Studie k posouzení bezpečnosti a účinnosti atezolizumabu (MPDL3280A) v porovnání s nejlepší podpůrnou péčí po chemoterapii u pacientů s rakovinou plic [IMpower010]
7. září 2026 aktualizováno: Hoffmann-La Roche
Otevřená, randomizovaná studie fáze III ke zkoumání účinnosti a bezpečnosti atezolizumabu (protilátka proti PD-L1) ve srovnání s nejlepší podpůrnou péčí po adjuvantní chemoterapii na bázi cisplatiny u pacientů s kompletně resekovaným nemalobuněčným stadiem IB-IIIA Rakovina plic
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.
Přehled studie
Postavení
Dokončeno
Podmínky
Intervence / Léčba
Typ studie
Intervenční
Zápis (Aktuální)
1280
Fáze
- Fáze 3
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Queensland
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Douglas, Queensland, Austrálie, 4814
- Townsville Hospital
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Victoria
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Malvern, Victoria, Austrálie, 3144
- Cabrini Hospital Malvern
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Brussels, Belgie, 1200
- Cliniques Universitaires St-Luc
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Liège, Belgie, 4000
- CHU de Liège (Sart Tilman)
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Limoges, Francie, 87042
- Hôpital Universitaire Dupuytren
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Lyon, Francie, 69373
- Centre Léon Bérard Centre Régional de Lutte Contre Le Cancer Rhône Alpes
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Marseille, Francie, 13008
- Hôpital Saint Joseph
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Mont-de-Marsan, Francie, 40000
- Centre Hospitalier de Mont de Marsan - Hopital Layne
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Montpellier, Francie, 34298
- Centre Regional de Lutte contre le Cancer Val d Aurelle - Paul Lamarque
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Montpellier, Francie, 34070
- Clinique Clémentville
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Nantes, Francie, 44093
- Centre René Gauducheau Centre de Lutte Contre Le Cancer Nantes Atlantique
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Saint-Mandé, Francie, 94160
- Hopital d'Instruction des Armees de Begin
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Saint-Pierre, Francie, 97448
- Centre Hospitalier Regional Sud Reunion
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Saint-Quentin, Francie, 02321
- Centre Hospitalier de Saint-Quentin
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Toulon, Francie, 83000
- Centre Hospitalier Intercommunal Toulon - La Seyne sur Mer
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Toulon, Francie, 83041
- Hopital d Instruction des Armees de Sainte Anne
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Groningen, Holandsko, 9728 NT
- Martini Ziekenhuis
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Nieuwegein, Holandsko, 3430 EM
- St. Antonius Ziekenhuis Nieuwegein
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North Brabant
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's-Hertogenbosch, North Brabant, Holandsko, 5223 GZ
- Jeroen Bosch Ziekenhuis
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Shatin, Hongkong
- Prince of Wales Hosp
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Abruzzo
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Chieti, Abruzzo, Itálie, 66013
- Ospedale Clinicizzato SS Annunziata
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Friuli Venezia Giulia
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Pordenone, Friuli Venezia Giulia, Itálie, 33170
- Azienda per l'Assistenza Sanitaria N° 5 - Friuli Occidentale
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Lazio
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Rome, Lazio, Itálie, 00128
- Policlinico Universitario Campus Biomedico Di Roma
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Lombardy
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Bergamo, Lombardy, Itálie, 24127
- Asst Papa Giovanni XXIII
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Brescia, Lombardy, Itálie, 25123
- ASST Spedali Civili di Brescia
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Milan, Lombardy, Itálie, 20132
- Ospedale San Raffaele
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Piedmont
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Cuneo, Piedmont, Itálie, 12100
- Azienda Sanitaria Ospedaliera s. Croce e Carle
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Novara, Piedmont, Itálie, 28100
- A.O.U. Maggiore della Carità
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Orbassano, Piedmont, Itálie, 10043
- Azienda Sanitaria Ospedaliera S Luigi Gonzaga
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Turin, Piedmont, Itálie, 10126
- Azienda Ospedaliera Città della Salute e della Scienza di Torino
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Sicily
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Catania, Sicily, Itálie, 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, Itálie, 38100
