폐암 환자에서 화학 요법 후 최상의 지지 요법과 비교하여 Atezolizumab(MPDL3280A)의 안전성 및 효능을 평가하기 위한 연구 [IMpower010]
완전히 절제된 IB-IIIA기 비소세포 환자에서 보조 시스플라틴 기반 화학 요법 후 최상의 지지 요법과 비교하여 Atezolizumab(항-PD-L1 항체)의 효능 및 안전성을 조사하기 위한 3상 공개 라벨 무작위 연구 폐암
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.
연구 개요
상태
정황
연구 유형
등록 (실제)
단계
- 3단계
연락처 및 위치
연구 장소
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Groningen, 네덜란드, 9728 NT
- Martini Ziekenhuis
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Nieuwegein, 네덜란드, 3430 EM
- St. Antonius Ziekenhuis Nieuwegein
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North Brabant
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's-Hertogenbosch, North Brabant, 네덜란드, 5223 GZ
- Jeroen Bosch Ziekenhuis
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Changhua, 대만, 500
- Changhua Christian Hospital
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Kaohsiung City, 대만, 807
- Kaohsiung Medical University Hospital
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Putzui City, 대만, 61363
- Chang Gung Memorial Hospital Chiayi
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Taichung, 대만, 40705
- Taichung Veterans General Hospital
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Tainan, 대만, 736
- Chi Mei Medical Center Liou Ying Campus
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Taipei, 대만, 104
- Mackay Memorial Hospital
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Taipei, 대만, 00112
- Taipei Veterans General Hospital
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Taipei, 대만, 10048
- National Taiwan Uni Hospital
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Taoyuan City, 대만, 333
- Chang Gung Medical Foundation Linkou Branch
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Jeonnam, 대한민국, 519-763
- Chonnam National University Hwasun Hospital
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Suwon, 대한민국, 442-723
- The Catholic University of Korea St. Vincent's Hospital
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Berlin, 독일, 13125
- Evang. Lungenklinik Berlin Klinik für Pneumologie
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Braunschweig, 독일, 38114
- Stadtisches Klinikum Braunschweig
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Chemnitz, 독일, 09113
- Klinikum Chemnitz gGmbH
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Cologne, 독일, 51109
- Kliniken der Stadt Koln gGmbH
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Frankfurt am Main, 독일, 60488
- Krankenhaus Nordwest
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Großhansdorf, 독일, 22927
- LungenClinic Grosshansdorf GmbH
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Halle, 독일, 06120
- Krankenhaus Martha-Maria
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Hamburg, 독일, 20246
- Universitätsklinikum Hamburg-Eppendorf
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Hamburg, 독일, 21075
- Asklepios Klinik Harburg
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Heidelberg, 독일, 69126
- Thoraxklinik Heidelberg gGmbH
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Hemer, 독일, 58675
- Lungenklinik Hemer
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Homburg, 독일, 66421
- Universität Des Saarlandes
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Immenhausen, 독일, 34376
- Fachklinik für Lungenerkrankungen
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Karlsruhe, 독일, 76137
- Vincentius-Diakonissen-Kliniken gAG
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Koblenz Am Rhein, 독일, 56073
- Katholisches Klinikum Marienhof
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München, 독일, 81925
- Klinikum Bogenhausen
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Münster, 독일, 48149
- Gemeinschaftspraxis für Hämatologie und Onkologie
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Oldenburg, 독일, 26121
- Pius-Hospital Oldenburg
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Regensburg, 독일, 93049
- Krankenhaus Barmherzige Bruder Regensburg
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Velbert, 독일, 42551
- Praxis fur Hamatologie und internistische Onkologie
