Study to Assess Safety and Efficacy of Atezolizumab (MPDL3280A) Compared to Best Supportive Care Following Chemotherapy in Patients With Lung Cancer [IMpower010]

A Phase III, Open-Label, Randomized Study to Investigate the Efficacy and Safety of Atezolizumab (Anti-PD-L1 Antibody) Compared With Best Supportive Care Following Adjuvant Cisplatin-Based Chemotherapy in Patients With Completely Resected Stage IB-IIIA Non-Small Cell Lung Cancer

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Non-Small Cell Lung Cancer
• Intervention / Treatment: Drug: Atezolizumab; Drug: Cisplatin; Drug: Vinorelbine; Drug: Docetaxel; Drug: Gemcitabine; Drug: Pemetrexed

• Study Type: Interventional
• Enrollment (Actual): 1280
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • Queensland
    • Townsville, Queensland, Australia, 4810
      • Townsville Hospital
  • Victoria
    • Malvern, Victoria, Australia, 3144
      • Cabrini Hospital Malvern
• Belgium
  • Bruxelles, Belgium, 1200
    • Cliniques Universitaires St-Luc
  • Liège, Belgium, 4000
    • CHU Sart-Tilman
• Canada
  • Ontario
    • Etobicoke, Ontario, Canada, M9V 1R8
      • William Osler Health Centre
  • Quebec
    • Laval, Quebec, Canada, H7M 3L9
      • Cite de La Sante de Laval; Hemato-Oncologie
• China
  • Beijing, China, 100142
    • Beijing Cancer Hospital
  • Beijing, China, 100021
    • Cancer Institute and Hospital Chinese Academy of Medical Sciences
  • Beijing, China, 100853
    • Chinese People's Liberation Army (PLA) General Hospital (301 Hospital)
  • Guangdong, China, 524023
    • Affiliated Hospital of Guangdong Medical University
  • Guangzhou, China, 510120
    • The First Affiliated Hospital of Guangzhou Medical University
  • Hefei City, China, 230031
    • Anhui Province Cancer Hospital
  • Shanghai, China, 200000
    • Shanghai Chest Hospital
  • Shanghai, China, 200433
    • Shanghai Pulmonary Hospital
  • Shengyang, China, 110042
    • Liaoning Provincial Cancer Hospital
  • Shenyang, China, 110001
    • First Hospital of China Medical University
  • Suzhou, China, 215006
    • First Affiliated Hospital of Soochow University
  • Zhejiang, China, 310022
    • Zhejiang Cancer Hospital
• France
  • Limoges, France, 87042
    • Hôpital Universitaire Dupuytren
  • Lyon, France, 69008
    • Centre Léon Bérard Centre Régional de Lutte Contre Le Cancer Rhône Alpes
  • Marseille, France, 13285
    • Hôpital Saint Joseph; Oncologie Medicale
  • Mont De Marsan, France, 40024
    • Centre Hospitalier de Mont de Marsan - Hopital Layne
  • Montpellier, France, 34298
    • Centre Regional de Lutte contre le Cancer Val d Aurelle - Paul Lamarque; Service d oncologie
  • Montpellier, France, 34070
    • Clinique Clementville
  • Nantes, France, 44805
    • Centre René Gauducheau Centre de Lutte Contre Le Cancer Nantes Atlantique
  • Saint Pierre, France, 97448
    • Centre Hospitalier Regional Sud Reunion; Service de Pneumologie
  • Saint-Mande, France, 94160
    • Hopital d'Instruction des Armees de Begin
  • Saint-Quentin, France, 02321
    • Centre Hospitalier de Saint-Quentin; Pharmacie-URCC
  • Toulon, France, 83000
    • Centre Hospitalier Intercommunal Toulon - La Seyne sur Mer
  • Toulon, France, 83041
    • Hopital d Instruction des Armees de Sainte Anne
• Germany
  • Berlin, Germany, 13125
    • Evang. Lungenklinik Berlin Klinik für Pneumologie
  • Bielefeld, Germany, 33611
    • Ev.Krankenhaus Bielefeld gGmbH; Klinik für Innere Medizin und Geriatrie
  • Braunschweig, Germany, 38114
    • Städtisches Klinikum Braunschweig
  • Chemnitz, Germany, 09116
    • Klinikum Chemnitz gGmbH
  • Frankfurt am Main, Germany, 60488
    • Krankenhaus Nordwest
  • Großhansdorf, Germany, 22927
    • LungenClinic Grosshansdorf GmbH
  • Halle, Germany, 06120
    • Krankenhaus Martha-Maria; Halle-Dolau gGmbH
  • Hamburg, Germany, 20246
    • Universitatsklinikum Hamburg-Eppendorf
  • Hamburg, Germany, 21075
    • Asklepios Klinik Harburg
  • Heidelberg, Germany, 69126
    • Thoraxklinik Heidelberg gGmbH
  • Hemer, Germany, 58675
    • Lungenklinik Hemer
  • Homburg, Germany, 66421
    • Universität des Saarlandes
  • Immenhausen, Germany, 34376
    • Fachklinik für Lungenerkrankungen
  • Karlsruhe, Germany, 76137
    • Vincentius-Diakonissen-Kliniken gAG
  • Koblenz Am Rhein, Germany, 56073
    • Katholisches Klinikum Marienhof
  • Koln, Germany, 51109
    • Kliniken der Stadt Koln gGmbH; Lungenklinik Onkologische Ambulanz
  • Löwenstein, Germany, 74245
    • SLK Kliniken Heilbronn GmbH, Standort Fachklinik Löwenstein; Onk & Pal
  • München, Germany, 81925
    • Klinikum Bogenhausen
  • Münster, Germany, 48153
    • Gemeinschaftspraxis für Hämatologie und Onkologie
  • Oldenburg, Germany, 26121
    • Pius-Hospital Oldenburg
  • Regensburg, Germany, 93049
    • Krankenhaus Barmherzige Brüder Regensburg
  • Velbert, Germany, 42551
    • Praxis für Hämatologie und Internistische Onkologie
• Hong Kong
  • Shatin, Hong Kong
    • Prince of Wales Hosp; Dept. Of Clinical Onc
• Hungary
  • Budapest, Hungary, 1088
    • Semmelweis Egyetem
  • Pecs, Hungary, 7624
    • University of Pecs, I st Dept of Internal Medicine
  • Szolnok, Hungary, 5000
    • Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rend.Int.
  • Torokbalint, Hungary, 2045
    • Tüdőgyógyintézet Törökbálint
• Israel
  • Haifa, Israel, 3109601
    • Rambam Medical Center; Oncology
  • Holon, Israel, 5822012
    • Edith Wolfson Medical Center
  • Kfar-Saba, Israel, 4428164
    • Meir Medical Center; Oncology
  • Petach Tikva, Israel, 4922297
    • Rabin Medical Center
  • Ramat Gan, Israel, 5262100
    • Chaim Sheba Medical Center; Oncology Dept
  • Tel Aviv, Israel, 6423906
    • Tel Aviv Sourasky Medical Ctr; Oncology
• Italy
  • Abruzzo
    • Chieti, Abruzzo, Italy, 66100
      • Ospedale Clinicizzato SS Annunziata
  • Friuli-Venezia Giulia
    • Pordenone, Friuli-Venezia Giulia, Italy, 33170
      • Azienda per l'Assistenza Sanitaria N° 5 - Friuli Occidentale; S.C. Oncologia Pordenone
  • Lazio
    • Roma, Lazio, Italy, 00128
      • Policlinico Universitario Campus Biomedico Di Roma; U.O.Oncologia Medica
  • Lombardia
    • Bergamo, Lombardia, Italy, 24127
      • Asst Papa Giovanni XXIII; Oncologia Medica
    • Brescia, Lombardia, Italy, 25123
      • ASST Spedali Civili di Brescia
    • Milano, Lombardia, Italy, 20132
      • Ospedale San Raffaele
  • Piemonte
    • Cuneo, Piemonte, Italy, 12100
      • Azienda Sanitaria Ospedaliera s. Croce e Carle; Oncologia Medica
    • Novara, Piemonte, Italy, 28100
      • A.O.U. Maggiore della Carità
    • Orbassano, Piemonte, Italy, 10043
      • Azienda Sanitaria Ospedaliera S Luigi Gonzaga
    • Torino, Piemonte, Italy, 10126
      • Azienda Ospedaliera Città della Salute e della Scienza di Torino
  • Sicilia
    • Palermo, Sicilia, Italy, 90127
      • Azienda Ospedaliera Di Rilievo Nazionale E Di Alta Specializzazione Garibaldi
  • Toscana
    • Pisa, Toscana, Italy, 56126
      • Azienda Ospedaliero Universitaria Pisana
  • Trentino-Alto Adige
    • Trento, Trentino-Alto Adige, Italy, 38100
      • Ospedale Santa Chiara; Oncologia Medica
  • Umbria
    • Perugia, Umbria, Italy, 06122
      • Ospedale Silvestrini
  • Veneto
    • Verona, Veneto, Italy, 37126
      • Azienda Ospedaliera Universitaria Integrata Verona; UOC Oncologia
• Japan
  • Aichi, Japan, 464-8681
    • Aichi Cancer Center Hospital
  • Aichi, Japan, 466-8560
    • Nagoya University Hospital
  • Chiba, Japan, 277-8577
    • National Cancer Center East
  • Ehime, Japan, 791-0280
    • Shikoku Cancer Center
  • Fukuoka, Japan, 812-8582
    • Kyushu University Hospital
  • Hiroshima, Japan, 734-8551
    • Hiroshima University Hospital
  • Hokkaido, Japan, 003-0804
    • National Hospital Organization Hokkaido Cancer Center
  • Hyogo, Japan, 673-0021
    • Hyogo Cancer Center
  • Kanagawa, Japan, 241-8515
    • Kanagawa Cancer Center
  • Kitakyushu-shi, Japan, 807-8556
    • Hospital of the University of Occupational and Environmental Health,Japan
  • Kumamoto, Japan, 860-8556
    • Kumamoto University Hospital
  • Kyoto, Japan, 606-8507
    • Kyoto University Hospital
  • Miyagi, Japan, 980-0873
    • Sendai Kousei Hospital
  • Niigata, Japan, 951-8566
    • Niigata Cancer Center Hospital
  • Okayama, Japan, 700-8558
    • Okayama University Hospital
  • Saitama, Japan, 362-0806
    • Saitama Cancer Center
  • Shizuoka, Japan, 411-8777
    • Shizuoka Cancer Center
  • Tokyo, Japan, 104-0045
    • National Cancer Center Hospital
  • Tokyo, Japan, 160-0023
    • Tokyo Medical University Hospital
  • Tokyo, Japan, 105-8470
    • Toranomon Hospital
  • Tokyo, Japan, 113-8431
    • Juntendo University Hospital
  • Tokyo, Japan, 113-8677
    • Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
  • Tokyo, Japan, 181-8611
    • Kyorin University Hospital
  • Wakayama, Japan, 641-8510
    • Wakayama Medical University Hospital
• Korea, Republic of
  • Jeollanam-do, Korea, Republic of, 58128
    • Chonnam National University Hwasun Hospital
  • Suwon-si, Korea, Republic of, 16247
    • The Catholic University of Korea St. Vincent's Hospital
• Netherlands
  • 'S Hertogenbosch, Netherlands, 5223 GZ
    • Jeroen Bosch Ziekenhuis
  • Groningen, Netherlands, 9728 NT
    • Martini Ziekenhuis
  • Nieuwegein, Netherlands, 3435 CM
    • St. Antonius Ziekenhuis Nieuwegein
• Poland
  • Otwock, Poland, 05-400
    • Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy
  • Poznan, Poland, 60-569
    • Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu
• Portugal
  • Coimbra, Portugal, 3000-075
    • Centro Hospitalar E Universitário de Coimbra EPE
  • Lisboa, Portugal, 1769-001
    • Centro Hospitalar de Lisboa Norte E.P.E ? Hospital Pulido Valente
  • Porto, Portugal, 4200-072
    • Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe
  • Porto, Portugal, 4200
    • Hospital de Sao Joao; Servico de Pneumologia
• Romania
  • Craiova, Romania, 200347
    • Oncology Center Sf. Nectarie
• Russian Federation
  • Novosibirsk, Russian Federation, 630047
    • City Clinical Hospital #1; Dpt of Oncology
  • Volgograd, Russian Federation, 400138
    • Volgograd Regional Clinical Oncology Dispensary
  • Yaroslavl, Russian Federation, 150040
    • Regional Clinical Oncology Hospital
  • Mordovija
    • Saransk, Mordovija, Russian Federation, 430032
      • Mordovia State University
  • Moskovskaja Oblast
    • Moscovskaya Oblast, Moskovskaja Oblast, Russian Federation, 143423
      • Moscow City Oncology Hospital #62
    • Moscow, Moskovskaja Oblast, Russian Federation, 105229
      • Principal Military Clinical Hospital n.a. N.N. Burdenko
    • Moscow, Moskovskaja Oblast, Russian Federation, 115478
      • Russian Oncology Research Center n a N N Blokhin
  • Sankt Petersburg
    • Pushkin, Sankt Petersburg, Russian Federation, 196603
      • Evromedservis LCC
    • Saint Petersburg, Sankt Petersburg, Russian Federation, 197758
      • GBUZ Saint Petersburg Clinical Research Center of Specialized Types of Care (Oncology)
    • Saint-Petersburg, Sankt Petersburg, Russian Federation, 197022
      • City Clinical Oncology Dispensary
    • St Petersburg, Sankt Petersburg, Russian Federation, 194291
      • Leningrad Regional Clinical Hospital
    • St Petersburg, Sankt Petersburg, Russian Federation, 197089
      • St. Petersburg Med Univ; n.a. I.P. Pavlov; Pulmonology Research
    • St. Petersburg, Sankt Petersburg, Russian Federation, 197758
      • Scientific Research Institute of Oncology n.a. N.N. Petrov; Department of Oncogynecology
  • Tatarstan
    • Kazan, Tatarstan, Russian Federation, 420029
      • Republican Clinical Oncology Dispensary of Ministry of Healthcare of Tatarstan Republic
• Spain
  • Barcelona, Spain, 08003
    • Hospital Del Mar
  • Barcelona, Spain, 08041
    • Hospital Santa Creu i Sant Pau
  • Cordoba, Spain, 14004
    • C.H. Regional Reina Sofia
  • Jaen, Spain, 23007
    • Complejo Hospitalario de Jaen
  • Lugo, Spain, 27003
    • Hospital Lucus Augusti; Servicio de Oncologia
  • Madrid, Spain, 28034
    • Hospital Ramon y Cajal; Servicio de Oncologia
  • Madrid, Spain, 28040
    • Hosp. Clinico San Carlos
  • Madrid, Spain, 280146
    • Hospital Universitario La Paz
  • Madrid, Spain, 28050
    • Hospital Universitario HM Sanchinarro-CIOCC; Oncología Médica
  • Valencia, Spain, 46010
    • Hospital Clínico Universitario de Valencia
  • Valencia, Spain, 46026
    • Hospital Universitari i Politecnic La Fe de Valencia
  • Valencia, Spain, 46015
    • Hospital NisA 9 de Octubre
  • Zaragoza, Spain, 50009
    • Hosp Clinico Univ Lozano Blesa
  • Barcelona
    • Badalona, Barcelona, Spain, 08916
      • Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia
    • Sant Andreu de La Barca, Barcelona, Spain, 08740
      • Hospital Univ Vall d'Hebron; Servicio de Oncologia
  • Cantabria
    • Santander, Cantabria, Spain, 39008
      • Hospital Universitario Marques de Valdecilla; Servicio de Oncologia
  • Castellon
    • Castellon DE LA Plana/castello DE LA Plana, Castellon, Spain, 12002
      • Consorcio Hospitalario Provincial de Castellon
  • Islas Baleares
    • Palma De Mallorca, Islas Baleares, Spain, 07014
      • Hospital Universitario Son Espases
  • LA Coruña
    • A Coruna, LA Coruña, Spain, 15009
      • Centro Oncologico de Galicia COG; Medical Oncology
  • Murcia
    • El Palmar, Murcia, Spain, 30120
      • Hospital Universitario Virgen de La Arrixaca; Servicio De Oncologia
  • Tenerife
    • S. Cristobal De La Laguna, Tenerife, Spain, 38320
      • Hospital Universitario de Canarias
• Taiwan
  • Chang Hua, Taiwan, 500
    • Changhua Christian Hospital
  • Kaohsiung City, Taiwan, 807
    • Kaohsiung Medical University Hospital; Department of Urology
  • Liuying Township, Taiwan, 736
    • Chi Mei Medical Center Liou Ying Campus
  • Putzu, Taiwan, 613
    • Chang Gung Memorial Hospital Chiayi
  • Taipei, Taiwan, 104
    • Mackay Memorial Hospital
  • Taipei City, Taiwan, 112
    • Taipei Veterans General Hospital
  • Taipei City, Taiwan, 10041
    • National Taiwan Uni Hospital
  • Taoyuan City, Taiwan, 333
    • Chang Gung Medical Foundation Linkou Branch
  • Xitun Dist., Taiwan, 40705
    • Taichung Veterans General Hospital
• Ukraine
  • Kirovograd, Ukraine, 25006
    • Private Enterprise Private Manufacturing Company Acinus
  • Kryvyi Rih, Ukraine, 50048
    • ME Kryviy Rih Oncology Dispensary of Dnipropetrovs?k Regional Council; Chemotherapy Department
  • Kyiv, Ukraine, 03115
    • Kyiv City Clinical Oncological Center
  • Sumy, Ukraine, 40005
    • Regional Municipal Institution Sumy Regional Clinical Oncology Dispensary
  • Zaporizhzhya, Ukraine, 69040
    • MI Zaporizhzhia Regional Clinical Oncological Dispensary Zaporizhzhia SMU Ch of Oncology
  • KIEV Governorate
    • Kyiv, KIEV Governorate, Ukraine, 02096
      • Kyiv Railway Clinical Hospital #3 of Branch Health Center of the PJSC Ukrainian Railway
    • Odesa, KIEV Governorate, Ukraine, 65055
      • Municipal Institution Odesa Regional Oncology Dispensary
    • Vinnytsia, KIEV Governorate, Ukraine, 21029
      • Communal Nonprofit Enterprise Podilsky Regional Center Of Oncology OfTheVinnytsia Regional Council
  • Katerynoslav Governorate
    • Dnipropetrovsk, Katerynoslav Governorate, Ukraine, 49102
      • MI Dnipropetrovsk City Multifield Clinical Hospital 4 of Dnipropetrovsk Regional Council
  • Kharkiv Governorate
    • Kharkiv, Kharkiv Governorate, Ukraine, 61070
      • Communal Non profit Enterprise Regional Center of Oncology; Oncosurgical dept of thoracic organs
  • Poltava Governorate
    • Ivano-Frankivsk, Poltava Governorate, Ukraine, 76018
      • Municipal Institution SubCarpathian ClinicalOncological Centre; Chemotherapy department
• United Kingdom
  • Birmingham, United Kingdom, B9 5SS
    • Birmingham Heartlands Hospital
  • Colchester, Essex, United Kingdom, CO4 5JL
    • Colchester General Hospital
  • London, United Kingdom, EC1M 6BQ
    • St Bartholomew's Hospital
• United States
  • Arkansas
    • Springdale, Arkansas, United States, 72762
      • Highlands Oncology Group
  • California
    • Bellflower, California, United States, 90706
      • Southern California Permanente Medical Group Bellflower
    • Corona, California, United States, 92882
      • Compassionate Cancer Care Medical Group, Inc
    • Palo Alto, California, United States, 94305
      • Stanford University
    • San Marcos, California, United States, 92069
      • California Cancer Associates for Research & Excellence, Inc.
    • Santa Monica, California, United States, 90404
      • University Of California Los Angeles
    • Vallejo, California, United States, 94589
      • Kaiser Permanente; Oncology Clinical Trials
    • Walnut Creek, California, United States, 94596
      • Kaiser Permanente - Walnut Creek
  • Connecticut
    • Danbury, Connecticut, United States, 06810
      • Praxair Cancer Center at Danbury Hospital
    • Norwich, Connecticut, United States, 06360
      • Eastern Connecticut Hematology and Oncology Associates; (ECHO)
  • Florida
    • Boca Raton, Florida, United States, 33428
      • Lynn Cancer Institute - West
    • Deerfield Beach, Florida, United States, Suite 200
      • University of Miami School of Medicine - Sylvester at Deerfield
    • Fort Lauderdale, Florida, United States, 33308
      • Holy Cross Hospital Inc
    • Fort Myers, Florida, United States, 33908
      • Florida Cancer Specialists-Broadway, Fort Myers
    • Saint Petersburg, Florida, United States, 33705
      • SCRI Florida Cancer Specialists North; Research Office North Region.
    • West Palm Beach, Florida, United States, 33401
      • SCRI Florida Cancer Specialists East
  • Georgia
    • Athens, Georgia, United States, 30607
      • University Cancer & Blood Center, LLC; Research
    • Carrollton, Georgia, United States, 30117
      • Northwest Georgia Oncology Centers, a Service of WellStar Cobb Hospital
    • Thomasville, Georgia, United States, 31792
      • Lewis Hall Singletary Oncology Center
  • Illinois
    • Chicago, Illinois, United States, 60612
      • University of Illinois at Chicago
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center
    • Harvey, Illinois, United States, 60426
      • Ingalls Memorial Hospital
    • Peoria, Illinois, United States, 61615
      • Illinois Cancer Care
    • Quincy, Illinois, United States, 62301
      • Quincy Medical Group; Canc Ctr at Blessing Hosp
    • Springfield, Illinois, United States, 62794
      • Southern Illinois University, Simmons Cancer Institute
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Norton Cancer Institute
  • Maine
    • Scarborough, Maine, United States, 04074
      • New England Cancer Specialists
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Karmanos Cancer Institute
    • Grand Rapids, Michigan, United States, 49503
      • Cancer and Hematology Centers of Western Michigan
  • Mississippi
    • Tupelo, Mississippi, United States, 38801
      • Hematology and Oncology Associates at Bridgepoint
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • St. Luke's Cancer Institute
  • Nevada
    • Henderson, Nevada, United States, 89014
      • Comprehensive Cancer Centers of Nevada
  • New Jersey
    • Florham Park, New Jersey, United States, 07932
      • Hematology Oncology Associates of Northern New Jersey
    • Livingston, New Jersey, United States, 07039
      • Saint Barnabas Medical Center
    • Paramus, New Jersey, United States, 07652
      • Valley Hospital; Oncology Research
    • Summit, New Jersey, United States, 07901
      • Overlook Medical Center; Medical Diagnostic Associates
  • New York
    • New York, New York, United States, 10065
      • Weill Cornell Medical College
    • Westbury, New York, United States, 11590
      • Clinical Research Alliance
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Presbyterian Hospital
  • Ohio
    • Cincinnati, Ohio, United States, 45203-0542
      • University of Cincinnati
    • Cincinnati, Ohio, United States, 45242
      • Oncology Hematology Care - SCRI
    • Columbus, Ohio, United States, 43219
      • SCRI Mark H. Zangmeister Center
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health and Science University
  • Pennsylvania
    • Bethlehem, Pennsylvania, United States, 18015
      • St. Luke's Cancer Care Associates
    • Harrisburg, Pennsylvania, United States, 17110
      • Pinnacle Health
    • Pittsburgh, Pennsylvania, United States, 15212
      • Allegheny General Hospital
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Rhode Island Hospital
  • South Carolina
    • Greenville, South Carolina, United States, 29605
      • Greenville Health System
  • Tennessee
    • Chattanooga, Tennessee, United States, 37404
      • Scri Tennessee Oncology Chattanooga
    • Chattanooga, Tennessee, United States, 37403
      • University Oncology Associates
    • Germantown, Tennessee, United States, 38138
      • Sarah Cannon Cancer Center
  • Texas
    • Houston, Texas, United States, 77030
      • Houston Methodist Cancer Center
  • Virginia
    • Bristol, Virginia, United States, 24201
      • Wellmont Medical Associates
    • Fredericksburg, Virginia, United States, 22408
      • Hematology Oncology Associates of Fredericksburg, Inc.
  • Washington
    • Auburn, Washington, United States, 98002-4117
      • MultiCare Regional Cancer Center - Auburn
    • Everett, Washington, United States, 98201
      • Providence Everett Med Ctr
    • Seattle, Washington, United States, 98104-1360
      • Swedish Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Atezolizumab; Enrollment Phase: Participants will receive four 21-day cycles of cisplatin-based chemotherapy (cisplatin plus either vinorelbine or docetaxel or gemcitabine or pemetrexed [non-squamous cell NSCLC only]), unless unacceptable toxicity, disease relapse, or participant's decision to discontinue occur. Randomization Phase: Participants will receive atezolizumab 1200 milligrams (mg) intravenously (IV) every 3 weeks (Q3W) for sixteen 21-day cycles and will undergo periodic chest X-ray and CT scan.	Drug: Atezolizumab; Participants will receive atezolizumab (1200 mg IV) Q3W for 16 cycles (cycle length=21 days).; Other Names: MPDL3280A; TECENTRIQ; Drug: Cisplatin; Participants will receive cisplatin 75 milligrams per square meter (mg/m^2) IV on Day 1 of up to four 21-day cycles.; Drug: Vinorelbine; Participants will receive vinorelbine 30 mg/m^2 IV on Days 1 and 8 of each of the four 21-day cycles.; Drug: Docetaxel; Participants will receive docetaxel 75 mg/m^2 IV on Day 1 of each of the four 21-day cycles.; Drug: Gemcitabine; Participants will receive gemcitabine 1250 mg/m^2 IV on Days 1 and 8 of each of the four 21-day cycles.; Drug: Pemetrexed; Participants will receive pemetrexed 500 mg/m^2 IV on Day 1 of each of the four 21-day cycles. Pemetrexed will be administered only in participants with non-squamous cell NSCLC.
Active Comparator: 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.	Drug: Cisplatin; Participants will receive cisplatin 75 milligrams per square meter (mg/m^2) IV on Day 1 of up to four 21-day cycles.; Drug: Vinorelbine; Participants will receive vinorelbine 30 mg/m^2 IV on Days 1 and 8 of each of the four 21-day cycles.; Drug: Docetaxel; Participants will receive docetaxel 75 mg/m^2 IV on Day 1 of each of the four 21-day cycles.; Drug: Gemcitabine; Participants will receive gemcitabine 1250 mg/m^2 IV on Days 1 and 8 of each of the four 21-day cycles.; Drug: Pemetrexed; Participants will receive pemetrexed 500 mg/m^2 IV on Day 1 of each of the four 21-day cycles. Pemetrexed will be administered only in participants with non-squamous cell NSCLC.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease-Free Survival (DFS), Assessed Using Computed Tomography (CT)/Magnetic Resonance Imaging (MRI)/X-Ray	DFS will be assessed by the investigator in PD-L1 subpopulation within the Stage II-IIIA population, in all randomized patients with Stage II-IIIA NSCLC, and in the ITT population.	From randomization to the date of first recurrence of NSCLC, occurrence of new primary NSCLC, or death from any cause, whichever occurs first (up to approximately 131 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS) in the ITT Population		Baseline up to death from any cause (up to approximately 131 months)
Percentage of Participants Who are Disease-Free at Year 3, Assessed Using CT/MRI/X-Ray	DFS rates will be measured in the PD-L1 subpopulation within the Stage II-IIIA population, in all randomized patients with Stage II-IIIA NSCLC, and in the ITT population.	Year 3
Percentage of Participants Who are Disease-Free at Year 5, Assessed Using CT/MRI/X-Ray	DFS rates will be measured in the PD-L1 subpopulation within the Stage II-IIIA population, in all randomized patients with Stage II-IIIA NSCLC, and in the ITT population.	Year 5
DFS Within Selected Populations	DFS rates will be measured within the PD-L1 subpopulation in patients with Stage II-IIIA NSCLC.	From randomization to the date of first recurrence of NSCLC, occurrence of new primary NSCLC, or death from any cause, whichever occurs first (up to approximately 67 months)
Percentage of Participants with Adverse Events		Baseline up to approximately 131 months
Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Atezolizumab		Predose (Hour 0) on Day (D) 1 of Cycles (Cy) 1, 2, 3, 4, 8, 16 (Cy length=21 days), at treatment discontinuation (TD) (up to 12 months), 120 days after last atezolizumab administration (up to 16 months)
Maximum Plasma Concentration (Cmax) of Atezolizumab		Post-infusion on Day 1 of Cycle 1 (cy length = 21 days)
Minimum Serum Concentration (Cmin) at Steady-State Within a Dosing Interval of Atezolizumab		Prior to infusion on D1 of Cy2, 3, 4, 8, 16 (Cy length = 21 days), and at study termination (up to approximately 131 months)

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche
• Investigators: Study Director: Clinical Trials, Hoffmann-La Roche

Publications and helpful links

General Publications

• 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. Erratum In: Lancet. 2021 Sep 23;:

Study record dates

Study Major Dates

• Study Start (Actual): October 31, 2015
• Primary Completion (Actual): January 26, 2024
• Study Completion (Estimated): August 30, 2035

Study Registration Dates

• First Submitted: June 4, 2015
• First Submitted That Met QC Criteria: June 26, 2015
• First Posted (Estimated): July 1, 2015

Study Record Updates

• Last Update Posted (Estimated): February 26, 2024
• Last Update Submitted That Met QC Criteria: February 23, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Molecular Mechanisms of Pharmacological Action; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Antineoplastic Agents, Immunological; Immune Checkpoint Inhibitors; Folic Acid Antagonists; Docetaxel; Vinorelbine; Pemetrexed; Atezolizumab; Gemcitabine
• Other Study ID Numbers: GO29527; 2014-003205-15 (EudraCT Number)