Estudo para avaliar a segurança e eficácia do atezolizumabe (MPDL3280A) em comparação com o melhor tratamento de suporte após quimioterapia em pacientes com câncer de pulmão [IMpower010]
7 de setembro de 2026 atualizado por: Hoffmann-La Roche
Um estudo randomizado de fase III, aberto, para investigar a eficácia e a segurança do atezolizumabe (anticorpo anti-PD-L1) em comparação com o melhor tratamento de suporte após quimioterapia adjuvante à base de cisplatina em pacientes com células não pequenas completamente ressecadas no estágio IB-IIIA Câncer de pulmão
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.
Visão geral do estudo
Status
Concluído
Condições
Tipo de estudo
Intervencional
Inscrição (Real)
1280
Estágio
- Fase 3
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Berlin, Alemanha, 13125
- Evang. Lungenklinik Berlin Klinik für Pneumologie
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Braunschweig, Alemanha, 38114
- Stadtisches Klinikum Braunschweig
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Chemnitz, Alemanha, 09113
- Klinikum Chemnitz gGmbH
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Cologne, Alemanha, 51109
- Kliniken der Stadt Koln gGmbH
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Frankfurt am Main, Alemanha, 60488
- Krankenhaus Nordwest
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Großhansdorf, Alemanha, 22927
- LungenClinic Grosshansdorf GmbH
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Halle, Alemanha, 06120
- Krankenhaus Martha-Maria
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Hamburg, Alemanha, 20246
- Universitätsklinikum Hamburg-Eppendorf
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Hamburg, Alemanha, 21075
- Asklepios Klinik Harburg
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Heidelberg, Alemanha, 69126
- Thoraxklinik Heidelberg gGmbH
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Hemer, Alemanha, 58675
- Lungenklinik Hemer
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Homburg, Alemanha, 66421
- Universität Des Saarlandes
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Immenhausen, Alemanha, 34376
- Fachklinik für Lungenerkrankungen
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Karlsruhe, Alemanha, 76137
- Vincentius-Diakonissen-Kliniken gAG
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Koblenz Am Rhein, Alemanha, 56073
- Katholisches Klinikum Marienhof
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München, Alemanha, 81925
- Klinikum Bogenhausen
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Münster, Alemanha, 48149
- Gemeinschaftspraxis für Hämatologie und Onkologie
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Oldenburg, Alemanha, 26121
- Pius-Hospital Oldenburg
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Regensburg, Alemanha, 93049
- Krankenhaus Barmherzige Bruder Regensburg
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Velbert, Alemanha, 42551
- Praxis fur Hamatologie und internistische Onkologie
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Baden-Wurttemberg
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Löwenstein, Baden-Wurttemberg, Alemanha, 74245
- SLK Kliniken Heilbronn GmbH, Standort Fachklinik Löwenstein
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North Rhine-Westphalia
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Bielefeld, North Rhine-Westphalia, Alemanha, 33611
- Ev.Krankenhaus Bielefeld gGmbH
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Queensland
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Douglas, Queensland, Austrália, 4814
- Townsville Hospital
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Victoria
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Malvern, Victoria, Austrália, 3144
- Cabrini Hospital Malvern
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Brussels, Bélgica, 1200
- Cliniques Universitaires St-Luc
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Liège, Bélgica, 4000
- CHU de Liège (Sart Tilman)
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Ontario
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Brampton, Ontario, Canadá, L6R 3J7
- William Osler Health Centre
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Quebec
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Laval, Quebec, Canadá, H7M 3L9
- Cite de La Sante de Laval
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Beijing, China, 100142
- Beijing Cancer Hospital
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Beijing, China, 100021
- Cancer Institute and Hospital Chinese Academy of Medical Sciences
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Beijing, China, 100853
- Chinese People's Liberation Army (PLA) General Hospital (301 Hospital)
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Guangdong, China, 524023
- Affiliated Hospital of Guangdong Medical University
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Guangzhou, China, 510120
- The First Affiliated Hospital of Guangzhou Medical University
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Hangzhou, China, 310022
- Zhejiang Cancer Hospital
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Hefei, China
- Anhui Province Cancer Hospital
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Shanghai, China, 200030
- Shanghai Chest Hospital
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Shanghai, China, 200433
- Shanghai Pulmonary Hospital
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Shengyang, China, 110042
- Liaoning Provincial Cancer Hospital
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Shenyang, China, 110001
- First Hospital of China Medical University
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Suzhou, China, 215006
- First Affiliated Hospital of Soochow University
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Jeonnam, Coréia do Sul, 519-763
- Chonnam National University Hwasun Hospital
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Suwon, Coréia do Sul, 442-723
- The Catholic University of Korea St. Vincent's Hospital
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Barcelona, Espanha, 08025
- Hospital Santa Creu i Sant Pau
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Barcelona, Espanha, 08916
- Hospital Universitari Germans Trias i Pujol
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Barcelona, Espanha, 08035
- Vall d'Hebron Institute of Oncology (VHIO), Barcelona
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Barcelona, Espanha, 08003
- Hospital del Mar
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Córdoba, Espanha, 14004
- C.H. Regional Reina Sofia
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Jaén, Espanha, 23007
- Complejo Hospitalario de Jaen
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Lugo, Espanha, 27003
- Hospital Lucus Augusti
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Madrid, Espanha, 28046
- Hospital Universitario La Paz
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Madrid, Espanha, 28034
- Hospital Ramon y Cajal
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Madrid, Espanha, 28040
- Hosp. Clinico San Carlos
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Madrid, Espanha, 28050
- Hospital Universitario HM Sanchinarro-CIOCC
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Valencia, Espanha, 46026
- Hospital Universitari i Politecnic La Fe de Valencia
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Valencia, Espanha, 46010
- Hospital Clinico Universitario de Valencia
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Zaragoza, Espanha, 50009
- Hosp Clinico Univ Lozano Blesa
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Balearic Islands
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Palma de Mallorca, Balearic Islands, Espanha, 07010
- Hospital Universitario Son Espases
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Cantabria
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Santander, Cantabria, Espanha, 39008
- Hospital Universitario Marques de Valdecilla
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Castellon
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Castellon, Castellon, Espanha, 12002
- Consorcio Hospitalario Provincial de Castellon
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LA Coruna
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A Coruña, LA Coruna, Espanha, 15009
- Centro Oncologico de Galicia COG
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Murcia
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El Palmar, Murcia, Espanha, 30120
- Hospital Universitario Virgen de La Arrixaca
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Tenerife
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San Cristóbal de La Laguna, Tenerife, Espanha, 3820
- Hospital Universitario de Canarias
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Arkansas
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Fayetteville, Arkansas, Estados Unidos, 72703
- Highlands Oncology Group
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California
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Encinitas, California, Estados Unidos, 92024
- California Cancer Associates for Research & Excellence, Inc.
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Fountain Valley, California, Estados Unidos, 92708
- Compassionate Cancer Care Medical Group, Inc
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Los Angeles, California, Estados Unidos, 90024
- University of California Los Angeles
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Los Angeles, California, Estados Unidos, 90027
- Southern California Permanente Medical Group Bellflower
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Stanford, California, Estados Unidos, 94305
- Stanford University
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Vallejo, California, Estados Unidos, 94589
- Kaiser Permanente
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Walnut Creek, California, Estados Unidos, 94596
- Kaiser Permanente - Walnut Creek
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Connecticut
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Norwich, Connecticut, Estados Unidos, 06360
- Eastern Connecticut Hematology and Oncology Associates
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Florida
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Boca Raton, Florida, Estados Unidos, 33486
- Lynn Cancer Institute - West
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Deerfield Beach, Florida, Estados Unidos, 33442
- University of Miami School of Medicine - Sylvester at Deerfield
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Fort Lauderdale, Florida, Estados Unidos, 33308
- Holy Cross Hospital Inc
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Fort Myers, Florida, Estados Unidos, 33916
- Florida Cancer Specialists-Broadway, Fort Myers
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St. Petersburg, Florida, Estados Unidos, 33705
- SCRI Florida Cancer Specialists North
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Georgia
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Marietta, Georgia, Estados Unidos, 30060
- Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital
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Thomasville, Georgia, Estados Unidos, 31792
- Lewis Hall Singletary Oncology Center
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Illinois
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Chicago, Illinois, Estados Unidos, 60612
- University of Illinois at Chicago
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Chicago, Illinois, Estados Unidos, 60612
- Rush University Medical Center
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Peoria, Illinois, Estados Unidos, 61615
- Illinois Cancer Care
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Springfield, Illinois, Estados Unidos, 62794
- Southern Illinois University, Simmons Cancer Institute
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Kentucky
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Louisville, Kentucky, Estados Unidos, 40402
- Norton Cancer Institute
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Missouri
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Kansas City, Missouri, Estados Unidos, 64111
