unless unacceptable toxicity, disease relapse, or participant's decision to discontinue occur. Randomization Phase: Participants will receive atezolizumab 1200 milligrams (mg) intravenously (IV) every 3 weeks (Q3W) for sixteen 21-day cycles and will undergo periodic chest X-ray and CT scan.	薬：Atezolizumab Participants will receive atezolizumab (1200 mg IV) Q3W for 16 cycles (cycle length=21 days). 他の名前： MPDL3280A;テセントリク薬：Cisplatin Participants will receive cisplatin 75 milligrams per square meter (mg/m^2) IV on Day 1 of up to four 21-day cycles. 薬：Vinorelbine Participants will receive vinorelbine 30 mg/m^2 IV on Days 1 and 8 of each of the four 21-day cycles. 薬：Docetaxel Participants will receive docetaxel 75 mg/m^2 IV on Day 1 of each of the four 21-day cycles. 薬：Gemcitabine Participants will receive gemcitabine 1250 mg/m^2 IV on Days 1 and 8 of each of the four 21-day cycles. 薬：Pemetrexed Participants will receive pemetrexed 500 mg/m^2 IV on Day 1 of each of the four 21-day cycles. Pemetrexed will be administered only in participants with non-squamous cell NSCLC.
アクティブコンパレータ：Best Supportive Care Enrollment Phase: Participants will receive four 21-day cycles of cisplatin-based chemotherapy (cisplatin plus either vinorelbine or docetaxel or gemcitabine or pemetrexed [non-squamous cell NSCLC only]), unless unacceptable toxicity, disease relapse, or participant's decision to discontinue occur. Randomization Phase: After enrollment phase participants will receive only the best supportive care and will undergo periodic chest X-ray and CT scan.	薬：Cisplatin Participants will receive cisplatin 75 milligrams per square meter (mg/m^2) IV on Day 1 of up to four 21-day cycles. 薬：Vinorelbine Participants will receive vinorelbine 30 mg/m^2 IV on Days 1 and 8 of each of the four 21-day cycles. 薬：Docetaxel Participants will receive docetaxel 75 mg/m^2 IV on Day 1 of each of the four 21-day cycles. 薬：Gemcitabine Participants will receive gemcitabine 1250 mg/m^2 IV on Days 1 and 8 of each of the four 21-day cycles. 薬：Pemetrexed Participants will receive pemetrexed 500 mg/m^2 IV on Day 1 of each of the four 21-day cycles. Pemetrexed will be administered only in participants with non-squamous cell NSCLC.

参加者グループ / アーム

介入・治療

実験的：Atezolizumab

Enrollment Phase: Participants will receive four 21-day cycles of cisplatin-based chemotherapy (cisplatin plus either vinorelbine or docetaxel or gemcitabine or pemetrexed [non-squamous cell NSCLC only]), unless unacceptable toxicity, disease relapse, or participant's decision to discontinue occur. Randomization Phase: Participants will receive atezolizumab 1200 milligrams (mg) intravenously (IV) every 3 weeks (Q3W) for sixteen 21-day cycles and will undergo periodic chest X-ray and CT scan.

薬：Atezolizumab

Participants will receive atezolizumab (1200 mg IV) Q3W for 16 cycles (cycle length=21 days).

他の名前：

MPDL3280A;テセントリク

薬：Cisplatin

Participants will receive cisplatin 75 milligrams per square meter (mg/m^2) IV on Day 1 of up to four 21-day cycles.

薬：Vinorelbine

Participants will receive vinorelbine 30 mg/m^2 IV on Days 1 and 8 of each of the four 21-day cycles.

薬：Docetaxel

Participants will receive docetaxel 75 mg/m^2 IV on Day 1 of each of the four 21-day cycles.

薬：Gemcitabine

Participants will receive gemcitabine 1250 mg/m^2 IV on Days 1 and 8 of each of the four 21-day cycles.

薬：Pemetrexed

Participants will receive pemetrexed 500 mg/m^2 IV on Day 1 of each of the four 21-day cycles. Pemetrexed will be administered only in participants with non-squamous cell NSCLC.

アクティブコンパレータ：Best Supportive Care

Enrollment Phase: Participants will receive four 21-day cycles of cisplatin-based chemotherapy (cisplatin plus either vinorelbine or docetaxel or gemcitabine or pemetrexed [non-squamous cell NSCLC only]), unless unacceptable toxicity, disease relapse, or participant's decision to discontinue occur. Randomization Phase: After enrollment phase participants will receive only the best supportive care and will undergo periodic chest X-ray and CT scan.

薬：Cisplatin

Participants will receive cisplatin 75 milligrams per square meter (mg/m^2) IV on Day 1 of up to four 21-day cycles.

薬：Vinorelbine

Participants will receive vinorelbine 30 mg/m^2 IV on Days 1 and 8 of each of the four 21-day cycles.

薬：Docetaxel

Participants will receive docetaxel 75 mg/m^2 IV on Day 1 of each of the four 21-day cycles.

薬：Gemcitabine

Participants will receive gemcitabine 1250 mg/m^2 IV on Days 1 and 8 of each of the four 21-day cycles.

薬：Pemetrexed

Participants will receive pemetrexed 500 mg/m^2 IV on Day 1 of each of the four 21-day cycles. Pemetrexed will be administered only in participants with non-squamous cell NSCLC.

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
Disease-Free Survival (DFS) in Intent-to-treat (ITT) Population 時間枠：Up to 95 months	DFS was defined as the time from randomization to the first recurrence of NSCLC or occurrence of new primary NSCLC as determined by the investigator or death, whichever occurs first. Kaplan-Meier methodology was used to estimate the median DFS for each treatment arm.	Up to 95 months
DFS in All Randomized Stage II-IIIA Population 時間枠：Up to 95 months	DFS was defined as the time from randomization to the first recurrence of NSCLC or occurrence of new primary NSCLC as determined by the investigator or death, whichever occurs first. DFS was analyzed in participants with disease stage II-IIIA. Kaplan-Meier methodology was used to estimate the median DFS for each treatment arm.	Up to 95 months
DFS in the Programmed Death-ligand 1 (PD-L1) SP263 ≥ 1% Tumor Cell (TC) Subpopulation Within the Stage II-IIIA Population 時間枠：Up to 95 months	DFS was defined as the time from randomization to the first recurrence of NSCLC or occurrence of new primary NSCLC as determined by the investigator or death, whichever occurs first. DFS was analyzed in PD-L1 ≥1% subpopulation within the Stage II-IIIA population. Kaplan-Meier methodology was used to estimate the median DFS for each treatment arm.	Up to 95 months

二次結果の測定

結果測定	メジャーの説明	時間枠
アテゾリズマブの最大血漿濃度（CMAX）時間枠：サイクル1の1日目の灌流後30分（サイクル長= 21日）		サイクル1の1日目の灌流後30分（サイクル長= 21日）
アテゾリズマブの投与間隔内の定常状態での最小血清濃度（CMIN）時間枠：サイクル1、2、3、4、8、16（サイクルの長さ= 21日）の1日目の1日目、研究中止訪問（最大12か月）、アテゾリズマブの最後の量（最大16か月）の120日目		サイクル1、2、3、4、8、16（サイクルの長さ= 21日）の1日目の1日目、研究中止訪問（最大12か月）、アテゾリズマブの最後の量（最大16か月）の120日目
Overall Survival (OS) in the ITT Population 時間枠：Baseline up to death from any cause (up to approximately 126 months)	OS was defined as the time from randomization to death from any cause.	Baseline up to death from any cause (up to approximately 126 months)
Disease-free Rate at Year 3 in ITT Population 時間枠：Year 3	DFS rate was defined as percentage of participants who were disease-free at Year 3. The DFS rate was estimated by the Kaplan-Meier methodology for each treatment arm. Percentages have been rounded off to the nearest decimal.	Year 3
Disease-free Rate at Year 3 in All Randomized Stage II-IIIA Population 時間枠：Year 3	DFS rate was defined as percentage of participants who were disease-free at Year 3. DFS rate was analyzed in participants with disease stage II-IIIA. The DFS rate was estimated by the Kaplan-Meier methodology for each treatment arm. Percentages have been rounded off to the nearest decimal.	Year 3
Disease-free Rate at Year 3 in PD-L1 (SP263 ≥ 1% TC) Subpopulation Within the Stage II-IIIA Population 時間枠：Year 3	DFS rate was defined as percentage of participants who were disease-free at Year 3. DFS rate was analyzed in PD-L1 subpopulation within the Stage II-IIIA population. The DFS rate was estimated by the Kaplan-Meier methodology for each treatment arm. Percentages have been rounded off to the nearest decimal.	Year 3
Disease-free Rate at Year 5 in ITT Population 時間枠：Year 5	DFS rate was defined as percentage of participants who were disease-free at Year 5. The DFS rate was estimated by the Kaplan-Meier methodology for each treatment arm. Percentages have been rounded off to the nearest decimal.	Year 5
Disease-free Rate at Year 5 in All Randomized Stage II-IIIA Population 時間枠：Year 5	DFS rate was defined as percentage of participants who were disease-free at Year 5. DFS rate was analyzed in participants with disease stage II-IIIA. The DFS rate was estimated by the Kaplan-Meier methodology for each treatment arm. Percentages have been rounded off to the nearest decimal.	Year 5
Disease-free Rate at Year 5 in PD-L1 (SP263 ≥ 1% TC) Subpopulation Within the Stage II-IIIA Population 時間枠：Year 5	DFS rate was defined as percentage of participants who were disease-free at Year 5. DFS rate was analyzed in PD-L1 subpopulation within the Stage II-IIIA population. The DFS rate was estimated by the Kaplan-Meier methodology for each treatment arm. Percentages have been rounded off to the nearest decimal.	Year 5
DFS in the PD-L1 (SP263 ≥ 50% TC) Subpopulation Within the Stage II-IIIA Population 時間枠：Up to 95 months	DFS was defined as the time from randomization to the first recurrence of NSCLC or occurrence of new primary NSCLC as determined by the investigator or death, whichever occurs first. DFS was analyzed in PD-L1 subpopulation within the Stage II-IIIA population. Kaplan-Meier methodology was used to estimate the median DFS for each treatment arm.	Up to 95 months
Percentage of Participants With Adverse Events (AEs) 時間枠：Up to 12 years	An AE is any untoward medical occurrence in a participant when administered a pharmaceutical product regardless of the causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom/disease temporally associated with the use of an investigational product, whether or not considered related to the investigational product.	Up to 12 years
Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Atezolizumab 時間枠：Predose (Hour 0) on Day 1 of Cycles 2, 3, 4, 8, 16 (Cycle length = 21 days), at treatment discontinuation (TD) (up to 12 months), 120 days after last atezolizumab administration (up to 16 months)	The percentage of ATA (Also called anti-drug antibodies (ADA))-positive participants after drug administration were determined for participants exposed to atezolizumab. For determining post-baseline incidence, participants were considered to be ADA-positive if they were ADA-negative or had missing data at baseline but developed an ADA response following study drug exposure, or if they were ADA-positive at baseline and the titer of 1 or more post-baseline samples was at least 0.60 titer units (t.u.) greater than the baseline titer result.	Predose (Hour 0) on Day 1 of Cycles 2, 3, 4, 8, 16 (Cycle length = 21 days), at treatment discontinuation (TD) (up to 12 months), 120 days after last atezolizumab administration (up to 16 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

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

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)

2015年10月31日

一次修了 (実際)

2024年1月26日

研究の完了 (実際)

2026年8月26日

試験登録日

最初に提出

2015年6月4日

QC基準を満たした最初の提出物

2015年6月26日

最初の投稿 (推定)

2015年7月1日

学習記録の更新

投稿された最後の更新 (実際)

2026年9月30日

QC基準を満たした最後の更新が送信されました

2026年9月7日

最終確認日

2026年9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

GO29527
2014 (米国 NIH グラント/契約)
2014-003205-15 (EudraCT番号)
2023-505981-26-00 (レジストリ識別子：CTIS (EU))
2023 (米国 NIH グラント/契約)

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

For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing

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。

肺がん患者における化学療法後の最善の支持療法と比較したアテゾリズマブ (MPDL3280A) の安全性と有効性を評価する研究 [IMpower010]

IB-IIIA期の非小細胞細胞を完全切除した患者を対象に、アテゾリズマブ（抗PD-L1抗体）の有効性と安全性を、補助シスプラチンベースの化学療法後の最良の支持療法と比較して調査する第III相、非盲検、無作為化試験肺癌

調査の概要

状態

条件

介入・治療

研究の種類

入学 (実際)

段階

連絡先と場所

研究場所

参加基準

適格基準

就学可能な年齢

健康ボランティアの受け入れ

受講資格のある性別

説明

研究計画

研究はどのように設計されていますか？

デザインの詳細

アーム数

武器と介入

参加者グループ / アーム

介入・治療

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

二次結果の測定

結果測定

メジャーの説明

時間枠

協力者と研究者

スポンサー

捜査官

出版物と役立つリンク

一般刊行物

研究記録日

主要日程の研究

研究開始 (実際)

一次修了 (実際)

研究の完了 (実際)

試験登録日

最初に提出

QC基準を満たした最初の提出物

最初の投稿 (推定)

学習記録の更新

投稿された最後の更新 (実際)

QC基準を満たした最後の更新が送信されました

最終確認日

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

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?

IPD プランの説明