Clinical trial NCT02367794: A Study of Atezolizumab in Combination With Carboplatin + Paclitaxel or Carboplatin + Nab-Paclitaxel Compared With Carboplatin + Nab-Paclitaxel in Participants With Stage IV Squamous Non-Small Cell Lung Cancer (NSCLC) [IMpower131]
Official title: A Phase III, Open-Label, Multicenter, Randomized Study Evaluating the Efficacy and Safety of Atezolizumab (MPDL3280A, Anti-PD-L1 Antibody) in Combination With Carboplatin+Paclitaxel or Atezolizumab in Combination With Carboplatin+Nab-Paclitaxel Versus Carboplatin+Nab-Paclitaxel in Chemotherapy-Naive Patients With Stage IV Squamous Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Squamous Non-Small Cell Lung Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2015-02-20
Enrollment: 1021
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 will evaluate the safety and efficacy of atezolizumab (MPDL3280A) in combination with carboplatin + paclitaxel or carboplatin + nab-paclitaxel compared with treatment with carboplatin + nab-paclitaxel in chemotherapy-naive participants with Stage IV squamous NSCLC.


Eligibility criteria: Inclusion Criteria:

* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
* Histologically or cytologically confirmed, treatment-naïve Stage IV squamous NSCLC
* Previously obtained archival tumor tissue or tissue obtained from biopsy at screening
* Measurable disease as defined by RECIST v1.1
* Adequate hematologic and end organ function

Exclusion Criteria:

* Active or untreated central nervous system (CNS) metastasis
* 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
* 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 (CT) scan, History of radiation pneumonitis in the radiation field (fibrosis) is permitted
* Positive test for Human Immunodeficiency Virus (HIV)
* Active hepatitis B or hepatitis C
* Prior treatment with cluster of differentiation 137 (CD137) agonists or immune checkpoint blockade therapies, anti-programmed death-1 (anti-PD-1), and anti-PD-L1 therapeutic antibody
* Severe infection within 4 weeks prior to randomization
* Significant history of cardiovascular disease

Primary outcomes:
measure: Progression Free Survival (PFS) as Determined by the Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) in the Intent-to-Treat (ITT) Population
timeFrame: Up to approximately 30 months after first participant enrolled
measure: Overall Survival (OS) in the ITT Population
timeFrame: Up to approximately 39 months after first participant enrolled
Secondary outcomes:
measure: OS in the in the Teff Population
timeFrame: Up to approximately 39 months after first participant enrolled
measure: PFS as Determined by the Investigator Using RECIST v1.1 in the Teff Population
timeFrame: Up to approximately 30 months after first participant enrolled
measure: PFS as Determined by the Investigator Using RECIST v1.1 in the Tumor Cell (TC) 2/3 or Tumor-Infiltrating Immune Cell (IC) 2/3 Population
timeFrame: Up to approximately 30 months after first participant enrolled
measure: PFS as Determined by the Investigator Using RECIST v1.1 in the TC1/2/3 or IC1/2/3 Population
timeFrame: Up to approximately 30 months after first participant enrolled
measure: OS in the TC2/3 or IC2/3 Population
timeFrame: Up to approximately 39 months after first participant enrolled
measure: OS in the TC1/2/3 or IC1/2/3 Population
timeFrame: Up to approximately 39 months after first participant enrolled
measure: Percentage of Participants With Objective Response as Determined by the Investigator Using RECIST v1.1 in the ITT Population
timeFrame: Up to approximately 30 months after first participant enrolled
measure: Duration of Response as Determined by the Investigator Using RECIST v1.1 in the ITT Population
timeFrame: Up to approximately 30 months after first participant enrolled
measure: Event Free Rate at 1 and 2 Years in the ITT Population
timeFrame: 1 and 2 years
measure: Time to Deterioration (TTD) in Patient-reported Lung Cancer Symptoms Using EORTC QLQ-C30 Symptom Subscales in the ITT Population
timeFrame: Up to approximately 30 months after first participant enrolled
measure: TTD in Patient-reported Lung Cancer Symptoms Using EORTC QLQ-LC13 Symptom Subscales in the ITT Population
timeFrame: Up to approximately 30 months after the first participant enrolled
measure: Change From Baseline in Patient-reported Lung Cancer Symptoms Score Using the SILC Scale Symptom Severity Score in the ITT Population
timeFrame: Baseline up to approximately 30 months after first participant enrolled
measure: PFS as Determined by the Investigator Using RECIST v1.1 in the ITT Population (Arm A and Arm B)
timeFrame: Up to approximately 30 months after first participant enrolled
measure: OS in the ITT Population (Arm A and Arm B)
timeFrame: Up to approximately 39 months after first participant enrolled
measure: Percentage of Participants With Adverse Events
timeFrame: Up to approximately 68 months after first participant enrolled
measure: Percentage of Participants With Anti-therapeutic Antibody (ATA) Response to Atezolizumab
timeFrame: Up to approximately 30 months after first participant enrolled
measure: Maximum Observed Serum Atezolizumab Concentration (Cmax)
timeFrame: Cycle 1 Day 1 and Cycle 3 Day 1 (Cycle length = 21 days)
measure: Minimum Observed Serum Atezolizumab Concentration (Cmin)
timeFrame: Predose on Day 1 of Cycles 1-4, 8, 16, every 8 cycle thereafter (up to 30 months), at treatment discontinuation (up to 30 months), and at 120 days after the last dose of atezolizumab (up to approximately 30 months, each cycle is 21 days)
measure: Plasma Concentrations for Paclitaxel
timeFrame: Prior to infusion (within same day of treatment administration), 5-10 minutes before the end of infusion, and 1 hour after the end of infusion (infusion duration 180 minutes) on Day 1 of Cycles 1 and 3 (each cycle is 21 days)
measure: Plasma Concentrations for Nab-Paclitaxel
timeFrame: Prior to infusion (within same day of treatment administration), 5-10 minutes before the end of infusion, and 1 hour after the end of infusion (infusion duration 30 minutes) on Day 1 of Cycles 1 and 3 (each cycle is 21 days)
measure: Plasma Concentrations for Carboplatin
timeFrame: Prior to infusion (within same day of treatment administration), 5-10 minutes before the end of infusion, and 1 hour after the end of infusion (infusion duration 15 to 30 minutes) on Day 1 of Cycles 1 and 3 (each cycle is 21 days)
Other outcomes:
Locations:
city: Chandler
country: United States
facility: Ironwood Cancer & Research Centers
state: Arizona
city: Springdale
country: United States
facility: Highlands Oncology Group
state: Arkansas
city: Bellflower
country: United States
facility: Southern CA Permanente Med Grp
state: California
city: Oakland
country: United States
facility: Kaiser Permanente Oakland Medical Center
state: California
city: Sacramento
country: United States
facility: Kaiser Permanente - Sacramento Medical Center and Medical Offices
state: California
city: San Leandro
country: United States
facility: Kaiser Permanente - San Leandro Medical Center
state: California
city: Santa Clara
country: United States
facility: Kaiser Permanente - Santa Clara
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: Denver
country: United States
facility: Rocky Mountain Cancer Center
state: Colorado
city: Danbury
country: United States
facility: Danbury Hospital
state: Connecticut
city: Fort Lauderdale
country: United States
facility: Holy Cross Hospital Inc
state: Florida
city: Fort Myers
country: United States
facility: SCRI Florida Cancer Specialists South
state: Florida
city: Palm Beach Gardens
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Port Saint Lucie
country: United States
facility: Hematology Oncology Associates of the Treasure Coast
state: Florida
city: Saint Petersburg
country: United States
facility: Florida Cancer Specialists (St. Petersburg - St. Anthony's Professional Building)
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: Macon
country: United States
facility: Central Georgia Cancer Care PC
state: Georgia
city: Newnan
country: United States
facility: Southeastern Regional Medical Center, Inc.
state: Georgia
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Joliet
country: United States
facility: Joliet Oncology-Hematology; Associates, Ltd.
state: Illinois
city: Quincy
country: United States
facility: Quincy Medical Group
state: Illinois
city: Fort Wayne
country: United States
facility: Fort Wayne Med Oncology & Hematology Inc
state: Indiana
city: Bettendorf
country: United States
facility: Hematology-Oncology; Associates of the Quad Cities
state: Iowa
city: Sioux City
country: United States
facility: Siouxland Hematology/Oncology
state: Iowa
city: Lexington
country: United States
facility: Lahey Clinic Med Ctr
state: Kentucky
city: Louisville
country: United States
facility: Norton Cancer Institute
state: Kentucky
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: Scarborough
country: United States
facility: New England Cancer Specialists
state: Maine
city: Fairhaven
country: United States
facility: Southcoast Health System; Southcoast Centers For Cancer Care
state: Massachusetts
city: Ann Arbor
country: United States
facility: St. Joseph Mercy Health System
state: Michigan
city: Detroit
country: United States
facility: Karmanos Cancer Institute
state: Michigan
city: Duluth
country: United States
facility: St. Luke's Regional Cancer Center
state: Minnesota
city: Tupelo
country: United States
facility: Hematology and Oncology Associates at Bridgepoint
state: Mississippi
city: Billings
country: United States
facility: Billings Clinic
state: Montana
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: Westbury
country: United States
facility: Clinical Research Alliance
state: New York
city: Salisbury
country: United States
facility: W.G. Bill Hefner VA Medical Center
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Columbus
country: United States
facility: Mark H. Zangmeister Center
state: Ohio
city: Hamilton
country: United States
facility: Oncology Hematology Care, Inc.
state: Ohio
city: Portland
country: United States
facility: Oregon Health & Science Uni
state: Oregon
city: Bethlehem
country: United States
facility: St. Luke's Cancer Care Associates
state: Pennsylvania
city: Gettysburg
country: United States
facility: Maryland Oncology Hematology (Lanham) - USOR
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: Chattanooga
country: United States
facility: SCRI Tennessee Oncology Chattanooga
state: Tennessee
city: Knoxville
country: United States
facility: Tennessee Cancer Specialists
state: Tennessee
city: Denton
country: United States
facility: SCRI The Center For Cancer and Blood Disorders
state: Texas
city: Longview
country: United States
facility: Longview Cancer Center
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: Roanoke
country: United States
facility: Blue Ridge Cancer Care
state: Virginia
city: Everett
country: United States
facility: Providence Regional Cancer Partnership
state: Washington
city: Spokane
country: United States
facility: Medical Oncology Associates
state: Washington
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: Pergamino
country: Argentina
facility: Clínica Pergamino
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: Waratah
country: Australia
facility: Calvary Mater Newcastle; Medical Oncology
state: New South Wales
city: Chermside
country: Australia
facility: Prince Charles Hospital
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: Heidelberg
country: Australia
facility: Austin Health
state: Victoria
city: Malvern
country: Australia
facility: Cabrini Hospital Malvern
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: Bruxelles
country: Belgium
facility: Cliniques Universitaires St-Luc
city: Liège
country: Belgium
facility: CHU Sart-Tilman
city: Namur
country: Belgium
facility: Clinique Ste-Elisabeth
city: Ronse
country: Belgium
facility: Werken Glorieux VZW
city: Wilrijk
country: Belgium
facility: GasthuisZusters Antwerpen
city: Belo Horizonte
country: Brazil
facility: Cenantron - Centro Avancado de Tratamento Oncologico
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: Lajeado
country: Brazil
facility: Hospital Bruno Born
state: RS
city: Porto Alegre
country: Brazil
facility: Hospital das Clinicas - UFRGS
state: RS
city: Porto Alegre
country: Brazil
facility: Hospital Mae de Deus
state: RS
city: Barretos
country: Brazil
facility: *X*Fundação Pio XII Hospital de Câncer de Barretos
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 Do Cancer A C Camargo
state: SP
city: Plovdiv
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment Central Onco Hospital OOD
city: Sofia
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment Serdika EOOD
city: Barrie
country: Canada
facility: Royal Victoria Regional Health Centre
state: Ontario
city: Etobicoke
country: Canada
facility: William Osler Health Centre
state: Ontario
city: Oshawa
country: Canada
facility: Lakeridge Health Center
state: Ontario
city: Laval
country: Canada
facility: Cite de La Sante de Laval; Hemato-Oncologie
state: Quebec
city: Montreal
country: Canada
facility: Hôpital du Sacré-Coeur de Montreal
state: Quebec
city: St. Jerome
country: Canada
facility: St. Jerome Medical Research
state: Quebec
city: Santiago
country: Chile
facility: Health & Care SPA
city: Temuco
country: Chile
facility: Sociedad de Investigaciones Medicas Ltda (SIM)
city: Grenoble
country: France
facility: CHU de Grenoble
city: Le Mans
country: France
facility: Ctr Jean Bernard Clin V. Hugo; Service d'Oncologie Méd
city: Lyon
country: France
facility: Centre Léon Bérard Centre Régional de Lutte Contre Le Cancer Rhône Alpes
city: Montpellier
country: France
facility: Clinique Clémentville
city: Orleans
country: France
facility: Hopital de La Source
city: Pierre Benite
country: France
facility: Centre Hospitalier Lyon Sud
city: Rennes
country: France
facility: Hopital de Pontchaillou; Service de Pneumologie
city: Saint Pierre
country: France
facility: Centre Hospitalier Regional Sud Reunion; Service de Pneumologie
city: Saint Quentin
country: France
facility: CH de Saint Quentin
city: Toulon Cedex 9
country: France
facility: Hôpital d'Instruction des Armées de Sainte Anne; Service Pharmacie Essais Cliniques
city: Berlin
country: Germany
facility: Charite - Universitätsmedizin Berlin
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: Gerlingen
country: Germany
facility: Robert Bosch Krankenhaus; Pneumologie und pneumologische Onkologie
city: Großhansdorf
country: Germany
facility: LungenClinic Großhansdorf GmbH
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: Hemer
country: Germany
facility: Lungenklinik Hemer
city: Homburg
country: Germany
facility: Universität Des Saarlandes; Klinik für Innere Medizin V
city: Immenhausen
country: Germany
facility: Fachklinik für Lungenerkrankungen
city: Koln
country: Germany
facility: Kliniken der Stadt Koln gGmbH
city: Minden
country: Germany
facility: Johannes Wesling Klinikum Minden; Hämatologie, Onkologie, Hämostaseologie und Palliativmedizin
city: München
country: Germany
facility: Klinikum Bogenhausen; Klinik für Pneumologie und Pneumologische Onkologie
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: Villingen-Schwenningen
country: Germany
facility: Schwarzwald-Baar Klinikum/VS GmbH; Onkologie/Hämatologie/Infektologie
city: Beer Sheva
country: Israel
facility: Soroka Medical Center
city: Jerusalem
country: Israel
facility: Hadassah University Hospital - Ein Kerem
city: Kfar-Saba
country: Israel
facility: Meir Medical Center; Oncology
city: Petach Tiqwa
country: Israel
facility: Rabin Medical Center
city: Ramat Gan
country: Israel
facility: Chaim Sheba Medical Center; Oncology Dept
city: Rambam
country: Israel
facility: Rambam Health Corporation; Oncology Institute
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Ctr; Oncology
city: Avellino
country: Italy
facility: Azienda Ospedaliera di Rilievo Nazionale e di Alta Specialita San Giuseppe Moscati
state: Campania
city: Napoli
country: Italy
facility: AORN A Cardarelli
state: Campania
city: Napoli
country: Italy
facility: Azienda Ospedaliero Universitaria Seconda Università degli Studi di Napoli; Farmacia Centralizzata
state: Campania
city: Napoli
country: Italy
facility: Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione G. Pascale
state: Campania
city: Roma
country: Italy
facility: Azienda Ospedaliera San Camillo Forlanini
state: Lazio
city: Genova
country: Italy
facility: ASL 3 Genovese; DSM
state: Liguria
city: Pavia
country: Italy
facility: Fondazione IRCCS Policlinico San Matteo
state: Lombardia
city: Bari
country: Italy
facility: IRCCS Giovanni Paolo II Istituto Oncologico
state: Puglia
city: Catania
country: Italy
facility: Policlinico Vittorio Emanuele
state: Sicilia
city: Livorno
country: Italy
facility: Ospedale Civile - Livorno
state: Toscana
city: Pisa
country: Italy
facility: Azienda Ospedaliero Universitaria Pisana
state: Toscana
city: Perugia
country: Italy
facility: Ospedale Silvestrini
state: Umbria
city: Aichi
country: Japan
facility: Aichi Cancer Center Hospital; Respiratory Medicine
city: Aichi
country: Japan
facility: Nagoya University Hospital; Respiratory Medicine
city: Chiba
country: Japan
facility: National Cancer Center Hospital East; Thoracic Oncology
city: Ehime
country: Japan
facility: National Hospital Organization Shikoku Cancer Center; Internal Medicine
city: Fukuoka
country: Japan
facility: National Hospital Organization Kyushu Medical Center; Respiratory Internal Medicine
city: Fukuoka
country: Japan
facility: Kyushu University Hospital; Respiratory
city: Hyogo
country: Japan
facility: Kobe City Medical Center General Hospital; Respiratory Medicine
city: Hyogo
country: Japan
facility: National Hospital Organization Himeji Medical Center
city: Hyogo
country: Japan
facility: Hyogo Cancer Center; Thoracic Oncology
city: Ibaraki
country: Japan
facility: Ibaraki Prefectural Central Hospital; Division of respiratory
city: Kanagawa
country: Japan
facility: Kanagawa Cancer Center;Thoracic Oncology
city: Kyoto
country: Japan
facility: Kyoto University Hospital, Respiratory Medicine
city: Miyagi
country: Japan
facility: Sendai Kousei Hospital; Pulmonary Medicine
city: Niigata
country: Japan
facility: Niigata University Medical & Dental Hospital; Respiratory Medicine and Infectious Disease
city: Okayama
country: Japan
facility: Okayama University Hospital; Respiratory and Allergy Medicine
city: Osaka
country: Japan
facility: Osaka International Cancer Institute; Thoracic Oncology
city: Osaka
country: Japan
facility: Osaka City Uni Hospital; Respiratory Medicine
city: Osaka
country: Japan
facility: Kansai Medical university Hospital; Thoracic Oncology
city: Osaka
country: Japan
facility: Osaka Habikino Medical Center
city: Sakai-shi
country: Japan
facility: National Hospital Organization Kinki-Chuo Chest Medical Center
city: Satima
country: Japan
facility: Saitama Cancer Center; Thoracic Oncology
city: Shizuoka
country: Japan
facility: Shizuoka Cancer Center; Thoracic Oncology
city: Tokyo
country: Japan
facility: National Cancer Center Hospital; Thoracic Medical Oncology
city: Tokyo
country: Japan
facility: Tokyo Medical University Hospital; Dept of Surgery
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: Cancerología
city: Amsterdam
country: Netherlands
facility: VU Medisch Centrum; VU University Medical Center
city: Amsterdam
country: Netherlands
facility: Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis
city: EDE
country: Netherlands
facility: Ziekenhuis Gelderse Vallei
city: Eindhoven
country: Netherlands
facility: Catharina Hospital; Afdeling Longgeneeskunde en Tuberculose
city: Nieuwegein
country: Netherlands
facility: St. Antonius Ziekenhuis; R&D Long
city: Arequipa
country: Peru
facility: Centro Medico Monte Carmelo
city: Lima
country: Peru
facility: Hospital Nacional Guillermo Almenara Irigoyen ESSALUD
city: Trujillo
country: Peru
facility: Instituto Regional de Enfermedades Neoplásicas Del Norte
city: Lisboa
country: Portugal
facility: IPO de Lisboa; Servico de Pneumologia
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: Saint-Petersburg
country: Russian Federation
facility: City Clinical Oncology Dispensary
city: Volgograd
country: Russian Federation
facility: Volgograd Regional Clinical Oncology Dispensary
city: Singapore
country: Singapore
facility: National University Hospital
city: Singapore
country: Singapore
facility: National Cancer Centre
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; Servicio de Oncologia
state: Cantabria
city: Palma De Mallorca
country: Spain
facility: Hospital Universitario Son Espases
state: Islas Baleares
city: A Coruña
country: Spain
facility: Complejo Hospitalario Universitario A Coruña
state: LA Coruña
city: Las Palmas de Gran Canaria
country: Spain
facility: Complejo Hospitalario Universitario Insular-Materno Infantil
state: LAS Palmas
city: Seville
country: Spain
facility: Hospital Nuestra Senora de Valme
state: Sevilla
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 Univ Vall d'Hebron; Servicio de Oncologia
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia
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: Fundación Jimenez Díaz
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos; Servicio de Oncologia
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio de Oncologia
city: Valencia
country: Spain
facility: Hospital Clinico Universitario de Valencia
city: Valencia
country: Spain
facility: Hospital General Universitario de Valencia
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet
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: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Taipei City
country: Taiwan
facility: National Taiwan Uni Hospital
city: Taipei
country: Taiwan
facility: Mackay Memorial Hospital
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: Vinnytsia
country: Ukraine
facility: Communal Nonprofit Enterprise Podilsky Regional Center Of Oncology OfTheVinnytsia Regional Council
state: KIEV Governorate
city: Lviv
country: Ukraine
facility: MI of the Lviv Regional Council Lviv Oncology Regional Treatment and Diagnostic Centre; Chemotherapy
state: Volhynian Governorate
city: Chernivtsi
country: Ukraine
facility: Municipal Institution Chernivtsi Regional Clinical Oncology Dispensary; Surgery Department #1
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: 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.