Clinical trial NCT02366143: A Study of Atezolizumab in Combination With Carboplatin Plus (+) Paclitaxel With or Without Bevacizumab Compared With Carboplatin+Paclitaxel+Bevacizumab in Participants With Stage IV Non-Squamous Non-Small Cell Lung Cancer (NSCLC)
Official title: A Phase III, Open-Label, Randomized Study of Atezolizumab (MPDL3280A, Anti-PD-L1 Antibody) in Combination With Carboplatin+Paclitaxel With or Without Bevacizumab Compared With Carboplatin + Paclitaxel + Bevacizumab in Chemotherapy-Naïve Patients With Stage IV Non-Squamous Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Carcinoma, Non-Small-Cell Lung
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2015-02-19
Enrollment: 1202
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 randomized, open-label study evaluated the safety and efficacy of atezolizumab (an engineered anti-programmed death-ligand 1 \[PD-L1\] antibody) in combination with carboplatin+paclitaxel with or without bevacizumab compared with treatment with carboplatin+paclitaxel+bevacizumab in chemotherapy-naïve participants with Stage IV non-squamous NSCLC. Participants were randomized in a 1:1:1 ratio to Arm A (Atezolizumab+Carboplatin+Paclitaxel), Arm B (Atezolizumab+Carboplatin+Paclitaxel+Bevacizumab), or Arm C (Carboplatin+Paclitaxel+Bevacizumab).


Eligibility criteria: Inclusion Criteria:

* Eastern Cooperative Oncology Group performance status 0 or 1
* Histologically or cytologically confirmed, Stage IV non-squamous NSCLC
* Participants with no prior treatment for Stage IV non-squamous NSCLC
* Known PD-L1 status as determined by immunohistochemistry assay performed on previously obtained archival tumor tissue or tissue obtained from a biopsy at screening
* Measurable disease as defined by RECIST v1.1
* Adequate hematologic and end organ function

Exclusion Criteria:

Cancer-Specific Exclusions:

* Active or untreated central nervous system metastases
* Malignancies other than NSCLC within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome

General Medical Exclusions:

* Pregnant or lactating women
* History of autoimmune disease
* History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted
* Positive test for human immunodeficiency virus
* Active hepatitis B or hepatitis C
* Severe infection within 4 weeks prior to randomization
* Significant cardiovascular disease
* Illness or condition that interferes with the participant's capacity to understand, follow and/or comply with study procedures

Exclusion Criteria Related to Medications:

* Prior treatment with cluster of differentiation 137 agonists or immune checkpoint blockade therapies, anti-programmed death-1, and anti-PD-L1 therapeutic antibodies

Primary outcomes:
measure: Progression Free Survival (PFS), as Determined by the Investigator in Arm B Versus Arm C in the Teff-high WT Population and ITT-WT Population
timeFrame: Baseline until disease progression or death, whichever occurs first until data cut-off on 15 September 2017 (up to approximately 29 months)
measure: Overall Survival (OS) in Arm B Versus Arm C in ITT-WT Population
timeFrame: Baseline until death until data cut-off on 22 January 2018 (up to approximately 34 months)
measure: Overall Survival (OS) in Arm A Versus Arm C in ITT-WT Population
timeFrame: Baseline until death (up approximately 53 months)
Secondary outcomes:
measure: PFS, as Determined by the Independent Review Facility (IRF) in Arm B Versus Arm C in Teff-High-WT Population and ITT-WT Population
timeFrame: Baseline until disease progression or death, whichever occurs first (up to approximately 29 months)
measure: PFS, as Determined by the Investigator in Arm B Versus Arm C in Teff High Population and ITT Population
timeFrame: Baseline until disease progression or death, whichever occurs first (up to approximately 29 months)
measure: PFS, as Determined by the Investigator in Arm A Versus Arm B in Teff High-WT Population and ITT-WT Population
timeFrame: Baseline until disease progression or death, whichever occurs first (up to approximately 29 months)
measure: PFS, as Determined by the Investigator in Arm B Versus Arm C by PD-L1 Subgroup
timeFrame: Baseline until disease progression or death, whichever occurs first (up to approximately 29 months)
measure: OS in Arm B Versus Arm C by PD-L1 Subgroup
timeFrame: Baseline until death (up to approximately 34 months)
measure: OS in Arm A Versus Arm C by PD-L1 Subgroup
timeFrame: Baseline until death (up approximately 53 months)
measure: OS in Arm B Versus Arm C in Teff High-WT Population, Teff High Population, and ITT Population
timeFrame: Baseline until death (up to approximately 34 months)
measure: OS in Arm A Versus Arm C in Teff High-WT Population, Teff High Population, and ITT Population
timeFrame: Baseline until death (up approximately 53 months)
measure: OS in Arm A Versus Arm B in Teff High-WT Population and ITT-WT Population
timeFrame: Baseline until death (up approximately 53 months)
measure: Duration of Response (DOR), as Determined By Investigator in Arm B Versus Arm C
timeFrame: Baseline until disease progression or death, whichever occurs first (up to approximately 29 months)
measure: Percentage of Participants With an Objective Response (OR) (Complete Response [CR] or Partial Response [PR]) as Determined by the Investigator in the Teff-High-WT Population and ITT-WT Population
timeFrame: Baseline until disease progression or death, whichever occurs first (up to approximately 29 months)
measure: OS Rates at Years 1 and 2 in Arm B Versus Arm C
timeFrame: Baseline to 2 years or death, whichever occurs first.
measure: OS Rates at Years 1 and 2 in Arm A Versus Arm C
timeFrame: Baseline to 2 years or death, whichever occurs first.
measure: Time to Deterioration (TTD) in Patient-Reported Lung Cancer Symptoms Determined by European Organization for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire-Core 30 (QLQ-C30) Score
timeFrame: Baseline up to approximately 29 months
measure: TTD in Patient-Reported Lung Cancer Symptoms as Determined by EORTC Quality-of-Life Questionnaire-Core Lung Cancer Module 13 (QLQ-LC13) Score
timeFrame: Baseline up to approximately 29 months
measure: Change From Baseline in Patient-Reported Lung Cancer Symptoms Score Using the Symptoms in Lung Cancer (SILC) Scale
timeFrame: Baseline up to approximately 29 months
measure: Percentage of Participants With Adverse Events
timeFrame: Baseline up to data cutoff date 7 December 2020 (up to approximately 68 months)
measure: Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Atezolizumab
timeFrame: Baseline up to approximately 29 months
measure: Maximum Observed Serum Concentration (Cmax) of Atezolizumab in Arm A and Arm B
timeFrame: Day 1 of Cycle 1 and 3 (Cycle length=21 days)
measure: Minimum Observed Serum Concentration (Cmin) of Atezolizumab Prior to Infusion in Arm A and Arm B
timeFrame: Day 21 of Cycles 1, 2 3, and 7 (Cycle length=21 days)
measure: Plasma Concentrations for Carboplatin in Arm A, Arm B, and Arm C
timeFrame: Predose (same day of treatment administration), 5-10 minutes before end of carboplatin infusion, 1 h after carboplatin infusion (infusion duration=15 to 30 minutes) on D1 of Cy1,3 (Cycle length=21 days)
measure: Plasma Concentrations for Paclitaxel in Arm A, Arm B, and Arm C
timeFrame: Predose (same day of treatment administration), 5-10 minutes before end of paclitaxel infusion, 1 h after paclitaxel infusion (infusion duration=3 h) on D1 of Cy1,3 (Cycle length=21 days)
measure: Cmax of Bevacizumab in Arm B and Arm C
timeFrame: Cycle 1 Day 1 and Cycle 3 Day 1 (Cycle length=21 days)
measure: Cmin of Bevacizumab in Arm B and Arm C
timeFrame: Cycle 1 Day 1 and Cycle 2 Day 21 (Cycle length=21 days)
Other outcomes:
Locations:
city: Chandler
country: United States
facility: Ironwood Cancer & Research Centers
state: Arizona
city: Flagstaff
country: United States
facility: Arizona Oncology Associates
state: Arizona
city: Bellflower
country: United States
facility: Southern CA Permanente Med Grp
state: California
city: Greenbrae
country: United States
facility: Marin Cancer Care Inc
state: California
city: La Jolla
country: United States
facility: Scripps Health
state: California
city: Orange
country: United States
facility: Chao Family Comprehensive Cancer Center UCI
state: California
city: Denver
country: United States
facility: Rocky Mountain Cancer Center
state: Colorado
city: Lonetree
country: United States
facility: Kaiser Permanente
state: Colorado
city: Danbury
country: United States
facility: Danbury Hospital
state: Connecticut
city: New Haven
country: United States
facility: Yale Cancer Center
state: Connecticut
city: Fort Lauderdale
country: United States
facility: Holy Cross Hospital Inc
state: Florida
city: Jacksonville
country: United States
facility: Cancer Specialists of North Florida - Baptist South
state: Florida
city: Miami Beach
country: United States
facility: Mount Sinai Medical Center
state: Florida
city: Port Saint Lucie
country: United States
facility: Hematology Oncology Associates of the Treasure Coast
state: Florida
city: Atlanta
country: United States
facility: Piedmont Cancer Institute, PC
state: Georgia
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Chicago
country: United States
facility: Univ of Chicago
state: Illinois
city: Harvey
country: United States
facility: Ingalls Memorial Hospital
state: Illinois
city: Park Ridge
country: United States
facility: Oncology Specialists, S.C.
state: Illinois
city: Bettendorf
country: United States
facility: Hematology-Oncology; Associates of the Quad Cities
state: Iowa
city: Louisville
country: United States
facility: Norton Cancer Institute
state: Kentucky
city: Scarborough
country: United States
facility: New England Cancer Specialists
state: Maine
city: Baltimore
country: United States
facility: Mercy Medical Center
state: Maryland
city: Bethesda
country: United States
facility: Regional Cancer Care Associates
state: Maryland
city: Columbia
country: United States
facility: Maryland Oncology Hematology, P.A.
state: Maryland
city: Ann Arbor
country: United States
facility: St. Joseph Mercy Health System
state: Michigan
city: Duluth
country: United States
facility: St. Luke's Regional Cancer Center
state: Minnesota
city: Saint Louis Park
country: United States
facility: Park Nicolett - Frauenshuh Cancer Center
state: Minnesota
city: Kansas City
country: United States
facility: St. Luke's Cancer Institute
state: Missouri
city: Saint Louis
country: United States
facility: Missouri Baptist Medical Center
state: Missouri
city: Billings
country: United States
facility: Billings Clinic
state: Montana
city: Missoula
country: United States
facility: Montana Cancer Specialists
state: Montana
city: Henderson
country: United States
facility: Comprehensive Cancer Centers of Nevada
state: Nevada
city: Berkeley Heights
country: United States
facility: Summit Medical Group
state: New Jersey
city: Paramus
country: United States
facility: Valley Hospital; Oncology Research
state: New Jersey
city: Sewell
country: United States
facility: Regional Cancer Care Associates LLC
state: New Jersey
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Brooklyn
country: United States
facility: Maimonides Medical Center
state: New York
city: Pinehurst
country: United States
facility: First Health of the Carolinas
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Toledo
country: United States
facility: Mercy St Anne Hospital
state: Ohio
city: Bend
country: United States
facility: Bend Memorial Clinic
state: Oregon
city: Bend
country: United States
facility: St. Charles Medical Center Bend; Cancer Care Of The Cascades
state: Oregon
city: Springfield
country: United States
facility: Willamette Valley Cancer Insitute and Research Center
state: Oregon
city: Bethlehem
country: United States
facility: St. Luke's Cancer Care Associates
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny Cancer Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Univ of Pittsburgh Medical Ctr
state: Pennsylvania
city: Germantown
country: United States
facility: West Clinic
state: Tennessee
city: Knoxville
country: United States
facility: Tennessee Cancer Specialists
state: Tennessee
city: Houston
country: United States
facility: Houston Methodist Cancer Center
state: Texas
city: Longview
country: United States
facility: Longview Cancer Center
state: Texas
city: San Antonio
country: United States
facility: University of Texas Health Science Center at San Antonio
state: Texas
city: Fairfax
country: United States
facility: Virginia Cancer Specialists, PC
state: Virginia
city: Norfolk
country: United States
facility: Virginia Oncology Associates
state: Virginia
city: Richmond
country: United States
facility: Virginia Cancer Institute
state: Virginia
city: Roanoke
country: United States
facility: Blue Ridge Cancer Care
state: Virginia
city: Auburn
country: United States
facility: MultiCare Regional Cancer Center - Auburn
state: Washington
city: Everett
country: United States
facility: Providence Regional Cancer Partnership
state: Washington
city: Seattle
country: United States
facility: Virginia Mason Medical Center
state: Washington
city: Spokane
country: United States
facility: Medical Oncology Associates
state: Washington
city: Morgantown
country: United States
facility: West Virginia University; Mary Babb Randolph Can Ctr
state: West Virginia
city: Buenos Aires
country: Argentina
facility: Centro Medico Austral
city: Buenos Aires
country: Argentina
facility: Fundación CENIT para la Investigación en Neurociencias
city: Cordoba
country: Argentina
facility: Sanatorio Allende
city: La Rioja
country: Argentina
facility: Centro Oncologico Riojano Integral (CORI)
city: Rosario
country: Argentina
facility: Hospital Provincial del Centenario
city: Santa Rosa
country: Argentina
facility: Fundacion Koriza
city: Viedma
country: Argentina
facility: Centro de Investigacion; Clinica - Clinica Viedma S.A.
city: Camperdown
country: Australia
facility: Chris O'Brien Lifehouse
state: New South Wales
city: Concord
country: Australia
facility: Concord Repatriation General Hospital
state: New South Wales
city: Sydney
country: Australia
facility: Nepean Cancer Care Centre
state: New South Wales
city: Chermside
country: Australia
facility: Prince Charles Hospital; Department of Medical Oncology
state: Queensland
city: Townsville
country: Australia
facility: Townsville Hospital
state: Queensland
city: Woolloongabba
country: Australia
facility: Princess Alexandra Hospital
state: Queensland
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: Kurralta Park
country: Australia
facility: Adelaide Cancer Centre
state: South Australia
city: Hobart
country: Australia
facility: Royal Hobart Hospital
state: Tasmania
city: Launceston
country: Australia
facility: Launceston General Hospital
state: Tasmania
city: Frankston
country: Australia
facility: Frankston Hospital
state: Victoria
city: Heidelberg
country: Australia
facility: Austin Health
state: Victoria
city: Malvern
country: Australia
facility: Cabrini Hospital Malvern
state: Victoria
city: Prahan
country: Australia
facility: The Alfred Hospital
state: Victoria
city: St Albans
country: Australia
facility: Sunshine Hospital
state: Victoria
city: Nedlands
country: Australia
facility: Sir Charles Gairdner Hospital
state: Western Australia
city: Salzburg
country: Austria
facility: Paracelsus Medizinische Privatuniversität
city: Wels
country: Austria
facility: Klinikum Wels-Grieskirchen
city: Liège
country: Belgium
facility: CHU de Liège
city: Namur
country: Belgium
facility: Clinique Ste-Elisabeth
city: Uberaba
country: Brazil
facility: CETUS Hospital Dia Oncologia
state: MG
city: Londrina
country: Brazil
facility: Instituto Do Cancer Delondrina_X; Unidade De Pesquisa Clinica
state: PR
city: Natal
country: Brazil
facility: Liga Norte Riograndense Contra O Câncer
state: RN
city: Caxias do Sul
country: Brazil
facility: IPCEM; Instituto de Pesquisa de Estudos Multicêntricos
state: RS
city: Porto Alegre
country: Brazil
facility: Hospital Mae de Deus
state: RS
city: Barretos
country: Brazil
facility: Hospital de Cancer de Barretos
state: SP
city: Ribeirão Preto
country: Brazil
facility: Instituto Ribeirãopretano de Combate Ao Câncer; Centro Especializado De Oncologia
state: SP
city: Sao Jose do Rio Preto
country: Brazil
facility: Hospital de Base de Sao Jose do Rio Preto
state: SP
city: Sao Paulo
country: Brazil
facility: Hospital A. C. Camargo; Oncologia
state: SP
city: Plovdiv
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment Central Onco Hospital OOD
city: Sofia
country: Bulgaria
facility: MHAT Serdika, EOOD
city: Oshawa
country: Canada
facility: Lakeridge Health Center
state: Ontario
city: Santiago
country: Chile
facility: Clinica Santa Maria
city: Santiago
country: Chile
facility: Health & Care SPA
city: Temuco
country: Chile
facility: Sociedad de Investigaciones Medicas Ltda (SIM)
city: Bordeaux
country: France
facility: Institut Bergonié Centre Régional de Lutte Contre Le Cancer de Bordeaux Et Sud Ouest
city: Grenoble
country: France
facility: CHU de Grenoble
city: Le Mans
country: France
facility: Centre Jean Bernard Clinique Victor Hugo
city: Marseille
country: France
facility: Hôpital Saint Joseph
city: Marseille
country: France
facility: Hopital Nord AP-HM
city: Paris
country: France
facility: Hôpital Européen Georges Pompidou
city: Pessac
country: France
facility: CHU de Bordeaux
city: Saint Denis Cedex
country: France
facility: Service de Pneumologie Centre Hospitalier Régional La Réunion Site Felix Guyon
city: Saint Quentin
country: France
facility: CH de Saint Quentin
city: Toulon
country: France
facility: Centre Hospitalier Intercommunal Toulon - La Seyne sur Mer
city: Toulon
country: France
facility: Hôpital d'Instruction des Armées de Sainte Anne; Service de Pneumologie
city: Toulouse
country: France
facility: Hôpital Larrey;Université Paul Sabatier
city: Augsburg
country: Germany
facility: Zentralklinikum Augsburg
city: Berlin
country: Germany
facility: Helios Klinikum Emil von Behring GmbH
city: Bielefeld
country: Germany
facility: Ev.Krankenhaus Bielefeld gGmbH; Klinik für Innere Medizin und Geriatrie
city: Bochum
country: Germany
facility: Augusta Kranken-Anstalt gGmbH
city: Dresden
country: Germany
facility: Universitätsklinikum "Carl Gustav Carus" der Technischen Universität Dresden
city: Frankfurt am Main
country: Germany
facility: St. Elisabethen Krankenhaus
city: Großhansdorf
country: Germany
facility: LungenClinic Großhansdorf GmbH
city: Halle
country: Germany
facility: Krankenhaus Martha-Maria; Halle-Dolau gGmbH
city: Hamburg
country: Germany
facility: Asklepios Klinik Harburg
city: Hemer
country: Germany
facility: Lungenklinik Hemer
city: Homburg
country: Germany
facility: Universität Des Saarlandes; Klinik für Innere Medizin V
city: Koln
country: Germany
facility: Kliniken der Stadt Koln gGmbH; Lungenklinik Onkologische Ambulanz
city: Loewenstein
country: Germany
facility: Klinik Loewenstein gGmbH; Onk & Pal
city: München
country: Germany
facility: Klinikum Bogenhausen
city: Regensburg
country: Germany
facility: Krankenhaus Barmherzige Bruder Regensburg
city: Regensburg
country: Germany
facility: Klinikum der Universität Regensburg
city: Rheine
country: Germany
facility: Stiftung Mathias-Spital Rheine
city: Napoli
country: Italy
facility: AORN A Cardarelli
state: Campania
city: Roma
country: Italy
facility: Policlinico Universitario Campus Biomedico; Uoc Oncologia Medica
state: Lazio
city: Roma
country: Italy
facility: Azienda Ospedaliera San Camillo Forlanini
state: Lazio
city: Roma
country: Italy
facility: Università Cattolica Del S Cuore
state: Lazio
city: Genova
country: Italy
facility: Istituto Nazionale per la Ricerca sul Cancro di Genova
state: Liguria
city: Genova
country: Italy
facility: ASL 3 Genovese; DSM
state: Liguria
city: Novara
country: Italy
facility: A.O.U. Maggiore della Carità
state: Piemonte
city: Sassari
country: Italy
facility: Azienda Unita Sanitaria Locale N1 Sassari; Unita Operativa Di Oncologia Medica
state: Sardegna
city: Catania
country: Italy
facility: Policlinico Vittorio Emanuele
state: Sicilia
city: Lido Di Camaiore
country: Italy
facility: Ospedale Versilia
state: Toscana
city: Livorno
country: Italy
facility: Ospedale Civile - Livorno
state: Toscana
city: Ehime
country: Japan
facility: National Hospital Organization Shikoku Cancer Center
city: Fukuoka
country: Japan
facility: National Hospital Organization Kyushu Medical Center
city: Fukuoka
country: Japan
facility: NHO Kyushu Cancer Center
city: Fukuoka
country: Japan
facility: Kurume University Hospital
city: Kanagawa
country: Japan
facility: Kanagawa Cardiovascular and Respiratory Center
city: Kanagawa
country: Japan
facility: Kitasato University Hospital
city: Kyoto
country: Japan
facility: Kyoto University Hospital
city: Miyagi
country: Japan
facility: Miyagi Cancer Center
city: Niigata
country: Japan
facility: Niigata Cancer Center Hospital
city: Osaka
country: Japan
facility: Osaka City University Hospital
city: Osaka
country: Japan
facility: National Hospital Organization Osaka Toneyama Medical Center
city: Tokyo
country: Japan
facility: Toranomon Hospital
city: Tokyo
country: Japan
facility: Center Hospital of the National Center for Global Health and Medicine
city: Tokyo
country: Japan
facility: Kyorin University Hospital
city: Wakayama
country: Japan
facility: Wakayama Medical University Hospital
city: Riga
country: Latvia
facility: Riga East Clinical University Hospital Latvian Oncology Centre
city: Rīga
country: Latvia
facility: Pauls Stradins Clinical University Hospital
city: Vilnius
country: Lithuania
facility: National Cancer Institute
city: Monterrey
country: Mexico
facility: Centro Universitario Contra El Cancer
city: Queretaro
country: Mexico
facility: Cancerologia de Queretaro
city: Toluca
country: Mexico
facility: Centro Hemato Oncologico Privado; Oncologia
city: 'S Hertogenbosch
country: Netherlands
facility: Jeroen Bosch Ziekenhuis
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC Location VUMC
city: Breda
country: Netherlands
facility: Amphia Ziekenhuis; Afdeling Longziekten
city: EDE
country: Netherlands
facility: Ziekenhuis Gelderse Vallei
city: Hilversum
country: Netherlands
facility: Tergooiziekenhuizen
city: Hoofddorp
country: Netherlands
facility: Spaarne Gasthuis; Spaarne Ziekenhuis
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
city: Nieuwegein
country: Netherlands
facility: St. Antonius Ziekenhuis; R&D Long
city: Rotterdam
country: Netherlands
facility: Erasmus MC; Afdeling Longziekten
city: Rotterdam
country: Netherlands
facility: Maasstad ziekenhuis
city: Utrecht
country: Netherlands
facility: Universitair Medisch Centrum Utrecht
city: Zutphen
country: Netherlands
facility: Gelre Ziekenhuizen, Zutphen
city: Arequipa
country: Peru
facility: Centro Medico Monte Carmelo
city: Arequipa
country: Peru
facility: Centro Especializado de Enfermedades Neoplásicas
city: Lima
country: Peru
facility: Instituto Nacional de Enfermedades Neoplasicas
city: Coimbra
country: Portugal
facility: Centro Hospitalar E Universitário de Coimbra EPE
city: Lisboa
country: Portugal
facility: Instituto Portugues Oncologia de Lisboa Francisco Gentil EPE
city: Lisboa
country: Portugal
facility: Hospital Pulido Valente; Servico de Pneumologia
city: Porto
country: Portugal
facility: Centro Hospitalar do Porto - Hospital de Santo António
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: Moscovskaya Oblast
country: Russian Federation
facility: Moscow City Oncology Hospital #62
state: Moskovskaja Oblast
city: Moscow
country: Russian Federation
facility: Russian Oncology Research Center n.a. N.N. Blokhin
city: Omsk
country: Russian Federation
facility: Clinical Oncology Dispensary
city: Pushkin
country: Russian Federation
facility: Evromedservis LCC
city: Saint-Petersburg
country: Russian Federation
facility: City Clinical Oncology Dispensary
city: Singapore
country: Singapore
facility: National Cancer Centre; Medical Oncology
city: Bratislava
country: Slovakia
facility: Univerzitna nemocnica Bratislava
city: Bratislava
country: Slovakia
facility: Narodny onkologicky ustav
city: Poprad
country: Slovakia
facility: POKO Poprad s.r.o.
city: L'Hospitalet de Llobregat
country: Spain
facility: Instituto Catalan de Oncologia de Hospitalet (ICO); Servicio de Farmacia
state: Barcelona
city: Sabadell
country: Spain
facility: Corporacio Sanitaria Parc Tauli; Servicio de Oncologia
state: Barcelona
city: Santander
country: Spain
facility: Hospital Universitario Marques de Valdecilla
state: Cantabria
city: Palma De Mallorca
country: Spain
facility: Hospital Universitario Son Espases
state: Islas Baleares
city: Las Palmas de Gran Canaria
country: Spain
facility: Hospital Universitario Insular de Gran Canaria
state: LAS Palmas
city: Ourense
country: Spain
facility: Complejo Hospitalario U. de Ourense
state: Orense
city: Xativa
country: Spain
facility: Hospital Lluis Alcanyis De Xativa
state: Valencia
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Hospital Univ Vall d'Hebron; Servicio de Oncologia
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Cordoba
country: Spain
facility: Hospital Universitario Reina Sofia
city: Lugo
country: Spain
facility: Hospital Lucus Augusti; Servicio de Oncologia
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañon; Servicio de Oncologia
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Madrid
country: Spain
facility: Hospital Ramon y Cajal; Servicio de Oncologia
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos; Servicio de Oncologia
city: Madrid
country: Spain
facility: Hospital Universitario Fundación Jimenez Díaz
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Universitario HM Sanchinarro-CIOCC
city: Valencia
country: Spain
facility: Hospital Clinico Universitario de Valencia
city: Bruderholz
country: Switzerland
facility: Kantonsspital Baselland
city: Luzern
country: Switzerland
facility: Luzerner Kantonsspital Sursee
city: St. Gallen
country: Switzerland
facility: Kantonsspital St. Gallen; Onkologie/Hämatologie
city: Changhua
country: Taiwan
facility: Changhua Christian Hospital; Hematology-Oncology
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: Tainan
country: Taiwan
facility: National Cheng Kung Univ Hosp
city: Taipei City
country: Taiwan
facility: National Taiwan Uni Hospital
city: Taipei
country: Taiwan
facility: Cheng Hsin General Hospital
city: Taipei
country: Taiwan
facility: Tri-Service General Hospital
city: Taoyuan City
country: Taiwan
facility: Chang Gung Medical Foundation Linkou Branch
city: Xitun Dist.
country: Taiwan
facility: Taichung Veterans General Hospital
city: Chernivtsi
country: Ukraine
facility: ME Bukovinian Clinical Oncology Center
state: Chernihiv Governorate
city: Dnipropetrovsk
country: Ukraine
facility: Municipal Institution City Clinical Hospital #4 of Dnipro City Council - PPDS; Dept of Chemotherapy
state: Katerynoslav Governorate
city: Uzhhorod
country: Ukraine
facility: Uzhgorod Central City Clinical Hospital
state: Katerynoslav Governorate
city: Zaporizhzhia
country: Ukraine
facility: MNPE Zaporizhzhia Regional Antitumor Center ZRC
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: Uzhhorod
country: Ukraine
facility: MNPE Transcarpathian Antitumor Center of the Transcarpathian Regional Council; Chemotherapy Dept
state: Kherson Governorate
city: Ivano-Frankivsk
country: Ukraine
facility: Municipal Institution SubCarpathian Clinical Oncological Centre; Surgical department#2
state: KIEV Governorate
city: Vinnytsia
country: Ukraine
facility: Communal Nonprofit Enterprise Podilsky Regional Center Of Oncology OfTheVinnytsia Regional Council
state: KIEV Governorate
city: Kharkiv
country: Ukraine
facility: SI Institute of Medical Radiology n.a. S.P. Hryhoriev of NAMS of Ukraine
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: Poltava
country: Ukraine
facility: Poltava Regional Clinical Oncology Dispensary of Poltava Regional Council; Thoracic department
city: Sumy
country: Ukraine
facility: Regional Municipal Institution Sumy Regional Clinical Oncology Dispensary
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Ton TGN, Pal N, Trinh H, Mahrus S, Bretscher MT, Machado RJM, Sadetsky N, Chaudhary N, Lu MW, Riely GJ. Replication of Overall Survival, Progression-Free Survival, and Overall Response in Chemotherapy Arms of Non-Small Cell Lung Cancer Trials Using Real-World Data. Clin Cancer Res. 2022 Jul 1;28(13):2844-2853. doi: 10.1158/1078-0432.CCR-22-0471.
citation: Nogami N, Barlesi F, Socinski MA, Reck M, Thomas CA, Cappuzzo F, Mok TSK, Finley G, Aerts JG, Orlandi F, Moro-Sibilot D, Jotte RM, Stroyakovskiy D, Villaruz LC, Rodriguez-Abreu D, Wan-Teck Lim D, Merritt D, Coleman S, Lee A, Shankar G, Yu W, Bara I, Nishio M. IMpower150 Final Exploratory Analyses for Atezolizumab Plus Bevacizumab and Chemotherapy in Key NSCLC Patient Subgroups With EGFR Mutations or Metastases in the Liver or Brain. J Thorac Oncol. 2022 Feb;17(2):309-323. doi: 10.1016/j.jtho.2021.09.014. Epub 2021 Oct 7.
citation: Socinski MA, Nishio M, Jotte RM, Cappuzzo F, Orlandi F, Stroyakovskiy D, Nogami N, Rodriguez-Abreu D, Moro-Sibilot D, Thomas CA, Barlesi F, Finley G, Kong S, Lee A, Coleman S, Zou W, McCleland M, Shankar G, Reck M. IMpower150 Final Overall Survival Analyses for Atezolizumab Plus Bevacizumab and Chemotherapy in First-Line Metastatic Nonsquamous NSCLC. J Thorac Oncol. 2021 Nov;16(11):1909-1924. doi: 10.1016/j.jtho.2021.07.009. Epub 2021 Jul 24.
citation: Reck M, Wehler T, Orlandi F, Nogami N, Barone C, Moro-Sibilot D, Shtivelband M, Gonzalez Larriba JL, Rothenstein J, Fruh M, Yu W, Deng Y, Coleman S, Shankar G, Patel H, Kelsch C, Lee A, Piault E, Socinski MA. Safety and Patient-Reported Outcomes of Atezolizumab Plus Chemotherapy With or Without Bevacizumab Versus Bevacizumab Plus Chemotherapy in Non-Small-Cell Lung Cancer. J Clin Oncol. 2020 Aug 1;38(22):2530-2542. doi: 10.1200/JCO.19.03158. Epub 2020 May 27.
citation: Reck M, Mok TSK, Nishio M, Jotte RM, Cappuzzo F, Orlandi F, Stroyakovskiy D, Nogami N, Rodriguez-Abreu D, Moro-Sibilot D, Thomas CA, Barlesi F, Finley G, Lee A, Coleman S, Deng Y, Kowanetz M, Shankar G, Lin W, Socinski MA; IMpower150 Study Group. Atezolizumab plus bevacizumab and chemotherapy in non-small-cell lung cancer (IMpower150): key subgroup analyses of patients with EGFR mutations or baseline liver metastases in a randomised, open-label phase 3 trial. Lancet Respir Med. 2019 May;7(5):387-401. doi: 10.1016/S2213-2600(19)30084-0. Epub 2019 Mar 25.
citation: Socinski MA, Jotte RM, Cappuzzo F, Orlandi F, Stroyakovskiy D, Nogami N, Rodriguez-Abreu D, Moro-Sibilot D, Thomas CA, Barlesi F, Finley G, Kelsch C, Lee A, Coleman S, Deng Y, Shen Y, Kowanetz M, Lopez-Chavez A, Sandler A, Reck M; IMpower150 Study Group. Atezolizumab for First-Line Treatment of Metastatic Nonsquamous NSCLC. N Engl J Med. 2018 Jun 14;378(24):2288-2301. doi: 10.1056/NEJMoa1716948. Epub 2018 Jun 4.