- Ospedale Santa Chiara
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Tuscany
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Pisa, Tuscany, Itálie, 56124
- Azienda Ospedaliero Universitaria Pisana
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Umbria
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Perugia, Umbria, Itálie, 06132
- Ospedale Silvestrini
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Veneto
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Verona, Veneto, Itálie, 37126
- Azienda Ospedaliera Universitaria Integrata Verona
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Haifa, Izrael, 31096
- Rambam Medical Center
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Holon, Izrael, 58100
- Edith Wolfson Medical Center
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Kfar Saba, Izrael, 44281
- Meir Medical Center
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Petah Tikva, Izrael, 49100
- Rabin Medical Center
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Tel Aviv, Izrael, 64239
- Tel Aviv Sourasky Medical Ctr
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Tel HaShomer, Izrael, 52621
- Chaim Sheba Medical Center
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Aichi, Japonsko, 464-8681
- Aichi Cancer Center Hospital
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Akashi, Japonsko, 673-0021
- Hyogo Cancer Center
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Bunkyō City, Japonsko, 113-8431
- Juntendo University Hospital
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Bunkyō City, Japonsko, 113-8677
- Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
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Chiba, Japonsko, 277-8577
- National Cancer Center East
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Chūō, Japonsko, 104-0045
- National Cancer Center Hospital
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Fukuoka, Japonsko, 812-8582
- Kyushu University Hospital
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Hiroshima, Japonsko, 734-8551
- Hiroshima University Hospital
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Kitaadachi-gun, Japonsko, 362-0806
- Saitama Cancer Center
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Kitakyushu-shi, Japonsko, 807-8555
- Hospital of the University of Occupational and Environmental Health,Japan
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Kumamoto, Japonsko, 860-8556
- Kumamoto University Hospital
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Kyoto, Japonsko, 606-8507
- Kyoto University Hospital
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Matsuyama, Japonsko, 791-0280
- Shikoku Cancer Center
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Mitaka-shi, Japonsko, 181-0004
- Kyorin University Hospital
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Nagoya, Japonsko, 466-8560
- Nagoya University Hospital
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Niigata, Japonsko, 951-8566
- Niigata Cancer Center Hospital
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Okayama, Japonsko, 700-8558
- Okayama University Hospital
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Sapporo, Japonsko, 003-0804
- National Hospital Organization Hokkaido Cancer Center
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Shizuoka, Japonsko, 411-8777
- Shizuoka Cancer Center
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Tokyo, Japonsko, 160-0023
- Tokyo Medical University Hospital
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Tokyo, Japonsko, 105-8470
- Toranomon Hospital
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Wakayama, Japonsko, 641-8510
- Wakayama Medical University Hospital
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Yokohama-shi, Asahi-ku, Japonsko, 241-8515
- Kanagawa Cancer Center
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Miyagi
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Sendai, Miyagi, Japonsko, 981-0914
- Sendai Kousei Hospital
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Jeonnam, Jižní Korea, 519-763
- Chonnam National University Hwasun Hospital
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Suwon, Jižní Korea, 442-723
- The Catholic University of Korea St. Vincent's Hospital
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Ontario
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Brampton, Ontario, Kanada, L6R 3J7
- William Osler Health Centre
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Quebec
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Laval, Quebec, Kanada, H7M 3L9
- Cite de La Sante de Laval
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Budapest, Maďarsko, 1125
- Semmelweis Egyetem
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Pécs, Maďarsko, 7624
- University of Pecs, I st Dept of Internal Medicine
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Szolnok, Maďarsko, 5004
- Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rend.Int.
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Törökbálint, Maďarsko, 2045
- Reformatus Pulmonologiai Centrum
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Berlin, Německo, 13125
- Evang. Lungenklinik Berlin Klinik für Pneumologie
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Braunschweig, Německo, 38114
- Stadtisches Klinikum Braunschweig
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Chemnitz, Německo, 09113
- Klinikum Chemnitz gGmbH
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Cologne, Německo, 51109
- Kliniken der Stadt Koln gGmbH
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Frankfurt am Main, Německo, 60488
- Krankenhaus Nordwest
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Großhansdorf, Německo, 22927
- LungenClinic Grosshansdorf GmbH
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Halle, Německo, 06120
- Krankenhaus Martha-Maria
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Hamburg, Německo, 20246
- Universitätsklinikum Hamburg-Eppendorf
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Hamburg, Německo, 21075
- Asklepios Klinik Harburg
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Heidelberg, Německo, 69126
- Thoraxklinik Heidelberg gGmbH
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Hemer, Německo, 58675
- Lungenklinik Hemer
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Homburg, Německo, 66421
- Universität Des Saarlandes
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Immenhausen, Německo, 34376
- Fachklinik für Lungenerkrankungen
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Karlsruhe, Německo, 76137
- Vincentius-Diakonissen-Kliniken gAG
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Koblenz Am Rhein, Německo, 56073
- Katholisches Klinikum Marienhof
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München, Německo, 81925
- Klinikum Bogenhausen
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Münster, Německo, 48149
- Gemeinschaftspraxis für Hämatologie und Onkologie
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Oldenburg, Německo, 26121
- Pius-Hospital Oldenburg
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Regensburg, Německo, 93049
- Krankenhaus Barmherzige Bruder Regensburg
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Velbert, Německo, 42551
- Praxis fur Hamatologie und internistische Onkologie
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Baden-Wurttemberg
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Löwenstein, Baden-Wurttemberg, Německo, 74245
- SLK Kliniken Heilbronn GmbH, Standort Fachklinik Löwenstein
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North Rhine-Westphalia
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Bielefeld, North Rhine-Westphalia, Německo, 33611
- Ev.Krankenhaus Bielefeld gGmbH
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Otwock, Polsko, 05-400
- Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy
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Poznan, Polsko, 60569
- Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu
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Coimbra, Portugalsko, 3000-602
- Centro Hospitalar E Universitário de Coimbra EPE
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Lisbon, Portugalsko, 1769-001
- Centro Hospitalar de Lisboa Norte E.P.E ? Hospital Pulido Valente
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Porto, Portugalsko, 4200-319
- Hospital de Sao Joao
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Porto, Portugalsko, 4200-072
- Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe
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Craiova, Rumunsko, 200542
- Oncology Center Sf. Nectarie
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Novosibirsk, Rusko, 630047
- City Clinical Hospital #1
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Volgograd, Rusko, 400138
- Volgograd Regional Clinical Oncology Dispensary
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Yaroslavl, Rusko, 150040
- Regional Clinical Oncology Hospital
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Moscow Oblast
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Moscovskaya Oblast, Moscow Oblast, Rusko, 143423
- Moscow City Oncology Hospital #62
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Moscow, Moscow Oblast, Rusko, 105229
- Principal Military Clinical Hospital n.a. N.N. Burdenko
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Moscow, Moscow Oblast, Rusko, 115478
- Russian Oncology Research Center n a N N Blokhin
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Respublika Mordoviya
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Saransk, Respublika Mordoviya, Rusko, 430032
- Mordovia State University
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Sankt-Peterburg
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Pushkin, Sankt-Peterburg, Rusko, 196603
- Evromedservis LCC
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Saint Petersburg, Sankt-Peterburg, Rusko, 194291
- Leningrad Regional Clinical Hospital
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Saint Petersburg, Sankt-Peterburg, Rusko, 197758
- GBUZ Saint Petersburg Clinical Research Center of Specialized Types of Care (Oncology)
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Saint Petersburg, Sankt-Peterburg, Rusko, 197758
- Scientific Research Institute of Oncology n.a. N.N. Petrov
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Saint Petersburg, Sankt-Peterburg, Rusko, 197022
- St. Petersburg Med Univ
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Saint Petersburg, Sankt-Peterburg, Rusko, 198255
- City Clinical Oncology Dispensary
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Tatarstan Republic
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Kazan', Tatarstan Republic, Rusko, 420029
- Republican Clinical Oncology Dispensary of Ministry of Healthcare of Tatarstan Republic
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Birmingham, Spojené království, B9 5SS
- Birmingham Heartlands Hospital
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Colchester, Essex, Spojené království, CO4 5JL
- Colchester General Hospital
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London, Spojené království, EC1A 7BE
- St Bartholomew's Hospital
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Arkansas
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Fayetteville, Arkansas, Spojené státy, 72703
- Highlands Oncology Group
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California
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Encinitas, California, Spojené státy, 92024
- California Cancer Associates for Research & Excellence, Inc.
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Fountain Valley, California, Spojené státy, 92708
- Compassionate Cancer Care Medical Group, Inc
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Los Angeles, California, Spojené státy, 90024
- University of California Los Angeles
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Los Angeles, California, Spojené státy, 90027
- Southern California Permanente Medical Group Bellflower
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Stanford, California, Spojené státy, 94305
- Stanford University
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Vallejo, California, Spojené státy, 94589
- Kaiser Permanente
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Walnut Creek, California, Spojené státy, 94596
- Kaiser Permanente - Walnut Creek
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Connecticut
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Norwich, Connecticut, Spojené státy, 06360
- Eastern Connecticut Hematology and Oncology Associates
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Florida
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Boca Raton, Florida, Spojené státy, 33486
- Lynn Cancer Institute - West
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Deerfield Beach, Florida, Spojené státy, 33442
- University of Miami School of Medicine - Sylvester at Deerfield
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Fort Lauderdale, Florida, Spojené státy, 33308
- Holy Cross Hospital Inc
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Fort Myers, Florida, Spojené státy, 33916
- Florida Cancer Specialists-Broadway, Fort Myers
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St. Petersburg, Florida, Spojené státy, 33705
- SCRI Florida Cancer Specialists North
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Georgia
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Marietta, Georgia, Spojené státy, 30060
- Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital
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Thomasville, Georgia, Spojené státy, 31792
- Lewis Hall Singletary Oncology Center
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Illinois
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Chicago, Illinois, Spojené státy, 60612
- University of Illinois at Chicago
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Chicago, Illinois, Spojené státy, 60612
- Rush University Medical Center
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Peoria, Illinois, Spojené státy, 61615
- Illinois Cancer Care
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Springfield, Illinois, Spojené státy, 62794
- Southern Illinois University, Simmons Cancer Institute
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Kentucky
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Louisville, Kentucky, Spojené státy, 40402
- Norton Cancer Institute
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Missouri
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Kansas City, Missouri, Spojené státy, 64111
- St. Luke's Cancer Institute
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Nevada
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Henderson, Nevada, Spojené státy, 89052
- Comprehensive Cancer Centers of Nevada
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New Jersey
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Florham Park, New Jersey, Spojené státy, 07932
- Hematology Oncology Associates of Northern New Jersey
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Livingston, New Jersey, Spojené státy, 07039
- Saint Barnabas Medical Center
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Paramus, New Jersey, Spojené státy, 07652
- Valley Hospital
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Summit, New Jersey, Spojené státy, 07901
- Overlook Medical Center
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New York
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Lake Success, New York, Spojené státy, 11042
- Clinical Research Alliance
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New York, New York, Spojené státy, 10065
- Weill Cornell Medical College
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North Carolina
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Charlotte, North Carolina, Spojené státy, 28204
- Presbyterian Hospital
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Ohio
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Cincinnati, Ohio, Spojené státy, 45219
- University of Cincinnati
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Cincinnati, Ohio, Spojené státy, 45242
- Oncology Hematology Care - SCRI
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Oregon
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Portland, Oregon, Spojené státy, 97239
- Oregon Health and Science University
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Pennsylvania
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Harrisburg, Pennsylvania, Spojené státy, 17109
- Pinnacle Health
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Pittsburgh, Pennsylvania, Spojené státy, 15212
- AHN Cancer Institute ? Allegheny General Hospital
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Rhode Island
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Providence, Rhode Island, Spojené státy, 02903
- Rhode Island Hospital
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Tennessee
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Chattanooga, Tennessee, Spojené státy, 37403
- University Oncology Associates
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Chattanooga, Tennessee, Spojené státy, 37403
- Sarah Cannon Research Institute / Tennessee Oncology
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Nashville, Tennessee, Spojené státy, 37203
- Sarah Cannon Cancer Center
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Texas
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Houston, Texas, Spojené státy, 77030
- Houston Methodist Cancer Center
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Virginia
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Bristol, Virginia, Spojené státy, 24201
- Wellmont Medical Associates
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Fredericksburg, Virginia, Spojené státy, 22408
- Hematology Oncology Associates of Fredericksburg, Inc.
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Washington
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Auburn, Washington, Spojené státy, 98002-4117
- MultiCare Regional Cancer Center - Auburn
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Everett, Washington, Spojené státy, 98201
- Providence Everett Med Ctr
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Seattle, Washington, Spojené státy, 98122
- Swedish Medical Center
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-
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Changhua, Tchaj-wan, 500
- Changhua Christian Hospital
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Kaohsiung City, Tchaj-wan, 807
- Kaohsiung Medical University Hospital
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Putzui City, Tchaj-wan, 61363
- Chang Gung Memorial Hospital Chiayi
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Taichung, Tchaj-wan, 40705
- Taichung Veterans General Hospital
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Tainan, Tchaj-wan, 736
- Chi Mei Medical Center Liou Ying Campus
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Taipei, Tchaj-wan, 104
- Mackay Memorial Hospital
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Taipei, Tchaj-wan, 00112
- Taipei Veterans General Hospital
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Taipei, Tchaj-wan, 10048
- National Taiwan Uni Hospital
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Taoyuan City, Tchaj-wan, 333
- Chang Gung Medical Foundation Linkou Branch
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-
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Kryvyi Rih, Ukrajina, 50048
- CE Kryvyi Rih Oncology Dispensary of Dnipropetrovsk Regional Council
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Kyiv, Ukrajina, 03115
- Kyiv City Clinical Oncological Center
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Sumy, Ukrajina, 40022
- Regional Municipal Institution Sumy Regional Clinical Oncology Dispensary
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Zaporizhzhya, Ukrajina, 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, Ukrajina, 25006
- Private Enterprise Private Manufacturing Company Acinus
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Kyiv, KIEV Governorate, Ukrajina, 02096
- Kyiv Railway Clinical Hospital #3 of Branch Health Center of the PJSC Ukrainian Railway
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Odesa, KIEV Governorate, Ukrajina, 65055
- Municipal Institution Odesa Regional Oncology Dispensary
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Katerynoslav Governorate
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Dnipropetrovsk, Katerynoslav Governorate, Ukrajina, 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, Ukrajina, 61070
- Communal Non profit Enterprise Regional Center of Oncology
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Poltava Governorate
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Ivano-Frankivsk, Poltava Governorate, Ukrajina, 76018
- Municipal Institution SubCarpathian ClinicalOncological Centre
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Vinnytsia Oblast
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Vinnytsia, Vinnytsia Oblast, Ukrajina, 21018
- Communal Nonprofit Enterprise Podilsky Regional Center Of Oncology OfTheVinnytsia Regional Council
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-
-
-
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Beijing, Čína, 100142
- Beijing Cancer Hospital
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Beijing, Čína, 100021
- Cancer Institute and Hospital Chinese Academy of Medical Sciences
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Beijing, Čína, 100853
- Chinese People's Liberation Army (PLA) General Hospital (301 Hospital)
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Guangdong, Čína, 524023
- Affiliated Hospital of Guangdong Medical University
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Guangzhou, Čína, 510120
- The First Affiliated Hospital of Guangzhou Medical University
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Hangzhou, Čína, 310022
- Zhejiang Cancer Hospital
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Hefei, Čína
- Anhui Province Cancer Hospital
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Shanghai, Čína, 200030
- Shanghai Chest Hospital
-
Shanghai, Čína, 200433
- Shanghai Pulmonary Hospital
-
Shengyang, Čína, 110042
- Liaoning Provincial Cancer Hospital
-
Shenyang, Čína, 110001
- First Hospital of China Medical University
-
Suzhou, Čína, 215006
- First Affiliated Hospital of Soochow University
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-
-
-
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Barcelona, Španělsko, 08025
- Hospital Santa Creu i Sant Pau
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Barcelona, Španělsko, 08916
- Hospital Universitari Germans Trias i Pujol
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Barcelona, Španělsko, 08035
- Vall d'Hebron Institute of Oncology (VHIO), Barcelona
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Barcelona, Španělsko, 08003
- Hospital del Mar
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Córdoba, Španělsko, 14004
- C.H. Regional Reina Sofia
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Jaén, Španělsko, 23007
- Complejo Hospitalario de Jaen
-
Lugo, Španělsko, 27003
- Hospital Lucus Augusti
-
Madrid, Španělsko, 28046
- Hospital Universitario La Paz
-
Madrid, Španělsko, 28034
- Hospital Ramon y Cajal
-
Madrid, Španělsko, 28040
- Hosp. Clinico San Carlos
-
Madrid, Španělsko, 28050
- Hospital Universitario HM Sanchinarro-CIOCC
-
Valencia, Španělsko, 46026
- Hospital Universitari i Politecnic La Fe de Valencia
-
Valencia, Španělsko, 46010
- Hospital Clinico Universitario de Valencia
-
Zaragoza, Španělsko, 50009
- Hosp Clinico Univ Lozano Blesa
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Balearic Islands
-
Palma de Mallorca, Balearic Islands, Španělsko, 07010
- Hospital Universitario Son Espases
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Cantabria
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Santander, Cantabria, Španělsko, 39008
- Hospital Universitario Marques de Valdecilla
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Castellon
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Castellon, Castellon, Španělsko, 12002
- Consorcio Hospitalario Provincial de Castellon
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LA Coruna
-
A Coruña, LA Coruna, Španělsko, 15009
- Centro Oncologico de Galicia COG
-
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Murcia
-
El Palmar, Murcia, Španělsko, 30120
- Hospital Universitario Virgen de La Arrixaca
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Tenerife
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San Cristóbal de La Laguna, Tenerife, Španělsko, 3820
- Hospital Universitario de Canarias
-
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
18 let a starší (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Všechno
Popis
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
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: 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).
Ostatní jména:
Participants will receive cisplatin 75 milligrams per square meter (mg/m^2) IV on Day 1 of up to four 21-day cycles. Participants will receive vinorelbine 30 mg/m^2 IV on Days 1 and 8 of each of the four 21-day cycles. Participants will receive docetaxel 75 mg/m^2 IV on Day 1 of each of the four 21-day cycles. Participants will receive gemcitabine 1250 mg/m^2 IV on Days 1 and 8 of each of the four 21-day cycles. Participants will receive pemetrexed 500 mg/m^2 IV on Day 1 of each of the four 21-day cycles. Pemetrexed will be administered only in participants with non-squamous cell NSCLC. |
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Aktivní komparátor: 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. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Disease-Free Survival (DFS) in Intent-to-treat (ITT) Population
Časové okno: 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
Časové okno: 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
Časové okno: 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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Maximální plazmatická koncentrace (CMAX) atezolizumabu
Časové okno: 30 minut po infuzi v den 1 cyklu 1 (délka cyklu = 21 dní)
|
30 minut po infuzi v den 1 cyklu 1 (délka cyklu = 21 dní)
|
|
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Minimální koncentrace séra (CMIN) v ustáleném stavu v dávkovacím intervalu atezolizumabu
Časové okno: Před infuzí v den 1 cyklů 1, 2, 3, 4, 8, 16 (délka cyklu = 21 dní) při návštěvě ukončení studie (až 12 měsíců), 120 po poslední dávce Atezolizumabu (až 16 měsíců)
|
Před infuzí v den 1 cyklů 1, 2, 3, 4, 8, 16 (délka cyklu = 21 dní) při návštěvě ukončení studie (až 12 měsíců), 120 po poslední dávce Atezolizumabu (až 16 měsíců)
|
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Overall Survival (OS) in the ITT Population
Časové okno: 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)
|
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Disease-free Rate at Year 3 in ITT Population
Časové okno: 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
Časové okno: 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
Časové okno: 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
|
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Disease-free Rate at Year 5 in ITT Population
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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
Časové okno: 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)
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Vyšetřovatelé
- Ředitel studie: Clinical Trials, Hoffmann-La Roche
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Obecné publikace
- 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.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
31. října 2015
Primární dokončení (Aktuální)
26. ledna 2024
Dokončení studie (Aktuální)
26. srpna 2026
Termíny zápisu do studia
První předloženo
4. června 2015
První předloženo, které splnilo kritéria kontroly kvality
26. června 2015
První zveřejněno (Odhadovaný)
1. července 2015
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
30. září 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
7. září 2026
Naposledy ověřeno
1. září 2026
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
- Novotvary podle místa
- Novotvary
- Nemoci dýchacích cest
- Plicní onemocnění
- Novotvary dýchacího traktu
- Novotvary hrudníku
- Novotvary plic
- Karcinom, Bronchogenní
- Bronchiální novotvary
- Karcinom, nemalobuněčné plíce
- Aminokyseliny, peptidy a proteiny
- Organické chemikálie
- Heterocyklické sloučeniny, 1 kruh
- Heterocyklické sloučeniny
- Heterocyklické sloučeniny, 2-prsten
- Heterocyklické sloučeniny, fúzované kroužek
- Uhlovodíky
- Cykloparafiny
- Uhlovodíky, alicyklické
- Uhlovodíky, cyklické
- Terpeny
- Alkaloidy
- Indoly
- Anorganické chemikálie
- Sloučeniny chloru
- Sloučeniny dusíku
- Guanine
- Hypoxanthiny
- Purinony
- Puriny
- Glutamáty
- Aminokyseliny, kyselé
- Aminokyseliny
- Aminokyseliny, dikarboxylové
- Taxoidy
- Cyclodecanes
- Diterpeny
- Deoxycytidin
- Cytidin
- Pyrimidinové nukleosidy
- Pyrimidiny
- Vinca alkaloidy
- Alkaloidy tryptaminu sezologaninu
- Indolské alkaloidy
- Indolizidiny
- Indoliziny
- Platinové sloučeniny
- Docetaxel
- Vinorelbin
- Pemetrexed
- Gemcitabin
- Cisplatina
- Atezolizumab
Další identifikační čísla studie
- GO29527
- 2014 (Grant/smlouva NIH USA)
- 2014-003205-15 (Číslo EudraCT)
- 2023-505981-26-00 (Identifikátor registru: CTIS (EU))
- 2023 (Grant/smlouva NIH USA)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
ANO
Popis plánu 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
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .