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

Non-Small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02486718
• Other study ID #: GO29527
• Secondary ID: 2014-003205-15
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: October 31, 2015
• Est. completion date: August 30, 2035

Study information

• Verified date: May 2024
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1280
• Est. completion date: August 30, 2035
• Est. primary completion date: January 26, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small Cell Lung Cancer

Intervention

Drug:
• Atezolizumab
Participants will receive atezolizumab (1200 mg IV) Q3W for 16 cycles (cycle length=21 days).
• Cisplatin
Participants will receive cisplatin 75 milligrams per square meter (mg/m^2) IV on Day 1 of up to four 21-day cycles.
• Vinorelbine
Participants will receive vinorelbine 30 mg/m^2 IV on Days 1 and 8 of each of the four 21-day cycles.
• Docetaxel
Participants will receive docetaxel 75 mg/m^2 IV on Day 1 of each of the four 21-day cycles.
• Gemcitabine
Participants will receive gemcitabine 1250 mg/m^2 IV on Days 1 and 8 of each of the four 21-day cycles.
• 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.

Locations

Country	Name	City	State
Australia	Cabrini Hospital Malvern	Malvern	Victoria
Australia	Townsville Hospital	Townsville	Queensland
Belgium	Cliniques Universitaires St-Luc	Bruxelles
Belgium	CHU Sart-Tilman	Liège
Canada	William Osler Health Centre	Etobicoke	Ontario
Canada	Cite de La Sante de Laval; Hemato-Oncologie	Laval	Quebec
China	Beijing Cancer Hospital	Beijing
China	Cancer Institute and Hospital Chinese Academy of Medical Sciences	Beijing
China	Chinese People's Liberation Army (PLA) General Hospital (301 Hospital)	Beijing
China	Affiliated Hospital of Guangdong Medical University	Guangdong
China	The First Affiliated Hospital of Guangzhou Medical University	Guangzhou
China	Anhui Province Cancer Hospital	Hefei City
China	Shanghai Chest Hospital	Shanghai
China	Shanghai Pulmonary Hospital	Shanghai
China	Liaoning Provincial Cancer Hospital	Shengyang
China	First Hospital of China Medical University	Shenyang
China	First Affiliated Hospital of Soochow University	Suzhou
China	Zhejiang Cancer Hospital	Zhejiang
France	Hôpital Universitaire Dupuytren	Limoges
France	Centre Léon Bérard Centre Régional de Lutte Contre Le Cancer Rhône Alpes	Lyon
France	Hôpital Saint Joseph; Oncologie Medicale	Marseille
France	Centre Hospitalier de Mont de Marsan - Hopital Layne	Mont De Marsan
France	Centre Regional de Lutte contre le Cancer Val d Aurelle - Paul Lamarque; Service d oncologie	Montpellier
France	Clinique Clémentville	Montpellier
France	Centre René Gauducheau Centre de Lutte Contre Le Cancer Nantes Atlantique	Nantes
France	Centre Hospitalier Regional Sud Reunion; Service de Pneumologie	Saint Pierre
France	Hopital d'Instruction des Armees de Begin	Saint-Mande
France	Centre Hospitalier de Saint-Quentin; Pharmacie-URCC	Saint-Quentin
France	Centre Hospitalier Intercommunal Toulon - La Seyne sur Mer	Toulon
France	Hopital d Instruction des Armees de Sainte Anne	Toulon
Germany	Evang. Lungenklinik Berlin Klinik für Pneumologie	Berlin
Germany	Ev.Krankenhaus Bielefeld gGmbH; Klinik für Innere Medizin und Geriatrie	Bielefeld
Germany	Stadtisches Klinikum Braunschweig	Braunschweig
Germany	Klinikum Chemnitz gGmbH	Chemnitz
Germany	Krankenhaus Nordwest	Frankfurt am Main
Germany	LungenClinic Grosshansdorf GmbH; Zentrum fur Pneumologie und Thoraxchirurgie	Großhansdorf
Germany	Krankenhaus Martha-Maria; Halle-Dolau gGmbH	Halle
Germany	Asklepios Klinik Harburg	Hamburg
Germany	Universitätsklinikum Hamburg-Eppendorf	Hamburg
Germany	Thoraxklinik Heidelberg gGmbH	Heidelberg
Germany	Lungenklinik Hemer	Hemer
Germany	Universität Des Saarlandes	Homburg
Germany	Fachklinik für Lungenerkrankungen	Immenhausen
Germany	Vincentius-Diakonissen-Kliniken gAG	Karlsruhe
Germany	Katholisches Klinikum Marienhof	Koblenz Am Rhein
Germany	Kliniken der Stadt Koln gGmbH; Lungenklinik Onkologische Ambulanz	Koln
Germany	SLK Kliniken Heilbronn GmbH, Standort Fachklinik Löwenstein; Onk & Pal	Löwenstein
Germany	Klinikum Bogenhausen	München
Germany	Gemeinschaftspraxis für Hämatologie und Onkologie	Münster
Germany	Pius-Hospital Oldenburg	Oldenburg
Germany	Krankenhaus Barmherzige Bruder Regensburg	Regensburg
Germany	Praxis fur Hamatologie und internistische Onkologie	Velbert
Hong Kong	Prince of Wales Hosp; Dept. Of Clinical Onc	Shatin
Hungary	Semmelweis Egyetem; Belgyogyaszati es Hematologiai Klinika	Budapest
Hungary	University of Pecs, I st Dept of Internal Medicine	Pecs
Hungary	Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rend.Int.	Szolnok
Hungary	Reformatus Pulmonologiai Centrum	Törökbálint
Israel	Rambam Medical Center; Oncology	Haifa
Israel	Edith Wolfson Medical Center	Holon
Israel	Meir Medical Center; Oncology	Kfar-Saba
Israel	Rabin Medical Center	Petach Tikva
Israel	Chaim Sheba Medical Center; Oncology Dept	Ramat Gan
Israel	Tel Aviv Sourasky Medical Ctr; Oncology	Tel Aviv
Italy	Asst Papa Giovanni XXIII; Oncologia Medica	Bergamo	Lombardia
Italy	ASST Spedali Civili di Brescia	Brescia	Lombardia
Italy	Ospedale Clinicizzato SS Annunziata	Chieti	Abruzzo
Italy	Azienda Sanitaria Ospedaliera s. Croce e Carle; Oncologia Medica	Cuneo	Piemonte
Italy	Ospedale San Raffaele	Milano	Lombardia
Italy	A.O.U. Maggiore della Carità	Novara	Piemonte
Italy	Azienda Sanitaria Ospedaliera S Luigi Gonzaga	Orbassano	Piemonte
Italy	Azienda Ospedaliera Di Rilievo Nazionale E Di Alta Specializzazione Garibaldi	Palermo	Sicilia
Italy	Ospedale Silvestrini	Perugia	Umbria
Italy	Azienda Ospedaliero Universitaria Pisana	Pisa	Toscana
Italy	Azienda per l'Assistenza Sanitaria N° 5 - Friuli Occidentale; S.C. Oncologia Pordenone	Pordenone	Friuli-Venezia Giulia
Italy	Policlinico Universitario Campus Biomedico Di Roma; U.O.Oncologia Medica	Roma	Lazio
Italy	Azienda Ospedaliera Città della Salute e della Scienza di Torino	Torino	Piemonte
Italy	Ospedale Santa Chiara; Oncologia Medica	Trento	Trentino-Alto Adige
Italy	Azienda Ospedaliera Universitaria Integrata Verona; UOC Oncologia	Verona	Veneto
Japan	Aichi Cancer Center Hospital	Aichi
Japan	Nagoya University Hospital	Aichi
Japan	National Cancer Center East	Chiba
Japan	Shikoku Cancer Center	Ehime
Japan	Kyushu University Hospital	Fukuoka
Japan	Hiroshima University Hospital	Hiroshima
Japan	National Hospital Organization Hokkaido Cancer Center	Hokkaido
Japan	Hyogo Cancer Center	Hyogo
Japan	Kanagawa Cancer Center	Kanagawa
Japan	Hospital of the University of Occupational and Environmental Health,Japan	Kitakyushu-shi
Japan	Kumamoto University Hospital	Kumamoto
Japan	Kyoto University Hospital	Kyoto
Japan	Sendai Kousei Hospital	Miyagi
Japan	Niigata Cancer Center Hospital	Niigata
Japan	Okayama University Hospital	Okayama
Japan	Saitama Cancer Center	Saitama
Japan	Shizuoka Cancer Center	Shizuoka
Japan	Juntendo University Hospital	Tokyo
Japan	Kyorin University Hospital	Tokyo
Japan	National Cancer Center Hospital	Tokyo
Japan	Tokyo Medical University Hospital	Tokyo
Japan	Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital	Tokyo
Japan	Toranomon Hospital	Tokyo
Japan	Wakayama Medical University Hospital	Wakayama
Korea, Republic of	Chonnam National University Hwasun Hospital	Jeollanam-do
Korea, Republic of	The Catholic University of Korea St. Vincent's Hospital	Suwon-si
Netherlands	Jeroen Bosch Ziekenhuis	'S Hertogenbosch
Netherlands	Martini Ziekenhuis	Groningen
Netherlands	St. Antonius Ziekenhuis Nieuwegein	Nieuwegein
Poland	Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy	Otwock
Poland	Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu	Poznan
Portugal	Centro Hospitalar E Universitário de Coimbra EPE	Coimbra
Portugal	Centro Hospitalar de Lisboa Norte E.P.E ? Hospital Pulido Valente	Lisboa
Portugal	Hospital de Sao Joao; Servico de Pneumologia	Porto
Portugal	Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe	Porto
Romania	Oncology Center Sf. Nectarie	Craiova
Russian Federation	Republican Clinical Oncology Dispensary of Ministry of Healthcare of Tatarstan Republic	Kazan	Tatarstan
Russian Federation	Moscow City Oncology Hospital #62	Moscovskaya Oblast	Moskovskaja Oblast
Russian Federation	Principal Military Clinical Hospital n.a. N.N. Burdenko	Moscow	Moskovskaja Oblast
Russian Federation	Russian Oncology Research Center n a N N Blokhin	Moscow	Moskovskaja Oblast
Russian Federation	City Clinical Hospital #1; Dpt of Oncology	Novosibirsk
Russian Federation	Evromedservis LCC	Pushkin	Sankt Petersburg
Russian Federation	GBUZ Saint Petersburg Clinical Research Center of Specialized Types of Care (Oncology)	Saint Petersburg	Sankt Petersburg
Russian Federation	City Clinical Oncology Dispensary	Saint-Petersburg	Sankt Petersburg
Russian Federation	Mordovia State University	Saransk	Mordovija
Russian Federation	Leningrad Regional Clinical Hospital	St Petersburg	Sankt Petersburg
Russian Federation	St. Petersburg Med Univ; n.a. I.P. Pavlov; Pulmonology Research	St Petersburg	Sankt Petersburg
Russian Federation	Scientific Research Institute of Oncology n.a. N.N. Petrov; Department of Oncogynecology	St. Petersburg	Sankt Petersburg
Russian Federation	Volgograd Regional Clinical Oncology Dispensary	Volgograd
Russian Federation	Regional Clinical Oncology Hospital	Yaroslavl
Spain	Centro Oncologico de Galicia COG; Medical Oncology	A Coruna	LA Coruña
Spain	Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia	Badalona	Barcelona
Spain	Hospital del Mar	Barcelona
Spain	Hospital Santa Creu i Sant Pau	Barcelona
Spain	Consorcio Hospitalario Provincial de Castellon	Castellon DE LA Plana/castello DE LA Plana	Castellon
Spain	C.H. Regional Reina Sofia	Cordoba
Spain	Hospital Universitario Virgen de La Arrixaca; Servicio De Oncologia	El Palmar	Murcia
Spain	Complejo Hospitalario de Jaen	Jaen
Spain	Hospital Lucus Augusti; Servicio de Oncologia	Lugo
Spain	Hosp. Clinico San Carlos	Madrid
Spain	Hospital Ramon y Cajal; Servicio de Oncologia	Madrid
Spain	Hospital Universitario HM Sanchinarro-CIOCC; Oncología Médica	Madrid
Spain	Hospital Universitario La Paz	Madrid
Spain	Hospital Universitario Son Espases	Palma De Mallorca	Islas Baleares
Spain	Hospital Universitario de Canarias	S. Cristobal De La Laguna	Tenerife
Spain	Hospital Univ Vall d'Hebron; Servicio de Oncologia	Sant Andreu de La Barca	Barcelona
Spain	Hospital Universitario Marques de Valdecilla; Servicio de Oncologia	Santander	Cantabria
Spain	Hospital Clinico Universitario de Valencia	Valencia
Spain	Hospital NisA 9 de Octubre	Valencia
Spain	Hospital Universitari i Politecnic La Fe de Valencia	Valencia
Spain	Hosp Clinico Univ Lozano Blesa	Zaragoza
Taiwan	Changhua Christian Hospital	Chang Hua
Taiwan	Kaohsiung Medical University Hospital; Department of Urology	Kaohsiung City
Taiwan	Chi Mei Medical Center Liou Ying Campus	Liuying Township
Taiwan	Chang Gung Memorial Hospital Chiayi	Putzu
Taiwan	Mackay Memorial Hospital	Taipei
Taiwan	National Taiwan Uni Hospital	Taipei City
Taiwan	Taipei Veterans General Hospital	Taipei City
Taiwan	Chang Gung Medical Foundation Linkou Branch	Taoyuan City
Taiwan	Taichung Veterans General Hospital	Xitun Dist.
Ukraine	MI Dnipropetrovsk City Multifield Clinical Hospital 4 of Dnipropetrovsk Regional Council	Dnipropetrovsk	Katerynoslav Governorate
Ukraine	Municipal Institution SubCarpathian ClinicalOncological Centre; Chemotherapy department	Ivano-Frankivsk	Poltava Governorate
Ukraine	Communal Non profit Enterprise Regional Center of Oncology; Oncosurgical dept of thoracic organs	Kharkiv	Kharkiv Governorate
Ukraine	Private Enterprise Private Manufacturing Company Acinus	Kirovograd
Ukraine	ME Kryviy Rih Oncology Dispensary of Dnipropetrovs?k Regional Council; Chemotherapy Department	Kryvyi Rih
Ukraine	Kyiv City Clinical Oncological Center	Kyiv
Ukraine	Kyiv Railway Clinical Hospital #3 of Branch Health Center of the PJSC Ukrainian Railway	Kyiv	KIEV Governorate
Ukraine	Municipal Institution Odesa Regional Oncology Dispensary	Odesa	KIEV Governorate
Ukraine	Regional Municipal Institution Sumy Regional Clinical Oncology Dispensary	Sumy
Ukraine	Communal Nonprofit Enterprise Podilsky Regional Center Of Oncology OfTheVinnytsia Regional Council	Vinnytsia	KIEV Governorate
Ukraine	MI Zaporizhzhia Regional Clinical Oncological Dispensary Zaporizhzhia SMU Ch of Oncology	Zaporizhzhya
United Kingdom	Birmingham Heartlands Hospital	Birmingham
United Kingdom	Colchester General Hospital	Colchester, Essex
United Kingdom	St Bartholomew's Hospital	London
United States	University Cancer & Blood Center, LLC; Research	Athens	Georgia
United States	MultiCare Regional Cancer Center - Auburn	Auburn	Washington
United States	Southern California Permanente Medical Group Bellflower	Bellflower	California
United States	St. Luke's Cancer Care Associates	Bethlehem	Pennsylvania
United States	Lynn Cancer Institute - West	Boca Raton	Florida
United States	Wellmont Medical Associates	Bristol	Virginia
United States	Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital	Carrollton	Georgia
United States	Presbyterian Hospital	Charlotte	North Carolina
United States	Sarah Cannon Research Institute / Tennessee Oncology	Chattanooga	Tennessee
United States	University Oncology Associates	Chattanooga	Tennessee
United States	Rush University Medical Center	Chicago	Illinois
United States	University of Illinois at Chicago	Chicago	Illinois
United States	Oncology Hematology Care - SCRI	Cincinnati	Ohio
United States	University of Cincinnati	Cincinnati	Ohio
United States	SCRI Mark H. Zangmeister Center	Columbus	Ohio
United States	Compassionate Cancer Care Medical Group, Inc	Corona	California
United States	Praxair Cancer Center at Danbury Hospital	Danbury	Connecticut
United States	University of Miami School of Medicine - Sylvester at Deerfield	Deerfield Beach	Florida
United States	Karmanos Cancer Institute	Detroit	Michigan
United States	Providence Everett Med Ctr	Everett	Washington
United States	Hematology Oncology Associates of Northern New Jersey	Florham Park	New Jersey
United States	Holy Cross Hospital Inc	Fort Lauderdale	Florida
United States	Florida Cancer Specialists-Broadway, Fort Myers	Fort Myers	Florida
United States	Hematology Oncology Associates of Fredericksburg, Inc.	Fredericksburg	Virginia
United States	Sarah Cannon Research Institute / Tennessee Oncology	Germantown	Tennessee
United States	Cancer and Hematology Centers of Western Michigan	Grand Rapids	Michigan
United States	Greenville Health System	Greenville	South Carolina
United States	Pinnacle Health	Harrisburg	Pennsylvania
United States	Ingalls Memorial Hospital	Harvey	Illinois
United States	Comprehensive Cancer Centers of Nevada	Henderson	Nevada
United States	Houston Methodist Cancer Center	Houston	Texas
United States	St. Luke's Cancer Institute	Kansas City	Missouri
United States	Saint Barnabas Medical Center	Livingston	New Jersey
United States	Norton Cancer Institute	Louisville	Kentucky
United States	Weill Cornell Medical College	New York	New York
United States	Eastern Connecticut Hematology and Oncology Associates; (ECHO)	Norwich	Connecticut
United States	Stanford University	Palo Alto	California
United States	Valley Hospital; Oncology Research	Paramus	New Jersey
United States	Illinois Cancer Care	Peoria	Illinois
United States	Allegheny General Hospital	Pittsburgh	Pennsylvania
United States	Oregon Health and Science University	Portland	Oregon
United States	Rhode Island Hospital	Providence	Rhode Island
United States	Quincy Medical Group; Canc Ctr at Blessing Hosp	Quincy	Illinois
United States	SCRI Florida Cancer Specialists North; Research Office North Region.	Saint Petersburg	Florida
United States	California Cancer Associates for Research & Excellence, Inc.	San Marcos	California
United States	University of California Los Angeles	Santa Monica	California
United States	New England Cancer Specialists	Scarborough	Maine
United States	Swedish Medical Center	Seattle	Washington
United States	Highlands Oncology Group	Springdale	Arkansas
United States	Southern Illinois University, Simmons Cancer Institute	Springfield	Illinois
United States	Overlook Medical Center; Medical Diagnostic Associates	Summit	New Jersey
United States	Lewis Hall Singletary Oncology Center	Thomasville	Georgia
United States	Hematology and Oncology Associates at Bridgepoint	Tupelo	Mississippi
United States	Kaiser Permanente; Oncology Clinical Trials	Vallejo	California
United States	Kaiser Permanente - Walnut Creek	Walnut Creek	California
United States	SCRI Florida Cancer Specialists East	West Palm Beach	Florida
United States	Clinical Research Alliance	Westbury	New York

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  China,  France,  Germany,  Hong Kong,  Hungary,  Israel,  Italy,  Japan,  Korea, Republic of,  Netherlands,  Poland,  Portugal,  Romania,  Russian Federation,  Spain,  Taiwan,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Overall Survival (OS) in the ITT Population		Baseline up to death from any cause (up to approximately 131 months)
Secondary	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
Secondary	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
Secondary	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)
Secondary	Percentage of Participants with Adverse Events		Baseline up to approximately 131 months
Secondary	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)
Secondary	Maximum Plasma Concentration (Cmax) of Atezolizumab		Post-infusion on Day 1 of Cycle 1 (cy length = 21 days)
Secondary	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)