- St. Luke's Cancer Institute
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Nevada
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Henderson, Nevada, Estados Unidos, 89052
- Comprehensive Cancer Centers of Nevada
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New Jersey
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Florham Park, New Jersey, Estados Unidos, 07932
- Hematology Oncology Associates of Northern New Jersey
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Livingston, New Jersey, Estados Unidos, 07039
- Saint Barnabas Medical Center
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Paramus, New Jersey, Estados Unidos, 07652
- Valley Hospital
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Summit, New Jersey, Estados Unidos, 07901
- Overlook Medical Center
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New York
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Lake Success, New York, Estados Unidos, 11042
- Clinical Research Alliance
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New York, New York, Estados Unidos, 10065
- Weill Cornell Medical College
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North Carolina
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Charlotte, North Carolina, Estados Unidos, 28204
- Presbyterian Hospital
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Ohio
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Cincinnati, Ohio, Estados Unidos, 45219
- University of Cincinnati
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Cincinnati, Ohio, Estados Unidos, 45242
- Oncology Hematology Care - SCRI
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Oregon
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Portland, Oregon, Estados Unidos, 97239
- Oregon Health and Science University
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Pennsylvania
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Harrisburg, Pennsylvania, Estados Unidos, 17109
- Pinnacle Health
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Pittsburgh, Pennsylvania, Estados Unidos, 15212
- AHN Cancer Institute ? Allegheny General Hospital
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Rhode Island
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Providence, Rhode Island, Estados Unidos, 02903
- Rhode Island Hospital
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Tennessee
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Chattanooga, Tennessee, Estados Unidos, 37403
- University Oncology Associates
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Chattanooga, Tennessee, Estados Unidos, 37403
- Sarah Cannon Research Institute / Tennessee Oncology
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Nashville, Tennessee, Estados Unidos, 37203
- Sarah Cannon Cancer Center
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Texas
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Houston, Texas, Estados Unidos, 77030
- Houston Methodist Cancer Center
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Virginia
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Bristol, Virginia, Estados Unidos, 24201
- Wellmont Medical Associates
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Fredericksburg, Virginia, Estados Unidos, 22408
- Hematology Oncology Associates of Fredericksburg, Inc.
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Washington
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Auburn, Washington, Estados Unidos, 98002-4117
- MultiCare Regional Cancer Center - Auburn
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Everett, Washington, Estados Unidos, 98201
- Providence Everett Med Ctr
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Seattle, Washington, Estados Unidos, 98122
- Swedish Medical Center
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Limoges, França, 87042
- Hôpital Universitaire Dupuytren
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Lyon, França, 69373
- Centre Léon Bérard Centre Régional de Lutte Contre Le Cancer Rhône Alpes
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Marseille, França, 13008
- Hôpital Saint Joseph
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Mont-de-Marsan, França, 40000
- Centre Hospitalier de Mont de Marsan - Hopital Layne
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Montpellier, França, 34298
- Centre Regional de Lutte contre le Cancer Val d Aurelle - Paul Lamarque
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Montpellier, França, 34070
- Clinique Clémentville
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Nantes, França, 44093
- Centre René Gauducheau Centre de Lutte Contre Le Cancer Nantes Atlantique
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Saint-Mandé, França, 94160
- Hopital d'Instruction des Armees de Begin
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Saint-Pierre, França, 97448
- Centre Hospitalier Regional Sud Reunion
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Saint-Quentin, França, 02321
- Centre Hospitalier de Saint-Quentin
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Toulon, França, 83000
- Centre Hospitalier Intercommunal Toulon - La Seyne sur Mer
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Toulon, França, 83041
- Hopital d Instruction des Armees de Sainte Anne
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Groningen, Holanda, 9728 NT
- Martini Ziekenhuis
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Nieuwegein, Holanda, 3430 EM
- St. Antonius Ziekenhuis Nieuwegein
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North Brabant
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's-Hertogenbosch, North Brabant, Holanda, 5223 GZ
- Jeroen Bosch Ziekenhuis
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Shatin, Hong Kong
- Prince of Wales Hosp
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Budapest, Hungria, 1125
- Semmelweis Egyetem
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Pécs, Hungria, 7624
- University of Pecs, I st Dept of Internal Medicine
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Szolnok, Hungria, 5004
- Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rend.Int.