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Baden-Wurttemberg
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Löwenstein, Baden-Wurttemberg, 독일, 74245
- SLK Kliniken Heilbronn GmbH, Standort Fachklinik Löwenstein
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North Rhine-Westphalia
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Bielefeld, North Rhine-Westphalia, 독일, 33611
- Ev.Krankenhaus Bielefeld gGmbH
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-
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Novosibirsk, 러시아 제국, 630047
- City Clinical Hospital #1
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Volgograd, 러시아 제국, 400138
- Volgograd Regional Clinical Oncology Dispensary
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Yaroslavl, 러시아 제국, 150040
- Regional Clinical Oncology Hospital
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Moscow Oblast
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Moscovskaya Oblast, Moscow Oblast, 러시아 제국, 143423
- Moscow City Oncology Hospital #62
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Moscow, Moscow Oblast, 러시아 제국, 105229
- Principal Military Clinical Hospital n.a. N.N. Burdenko
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Moscow, Moscow Oblast, 러시아 제국, 115478
- Russian Oncology Research Center n a N N Blokhin
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Respublika Mordoviya
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Saransk, Respublika Mordoviya, 러시아 제국, 430032
- Mordovia State University
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Sankt-Peterburg
-
Pushkin, Sankt-Peterburg, 러시아 제국, 196603
- Evromedservis LCC
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Saint Petersburg, Sankt-Peterburg, 러시아 제국, 194291
- Leningrad Regional Clinical Hospital
-
Saint Petersburg, Sankt-Peterburg, 러시아 제국, 197758
- GBUZ Saint Petersburg Clinical Research Center of Specialized Types of Care (Oncology)
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Saint Petersburg, Sankt-Peterburg, 러시아 제국, 197758
- Scientific Research Institute of Oncology n.a. N.N. Petrov
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Saint Petersburg, Sankt-Peterburg, 러시아 제국, 197022
- St. Petersburg Med Univ
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Saint Petersburg, Sankt-Peterburg, 러시아 제국, 198255
- City Clinical Oncology Dispensary
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Tatarstan Republic
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Kazan', Tatarstan Republic, 러시아 제국, 420029
- Republican Clinical Oncology Dispensary of Ministry of Healthcare of Tatarstan Republic
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-
-
-
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Craiova, 루마니아, 200542
- Oncology Center Sf. Nectarie
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-
-
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Arkansas
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Fayetteville, Arkansas, 미국, 72703
- Highlands Oncology Group
-
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California
-
Encinitas, California, 미국, 92024
- California Cancer Associates for Research & Excellence, Inc.
-
Fountain Valley, California, 미국, 92708
- Compassionate Cancer Care Medical Group, Inc
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Los Angeles, California, 미국, 90024
- University of California Los Angeles
-
Los Angeles, California, 미국, 90027
- Southern California Permanente Medical Group Bellflower
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Stanford, California, 미국, 94305
- Stanford University
-
Vallejo, California, 미국, 94589
- Kaiser Permanente
-
Walnut Creek, California, 미국, 94596
- Kaiser Permanente - Walnut Creek
-
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Connecticut
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Norwich, Connecticut, 미국, 06360
- Eastern Connecticut Hematology and Oncology Associates
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Florida
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Boca Raton, Florida, 미국, 33486
- Lynn Cancer Institute - West
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Deerfield Beach, Florida, 미국, 33442
- University of Miami School of Medicine - Sylvester at Deerfield
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Fort Lauderdale, Florida, 미국, 33308
- Holy Cross Hospital Inc
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Fort Myers, Florida, 미국, 33916
- Florida Cancer Specialists-Broadway, Fort Myers
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St. Petersburg, Florida, 미국, 33705
- SCRI Florida Cancer Specialists North
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Georgia
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Marietta, Georgia, 미국, 30060
- Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital
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Thomasville, Georgia, 미국, 31792
- Lewis Hall Singletary Oncology Center
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Illinois
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Chicago, Illinois, 미국, 60612
- University of Illinois at Chicago
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Chicago, Illinois, 미국, 60612
- Rush University Medical Center
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Peoria, Illinois, 미국, 61615
- Illinois Cancer Care
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Springfield, Illinois, 미국, 62794
- Southern Illinois University, Simmons Cancer Institute
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Kentucky
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Louisville, Kentucky, 미국, 40402
- Norton Cancer Institute
-
-
Missouri
-
Kansas City, Missouri, 미국, 64111
- St. Luke's Cancer Institute
-
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Nevada
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Henderson, Nevada, 미국, 89052
- Comprehensive Cancer Centers of Nevada
-
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New Jersey
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Florham Park, New Jersey, 미국, 07932
- Hematology Oncology Associates of Northern New Jersey
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Livingston, New Jersey, 미국, 07039
- Saint Barnabas Medical Center
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Paramus, New Jersey, 미국, 07652
- Valley Hospital
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Summit, New Jersey, 미국, 07901
- Overlook Medical Center
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New York
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Lake Success, New York, 미국, 11042
- Clinical Research Alliance
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New York, New York, 미국, 10065
- Weill Cornell Medical College
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North Carolina
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Charlotte, North Carolina, 미국, 28204
- Presbyterian Hospital
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Ohio
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Cincinnati, Ohio, 미국, 45219
- University of Cincinnati
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Cincinnati, Ohio, 미국, 45242
- Oncology Hematology Care - SCRI
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Oregon
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Portland, Oregon, 미국, 97239
- Oregon Health and Science University
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Pennsylvania
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Harrisburg, Pennsylvania, 미국, 17109
- Pinnacle Health
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Pittsburgh, Pennsylvania, 미국, 15212
- AHN Cancer Institute ? Allegheny General Hospital
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Rhode Island
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Providence, Rhode Island, 미국, 02903
- Rhode Island Hospital
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Tennessee
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Chattanooga, Tennessee, 미국, 37403
- University Oncology Associates
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Chattanooga, Tennessee, 미국, 37403
- Sarah Cannon Research Institute / Tennessee Oncology
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Nashville, Tennessee, 미국, 37203
- Sarah Cannon Cancer Center
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Texas
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Houston, Texas, 미국, 77030
- Houston Methodist Cancer Center
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Virginia
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Bristol, Virginia, 미국, 24201
- Wellmont Medical Associates
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Fredericksburg, Virginia, 미국, 22408
- Hematology Oncology Associates of Fredericksburg, Inc.
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Washington
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Auburn, Washington, 미국, 98002-4117
- MultiCare Regional Cancer Center - Auburn
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Everett, Washington, 미국, 98201
- Providence Everett Med Ctr
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Seattle, Washington, 미국, 98122
- Swedish Medical Center
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-
-
-
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Brussels, 벨기에, 1200
- Cliniques Universitaires St-Luc
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Liège, 벨기에, 4000
- CHU de Liège (Sart Tilman)
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-
-
-
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Barcelona, 스페인, 08025
- Hospital Santa Creu i Sant Pau
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Barcelona, 스페인, 08916
- Hospital Universitari Germans Trias i Pujol
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Barcelona, 스페인, 08035
- Vall d'Hebron Institute of Oncology (VHIO), Barcelona
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Barcelona, 스페인, 08003
- Hospital del Mar
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Córdoba, 스페인, 14004
- C.H. Regional Reina Sofia
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Jaén, 스페인, 23007
- Complejo Hospitalario de Jaen
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Lugo, 스페인, 27003
- Hospital Lucus Augusti
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Madrid, 스페인, 28046
- Hospital Universitario La Paz
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Madrid, 스페인, 28034
- Hospital Ramon y Cajal
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Madrid, 스페인, 28040
- Hosp. Clinico San Carlos
-
Madrid, 스페인, 28050
- Hospital Universitario HM Sanchinarro-CIOCC
-
Valencia, 스페인, 46026
- Hospital Universitari i Politecnic La Fe de Valencia
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Valencia, 스페인, 46010
- Hospital Clinico Universitario de Valencia
-
Zaragoza, 스페인, 50009
- Hosp Clinico Univ Lozano Blesa
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-
Balearic Islands
-
Palma de Mallorca, Balearic Islands, 스페인, 07010
- Hospital Universitario Son Espases
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-
Cantabria
-
Santander, Cantabria, 스페인, 39008
- Hospital Universitario Marques de Valdecilla
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Castellon
-
Castellon, Castellon, 스페인, 12002
- Consorcio Hospitalario Provincial de Castellon
-
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LA Coruna
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A Coruña, LA Coruna, 스페인, 15009
- Centro Oncologico de Galicia COG
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Murcia
-
El Palmar, Murcia, 스페인, 30120
- Hospital Universitario Virgen de La Arrixaca
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Tenerife
-
San Cristóbal de La Laguna, Tenerife, 스페인, 3820
- Hospital Universitario de Canarias
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-
-
-
-
Birmingham, 영국, B9 5SS
- Birmingham Heartlands Hospital
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Colchester, Essex, 영국, CO4 5JL
- Colchester General Hospital
-
London, 영국, EC1A 7BE
- St Bartholomew's Hospital
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-
-
-
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Kryvyi Rih, 우크라이나, 50048
- CE Kryvyi Rih Oncology Dispensary of Dnipropetrovsk Regional Council
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Kyiv, 우크라이나, 03115
- Kyiv City Clinical Oncological Center
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Sumy, 우크라이나, 40022
- Regional Municipal Institution Sumy Regional Clinical Oncology Dispensary
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Zaporizhzhya, 우크라이나, 69040
- MI Zaporizhzhia Regional Clinical Oncological Dispensary Zaporizhzhia SMU Ch of Oncology
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-
KIEV Governorate
-
Kropyvnytskyi, KIEV Governorate, 우크라이나, 25006
- Private Enterprise Private Manufacturing Company Acinus
-
Kyiv, KIEV Governorate, 우크라이나, 02096
- Kyiv Railway Clinical Hospital #3 of Branch Health Center of the PJSC Ukrainian Railway
-
Odesa, KIEV Governorate, 우크라이나, 65055
- Municipal Institution Odesa Regional Oncology Dispensary
-
-
Katerynoslav Governorate
-
Dnipropetrovsk, Katerynoslav Governorate, 우크라이나, 49102
- MI Dnipropetrovsk City Multifield Clinical Hospital 4 of Dnipropetrovsk Regional Council
-
-
Kharkiv Governorate
-
Kharkiv, Kharkiv Governorate, 우크라이나, 61070
- Communal Non profit Enterprise Regional Center of Oncology
-
-
Poltava Governorate
-
Ivano-Frankivsk, Poltava Governorate, 우크라이나, 76018
- Municipal Institution SubCarpathian ClinicalOncological Centre
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Vinnytsia Oblast
-
Vinnytsia, Vinnytsia Oblast, 우크라이나, 21018
- Communal Nonprofit Enterprise Podilsky Regional Center Of Oncology OfTheVinnytsia Regional Council
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-
-
-
-
Haifa, 이스라엘, 31096
- Rambam Medical Center
-
Holon, 이스라엘, 58100
- Edith Wolfson Medical Center
-
Kfar Saba, 이스라엘, 44281
- Meir Medical Center
-
Petah Tikva, 이스라엘, 49100
- Rabin Medical Center
-
Tel Aviv, 이스라엘, 64239
- Tel Aviv Sourasky Medical Ctr
-
Tel HaShomer, 이스라엘, 52621
- Chaim Sheba Medical Center
-
-
-
-
Abruzzo
-
Chieti, Abruzzo, 이탈리아, 66013
- Ospedale Clinicizzato SS Annunziata
-
-
Friuli Venezia Giulia
-
Pordenone, Friuli Venezia Giulia, 이탈리아, 33170
- Azienda per l'Assistenza Sanitaria N° 5 - Friuli Occidentale
-
-
Lazio
-
Rome, Lazio, 이탈리아, 00128
- Policlinico Universitario Campus Biomedico Di Roma
-
-
Lombardy
-
Bergamo, Lombardy, 이탈리아, 24127
- Asst Papa Giovanni XXIII
-
Brescia, Lombardy, 이탈리아, 25123
- ASST Spedali Civili di Brescia
-
Milan, Lombardy, 이탈리아, 20132
- Ospedale San Raffaele
-
-
Piedmont
-
Cuneo, Piedmont, 이탈리아, 12100
- Azienda Sanitaria Ospedaliera s. Croce e Carle
-
Novara, Piedmont, 이탈리아, 28100
- A.O.U. Maggiore della Carità
-
Orbassano, Piedmont, 이탈리아, 10043
- Azienda Sanitaria Ospedaliera S Luigi Gonzaga
-
Turin, Piedmont, 이탈리아, 10126
- Azienda Ospedaliera Città della Salute e della Scienza di Torino
-
-
Sicily
-
Catania, Sicily, 이탈리아, 95122
- Azienda Ospedaliera Di Rilievo Nazionale E Di Alta Specializzazione Garibaldi
-
-
Trentino-Alto Adige
-
Trento, Trentino-Alto Adige, 이탈리아, 38100
- Ospedale Santa Chiara
-
-
Tuscany
-
Pisa, Tuscany, 이탈리아, 56124
- Azienda Ospedaliero Universitaria Pisana
-
-
Umbria
-
Perugia, Umbria, 이탈리아, 06132
- Ospedale Silvestrini
-
-
Veneto
-
Verona, Veneto, 이탈리아, 37126
- Azienda Ospedaliera Universitaria Integrata Verona
-
-
-
-
-
Aichi, 일본, 464-8681
- Aichi Cancer Center Hospital
-
Akashi, 일본, 673-0021
- Hyogo Cancer Center
-
Bunkyō City, 일본, 113-8431
- Juntendo University Hospital
-
Bunkyō City, 일본, 113-8677
- Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
-
Chiba, 일본, 277-8577
- National Cancer Center East
-
Chūō, 일본, 104-0045
- National Cancer Center Hospital
-
Fukuoka, 일본, 812-8582
- Kyushu University Hospital
-
Hiroshima, 일본, 734-8551
- Hiroshima University Hospital
-
Kitaadachi-gun, 일본, 362-0806
- Saitama Cancer Center
-
Kitakyushu-shi, 일본, 807-8555
- Hospital of the University of Occupational and Environmental Health,Japan
-
Kumamoto, 일본, 860-8556
- Kumamoto University Hospital
-
Kyoto, 일본, 606-8507
- Kyoto University Hospital
-
Matsuyama, 일본, 791-0280
- Shikoku Cancer Center
-
Mitaka-shi, 일본, 181-0004
- Kyorin University Hospital
-
Nagoya, 일본, 466-8560
- Nagoya University Hospital
-
Niigata, 일본, 951-8566
- Niigata Cancer Center Hospital
-
Okayama, 일본, 700-8558
- Okayama University Hospital
-
Sapporo, 일본, 003-0804
- National Hospital Organization Hokkaido Cancer Center
-
Shizuoka, 일본, 411-8777
- Shizuoka Cancer Center
-
Tokyo, 일본, 160-0023
- Tokyo Medical University Hospital
-
Tokyo, 일본, 105-8470
- Toranomon Hospital
-
Wakayama, 일본, 641-8510
- Wakayama Medical University Hospital
-
Yokohama-shi, Asahi-ku, 일본, 241-8515
- Kanagawa Cancer Center
-
-
Miyagi
-
Sendai, Miyagi, 일본, 981-0914
- Sendai Kousei Hospital
-
-
-
-
-
Beijing, 중국, 100142
- Beijing Cancer Hospital
-
Beijing, 중국, 100021
- Cancer Institute and Hospital Chinese Academy of Medical Sciences
-
Beijing, 중국, 100853
- Chinese People's Liberation Army (PLA) General Hospital (301 Hospital)
-
Guangdong, 중국, 524023
- Affiliated Hospital of Guangdong Medical University
-
Guangzhou, 중국, 510120
- The First Affiliated Hospital of Guangzhou Medical University
-
Hangzhou, 중국, 310022
- Zhejiang Cancer Hospital
-
Hefei, 중국
- Anhui Province Cancer Hospital
-
Shanghai, 중국, 200030
- Shanghai Chest Hospital
-
Shanghai, 중국, 200433
- Shanghai Pulmonary Hospital
-
Shengyang, 중국, 110042
- Liaoning Provincial Cancer Hospital
-
Shenyang, 중국, 110001
- First Hospital of China Medical University
-
Suzhou, 중국, 215006
- First Affiliated Hospital of Soochow University
-
-
-
-
Ontario
-
Brampton, Ontario, 캐나다, L6R 3J7
- William Osler Health Centre
-
-
Quebec
-
Laval, Quebec, 캐나다, H7M 3L9
- Cite de La Sante de Laval
-
-
-
-
-
Coimbra, 포르투갈, 3000-602
- Centro Hospitalar E Universitário de Coimbra EPE
-
Lisbon, 포르투갈, 1769-001
- Centro Hospitalar de Lisboa Norte E.P.E ? Hospital Pulido Valente
-
Porto, 포르투갈, 4200-319
- Hospital de Sao Joao
-
Porto, 포르투갈, 4200-072
- Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe
-
-
-
-
-
Otwock, 폴란드, 05-400
- Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy
-
Poznan, 폴란드, 60569
- Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu
-
-
-
-
-
Limoges, 프랑스, 87042
- Hôpital Universitaire Dupuytren
-
Lyon, 프랑스, 69373
- Centre Léon Bérard Centre Régional de Lutte Contre Le Cancer Rhône Alpes
-
Marseille, 프랑스, 13008
- Hôpital Saint Joseph
-
Mont-de-Marsan, 프랑스, 40000
- Centre Hospitalier de Mont de Marsan - Hopital Layne
-
Montpellier, 프랑스, 34298
- Centre Regional de Lutte contre le Cancer Val d Aurelle - Paul Lamarque
-
Montpellier, 프랑스, 34070
- Clinique Clémentville
-
Nantes, 프랑스, 44093
- Centre René Gauducheau Centre de Lutte Contre Le Cancer Nantes Atlantique
-
Saint-Mandé, 프랑스, 94160
- Hopital d'Instruction des Armees de Begin
-
Saint-Pierre, 프랑스, 97448
- Centre Hospitalier Regional Sud Reunion
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Saint-Quentin, 프랑스, 02321
- Centre Hospitalier de Saint-Quentin
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Toulon, 프랑스, 83000
- Centre Hospitalier Intercommunal Toulon - La Seyne sur Mer
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Toulon, 프랑스, 83041
- Hopital d Instruction des Armees de Sainte Anne
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Budapest, 헝가리, 1125
- Semmelweis Egyetem
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Pécs, 헝가리, 7624
- University of Pecs, I st Dept of Internal Medicine
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Szolnok, 헝가리, 5004
- Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rend.Int.
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Törökbálint, 헝가리, 2045
- Reformatus Pulmonologiai Centrum
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Queensland
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Douglas, Queensland, 호주, 4814
- Townsville Hospital
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Victoria
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Malvern, Victoria, 호주, 3144
- Cabrini Hospital Malvern
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Shatin, 홍콩
- Prince of Wales Hosp
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 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. |
Participants will receive atezolizumab (1200 mg IV) Q3W for 16 cycles (cycle length=21 days).
다른 이름들:
Participants will receive cisplatin 75 milligrams per square meter (mg/m^2) IV on Day 1 of up to four 21-day cycles. Participants will receive vinorelbine 30 mg/m^2 IV on Days 1 and 8 of each of the four 21-day cycles. Participants will receive docetaxel 75 mg/m^2 IV on Day 1 of each of the four 21-day cycles. Participants will receive gemcitabine 1250 mg/m^2 IV on Days 1 and 8 of each of the four 21-day cycles. 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. |
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활성 비교기: 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. |
Participants will receive cisplatin 75 milligrams per square meter (mg/m^2) IV on Day 1 of up to four 21-day cycles. Participants will receive vinorelbine 30 mg/m^2 IV on Days 1 and 8 of each of the four 21-day cycles. Participants will receive docetaxel 75 mg/m^2 IV on Day 1 of each of the four 21-day cycles. Participants will receive gemcitabine 1250 mg/m^2 IV on Days 1 and 8 of each of the four 21-day cycles. 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. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Disease-Free Survival (DFS) in Intent-to-treat (ITT) Population
기간: 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
기간: 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
기간: 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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
아테 졸리 주맙의 최대 혈장 농도 (CMAX)
기간: 사이클 1의 1 일차에 감독 후 30 분 (사이클 길이 = 21 일)
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사이클 1의 1 일차에 감독 후 30 분 (사이클 길이 = 21 일)
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Atezolizumab의 투여 간격 내에서 정상 상태에서 최소 혈청 농도 (CMIN)
기간: 주기 1, 2, 3, 4, 8, 16 (사이클 길이 = 21 일)의 1 일차 주입 전, 연구 중단 방문 (최대 12 개월), 120 일은 아테 졸리 주맙의 마지막 복용량 (최대 16 개월)
|
주기 1, 2, 3, 4, 8, 16 (사이클 길이 = 21 일)의 1 일차 주입 전, 연구 중단 방문 (최대 12 개월), 120 일은 아테 졸리 주맙의 마지막 복용량 (최대 16 개월)
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Overall Survival (OS) in the ITT Population
기간: Baseline up to death from any cause (up to approximately 126 months)
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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)
|
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Disease-free Rate at Year 3 in ITT Population
기간: Year 3
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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
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Disease-free Rate at Year 3 in All Randomized Stage II-IIIA Population
기간: 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
|
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Disease-free Rate at Year 3 in PD-L1 (SP263 ≥ 1% TC) Subpopulation Within the Stage II-IIIA Population
기간: 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
기간: 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
|
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Disease-free Rate at Year 5 in All Randomized Stage II-IIIA Population
기간: 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
|
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Disease-free Rate at Year 5 in PD-L1 (SP263 ≥ 1% TC) Subpopulation Within the Stage II-IIIA Population
기간: 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
기간: 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)
기간: 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
기간: 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)
|
공동 작업자 및 조사자
수사관
- 연구 책임자: Clinical Trials, Hoffmann-La Roche
간행물 및 유용한 링크
일반 간행물
- Mohindra NA, Patel JD. Top advances in lung cancer, 2021. Cancer. 2022 Oct 1;128(19):3434-3437. doi: 10.1002/cncr.34406. Epub 2022 Aug 10.
- Felip E, Altorki N, Zhou C, Csoszi T, Vynnychenko I, Goloborodko O, Luft A, Akopov A, Martinez-Marti A, Kenmotsu H, Chen YM, Chella A, Sugawara S, Voong D, Wu F, Yi J, Deng Y, McCleland M, Bennett E, Gitlitz B, Wakelee H; IMpower010 Investigators. Adjuvant atezolizumab after adjuvant chemotherapy in resected stage IB-IIIA non-small-cell lung cancer (IMpower010): a randomised, multicentre, open-label, phase 3 trial. Lancet. 2021 Oct 9;398(10308):1344-1357. doi: 10.1016/S0140-6736(21)02098-5. Epub 2021 Sep 20.
- Felip E, Altorki N, Zhou C, Vallieres E, Csoszi T, Vynnychenko IO, Goloborodko O, Rittmeyer A, Reck M, Martinez-Marti A, Kenmotsu H, Chen YM, Chella A, Sugawara S, Fu C, Ballinger M, Deng Y, Srivastava MK, Bennett E, Gitlitz BJ, Wakelee HA; IMpower010 Study Investigators. Five-Year Survival Outcomes With Atezolizumab After Chemotherapy in Resected Stage IB-IIIA Non-Small Cell Lung Cancer (IMpower010): An Open-Label, Randomized, Phase III Trial. J Clin Oncol. 2025 Jul 20;43(21):2343-2349. doi: 10.1200/JCO-24-01681. Epub 2025 May 30.
- Zhou C, Srivastava MK, Xu H, Felip E, Wakelee H, Altorki N, Reck M, Liersch R, Kryzhanivska A, Oizumi S, Tanaka H, Hamm J, McCune SL, Bennett E, Gitlitz B, McNally V, Ballinger M, McCleland M, Zou W, Das Thakur M, Novello S. Comparison of SP263 and 22C3 immunohistochemistry PD-L1 assays for clinical efficacy of adjuvant atezolizumab in non-small cell lung cancer: results from the randomized phase III IMpower010 trial. J Immunother Cancer. 2023 Oct;11(10):e007047. doi: 10.1136/jitc-2023-007047.
- Felip E, Altorki N, Zhou C, Vallieres E, Martinez-Marti A, Rittmeyer A, Chella A, Reck M, Goloborodko O, Huang M, Belleli R, McNally V, Srivastava MK, Bennett E, Gitlitz BJ, Wakelee HA. Overall survival with adjuvant atezolizumab after chemotherapy in resected stage II-IIIA non-small-cell lung cancer (IMpower010): a randomised, multicentre, open-label, phase III trial. Ann Oncol. 2023 Oct;34(10):907-919. doi: 10.1016/j.annonc.2023.07.001. Epub 2023 Jul 17.
- Okada M, Sugawara S, Watanabe Y, Saito H, Chen-Yoshikawa TF, Goto Y, Nishio W, Nakagawa S, Hayashi M, Kenmotsu H. IMpower010: 5-Year Outcomes of Atezolizumab in Japanese Patients With Resected Stage IB-IIIA Non-Small Cell Lung Cancer. Cancer Sci. 2026 Mar;117(3):749-758. doi: 10.1111/cas.70297. Epub 2025 Dec 19.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정된)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
- 부위별 신생물
- 신생물
- 호흡기 질환
- 폐 질환
- 호흡기 신생물
- 흉부 신생물
- 폐 신생물
- 기관지 암종
- 기관지 신생물
- 암종, 비소세포폐
- 아미노산, 펩티드 및 단백질
- 유기 화학 물질
- 이종 사이 클릭 화합물, 1- 링
- 이종 사이 클릭 화합물
- 이종 사이 클릭 화합물, 2- 링
- 이종 사이 클릭 화합물, 융합 링
- 탄화수소
- 사이클로 파라핀
- 탄화수소, alicyclic
- 탄화수소, 순환
- 테르펜
- 알칼로이드
- 인돌
- 무기 화학 물질
- 염소 화합물
- 질소 화합물
- 구아닌
- Hypoxanthines
- 푸리 논
- 퓨린
- 글루타메이트
- 아미노산, 산성
- 아미노산
- 아미노산, 디카 르 복실
- 박습니다
- 사이클로 데카네
- Diterpenes
- 데 옥시 시티 딘
- 시티 딘
- 피리 미딘 뉴 클레오 시드
- 피리 미딘
- Vinca 알칼로이드
- Secologanin Tryptamine 알칼로이드
- 인돌 알칼로이드
- 인돌리 지딘
- 인도인
- 백금 화합물
- 도세탁셀
- 비노렐빈
- 페메트렉시드
- 젬시타빈
- 시스플라틴
- 아테 졸리 주맙
기타 연구 ID 번호
- GO29527
- 2014 (미국 NIH 보조금/계약)
- 2014-003205-15 (EudraCT 번호)
- 2023-505981-26-00 (레지스트리 식별자: CTIS (EU))
- 2023 (미국 NIH 보조금/계약)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
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
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .