Clinical trial NCT02486718: Study to Assess Safety and Efficacy of Atezolizumab (MPDL3280A) Compared to Best Supportive Care Following Chemotherapy in Patients With Lung Cancer [IMpower010]
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Non-Small Cell Lung Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2015-07-01
Enrollment: 1280
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Disease-Free Survival (DFS) in Intent-to-treat (ITT) Population
timeFrame: Up to 95 months
measure: DFS in All Randomized Stage II-IIIA Population
timeFrame: Up to 95 months
measure: DFS in the Programmed Death-ligand 1 (PD-L1) SP263 ≥ 1% Tumor Cell (TC) Subpopulation Within the Stage II-IIIA Population
timeFrame: Up to 95 months
Secondary outcomes:
measure: Overall Survival (OS) in the ITT Population
timeFrame: Up to 20 years
measure: Disease-free Rate at Year 3 in ITT Population
timeFrame: Year 3
measure: Disease-free Rate at Year 3 in All Randomized Stage II-IIIA Population
timeFrame: Year 3
measure: Disease-free Rate at Year 3 in PD-L1 (SP263 ≥ 1% TC) Subpopulation Within the Stage II-IIIA Population
timeFrame: Year 3
measure: Disease-free Rate at Year 5 in ITT Population
timeFrame: Year 5
measure: Disease-free Rate at Year 5 in All Randomized Stage II-IIIA Population
timeFrame: Year 5
measure: Disease-free Rate at Year 5 in PD-L1 (SP263 ≥ 1% TC) Subpopulation Within the Stage II-IIIA Population
timeFrame: Year 5
measure: DFS in the PD-L1 (SP263 ≥ 50% TC) Subpopulation Within the Stage II-IIIA Population
timeFrame: Up to 95 months
measure: Percentage of Participants With Adverse Events (AEs)
timeFrame: Up to 20 years
measure: Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Atezolizumab
timeFrame: 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)
measure: Maximum Plasma Concentration (Cmax) of Atezolizumab
timeFrame: 30 min post-infusion on Day 1 of Cycle 1 (Cycle length = 21 days)
measure: Minimum Serum Concentration (Cmin) at Steady-State Within a Dosing Interval of Atezolizumab
timeFrame: Prior to infusion on Day 1 of Cycles 1, 2, 3, 4, 8, 16 (Cycle length = 21 days), at study discontinuation visit (up to 12 months), Day 120 post last dose of atezolizumab (up to 16 months)
Other outcomes:
Locations:
city: Springdale
country: United States
facility: Highlands Oncology Group
state: Arkansas
city: Bellflower
country: United States
facility: Southern California Permanente Medical Group Bellflower
state: California
city: Corona
country: United States
facility: Compassionate Cancer Care Medical Group, Inc
state: California
city: Palo Alto
country: United States
facility: Stanford University
state: California
city: San Marcos
country: United States
facility: California Cancer Associates for Research & Excellence, Inc.
state: California
city: Santa Monica
country: United States
facility: University of California Los Angeles
state: California
city: Vallejo
country: United States
facility: Kaiser Permanente; Oncology Clinical Trials
state: California
city: Walnut Creek
country: United States
facility: Kaiser Permanente - Walnut Creek
state: California
city: Danbury
country: United States
facility: Praxair Cancer Center at Danbury Hospital
state: Connecticut
city: Norwich
country: United States
facility: Eastern Connecticut Hematology and Oncology Associates; (ECHO)
state: Connecticut
city: Boca Raton
country: United States
facility: Lynn Cancer Institute - West
state: Florida
city: Deerfield Beach
country: United States
facility: University of Miami School of Medicine - Sylvester at Deerfield
state: Florida
city: Fort Lauderdale
country: United States
facility: Holy Cross Hospital Inc
state: Florida
city: Fort Myers
country: United States
facility: Florida Cancer Specialists-Broadway, Fort Myers
state: Florida
city: Saint Petersburg
country: United States
facility: SCRI Florida Cancer Specialists North; Research Office North Region.
state: Florida
city: West Palm Beach
country: United States
facility: SCRI Florida Cancer Specialists East
state: Florida
city: Athens
country: United States
facility: University Cancer & Blood Center, LLC; Research
state: Georgia
city: Carrollton
country: United States
facility: Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital
state: Georgia
city: Thomasville
country: United States
facility: Lewis Hall Singletary Oncology Center
state: Georgia
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
city: Harvey
country: United States
facility: Ingalls Memorial Hospital
state: Illinois
city: Peoria
country: United States
facility: Illinois Cancer Care
state: Illinois
city: Quincy
country: United States
facility: Quincy Medical Group; Canc Ctr at Blessing Hosp
state: Illinois
city: Springfield
country: United States
facility: Southern Illinois University, Simmons Cancer Institute
state: Illinois
city: Louisville
country: United States
facility: Norton Cancer Institute
state: Kentucky
city: Scarborough
country: United States
facility: New England Cancer Specialists
state: Maine
city: Detroit
country: United States
facility: Karmanos Cancer Institute
state: Michigan
city: Grand Rapids
country: United States
facility: Cancer and Hematology Centers of Western Michigan
state: Michigan
city: Tupelo
country: United States
facility: Hematology and Oncology Associates at Bridgepoint
state: Mississippi
city: Kansas City
country: United States
facility: St. Luke's Cancer Institute
state: Missouri
city: Henderson
country: United States
facility: Comprehensive Cancer Centers of Nevada
state: Nevada
city: Florham Park
country: United States
facility: Hematology Oncology Associates of Northern New Jersey
state: New Jersey
city: Livingston
country: United States
facility: Saint Barnabas Medical Center
state: New Jersey
city: Paramus
country: United States
facility: Valley Hospital; Oncology Research
state: New Jersey
city: Summit
country: United States
facility: Overlook Medical Center; Medical Diagnostic Associates
state: New Jersey
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
city: Westbury
country: United States
facility: Clinical Research Alliance
state: New York
city: Charlotte
country: United States
facility: Presbyterian Hospital
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Cincinnati
country: United States
facility: Oncology Hematology Care - SCRI
state: Ohio
city: Columbus
country: United States
facility: SCRI Mark H. Zangmeister Center
state: Ohio
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Bethlehem
country: United States
facility: St. Luke's Cancer Care Associates
state: Pennsylvania
city: Harrisburg
country: United States
facility: Pinnacle Health
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny General Hospital
state: Pennsylvania
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Greenville
country: United States
facility: Greenville Health System
state: South Carolina
city: Chattanooga
country: United States
facility: University Oncology Associates
state: Tennessee
city: Chattanooga
country: United States
facility: Sarah Cannon Research Institute / Tennessee Oncology
state: Tennessee
city: Nashville
country: United States
facility: Sarah Cannon Research Institute / Tennessee Oncology
state: Tennessee
city: Houston
country: United States
facility: Houston Methodist Cancer Center
state: Texas
city: Bristol
country: United States
facility: Wellmont Medical Associates
state: Virginia
city: Fredericksburg
country: United States
facility: Hematology Oncology Associates of Fredericksburg, Inc.
state: Virginia
city: Auburn
country: United States
facility: MultiCare Regional Cancer Center - Auburn
state: Washington
city: Everett
country: United States
facility: Providence Everett Med Ctr
state: Washington
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
city: Townsville
country: Australia
facility: Townsville Hospital
state: Queensland
city: Malvern
country: Australia
facility: Cabrini Hospital Malvern
state: Victoria
city: Bruxelles
country: Belgium
facility: Cliniques Universitaires St-Luc
city: Liège
country: Belgium
facility: CHU Sart-Tilman
city: Etobicoke
country: Canada
facility: William Osler Health Centre
state: Ontario
city: Laval
country: Canada
facility: Cite de La Sante de Laval; Hemato-Oncologie
state: Quebec
city: Beijing
country: China
facility: Cancer Institute and Hospital Chinese Academy of Medical Sciences
city: Beijing
country: China
facility: Beijing Cancer Hospital
city: Beijing
country: China
facility: Chinese People's Liberation Army (PLA) General Hospital (301 Hospital)
city: Guangdong
country: China
facility: Affiliated Hospital of Guangdong Medical University
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangzhou Medical University
city: Hefei City
country: China
facility: Anhui Province Cancer Hospital
city: Shanghai
country: China
facility: Shanghai Chest Hospital
city: Shanghai
country: China
facility: Shanghai Pulmonary Hospital
city: Shengyang
country: China
facility: Liaoning Provincial Cancer Hospital
city: Shenyang
country: China
facility: First Hospital of China Medical University
city: Suzhou
country: China
facility: First Affiliated Hospital of Soochow University
city: Zhejiang
country: China
facility: Zhejiang Cancer Hospital
city: Limoges
country: France
facility: Hôpital Universitaire Dupuytren
city: Lyon
country: France
facility: Centre Léon Bérard Centre Régional de Lutte Contre Le Cancer Rhône Alpes
city: Marseille
country: France
facility: Hôpital Saint Joseph; Oncologie Medicale
city: Mont De Marsan
country: France
facility: Centre Hospitalier de Mont de Marsan - Hopital Layne
city: Montpellier
country: France
facility: Clinique Clémentville
city: Montpellier
country: France
facility: Centre Regional de Lutte contre le Cancer Val d Aurelle - Paul Lamarque; Service d oncologie
city: Nantes
country: France
facility: Centre René Gauducheau Centre de Lutte Contre Le Cancer Nantes Atlantique
city: Saint Pierre
country: France
facility: Centre Hospitalier Regional Sud Reunion; Service de Pneumologie
city: Saint-Mande
country: France
facility: Hopital d'Instruction des Armees de Begin
city: Saint-Quentin
country: France
facility: Centre Hospitalier de Saint-Quentin; Pharmacie-URCC
city: Toulon
country: France
facility: Centre Hospitalier Intercommunal Toulon - La Seyne sur Mer
city: Toulon
country: France
facility: Hopital d Instruction des Armees de Sainte Anne
city: Berlin
country: Germany
facility: Evang. Lungenklinik Berlin Klinik für Pneumologie
city: Bielefeld
country: Germany
facility: Ev.Krankenhaus Bielefeld gGmbH; Klinik für Innere Medizin und Geriatrie
city: Braunschweig
country: Germany
facility: Stadtisches Klinikum Braunschweig
city: Chemnitz
country: Germany
facility: Klinikum Chemnitz gGmbH
city: Frankfurt am Main
country: Germany
facility: Krankenhaus Nordwest
city: Großhansdorf
country: Germany
facility: LungenClinic Grosshansdorf GmbH; Zentrum fur Pneumologie und Thoraxchirurgie
city: Halle
country: Germany
facility: Krankenhaus Martha-Maria; Halle-Dolau gGmbH
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg-Eppendorf
city: Hamburg
country: Germany
facility: Asklepios Klinik Harburg
city: Heidelberg
country: Germany
facility: Thoraxklinik Heidelberg gGmbH
city: Hemer
country: Germany
facility: Lungenklinik Hemer
city: Homburg
country: Germany
facility: Universität Des Saarlandes
city: Immenhausen
country: Germany
facility: Fachklinik für Lungenerkrankungen
city: Karlsruhe
country: Germany
facility: Vincentius-Diakonissen-Kliniken gAG
city: Koblenz Am Rhein
country: Germany
facility: Katholisches Klinikum Marienhof
city: Koln
country: Germany
facility: Kliniken der Stadt Koln gGmbH; Lungenklinik Onkologische Ambulanz
city: Löwenstein
country: Germany
facility: SLK Kliniken Heilbronn GmbH, Standort Fachklinik Löwenstein; Onk & Pal
city: München
country: Germany
facility: Klinikum Bogenhausen
city: Münster
country: Germany
facility: Gemeinschaftspraxis für Hämatologie und Onkologie
city: Oldenburg
country: Germany
facility: Pius-Hospital Oldenburg
city: Regensburg
country: Germany
facility: Krankenhaus Barmherzige Bruder Regensburg
city: Velbert
country: Germany
facility: Praxis fur Hamatologie und internistische Onkologie
city: Shatin
country: Hong Kong
facility: Prince of Wales Hosp; Dept. Of Clinical Onc
city: Budapest
country: Hungary
facility: Semmelweis Egyetem; Belgyogyaszati es Hematologiai Klinika
city: Pecs
country: Hungary
facility: University of Pecs, I st Dept of Internal Medicine
city: Szolnok
country: Hungary
facility: Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rend.Int.
city: Törökbálint
country: Hungary
facility: Reformatus Pulmonologiai Centrum
city: Haifa
country: Israel
facility: Rambam Medical Center; Oncology
city: Holon
country: Israel
facility: Edith Wolfson Medical Center
city: Kfar-Saba
country: Israel
facility: Meir Medical Center; Oncology
city: Petach Tikva
country: Israel
facility: Rabin Medical Center
city: Ramat Gan
country: Israel
facility: Chaim Sheba Medical Center; Oncology Dept
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Ctr; Oncology
city: Chieti
country: Italy
facility: Ospedale Clinicizzato SS Annunziata
state: Abruzzo
city: Pordenone
country: Italy
facility: Azienda per l'Assistenza Sanitaria N° 5 - Friuli Occidentale; S.C. Oncologia Pordenone
state: Friuli-Venezia Giulia
city: Roma
country: Italy
facility: Policlinico Universitario Campus Biomedico Di Roma; U.O.Oncologia Medica
state: Lazio
city: Bergamo
country: Italy
facility: Asst Papa Giovanni XXIII; Oncologia Medica
state: Lombardia
city: Brescia
country: Italy
facility: ASST Spedali Civili di Brescia
state: Lombardia
city: Milano
country: Italy
facility: Ospedale San Raffaele
state: Lombardia
city: Cuneo
country: Italy
facility: Azienda Sanitaria Ospedaliera s. Croce e Carle; Oncologia Medica
state: Piemonte
city: Novara
country: Italy
facility: A.O.U. Maggiore della Carità
state: Piemonte
city: Orbassano
country: Italy
facility: Azienda Sanitaria Ospedaliera S Luigi Gonzaga
state: Piemonte
city: Torino
country: Italy
facility: Azienda Ospedaliera Città della Salute e della Scienza di Torino
state: Piemonte
city: Palermo
country: Italy
facility: Azienda Ospedaliera Di Rilievo Nazionale E Di Alta Specializzazione Garibaldi
state: Sicilia
city: Pisa
country: Italy
facility: Azienda Ospedaliero Universitaria Pisana
state: Toscana
city: Trento
country: Italy
facility: Ospedale Santa Chiara; Oncologia Medica
state: Trentino-Alto Adige
city: Perugia
country: Italy
facility: Ospedale Silvestrini
state: Umbria
city: Verona
country: Italy
facility: Azienda Ospedaliera Universitaria Integrata Verona; UOC Oncologia
state: Veneto
city: Aichi
country: Japan
facility: Aichi Cancer Center Hospital
city: Aichi
country: Japan
facility: Nagoya University Hospital
city: Chiba
country: Japan
facility: National Cancer Center East
city: Ehime
country: Japan
facility: Shikoku Cancer Center
city: Fukuoka
country: Japan
facility: Kyushu University Hospital
city: Hiroshima
country: Japan
facility: Hiroshima University Hospital
city: Hokkaido
country: Japan
facility: National Hospital Organization Hokkaido Cancer Center
city: Hyogo
country: Japan
facility: Hyogo Cancer Center
city: Kanagawa
country: Japan
facility: Kanagawa Cancer Center
city: Kitakyushu-shi
country: Japan
facility: Hospital of the University of Occupational and Environmental Health,Japan
city: Kumamoto
country: Japan
facility: Kumamoto University Hospital
city: Kyoto
country: Japan
facility: Kyoto University Hospital
city: Miyagi
country: Japan
facility: Sendai Kousei Hospital
city: Niigata
country: Japan
facility: Niigata Cancer Center Hospital
city: Okayama
country: Japan
facility: Okayama University Hospital
city: Saitama
country: Japan
facility: Saitama Cancer Center
city: Shizuoka
country: Japan
facility: Shizuoka Cancer Center
city: Tokyo
country: Japan
facility: National Cancer Center Hospital
city: Tokyo
country: Japan
facility: Toranomon Hospital
city: Tokyo
country: Japan
facility: Juntendo University Hospital
city: Tokyo
country: Japan
facility: Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
city: Tokyo
country: Japan
facility: Tokyo Medical University Hospital
city: Tokyo
country: Japan
facility: Kyorin University Hospital
city: Wakayama
country: Japan
facility: Wakayama Medical University Hospital
city: Jeollanam-do
country: Korea, Republic of
facility: Chonnam National University Hwasun Hospital
city: Suwon
country: Korea, Republic of
facility: The Catholic University of Korea St. Vincent's Hospital
city: 'S Hertogenbosch
country: Netherlands
facility: Jeroen Bosch Ziekenhuis
city: Groningen
country: Netherlands
facility: Martini Ziekenhuis
city: Nieuwegein
country: Netherlands
facility: St. Antonius Ziekenhuis Nieuwegein
city: Otwock
country: Poland
facility: Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy
city: Poznan
country: Poland
facility: Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu
city: Coimbra
country: Portugal
facility: Centro Hospitalar E Universitário de Coimbra EPE
city: Lisboa
country: Portugal
facility: Centro Hospitalar de Lisboa Norte E.P.E ? Hospital Pulido Valente
city: Porto
country: Portugal
facility: Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe
city: Porto
country: Portugal
facility: Hospital de Sao Joao; Servico de Pneumologia
city: Craiova
country: Romania
facility: Oncology Center Sf. Nectarie
city: Saransk
country: Russian Federation
facility: Mordovia State University
state: Mordovija
city: Moscovskaya Oblast
country: Russian Federation
facility: Moscow City Oncology Hospital #62
state: Moskovskaja Oblast
city: Moscow
country: Russian Federation
facility: Principal Military Clinical Hospital n.a. N.N. Burdenko
state: Moskovskaja Oblast
city: Moscow
country: Russian Federation
facility: Russian Oncology Research Center n a N N Blokhin
state: Moskovskaja Oblast
city: Pushkin
country: Russian Federation
facility: Evromedservis LCC
state: Sankt Petersburg
city: Saint Petersburg
country: Russian Federation
facility: GBUZ Saint Petersburg Clinical Research Center of Specialized Types of Care (Oncology)
state: Sankt Petersburg
city: Saint-Petersburg
country: Russian Federation
facility: City Clinical Oncology Dispensary
state: Sankt Petersburg
city: St Petersburg
country: Russian Federation
facility: Leningrad Regional Clinical Hospital
state: Sankt Petersburg
city: St Petersburg
country: Russian Federation
facility: St. Petersburg Med Univ; n.a. I.P. Pavlov; Pulmonology Research
state: Sankt Petersburg
city: St. Petersburg
country: Russian Federation
facility: Scientific Research Institute of Oncology n.a. N.N. Petrov; Department of Oncogynecology
state: Sankt Petersburg
city: Kazan
country: Russian Federation
facility: Republican Clinical Oncology Dispensary of Ministry of Healthcare of Tatarstan Republic
state: Tatarstan
city: Novosibirsk
country: Russian Federation
facility: City Clinical Hospital #1; Dpt of Oncology
city: Volgograd
country: Russian Federation
facility: Volgograd Regional Clinical Oncology Dispensary
city: Yaroslavl
country: Russian Federation
facility: Regional Clinical Oncology Hospital
city: Badalona
country: Spain
facility: Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia
state: Barcelona
city: Sant Andreu de La Barca
country: Spain
facility: Hospital Univ Vall d'Hebron; Servicio de Oncologia
state: Barcelona
city: Santander
country: Spain
facility: Hospital Universitario Marques de Valdecilla; Servicio de Oncologia
state: Cantabria
city: Castellon DE LA Plana/castello DE LA Plana
country: Spain
facility: Consorcio Hospitalario Provincial de Castellon
state: Castellon
city: Palma De Mallorca
country: Spain
facility: Hospital Universitario Son Espases
state: Islas Baleares
city: A Coruna
country: Spain
facility: Centro Oncologico de Galicia COG; Medical Oncology
state: LA Coruña
city: El Palmar
country: Spain
facility: Hospital Universitario Virgen de La Arrixaca; Servicio De Oncologia
state: Murcia
city: S. Cristobal De La Laguna
country: Spain
facility: Hospital Universitario de Canarias
state: Tenerife
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Hospital Santa Creu i Sant Pau
city: Cordoba
country: Spain
facility: C.H. Regional Reina Sofia
city: Jaen
country: Spain
facility: Complejo Hospitalario de Jaen
city: Lugo
country: Spain
facility: Hospital Lucus Augusti; Servicio de Oncologia
city: Madrid
country: Spain
facility: Hospital Ramon y Cajal; Servicio de Oncologia
city: Madrid
country: Spain
facility: Hosp. Clinico San Carlos
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Madrid
country: Spain
facility: Hospital Universitario HM Sanchinarro-CIOCC; Oncología Médica
city: Valencia
country: Spain
facility: Hospital Clinico Universitario de Valencia
city: Valencia
country: Spain
facility: Hospital NisA 9 de Octubre
city: Valencia
country: Spain
facility: Hospital Universitari i Politecnic La Fe de Valencia
city: Zaragoza
country: Spain
facility: Hosp Clinico Univ Lozano Blesa
city: Chang Hua
country: Taiwan
facility: Changhua Christian Hospital
city: Kaohsiung City
country: Taiwan
facility: Kaohsiung Medical University Hospital; Department of Urology
city: Liuying Township
country: Taiwan
facility: Chi Mei Medical Center Liou Ying Campus
city: Putzu
country: Taiwan
facility: Chang Gung Memorial Hospital Chiayi
city: Taipei City
country: Taiwan
facility: National Taiwan Uni Hospital
city: Taipei City
country: Taiwan
facility: Taipei Veterans General Hospital
city: Taipei
country: Taiwan
facility: Mackay Memorial Hospital
city: Taoyuan City
country: Taiwan
facility: Chang Gung Medical Foundation Linkou Branch
city: Xitun Dist.
country: Taiwan
facility: Taichung Veterans General Hospital
city: Dnipropetrovsk
country: Ukraine
facility: MI Dnipropetrovsk City Multifield Clinical Hospital 4 of Dnipropetrovsk Regional Council
state: Katerynoslav Governorate
city: Kharkiv
country: Ukraine
facility: Communal Non profit Enterprise Regional Center of Oncology; Oncosurgical dept of thoracic organs
state: Kharkiv Governorate
city: Kyiv
country: Ukraine
facility: Kyiv Railway Clinical Hospital #3 of Branch Health Center of the PJSC Ukrainian Railway
state: KIEV Governorate
city: Odesa
country: Ukraine
facility: Municipal Institution Odesa Regional Oncology Dispensary
state: KIEV Governorate
city: Vinnytsia
country: Ukraine
facility: Communal Nonprofit Enterprise Podilsky Regional Center Of Oncology OfTheVinnytsia Regional Council
state: KIEV Governorate
city: Ivano-Frankivsk
country: Ukraine
facility: Municipal Institution SubCarpathian ClinicalOncological Centre; Chemotherapy department
state: Poltava Governorate
city: Kirovograd
country: Ukraine
facility: Private Enterprise Private Manufacturing Company Acinus
city: Kryvyi Rih
country: Ukraine
facility: ME Kryviy Rih Oncology Dispensary of Dnipropetrovs?k Regional Council; Chemotherapy Department
city: Kyiv
country: Ukraine
facility: Kyiv City Clinical Oncological Center
city: Sumy
country: Ukraine
facility: Regional Municipal Institution Sumy Regional Clinical Oncology Dispensary
city: Zaporizhzhya
country: Ukraine
facility: MI Zaporizhzhia Regional Clinical Oncological Dispensary Zaporizhzhia SMU Ch of Oncology
city: Birmingham
country: United Kingdom
facility: Birmingham Heartlands Hospital
city: Colchester, Essex
country: United Kingdom
facility: Colchester General Hospital
city: London
country: United Kingdom
facility: St Bartholomew's Hospital
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.