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Törökbálint, Hungria, 2045
- Reformatus Pulmonologiai Centrum
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Haifa, Israel, 31096
- Rambam Medical Center
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Holon, Israel, 58100
- Edith Wolfson Medical Center
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Kfar Saba, Israel, 44281
- Meir Medical Center
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Petah Tikva, Israel, 49100
- Rabin Medical Center
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Tel Aviv, Israel, 64239
- Tel Aviv Sourasky Medical Ctr
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Tel HaShomer, Israel, 52621
- Chaim Sheba Medical Center
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Abruzzo
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Chieti, Abruzzo, Itália, 66013
- Ospedale Clinicizzato SS Annunziata
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Friuli Venezia Giulia
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Pordenone, Friuli Venezia Giulia, Itália, 33170
- Azienda per l'Assistenza Sanitaria N° 5 - Friuli Occidentale
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Lazio
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Rome, Lazio, Itália, 00128
- Policlinico Universitario Campus Biomedico Di Roma
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Lombardy
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Bergamo, Lombardy, Itália, 24127
- Asst Papa Giovanni XXIII
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Brescia, Lombardy, Itália, 25123
- ASST Spedali Civili di Brescia
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Milan, Lombardy, Itália, 20132
- Ospedale San Raffaele
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Piedmont
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Cuneo, Piedmont, Itália, 12100
- Azienda Sanitaria Ospedaliera s. Croce e Carle
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Novara, Piedmont, Itália, 28100
- A.O.U. Maggiore della Carità
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Orbassano, Piedmont, Itália, 10043
- Azienda Sanitaria Ospedaliera S Luigi Gonzaga
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Turin, Piedmont, Itália, 10126
- Azienda Ospedaliera Città della Salute e della Scienza di Torino
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Sicily
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Catania, Sicily, Itália, 95122
- Azienda Ospedaliera Di Rilievo Nazionale E Di Alta Specializzazione Garibaldi
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Trentino-Alto Adige
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Trento, Trentino-Alto Adige, Itália, 38100
- Ospedale Santa Chiara
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Tuscany
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Pisa, Tuscany, Itália, 56124
- Azienda Ospedaliero Universitaria Pisana
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Umbria
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Perugia, Umbria, Itália, 06132
- Ospedale Silvestrini
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Veneto
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Verona, Veneto, Itália, 37126
- Azienda Ospedaliera Universitaria Integrata Verona
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Aichi, Japão, 464-8681
- Aichi Cancer Center Hospital
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Akashi, Japão, 673-0021
- Hyogo Cancer Center
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Bunkyō City, Japão, 113-8431
- Juntendo University Hospital
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Bunkyō City, Japão, 113-8677
- Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
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Chiba, Japão, 277-8577
- National Cancer Center East
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Chūō, Japão, 104-0045
- National Cancer Center Hospital
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Fukuoka, Japão, 812-8582
- Kyushu University Hospital
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Hiroshima, Japão, 734-8551
- Hiroshima University Hospital
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Kitaadachi-gun, Japão, 362-0806
- Saitama Cancer Center
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Kitakyushu-shi, Japão, 807-8555
- Hospital of the University of Occupational and Environmental Health,Japan
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Kumamoto, Japão, 860-8556
- Kumamoto University Hospital
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Kyoto, Japão, 606-8507
- Kyoto University Hospital
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Matsuyama, Japão, 791-0280
- Shikoku Cancer Center
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Mitaka-shi, Japão, 181-0004
- Kyorin University Hospital
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Nagoya, Japão, 466-8560
- Nagoya University Hospital
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Niigata, Japão, 951-8566
- Niigata Cancer Center Hospital
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Okayama, Japão, 700-8558
- Okayama University Hospital
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Sapporo, Japão, 003-0804
- National Hospital Organization Hokkaido Cancer Center
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Shizuoka, Japão, 411-8777
- Shizuoka Cancer Center
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Tokyo, Japão, 160-0023
- Tokyo Medical University Hospital
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Tokyo, Japão, 105-8470
- Toranomon Hospital
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Wakayama, Japão, 641-8510
- Wakayama Medical University Hospital
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Yokohama-shi, Asahi-ku, Japão, 241-8515
- Kanagawa Cancer Center
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Miyagi
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Sendai, Miyagi, Japão, 981-0914
- Sendai Kousei Hospital
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Otwock, Polônia, 05-400
- Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy
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Poznan, Polônia, 60569
- Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu
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Coimbra, Portugal, 3000-602
- Centro Hospitalar E Universitário de Coimbra EPE
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Lisbon, Portugal, 1769-001
- Centro Hospitalar de Lisboa Norte E.P.E ? Hospital Pulido Valente
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Porto, Portugal, 4200-319
- Hospital de Sao Joao
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Porto, Portugal, 4200-072
- Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe
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Birmingham, Reino Unido, B9 5SS
- Birmingham Heartlands Hospital
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Colchester, Essex, Reino Unido, CO4 5JL
- Colchester General Hospital
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London, Reino Unido, EC1A 7BE
- St Bartholomew's Hospital
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Craiova, Romênia, 200542
- Oncology Center Sf. Nectarie
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Novosibirsk, Rússia, 630047
- City Clinical Hospital #1
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Volgograd, Rússia, 400138
- Volgograd Regional Clinical Oncology Dispensary
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Yaroslavl, Rússia, 150040
- Regional Clinical Oncology Hospital
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Moscow Oblast
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Moscovskaya Oblast, Moscow Oblast, Rússia, 143423
- Moscow City Oncology Hospital #62
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Moscow, Moscow Oblast, Rússia, 105229
- Principal Military Clinical Hospital n.a. N.N. Burdenko
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Moscow, Moscow Oblast, Rússia, 115478
- Russian Oncology Research Center n a N N Blokhin
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Respublika Mordoviya
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Saransk, Respublika Mordoviya, Rússia, 430032
- Mordovia State University
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Sankt-Peterburg
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Pushkin, Sankt-Peterburg, Rússia, 196603
- Evromedservis LCC
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Saint Petersburg, Sankt-Peterburg, Rússia, 194291
- Leningrad Regional Clinical Hospital
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Saint Petersburg, Sankt-Peterburg, Rússia, 197758
- GBUZ Saint Petersburg Clinical Research Center of Specialized Types of Care (Oncology)
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Saint Petersburg, Sankt-Peterburg, Rússia, 197758
- Scientific Research Institute of Oncology n.a. N.N. Petrov
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Saint Petersburg, Sankt-Peterburg, Rússia, 197022
- St. Petersburg Med Univ
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Saint Petersburg, Sankt-Peterburg, Rússia, 198255
- City Clinical Oncology Dispensary
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Tatarstan Republic
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Kazan', Tatarstan Republic, Rússia, 420029
- Republican Clinical Oncology Dispensary of Ministry of Healthcare of Tatarstan Republic
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Changhua, Taiwan, 500
- Changhua Christian Hospital
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Kaohsiung City, Taiwan, 807
- Kaohsiung Medical University Hospital
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Putzui City, Taiwan, 61363
- Chang Gung Memorial Hospital Chiayi
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Taichung, Taiwan, 40705
- Taichung Veterans General Hospital
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Tainan, Taiwan, 736
- Chi Mei Medical Center Liou Ying Campus
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Taipei, Taiwan, 104
- Mackay Memorial Hospital
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Taipei, Taiwan, 00112
- Taipei Veterans General Hospital
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Taipei, Taiwan, 10048
- National Taiwan Uni Hospital
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Taoyuan City, Taiwan, 333
- Chang Gung Medical Foundation Linkou Branch
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Kryvyi Rih, Ucrânia, 50048
- CE Kryvyi Rih Oncology Dispensary of Dnipropetrovsk Regional Council
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Kyiv, Ucrânia, 03115
- Kyiv City Clinical Oncological Center
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Sumy, Ucrânia, 40022
- Regional Municipal Institution Sumy Regional Clinical Oncology Dispensary
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Zaporizhzhya, Ucrânia, 69040
- MI Zaporizhzhia Regional Clinical Oncological Dispensary Zaporizhzhia SMU Ch of Oncology
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KIEV Governorate
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Kropyvnytskyi, KIEV Governorate, Ucrânia, 25006
- Private Enterprise Private Manufacturing Company Acinus
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Kyiv, KIEV Governorate, Ucrânia, 02096
- Kyiv Railway Clinical Hospital #3 of Branch Health Center of the PJSC Ukrainian Railway
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Odesa, KIEV Governorate, Ucrânia, 65055
- Municipal Institution Odesa Regional Oncology Dispensary
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Katerynoslav Governorate
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Dnipropetrovsk, Katerynoslav Governorate, Ucrânia, 49102
- MI Dnipropetrovsk City Multifield Clinical Hospital 4 of Dnipropetrovsk Regional Council
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Kharkiv Governorate
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Kharkiv, Kharkiv Governorate, Ucrânia, 61070
- Communal Non profit Enterprise Regional Center of Oncology
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Poltava Governorate
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Ivano-Frankivsk, Poltava Governorate, Ucrânia, 76018
- Municipal Institution SubCarpathian ClinicalOncological Centre
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Vinnytsia Oblast
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Vinnytsia, Vinnytsia Oblast, Ucrânia, 21018
- Communal Nonprofit Enterprise Podilsky Regional Center Of Oncology OfTheVinnytsia Regional Council
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: 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).
Outros nomes:
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. |
|
Comparador Ativo: 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. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Disease-Free Survival (DFS) in Intent-to-treat (ITT) Population
Prazo: 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
Prazo: 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
Prazo: 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
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Concentração plasmática máxima (CMAX) do Atezolizumab
Prazo: 30 min após a infusão no dia 1 do ciclo 1 (comprimento do ciclo = 21 dias)
|
30 min após a infusão no dia 1 do ciclo 1 (comprimento do ciclo = 21 dias)
|
|
|
Concentração sérica mínima (CMIN) em estado estacionário dentro de um intervalo de dosagem de Atezolizumab
Prazo: Antes da infusão no dia 1 dos ciclos 1, 2, 3, 4, 8, 16 (comprimento do ciclo = 21 dias), na visita de descontinuação do estudo (até 12 meses), dia 120 Post Last Dose of Atezolizumab (até 16 meses)
|
Antes da infusão no dia 1 dos ciclos 1, 2, 3, 4, 8, 16 (comprimento do ciclo = 21 dias), na visita de descontinuação do estudo (até 12 meses), dia 120 Post Last Dose of Atezolizumab (até 16 meses)
|
|
|
Overall Survival (OS) in the ITT Population
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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
Prazo: 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)
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Diretor de estudo: Clinical Trials, Hoffmann-La Roche
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- 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.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
31 de outubro de 2015
Conclusão Primária (Real)
26 de janeiro de 2024
Conclusão do estudo (Real)
26 de agosto de 2026
Datas de inscrição no estudo
Enviado pela primeira vez
4 de junho de 2015
Enviado pela primeira vez que atendeu aos critérios de CQ
26 de junho de 2015
Primeira postagem (Estimado)
1 de julho de 2015
Atualizações de registro de estudo
Última Atualização Postada (Real)
30 de setembro de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
7 de setembro de 2026
Última verificação
1 de setembro de 2026
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
- Neoplasias por local
- Neoplasias
- Doenças Respiratórias
- Doenças pulmonares
- Neoplasias do Trato Respiratório
- Neoplasias Torácicas
- Neoplasias Pulmonares
- Carcinoma Broncogênico
- Neoplasias Brônquicas
- Carcinoma pulmonar de células não pequenas
- Aminoácidos, peptídeos e proteínas
- Produtos químicos orgânicos
- Compostos heterocíclicos, 1 anel
- Compostos heterocíclicos
- Compostos heterocíclicos, 2 anel
- Compostos heterocíclicos, anel fundido
- Hidrocarbonetos
- Cicloparaffinas
- Hidrocarbonetos, aliciclicos
- Hidrocarbonetos, cíclicos
- Terpenos
- Alcalóides
- Indoles
- Produtos químicos inorgânicos
- Compostos de cloro
- Compostos de nitrogênio
- Guanina
- Hipoxantinas
- Purinonas
- Purinas
- Glutamatos
- Aminoácidos, ácido
- Aminoácidos
- Aminoácidos, dicarboxílico
- Taxóides
- Ciclodecanos
- Diterpenos
- Desoxicitidina
- Citidina
- Nucleosídeos de pirimidina
- Pirimidinas
- Alcalóides de Vinca
- Alcalóides de triptamina de secologanin
- Alcalóides indol
- Indolizidinas
- Indolizinas
- Compostos de platina
- Docetaxel
- Vinorelbina
- Pemetrexede
- Gemcitabina
- Cisplatina
- Atezolizumab
Outros números de identificação do estudo
- GO29527
- 2014 (Concessão/Contrato do NIH dos EUA)
- 2014-003205-15 (Número EudraCT)
- 2023-505981-26-00 (Identificador de registro: CTIS (EU))
- 2023 (Concessão/Contrato do NIH dos EUA)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Descrição do plano IPD
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
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .