Исследование по оценке безопасности и эффективности атезолизумаба (MPDL3280A) по сравнению с наилучшей поддерживающей терапией после химиотерапии у пациентов с раком легких [IMpower010]
7 сентября 2026 г. обновлено: Hoffmann-La Roche
Открытое рандомизированное исследование фазы III по изучению эффективности и безопасности атезолизумаба (антитела к PD-L1) по сравнению с наилучшей поддерживающей терапией после адъювантной химиотерапии на основе цисплатина у пациентов с полностью резецированной немелкоклеточной стадией IB-IIIA Рак легких
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.
Обзор исследования
Статус
Завершенный
Условия
Тип исследования
Интервенционный
Регистрация (Действительный)
1280
Фаза
- Фаза 3
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Места учебы
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Queensland
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Douglas, Queensland, Австралия, 4814
- Townsville Hospital
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Victoria
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Malvern, Victoria, Австралия, 3144
- Cabrini Hospital Malvern
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Brussels, Бельгия, 1200
- Cliniques Universitaires St-Luc
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Liège, Бельгия, 4000
- CHU de Liège (Sart Tilman)
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Budapest, Венгрия, 1125
- Semmelweis Egyetem
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Pécs, Венгрия, 7624
- University of Pecs, I st Dept of Internal Medicine
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Szolnok, Венгрия, 5004
- Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rend.Int.
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Törökbálint, Венгрия, 2045
- Reformatus Pulmonologiai Centrum
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Berlin, Германия, 13125
- Evang. Lungenklinik Berlin Klinik für Pneumologie
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Braunschweig, Германия, 38114
- Stadtisches Klinikum Braunschweig
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Chemnitz, Германия, 09113
- Klinikum Chemnitz gGmbH
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Cologne, Германия, 51109
- Kliniken der Stadt Koln gGmbH
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Frankfurt am Main, Германия, 60488
- Krankenhaus Nordwest
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Großhansdorf, Германия, 22927
- LungenClinic Grosshansdorf GmbH
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Halle, Германия, 06120
- Krankenhaus Martha-Maria
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Hamburg, Германия, 20246
- Universitätsklinikum Hamburg-Eppendorf
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Hamburg, Германия, 21075
- Asklepios Klinik Harburg
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Heidelberg, Германия, 69126
- Thoraxklinik Heidelberg gGmbH
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Hemer, Германия, 58675
- Lungenklinik Hemer
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Homburg, Германия, 66421
- Universität Des Saarlandes
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Immenhausen, Германия, 34376
- Fachklinik für Lungenerkrankungen
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Karlsruhe, Германия, 76137
- Vincentius-Diakonissen-Kliniken gAG
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Koblenz Am Rhein, Германия, 56073
- Katholisches Klinikum Marienhof
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München, Германия, 81925
- Klinikum Bogenhausen
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Münster, Германия, 48149
- Gemeinschaftspraxis für Hämatologie und Onkologie
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Oldenburg, Германия, 26121
- Pius-Hospital Oldenburg
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Regensburg, Германия, 93049
- Krankenhaus Barmherzige Bruder Regensburg
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Velbert, Германия, 42551
- Praxis fur Hamatologie und internistische Onkologie
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Baden-Wurttemberg
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Löwenstein, Baden-Wurttemberg, Германия, 74245
- SLK Kliniken Heilbronn GmbH, Standort Fachklinik Löwenstein
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North Rhine-Westphalia
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Bielefeld, North Rhine-Westphalia, Германия, 33611
- Ev.Krankenhaus Bielefeld gGmbH
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Shatin, Гонконг
- Prince of Wales Hosp
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Haifa, Израиль, 31096
- Rambam Medical Center
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Holon, Израиль, 58100
- Edith Wolfson Medical Center
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Kfar Saba, Израиль, 44281
- Meir Medical Center
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Petah Tikva, Израиль, 49100
- Rabin Medical Center
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Tel Aviv, Израиль, 64239
- Tel Aviv Sourasky Medical Ctr
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Tel HaShomer, Израиль, 52621
- Chaim Sheba Medical Center
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Barcelona, Испания, 08025
- Hospital Santa Creu i Sant Pau
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Barcelona, Испания, 08916
- Hospital Universitari Germans Trias i Pujol
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Barcelona, Испания, 08035
- Vall d'Hebron Institute of Oncology (VHIO), Barcelona
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Barcelona, Испания, 08003
- Hospital del Mar
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Córdoba, Испания, 14004
- C.H. Regional Reina Sofia
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Jaén, Испания, 23007
- Complejo Hospitalario de Jaen
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Lugo, Испания, 27003
- Hospital Lucus Augusti
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Madrid, Испания, 28046
- Hospital Universitario La Paz
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Madrid, Испания, 28034
- Hospital Ramon y Cajal
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Madrid, Испания, 28040
- Hosp. Clinico San Carlos
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Madrid, Испания, 28050
- Hospital Universitario HM Sanchinarro-CIOCC
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Valencia, Испания, 46026
- Hospital Universitari i Politecnic La Fe de Valencia
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Valencia, Испания, 46010
- Hospital Clinico Universitario de Valencia
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Zaragoza, Испания, 50009
- Hosp Clinico Univ Lozano Blesa
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Balearic Islands
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Palma de Mallorca, Balearic Islands, Испания, 07010
- Hospital Universitario Son Espases
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Cantabria
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Santander, Cantabria, Испания, 39008
- Hospital Universitario Marques de Valdecilla
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Castellon
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Castellon, Castellon, Испания, 12002
- Consorcio Hospitalario Provincial de Castellon
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LA Coruna
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A Coruña, LA Coruna, Испания, 15009
- Centro Oncologico de Galicia COG
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Murcia
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El Palmar, Murcia, Испания, 30120
- Hospital Universitario Virgen de La Arrixaca
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Tenerife
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San Cristóbal de La Laguna, Tenerife, Испания, 3820
- Hospital Universitario de Canarias
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Abruzzo
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Chieti, Abruzzo, Италия, 66013
- Ospedale Clinicizzato SS Annunziata
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Friuli Venezia Giulia
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Pordenone, Friuli Venezia Giulia, Италия, 33170
- Azienda per l'Assistenza Sanitaria N° 5 - Friuli Occidentale
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Lazio
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Rome, Lazio, Италия, 00128
- Policlinico Universitario Campus Biomedico Di Roma
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Lombardy
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Bergamo, Lombardy, Италия, 24127
- Asst Papa Giovanni XXIII
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Brescia, Lombardy, Италия, 25123
- ASST Spedali Civili di Brescia
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Milan, Lombardy, Италия, 20132
- Ospedale San Raffaele
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Piedmont
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Cuneo, Piedmont, Италия, 12100
- Azienda Sanitaria Ospedaliera s. Croce e Carle
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Novara, Piedmont, Италия, 28100
- A.O.U. Maggiore della Carità
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Orbassano, Piedmont, Италия, 10043
- Azienda Sanitaria Ospedaliera S Luigi Gonzaga
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Turin, Piedmont, Италия, 10126
- Azienda Ospedaliera Città della Salute e della Scienza di Torino
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Sicily
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Catania, Sicily, Италия, 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, Италия, 38100
- Ospedale Santa Chiara
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Tuscany
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Pisa, Tuscany, Италия, 56124
- Azienda Ospedaliero Universitaria Pisana
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Umbria
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Perugia, Umbria, Италия, 06132
- Ospedale Silvestrini
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Veneto
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Verona, Veneto, Италия, 37126
- Azienda Ospedaliera Universitaria Integrata Verona
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Ontario
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Brampton, Ontario, Канада, L6R 3J7
- William Osler Health Centre
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Quebec
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Laval, Quebec, Канада, H7M 3L9
- Cite de La Sante de Laval
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Beijing, Китай, 100142
- Beijing Cancer Hospital
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Beijing, Китай, 100021
- Cancer Institute and Hospital Chinese Academy of Medical Sciences
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Beijing, Китай, 100853
- Chinese People's Liberation Army (PLA) General Hospital (301 Hospital)
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Guangdong, Китай, 524023
- Affiliated Hospital of Guangdong Medical University
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Guangzhou, Китай, 510120
- The First Affiliated Hospital of Guangzhou Medical University
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Hangzhou, Китай, 310022
- Zhejiang Cancer Hospital
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Hefei, Китай
- Anhui Province Cancer Hospital
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Shanghai, Китай, 200030
- Shanghai Chest Hospital
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Shanghai, Китай, 200433
- Shanghai Pulmonary Hospital
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Shengyang, Китай, 110042
- Liaoning Provincial Cancer Hospital
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Shenyang, Китай, 110001
- First Hospital of China Medical University
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Suzhou, Китай, 215006
- First Affiliated Hospital of Soochow University
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Groningen, Нидерланды, 9728 NT
- Martini Ziekenhuis
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Nieuwegein, Нидерланды, 3430 EM
- St. Antonius Ziekenhuis Nieuwegein
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North Brabant
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's-Hertogenbosch, North Brabant, Нидерланды, 5223 GZ
- Jeroen Bosch Ziekenhuis
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Otwock, Польша, 05-400
- Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy
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Poznan, Польша, 60569
- Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu
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Coimbra, Португалия, 3000-602
- Centro Hospitalar E Universitário de Coimbra EPE
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Lisbon, Португалия, 1769-001
- Centro Hospitalar de Lisboa Norte E.P.E ? Hospital Pulido Valente
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Porto, Португалия, 4200-319
- Hospital de Sao Joao
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Porto, Португалия, 4200-072
- Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe
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Novosibirsk, Россия, 630047
- City Clinical Hospital #1
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Volgograd, Россия, 400138
- Volgograd Regional Clinical Oncology Dispensary
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Yaroslavl, Россия, 150040
- Regional Clinical Oncology Hospital
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Moscow Oblast
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Moscovskaya Oblast, Moscow Oblast, Россия, 143423
- Moscow City Oncology Hospital #62
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Moscow, Moscow Oblast, Россия, 105229
- Principal Military Clinical Hospital n.a. N.N. Burdenko
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Moscow, Moscow Oblast, Россия, 115478
- Russian Oncology Research Center n a N N Blokhin
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Respublika Mordoviya
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Saransk, Respublika Mordoviya, Россия, 430032
- Mordovia State University
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Sankt-Peterburg
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Pushkin, Sankt-Peterburg, Россия, 196603
- Evromedservis LCC
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Saint Petersburg, Sankt-Peterburg, Россия, 194291
- Leningrad Regional Clinical Hospital
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Saint Petersburg, Sankt-Peterburg, Россия, 197758
- GBUZ Saint Petersburg Clinical Research Center of Specialized Types of Care (Oncology)
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Saint Petersburg, Sankt-Peterburg, Россия, 197758
- Scientific Research Institute of Oncology n.a. N.N. Petrov
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Saint Petersburg, Sankt-Peterburg, Россия, 197022
- St. Petersburg Med Univ
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Saint Petersburg, Sankt-Peterburg, Россия, 198255
- City Clinical Oncology Dispensary
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Tatarstan Republic
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Kazan', Tatarstan Republic, Россия, 420029
- Republican Clinical Oncology Dispensary of Ministry of Healthcare of Tatarstan Republic
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Craiova, Румыния, 200542
- Oncology Center Sf. Nectarie
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Birmingham, Соединенное Королевство, B9 5SS
- Birmingham Heartlands Hospital
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Colchester, Essex, Соединенное Королевство, CO4 5JL
- Colchester General Hospital
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London, Соединенное Королевство, EC1A 7BE
- St Bartholomew's Hospital
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Arkansas
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Fayetteville, Arkansas, Соединенные Штаты, 72703
- Highlands Oncology Group
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California
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Encinitas, California, Соединенные Штаты, 92024
- California Cancer Associates for Research & Excellence, Inc.
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Fountain Valley, California, Соединенные Штаты, 92708
- Compassionate Cancer Care Medical Group, Inc
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Los Angeles, California, Соединенные Штаты, 90024
- University of California Los Angeles
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Los Angeles, California, Соединенные Штаты, 90027
- Southern California Permanente Medical Group Bellflower
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Stanford, California, Соединенные Штаты, 94305
- Stanford University
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Vallejo, California, Соединенные Штаты, 94589
- Kaiser Permanente
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Walnut Creek, California, Соединенные Штаты, 94596
- Kaiser Permanente - Walnut Creek
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Connecticut
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Norwich, Connecticut, Соединенные Штаты, 06360
- Eastern Connecticut Hematology and Oncology Associates
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Florida
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Boca Raton, Florida, Соединенные Штаты, 33486
- Lynn Cancer Institute - West
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Deerfield Beach, Florida, Соединенные Штаты, 33442
- University of Miami School of Medicine - Sylvester at Deerfield
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Fort Lauderdale, Florida, Соединенные Штаты, 33308
- Holy Cross Hospital Inc
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Fort Myers, Florida, Соединенные Штаты, 33916
- Florida Cancer Specialists-Broadway, Fort Myers
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St. Petersburg, Florida, Соединенные Штаты, 33705
- SCRI Florida Cancer Specialists North
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Georgia
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Marietta, Georgia, Соединенные Штаты, 30060
- Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital
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Thomasville, Georgia, Соединенные Штаты, 31792
- Lewis Hall Singletary Oncology Center
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Illinois
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Chicago, Illinois, Соединенные Штаты, 60612
- University of Illinois at Chicago
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Chicago, Illinois, Соединенные Штаты, 60612
- Rush University Medical Center
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Peoria, Illinois, Соединенные Штаты, 61615
- Illinois Cancer Care
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Springfield, Illinois, Соединенные Штаты, 62794
- Southern Illinois University, Simmons Cancer Institute
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Kentucky
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Louisville, Kentucky, Соединенные Штаты, 40402
- Norton Cancer Institute
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Missouri
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Kansas City, Missouri, Соединенные Штаты, 64111
- St. Luke's Cancer Institute
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Nevada
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Henderson, Nevada, Соединенные Штаты, 89052
- Comprehensive Cancer Centers of Nevada
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New Jersey
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Florham Park, New Jersey, Соединенные Штаты, 07932
- Hematology Oncology Associates of Northern New Jersey
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Livingston, New Jersey, Соединенные Штаты, 07039
- Saint Barnabas Medical Center
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Paramus, New Jersey, Соединенные Штаты, 07652
- Valley Hospital
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Summit, New Jersey, Соединенные Штаты, 07901
- Overlook Medical Center
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New York
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Lake Success, New York, Соединенные Штаты, 11042
- Clinical Research Alliance
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New York, New York, Соединенные Штаты, 10065
- Weill Cornell Medical College
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North Carolina
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Charlotte, North Carolina, Соединенные Штаты, 28204
- Presbyterian Hospital
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Ohio
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Cincinnati, Ohio, Соединенные Штаты, 45219
- University of Cincinnati
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Cincinnati, Ohio, Соединенные Штаты, 45242
- Oncology Hematology Care - SCRI
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Oregon
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Portland, Oregon, Соединенные Штаты, 97239
- Oregon Health and Science University
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Pennsylvania
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Harrisburg, Pennsylvania, Соединенные Штаты, 17109
- Pinnacle Health
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Pittsburgh, Pennsylvania, Соединенные Штаты, 15212
- AHN Cancer Institute ? Allegheny General Hospital
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Rhode Island
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Providence, Rhode Island, Соединенные Штаты, 02903
- Rhode Island Hospital
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Tennessee
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Chattanooga, Tennessee, Соединенные Штаты, 37403
- University Oncology Associates
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Chattanooga, Tennessee, Соединенные Штаты, 37403
- Sarah Cannon Research Institute / Tennessee Oncology
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Nashville, Tennessee, Соединенные Штаты, 37203
- Sarah Cannon Cancer Center
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Texas
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Houston, Texas, Соединенные Штаты, 77030
- Houston Methodist Cancer Center
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Virginia
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Bristol, Virginia, Соединенные Штаты, 24201
- Wellmont Medical Associates
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Fredericksburg, Virginia, Соединенные Штаты, 22408
- Hematology Oncology Associates of Fredericksburg, Inc.
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Washington
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Auburn, Washington, Соединенные Штаты, 98002-4117
- MultiCare Regional Cancer Center - Auburn
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Everett, Washington, Соединенные Штаты, 98201
- Providence Everett Med Ctr
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Seattle, Washington, Соединенные Штаты, 98122
- Swedish Medical Center
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-
-
-
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Changhua, Тайвань, 500
- Changhua Christian Hospital
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Kaohsiung City, Тайвань, 807
- Kaohsiung Medical University Hospital
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Putzui City, Тайвань, 61363
- Chang Gung Memorial Hospital Chiayi
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Taichung, Тайвань, 40705
- Taichung Veterans General Hospital
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Tainan, Тайвань, 736
- Chi Mei Medical Center Liou Ying Campus
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Taipei, Тайвань, 104
- Mackay Memorial Hospital
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Taipei, Тайвань, 00112
- Taipei Veterans General Hospital
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Taipei, Тайвань, 10048
- National Taiwan Uni Hospital
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Taoyuan City, Тайвань, 333
- Chang Gung Medical Foundation Linkou Branch
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-
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-
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Kryvyi Rih, Украина, 50048
- CE Kryvyi Rih Oncology Dispensary of Dnipropetrovsk Regional Council
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Kyiv, Украина, 03115
- Kyiv City Clinical Oncological Center
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Sumy, Украина, 40022
- Regional Municipal Institution Sumy Regional Clinical Oncology Dispensary
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Zaporizhzhya, Украина, 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, Украина, 25006
- Private Enterprise Private Manufacturing Company Acinus
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Kyiv, KIEV Governorate, Украина, 02096
- Kyiv Railway Clinical Hospital #3 of Branch Health Center of the PJSC Ukrainian Railway
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Odesa, KIEV Governorate, Украина, 65055
- Municipal Institution Odesa Regional Oncology Dispensary
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Katerynoslav Governorate
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Dnipropetrovsk, Katerynoslav Governorate, Украина, 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, Украина, 61070
- Communal Non profit Enterprise Regional Center of Oncology
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Poltava Governorate
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Ivano-Frankivsk, Poltava Governorate, Украина, 76018
- Municipal Institution SubCarpathian ClinicalOncological Centre
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Vinnytsia Oblast
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Vinnytsia, Vinnytsia Oblast, Украина, 21018
- Communal Nonprofit Enterprise Podilsky Regional Center Of Oncology OfTheVinnytsia Regional Council
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-
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Limoges, Франция, 87042
- Hôpital Universitaire Dupuytren
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Lyon, Франция, 69373
- Centre Léon Bérard Centre Régional de Lutte Contre Le Cancer Rhône Alpes
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Marseille, Франция, 13008
- Hôpital Saint Joseph
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Mont-de-Marsan, Франция, 40000
- Centre Hospitalier de Mont de Marsan - Hopital Layne
-
Montpellier, Франция, 34298
- Centre Regional de Lutte contre le Cancer Val d Aurelle - Paul Lamarque
-
Montpellier, Франция, 34070
- Clinique Clémentville
-
Nantes, Франция, 44093
- Centre René Gauducheau Centre de Lutte Contre Le Cancer Nantes Atlantique
-
Saint-Mandé, Франция, 94160
- Hopital d'Instruction des Armees de Begin
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Saint-Pierre, Франция, 97448
- Centre Hospitalier Regional Sud Reunion
-
Saint-Quentin, Франция, 02321
- Centre Hospitalier de Saint-Quentin
-
Toulon, Франция, 83000
- Centre Hospitalier Intercommunal Toulon - La Seyne sur Mer
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Toulon, Франция, 83041
- Hopital d Instruction des Armees de Sainte Anne
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-
-
-
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Jeonnam, Южная Корея, 519-763
- Chonnam National University Hwasun Hospital
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Suwon, Южная Корея, 442-723
- The Catholic University of Korea St. Vincent's Hospital
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-
-
-
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Aichi, Япония, 464-8681
- Aichi Cancer Center Hospital
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Akashi, Япония, 673-0021
- Hyogo Cancer Center
-
Bunkyō City, Япония, 113-8431
- Juntendo University Hospital
-
Bunkyō City, Япония, 113-8677
- Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
-
Chiba, Япония, 277-8577
- National Cancer Center East
-
Chūō, Япония, 104-0045
- National Cancer Center Hospital
-
Fukuoka, Япония, 812-8582
- Kyushu University Hospital
-
Hiroshima, Япония, 734-8551
- Hiroshima University Hospital
-
Kitaadachi-gun, Япония, 362-0806
- Saitama Cancer Center
-
Kitakyushu-shi, Япония, 807-8555
- Hospital of the University of Occupational and Environmental Health,Japan
-
Kumamoto, Япония, 860-8556
- Kumamoto University Hospital
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Kyoto, Япония, 606-8507
- Kyoto University Hospital
-
Matsuyama, Япония, 791-0280
- Shikoku Cancer Center
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Mitaka-shi, Япония, 181-0004
- Kyorin University Hospital
-
Nagoya, Япония, 466-8560
- Nagoya University Hospital
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Niigata, Япония, 951-8566
- Niigata Cancer Center Hospital
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Okayama, Япония, 700-8558
- Okayama University Hospital
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Sapporo, Япония, 003-0804
- National Hospital Organization Hokkaido Cancer Center
-
Shizuoka, Япония, 411-8777
- Shizuoka Cancer Center
-
Tokyo, Япония, 160-0023
- Tokyo Medical University Hospital
-
Tokyo, Япония, 105-8470
- Toranomon Hospital
-
Wakayama, Япония, 641-8510
- Wakayama Medical University Hospital
-
Yokohama-shi, Asahi-ku, Япония, 241-8515
- Kanagawa Cancer Center
-
-
Miyagi
-
Sendai, Miyagi, Япония, 981-0914
- Sendai Kousei Hospital
-
-
Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
18 лет и старше (Взрослый, Пожилой взрослый)
Принимает здоровых добровольцев
Нет
Полы, имеющие право на обучение
Все
Описание
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
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: 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).
Другие имена:
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. |
|
Активный компаратор: 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. |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Disease-Free Survival (DFS) in Intent-to-treat (ITT) Population
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Максимальная концентрация в плазме (CMAX) атезолизумаба
Временное ограничение: Через 30 минут после инфузии в день 1 цикла 1 (длина цикла = 21 день)
|
Через 30 минут после инфузии в день 1 цикла 1 (длина цикла = 21 день)
|
|
|
Минимальная концентрация в сыворотке (CMIN) в стационарном состоянии в пределах интервала дозирования атезолизумаба
Временное ограничение: Перед инфузией в 1 -й день циклов 1, 2, 3, 4, 8, 16 (длина цикла = 21 день), при посещении прекращения исследования (до 12 месяцев), дни 120 после последней дозы атезолизумаба (до 16 месяцев)
|
Перед инфузией в 1 -й день циклов 1, 2, 3, 4, 8, 16 (длина цикла = 21 день), при посещении прекращения исследования (до 12 месяцев), дни 120 после последней дозы атезолизумаба (до 16 месяцев)
|
|
|
Overall Survival (OS) in the ITT Population
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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)
|
Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Спонсор
Следователи
- Директор по исследованиям: Clinical Trials, Hoffmann-La Roche
Публикации и полезные ссылки
Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.
Общие публикации
- 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.
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Действительный)
31 октября 2015 г.
Первичное завершение (Действительный)
26 января 2024 г.
Завершение исследования (Действительный)
26 августа 2026 г.
Даты регистрации исследования
Первый отправленный
4 июня 2015 г.
Впервые представлено, что соответствует критериям контроля качества
26 июня 2015 г.
Первый опубликованный (Оцененный)
1 июля 2015 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
30 сентября 2026 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
7 сентября 2026 г.
Последняя проверка
1 сентября 2026 г.
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
- Новообразования по локализации
- Новообразования
- Заболевания дыхательных путей
- Легочные заболевания
- Новообразования дыхательных путей
- Грудные новообразования
- Новообразования легких
- Рак, Бронхогенный
- Бронхиальные новообразования
- Карцинома немелкоклеточного легкого
- Аминокислоты, пептиды и белки
- Органические химические вещества
- Гетероциклические соединения, 1-кольцо
- Гетероциклические соединения
- Гетероциклические соединения, 2-кольцо
- Гетероциклические соединения, слитое кольцо
- Углеводороды
- Циклопарафины
- Углеводороды, алициклический
- Углеводороды, циклические
- Терпена
- Алкалоиды
- Индолы
- Неорганические химические вещества
- Хлорные соединения
- Азотные соединения
- Гуанин
- Гипоксантины
- Пуриноны
- Пурины
- Глутаматы
- Аминокислоты, кислые
- Аминокислоты
- Аминокислоты, дикарбоновые
- Таксииды
- Циклодеканы
- Diterpenes
- Дезоксицитидин
- Цитидин
- Пиримидиновые нуклеозиды
- Пиримидины
- VINCA ALKALOIDS
- Секологические триптаминовые алкалоиды
- Индольные алкалоиды
- Индолизидины
- Индолизины
- Платиновые соединения
- Доцетаксел
- Винорелбин
- Пеметрексед
- Гемцитабин
- Цисплатин
- Атезолизумаб
Другие идентификационные номера исследования
- GO29527
- 2014 (Грант/контракт NIH США)
- 2014-003205-15 (Номер EudraCT)
- 2023-505981-26-00 (Идентификатор реестра: CTIS (EU))
- 2023 (Грант/контракт NIH США)
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
ДА
Описание плана 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
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .