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]

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

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.

Study Overview

• Status: Completed
• Conditions: Squamous Non-Small Cell Lung Cancer
• Intervention / Treatment: Drug: Atezolizumab (MPDL3280A), an engineered anti-programmed death-ligand 1 (anti-PD-L1) antibody; Drug: Carboplatin; Drug: Paclitaxel; Drug: Nab-Paclitaxel

• Study Type: Interventional
• Enrollment (Actual): 1021
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1125ABD
    • Fundación CENIT para la Investigación en Neurociencias
  • Cordoba, Argentina, X5000JHQ
    • Sanatorio Allende
  • La Rioja, Argentina, F5300COE
    • Centro Oncologico Riojano Integral (CORI)
  • Pergamino, Argentina, B2700CPM
    • Clínica Pergamino
  • Santa Rosa, Argentina, L6304BOC
    • Fundacion Koriza
  • Viedma, Argentina, R8500ACE
    • Centro de Investigacion; Clinica - Clinica Viedma S.A.
• Australia
  • New South Wales
    • Camperdown, New South Wales, Australia, 2050
      • Chris O'Brien Lifehouse
    • Waratah, New South Wales, Australia, 2298
      • Calvary Mater Newcastle; Medical Oncology
  • Queensland
    • Chermside, Queensland, Australia, 4032
      • Prince Charles Hospital
    • Townsville, Queensland, Australia, 4810
      • Townsville Hospital
    • Woolloongabba, Queensland, Australia, 4102
      • Princess Alexandra Hospital
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • Royal Adelaide Hospital
  • Victoria
    • Heidelberg, Victoria, Australia, 3084
      • Austin Health
    • Malvern, Victoria, Australia, 3144
      • Cabrini Hospital Malvern
    • St Albans, Victoria, Australia, 3021
      • Sunshine Hospital
  • Western Australia
    • Nedlands, Western Australia, Australia, 6009
      • Sir Charles Gairdner Hospital
• Austria
  • Salzburg, Austria, 5020
    • Paracelsus Medizinische Privatuniversitat
• Belgium
  • Bruxelles, Belgium, 1200
    • Cliniques Universitaires St-Luc
  • Liège, Belgium, 4000
    • CHU Sart-Tilman
  • Namur, Belgium, 5000
    • Clinique Ste-Elisabeth
  • Ronse, Belgium, 9600
    • Werken Glorieux VZW
  • Wilrijk, Belgium, 2610
    • GasthuisZusters Antwerpen
• Brazil
  • MG
    • Belo Horizonte, MG, Brazil, 30130-090
      • Cenantron - Centro Avancado de Tratamento Oncologico
  • PR
    • Londrina, PR, Brazil, 86 015 520
      • Instituto Do Cancer Delondrina_X; Unidade De Pesquisa Clinica
  • RN
    • Natal, RN, Brazil, 59040150
      • Liga Norte Riograndense Contra O Cancer
  • RS
    • Caxias do Sul, RS, Brazil, 95070-560
      • IPCEM; Instituto de Pesquisa de Estudos Multicêntricos
    • Lajeado, RS, Brazil, 95900-000
      • Hospital Bruno Born
    • Porto Alegre, RS, Brazil, 90035-903
      • Hospital das Clinicas - UFRGS
    • Porto Alegre, RS, Brazil, 90470-340
      • Hospital Mãe de Deus
  • SP
    • Barretos, SP, Brazil, 14784-400
      • *X*Fundação Pio XII Hospital de Câncer de Barretos
    • Sao Jose do Rio Preto, SP, Brazil, 15090-000
      • Hospital de Base de Sao Jose do Rio Preto
    • Sao Paulo, SP, Brazil, 01525-001
      • Hospital Do Cancer A C Camargo
• Bulgaria
  • Plovdiv, Bulgaria, 4000
    • Multiprofile Hospital for Active Treatment Central Onco Hospital OOD
  • Sofia, Bulgaria, 1303
    • Multiprofile Hospital for Active Treatment Serdika EOOD
• Canada
  • Ontario
    • Barrie, Ontario, Canada, L4M 6M2
      • Royal Victoria Regional Health Centre
    • Etobicoke, Ontario, Canada, M9V 1R8
      • William Osler Health Centre
    • Oshawa, Ontario, Canada, L1J 2J2
      • Lakeridge Health Center
  • Quebec
    • Laval, Quebec, Canada, H7M 3L9
      • Cite de La Sante de Laval; Hemato-Oncologie
    • Montreal, Quebec, Canada, H4J 1C5
      • Hôpital du Sacré-Coeur de Montreal
    • St. Jerome, Quebec, Canada, J7Z 5T3
      • St. Jerome Medical Research
• Chile
  • Santiago, Chile, 7500006
    • Health & Care SPA
  • Temuco, Chile, 4810469
    • Sociedad de Investigaciones Medicas Ltda (SIM)
• France
  • Grenoble, France, 38043
    • CHU de Grenoble
  • Le Mans, France, 72000
    • Ctr Jean Bernard Clin V. Hugo; Service d'Oncologie Méd
  • Lyon, France, 69008
    • Centre Léon Bérard Centre Régional de Lutte Contre Le Cancer Rhône Alpes
  • Montpellier, France, 34070
    • Clinique Clémentville
  • Orleans, France, 45067
    • Hôpital de la Source
  • Pierre Benite, France, 69495
    • Centre Hospitalier Lyon Sud
  • Rennes, France, 35033
    • Hopital de Pontchaillou; Service de Pneumologie
  • Saint Pierre, France, 97448
    • Centre Hospitalier Regional Sud Reunion; Service de Pneumologie
  • Saint Quentin, France, 2100
    • CH de Saint Quentin
  • Toulon Cedex 9, France, 83800
    • Hôpital d'Instruction des Armées de Sainte Anne; Service Pharmacie Essais Cliniques
• Germany
  • Berlin, Germany, 12203
    • Charite - Universitatsmedizin Berlin
  • Bielefeld, Germany, 33611
    • Ev.Krankenhaus Bielefeld gGmbH; Klinik für Innere Medizin und Geriatrie
  • Bochum, Germany, 44791
    • Augusta Kranken-Anstalt gGmbH
  • Dresden, Germany, 01307
    • Universitätsklinikum "Carl Gustav Carus" der Technischen Universität Dresden
  • Frankfurt am Main, Germany, 60487
    • St. Elisabethen Krankenhaus
  • Gerlingen, Germany, 70839
    • Robert Bosch Krankenhaus; Pneumologie und pneumologische Onkologie
  • Großhansdorf, Germany, 22927
    • LungenClinic Grosshansdorf GmbH
  • Halle, Germany, 06120
    • Krankenhaus Martha-Maria; Halle-Dolau gGmbH
  • Hamburg, Germany, 20246
    • Universitätsklinikum Hamburg-Eppendorf
  • Hamburg, Germany, 21075
    • Asklepios Klinik Harburg
  • Hemer, Germany, 58675
    • Lungenklinik Hemer
  • Homburg, Germany, 66421
    • Universität Des Saarlandes; Klinik für Innere Medizin V
  • Immenhausen, Germany, 34376
    • Fachklinik für Lungenerkrankungen
  • Koln, Germany, 51109
    • Kliniken der Stadt Koln gGmbH
  • Minden, Germany, 32429
    • Johannes Wesling Klinikum Minden; Hämatologie, Onkologie, Hämostaseologie und Palliativmedizin
  • München, Germany, 81925
    • Klinikum Bogenhausen; Klinik für Pneumologie und Pneumologische Onkologie
  • Regensburg, Germany, 93049
    • Krankenhaus Barmherzige Bruder Regensburg
  • Regensburg, Germany, 93053
    • Klinikum der Universität Regensburg
  • Rheine, Germany, 48431
    • Stiftung Mathias-Spital Rheine
  • Villingen-Schwenningen, Germany, 78052
    • Schwarzwald-Baar Klinikum/VS GmbH; Onkologie/Hämatologie/Infektologie
• Israel
  • Beer Sheva, Israel, 8410101
    • Soroka Medical Center
  • Jerusalem, Israel, 9112001
    • Hadassah University Hospital - Ein Kerem
  • Kfar-Saba, Israel, 4428164
    • Meir Medical Center; Oncology
  • Petach Tiqwa, Israel, 4941492
    • Rabin Medical Center
  • Ramat Gan, Israel, 5262100
    • Chaim Sheba Medical Center; Oncology Dept
  • Rambam, Israel, 3525408
    • Rambam Health Corporation; Oncology Institute
  • Tel Aviv, Israel, 6423906
    • Tel Aviv Sourasky Medical Ctr; Oncology
• Italy
  • Campania
    • Avellino, Campania, Italy, 83100
      • Azienda Ospedaliera di Rilievo Nazionale e di Alta Specialita San Giuseppe Moscati
    • Napoli, Campania, Italy, 80131
      • Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione G. Pascale
    • Napoli, Campania, Italy, 80131
      • AORN A Cardarelli
    • Napoli, Campania, Italy, 80131
      • Azienda Ospedaliero Universitaria Seconda Università degli Studi di Napoli; Farmacia Centralizzata
  • Lazio
    • Roma, Lazio, Italy, 00152
      • Azienda Ospedaliera San Camillo Forlanini
  • Liguria
    • Genova, Liguria, Italy, 16147
      • ASL 3 Genovese; DSM
  • Lombardia
    • Pavia, Lombardia, Italy, 27100
      • Fondazione IRCCS Policlinico San Matteo
  • Puglia
    • Bari, Puglia, Italy, 70124
      • IRCCS Giovanni Paolo II Istituto Oncologico
  • Sicilia
    • Catania, Sicilia, Italy, 95123
      • Policlinico Vittorio Emanuele
  • Toscana
    • Livorno, Toscana, Italy, 57124
      • Ospedale Civile - Livorno
    • Pisa, Toscana, Italy, 56100
      • Azienda Ospedaliero Universitaria Pisana
  • Umbria
    • Perugia, Umbria, Italy, 06122
      • Ospedale Silvestrini
• Japan
  • Aichi, Japan, 464-8681
    • Aichi Cancer Center Hospital; Respiratory Medicine
  • Aichi, Japan, 466-8560
    • Nagoya University Hospital; Respiratory Medicine
  • Chiba, Japan, 277-8577
    • National Cancer Center Hospital East; Thoracic Oncology
  • Ehime, Japan, 791-0280
    • National Hospital Organization Shikoku Cancer Center; Internal Medicine
  • Fukuoka, Japan, 812-8582
    • Kyushu University Hospital; Respiratory
  • Fukuoka, Japan, 810-8563
    • National Hospital Organization Kyushu Medical Center; Respiratory Internal Medicine
  • Hyogo, Japan, 670-8520
    • National Hospital Organization Himeji Medical Center
  • Hyogo, Japan, 650-0047
    • Kobe City Medical Center General Hospital; Respiratory Medicine
  • Hyogo, Japan, 673-8558
    • Hyogo Cancer Center; Thoracic Oncology
  • Ibaraki, Japan, 309-1793
    • Ibaraki Prefectural Central Hospital; Division of respiratory
  • Kanagawa, Japan, 241-8515
    • Kanagawa Cancer Center;Thoracic Oncology
  • Kyoto, Japan, 606-8507
    • Kyoto University Hospital, Respiratory Medicine
  • Miyagi, Japan, 980-0873
    • Sendai Kousei Hospital; Pulmonary Medicine
  • Niigata, Japan, 951-8520
    • Niigata University Medical & Dental Hospital; Respiratory Medicine and Infectious Disease
  • Okayama, Japan, 700-8558
    • Okayama University Hospital; Respiratory and Allergy Medicine
  • Osaka, Japan, 541-8567
    • Osaka International Cancer Institute; Thoracic Oncology
  • Osaka, Japan, 545-8586
    • Osaka City Uni Hospital; Respiratory Medicine
  • Osaka, Japan, 573-1191
    • Kansai Medical university Hospital; Thoracic Oncology
  • Osaka, Japan, 583-8588
    • Osaka Habikino Medical Center
  • Sakai-shi, Japan, 591-8555
    • National Hospital Organization Kinki-Chuo Chest Medical Center
  • Satima, Japan, 362-0806
    • Saitama Cancer Center; Thoracic Oncology
  • Shizuoka, Japan, 411-8777
    • Shizuoka Cancer Center; Thoracic Oncology
  • Tokyo, Japan, 104-0045
    • National Cancer Center Hospital; Thoracic Medical Oncology
  • Tokyo, Japan, 160-0023
    • Tokyo Medical University Hospital; Dept of Surgery
• Latvia
  • Riga, Latvia, LV-1079
    • Riga East Clinical University Hospital Latvian Oncology Centre
  • Rīga, Latvia, LV-1002
    • Pauls Stradins Clinical University Hospital
• Lithuania
  • Vilnius, Lithuania, 08660
    • National Cancer Institute
• Mexico
  • Monterrey, Mexico, 64020
    • Centro Universitario Contra El Cancer
  • Queretaro, Mexico, 76090
    • Cancerología
• Netherlands
  • Amsterdam, Netherlands, 1066 CX
    • Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis
  • Amsterdam, Netherlands, 1007 MB
    • VU Medisch Centrum; VU University Medical Center
  • EDE, Netherlands, 6716 RP
    • Ziekenhuis Gelderse Vallei
  • Eindhoven, Netherlands, 5623 EJ
    • Catharina Hospital; Afdeling Longgeneeskunde en Tuberculose
  • Nieuwegein, Netherlands, 3435 CM
    • St. Antonius Ziekenhuis; R&D Long
• Peru
  • Arequipa, Peru, 04001
    • Centro Medico Monte Carmelo
  • Lima, Peru, Lima 13
    • Hospital Nacional Guillermo Almenara Irigoyen ESSALUD
  • Trujillo, Peru, 12345
    • Instituto Regional de Enfermedades Neoplásicas Del Norte
• Portugal
  • Lisboa, Portugal, 1099-023
    • IPO de Lisboa; Servico de Pneumologia
  • Lisboa, Portugal, 1796-001
    • Hospital Pulido Valente; Servico de Pneumologia
  • Porto, Portugal, 4099-001
    • Centro Hospitalar do Porto - Hospital de Santo Antonio
  • Porto, Portugal, 4200-072
    • Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe
  • Porto, Portugal, 4200
    • Hospital de Sao Joao; Servico de Pneumologia
• Russian Federation
  • Moscow, Russian Federation, 115478
    • Russian Oncology Research Center n.a. N.N. Blokhin
  • Omsk, Russian Federation, 644013
    • Clinical Oncology Dispensary
  • Saint-Petersburg, Russian Federation, 197022
    • City Clinical Oncology Dispensary
  • Volgograd, Russian Federation, 400138
    • Volgograd regional clinical oncology dispensary
  • Moskovskaja Oblast
    • Moscovskaya Oblast, Moskovskaja Oblast, Russian Federation, 143423
      • Moscow City Oncology Hospital #62
• Singapore
  • Singapore, Singapore, 119074
    • National University Hospital
  • Singapore, Singapore, 169610
    • National Cancer Centre
• Slovakia
  • Bratislava, Slovakia, 833 10
    • Narodny onkologicky ustav
  • Bratislava, Slovakia, 813 69
    • Univerzitna nemocnica Bratislava
  • Poprad, Slovakia, 058 01
    • POKO Poprad s.r.o.
• Spain
  • Barcelona, Spain, 08003
    • Hospital del Mar
  • Barcelona, Spain, 08036
    • Hospital Clinic de Barcelona
  • Barcelona, Spain, 08035
    • Hospital Univ Vall d'Hebron; Servicio de Oncologia
  • Barcelona, Spain, 08041
    • Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia
  • Cordoba, Spain, 14008
    • Hospital Universitario Reina Sofia
  • Lugo, Spain, 27003
    • Hospital Lucus Augusti; Servicio de Oncologia
  • Madrid, Spain, 28040
    • Fundacion Jimenez Diaz
  • Madrid, Spain, 28041
    • Hospital Universitario 12 de Octubre
  • Madrid, Spain, 28034
    • Hospital Ramon y Cajal; Servicio de Oncologia
  • Madrid, Spain, 28050
    • HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio de Oncologia
  • Madrid, Spain, 28040
    • Hospital Clinico San Carlos; Servicio de Oncologia
  • Madrid, Spain, 28007
    • Hospital General Universitario Gregorio Marañon; Servicio de Oncologia
  • Madrid, Spain, 280146
    • Hospital Universitario La Paz
  • Valencia, Spain, 46010
    • Hospital Clínico Universitario de Valencia
  • Valencia, Spain, 46014
    • Hospital General Universitario de Valencia
  • Zaragoza, Spain, 50009
    • Hospital Universitario Miguel Servet
  • Barcelona
    • L'Hospitalet de Llobregat, Barcelona, Spain, 08908
      • Instituto Catalan de Oncologia de Hospitalet (ICO); Servicio de Farmacia
    • Sabadell, Barcelona, Spain, 8208
      • Corporacio Sanitaria Parc Tauli; Servicio de Oncologia
  • Cantabria
    • Santander, Cantabria, Spain, 39008
      • Hospital Universitario Marques de Valdecilla; Servicio de Oncologia
  • Islas Baleares
    • Palma De Mallorca, Islas Baleares, Spain, 07014
      • Hospital Universitario Son Espases
  • LA Coruña
    • A Coruña, LA Coruña, Spain, 15006
      • Complejo Hospitalario Universitario A Coruña
  • LAS Palmas
    • Las Palmas de Gran Canaria, LAS Palmas, Spain, 35016
      • Complejo hospitalario Universitario Insular-Materno Infantil
  • Sevilla
    • Seville, Sevilla, Spain, 41014
      • Hospital Nuestra Señora de Valme
  • Tenerife
    • S. Cristobal De La Laguna, Tenerife, Spain, 38320
      • Hospital Universitario de Canarias
• Taiwan
  • Changhua, Taiwan, 500
    • Changhua Christian Hospital; Hematology-Oncology
  • Kaohsiung City, Taiwan, 807
    • Kaohsiung Medical University Hospital; Department of Urology
  • Liuying Township, Taiwan, 736
    • Chi Mei Medical Center Liou Ying Campus
  • Putzu, Taiwan, 613
    • Chang Gung Memorial Hospital Chiayi
  • Taichung, Taiwan, 40447
    • China Medical University Hospital
  • Taipei, Taiwan, 104
    • Mackay Memorial Hospital
  • Taipei City, Taiwan, 10041
    • National Taiwan Uni Hospital
• Ukraine
  • Chernivtsi, Ukraine, 58013
    • Municipal Institution Chernivtsi Regional Clinical Oncology Dispensary; Surgery Department #1
  • Kharkiv, Ukraine, 61024
    • SI Institute of Medical Radiology n.a. S.P. Hryhoriev of NAMS of Ukraine
  • Kryvyi Rih, Ukraine, 50048
    • ME Kryviy Rih Oncology Dispensary of Dnipropetrovs'k Regional Council; Chemotherapy Department
  • Poltava, Ukraine, 36011
    • Poltava Regional Clinical Oncology Dispensary of Poltava Regional Council; Thoracic department
  • Sumy, Ukraine, 40005
    • Regional Municipal Institution Sumy Regional Clinical Oncology Dispensary
  • KIEV Governorate
    • Vinnytsia, KIEV Governorate, Ukraine, 21029
      • Communal Nonprofit Enterprise Podilsky Regional Center Of Oncology OfTheVinnytsia Regional Council
  • Katerynoslav Governorate
    • Dnipropetrovsk, Katerynoslav Governorate, Ukraine, 49102
      • Municipal Institution City Clinical Hospital #4 of Dnipro City Council - PPDS; Dept of Chemotherapy
    • Uzhhorod, Katerynoslav Governorate, Ukraine, 88000
      • Uzhgorod Central City Clinical Hospital
    • Zaporizhzhia, Katerynoslav Governorate, Ukraine, 69040
      • MNPE Zaporizhzhia Regional Antitumor Center ZRC
  • Kharkiv Governorate
    • Kharkiv, Kharkiv Governorate, Ukraine, 61070
      • Communal Non profit Enterprise Regional Center of Oncology; Oncosurgical dept of thoracic organs
  • Volhynian Governorate
    • Lviv, Volhynian Governorate, Ukraine, 79031
      • MI of the Lviv Regional Council Lviv Oncology Regional Treatment and Diagnostic Centre; Chemotherapy
• United States
  • Arizona
    • Chandler, Arizona, United States, 85224
      • Ironwood Cancer & Research Centers
  • Arkansas
    • Springdale, Arkansas, United States, 72762
      • Highlands Oncology Group
  • California
    • Bellflower, California, United States
      • Southern CA Permanente Med Grp
    • Oakland, California, United States, 94611
      • Kaiser Permanente Oakland Medical Center
    • Sacramento, California, United States, 95825
      • Kaiser Permanente - Sacramento Medical Center and Medical Offices
    • San Leandro, California, United States, 94577
      • Kaiser Permanente - San Leandro Medical Center
    • Santa Clara, California, United States, 95051
      • Kaiser Permanente - Santa Clara
    • Vallejo, California, United States, 94589
      • Kaiser Permanente; Oncology Clinical Trials
    • Walnut Creek, California, United States, 94596
      • Kaiser Permanente - Walnut Creek
  • Colorado
    • Denver, Colorado, United States, 80218
      • Rocky Mountain Cancer Center
  • Connecticut
    • Danbury, Connecticut, United States, 06810
      • Danbury Hospital
  • Florida
    • Fort Lauderdale, Florida, United States, 33308
      • Holy Cross Hospital Inc
    • Fort Myers, Florida, United States, 33916
      • Scri Florida Cancer Specialists South
    • Palm Beach Gardens, Florida, United States, 33410
      • Florida Cancer Specialists
    • Port Saint Lucie, Florida, United States, 34952
      • Hematology Oncology Associates of the Treasure Coast
    • Saint Petersburg, Florida, United States, 33705
      • Florida Cancer Specialists (St. Petersburg - St. Anthony's Professional Building)
  • Georgia
    • Athens, Georgia, United States, 30607
      • University Cancer & Blood Center, LLC; Research
    • Carrollton, Georgia, United States, 30117
      • Northwest Georgia Oncology Centers, a Service of WellStar Cobb Hospital
    • Macon, Georgia, United States, 31201
      • Central Georgia Cancer Care PC
    • Newnan, Georgia, United States, 30265
      • Southeastern Regional Medical Center, Inc.
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago
    • Joliet, Illinois, United States, 60435
      • Joliet Oncology-Hematology; Associates, Ltd.
    • Quincy, Illinois, United States, 62301
      • Quincy Medical Group
  • Indiana
    • Fort Wayne, Indiana, United States, 46845
      • Fort Wayne Med Oncology & Hematology Inc
  • Iowa
    • Bettendorf, Iowa, United States, 52722
      • Hematology-Oncology; Associates of the Quad Cities
    • Sioux City, Iowa, United States, 51101
      • Siouxland Hematology/Oncology
  • Kentucky
    • Lexington, Kentucky, United States, 02421
      • Lahey Clinic Med Ctr
    • Louisville, Kentucky, United States, 40202
      • Norton Cancer Institute
  • Louisiana
    • New Orleans, Louisiana, United States, 70121
      • Ochsner Clinic Foundation
  • Maine
    • Scarborough, Maine, United States, 04074
      • New England Cancer Specialists
  • Massachusetts
    • Fairhaven, Massachusetts, United States, 02719
      • Southcoast Health System; Southcoast Centers For Cancer Care
  • Michigan
    • Ann Arbor, Michigan, United States, 48106
      • St. Joseph Mercy Health System
    • Detroit, Michigan, United States, 48201
      • Karmanos Cancer Institute
  • Minnesota
    • Duluth, Minnesota, United States, 55805
      • St. Luke's Regional Cancer Center
  • Mississippi
    • Tupelo, Mississippi, United States, 38801
      • Hematology and Oncology Associates at Bridgepoint
  • Montana
    • Billings, Montana, United States, 59102
      • Billings Clinic
  • New Jersey
    • Paramus, New Jersey, United States, 07652
      • Valley Hospital; Oncology Research
    • Sewell, New Jersey, United States, 08080
      • Regional Cancer Care Associates LLC
  • New York
    • Westbury, New York, United States, 11590
      • Clinical Research Alliance
  • North Carolina
    • Salisbury, North Carolina, United States
      • W.G. Bill Hefner VA Medical Center
  • Ohio
    • Cincinnati, Ohio, United States, 45203-0542
      • University of Cincinnati
    • Columbus, Ohio, United States, 43219
      • Mark H. Zangmeister Center
    • Hamilton, Ohio, United States, 45103
      • Oncology Hematology Care, Inc.
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health & Science Uni
  • Pennsylvania
    • Bethlehem, Pennsylvania, United States, 18015
      • St. Luke's Cancer Care Associates
    • Gettysburg, Pennsylvania, United States, 17325
      • Maryland Oncology Hematology (Lanham) - USOR
    • Pittsburgh, Pennsylvania, United States, 15212
      • Allegheny Cancer Center
    • Pittsburgh, Pennsylvania, United States, 15232
      • Univ of Pittsburgh Medical Ctr
  • Tennessee
    • Chattanooga, Tennessee, United States, 37404
      • Scri Tennessee Oncology Chattanooga
    • Knoxville, Tennessee, United States, 37920
      • Tennessee Cancer Specialists
  • Texas
    • Denton, Texas, United States, 76210
      • SCRI The Center For Cancer and Blood Disorders
    • Longview, Texas, United States, 75601
      • Longview Cancer Center
  • Virginia
    • Fairfax, Virginia, United States, 22031
      • Virginia Cancer Specialists, PC
    • Norfolk, Virginia, United States, 23502
      • Virginia Oncology Associates
    • Roanoke, Virginia, United States, 24014
      • Blue Ridge Cancer Care
  • Washington
    • Everett, Washington, United States, 98201
      • Providence Regional Cancer Partnership
    • Spokane, Washington, United States, 99208
      • Medical Oncology Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm A: Atezolizumab + Paclitaxel + Carboplatin; The induction phase of the study will consist of four or six cycles; atezolizumab, paclitaxel, and carboplatin will be administered on Day 1 of each 21-day cycle. The Day 1 order of drug administration is as follows: atezolizumab, then paclitaxel, then carboplatin. Participants who experience no further clinical benefit at any time during the induction phase will discontinue all study treatments. In the absence of the above criteria, after the 4- or 6-cycle induction phase, participants will begin maintenance therapy with atezolizumab. Atezolizumab will be continued as long as there is a clinical benefit to the participant.	Drug: Atezolizumab (MPDL3280A), an engineered anti-programmed death-ligand 1 (anti-PD-L1) antibody; Atezolizumab 1200 milligrams (mg) intravenous infusion (IV) on day 1 of each 21-day cycle.; Other Names: Tecentriq; Drug: Carboplatin; Carboplatin area under the concentration curve (AUC) 6 milligrams per milliliter per minute (mg/mL/min) on Day 1 of each 21-day cycle for 4 or 6 cycles.; Drug: Paclitaxel; Paclitaxel 200 mg/m^2 IV on Day 1 of each 21-day cycle for 4 or 6 cycles. Participants of Asian race/ethnicity will be administered paclitaxel 175 mg/m^2 IV.
Experimental: Arm B: Atezolizumab + Nab-Paclitaxel + Carboplatin; The induction phase of the study will consist of four or six cycles; atezolizumab and carboplatin will be administered on Day 1 of each 21-day cycle. Nab-Paclitaxel will be administered on Days 1, 8, and 15 of each 21-day cycle. The Day 1 order of drug administration is as follows: atezolizumab, then nab-paclitaxel, then carboplatin. Participants who experience no further clinical benefit at any time during the induction phase will discontinue all study treatments. In the absence of the above criteria, after the 4- or 6-cycle induction phase, participants will begin maintenance therapy with atezolizumab. Atezolizumab will be continued as long as there is a clinical benefit to the participant.	Drug: Atezolizumab (MPDL3280A), an engineered anti-programmed death-ligand 1 (anti-PD-L1) antibody; Atezolizumab 1200 milligrams (mg) intravenous infusion (IV) on day 1 of each 21-day cycle.; Other Names: Tecentriq; Drug: Carboplatin; Carboplatin area under the concentration curve (AUC) 6 milligrams per milliliter per minute (mg/mL/min) on Day 1 of each 21-day cycle for 4 or 6 cycles.; Drug: Nab-Paclitaxel; Nab-paclitaxel 100 milligrams per meter squared (mg/m^2) IV on Day 1, 8, and 15 of each 21-day cycle for 4 or 6 cycles.
Active Comparator: Arm C: Nab-Paclitaxel + Carboplatin; The induction phase of the study will consist of four or six cycles; carboplatin will be administered on Day 1 of each 21-day cycle, nab-paclitaxel will be administered on Days 1, 8, and 15 of each 21-day cycle. The Day 1 order of drug administration is as follows: nab-paclitaxel, then carboplatin. Participants who experience disease progression at any time during the induction phase will discontinue all study treatment. In the maintenance phase, participants will receive best supportive care.	Drug: Carboplatin; Carboplatin area under the concentration curve (AUC) 6 milligrams per milliliter per minute (mg/mL/min) on Day 1 of each 21-day cycle for 4 or 6 cycles.; Drug: Nab-Paclitaxel; Nab-paclitaxel 100 milligrams per meter squared (mg/m^2) IV on Day 1, 8, and 15 of each 21-day cycle for 4 or 6 cycles.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	PFS is defined as the time between the date of randomization and the date of first documented disease progression or death, whichever occurs first, in the ITT population.	Up to approximately 30 months after first participant enrolled
Overall Survival (OS) in the ITT Population	OS is defined as the time between the date of randomization and date of death from any cause in the ITT population.	Up to approximately 39 months after first participant enrolled

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
OS in the in the Teff Population	OS is defined as the time between the date of randomization and date of death from any cause in the in the Teff Population.	Up to approximately 39 months after first participant enrolled
PFS as Determined by the Investigator Using RECIST v1.1 in the Teff Population	PFS is defined as the time between the date of randomization and the date of first documented disease progression or death, whichever occurs first, in the Teff Population.	Up to approximately 30 months after first participant enrolled
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	PFS is defined as the time between the date of randomization and the date of first documented disease progression or death, whichever occurs first, in the Tumor Cell (TC) 2/3 or Tumor-Infiltrating Immune Cell (IC) 2/3 Population.	Up to approximately 30 months after first participant enrolled
PFS as Determined by the Investigator Using RECIST v1.1 in the TC1/2/3 or IC1/2/3 Population	PFS is defined as the time between the date of randomization and the date of first documented disease progression or death, whichever occurs first, in the TC1/2/3 or IC1/2/3 Population.	Up to approximately 30 months after first participant enrolled
OS in the TC2/3 or IC2/3 Population	OS is defined as the time between the date of randomization and date of death from any cause, in the TC2/3 or IC2/3 Population.	Up to approximately 39 months after first participant enrolled
OS in the TC1/2/3 or IC1/2/3 Population	OS is defined as the time between the date of randomization and date of death from any cause in the TC1/2/3 or IC1/2/3 Population.	Up to approximately 39 months after first participant enrolled
Percentage of Participants With Objective Response as Determined by the Investigator Using RECIST v1.1 in the ITT Population	Proportion of participants with an objective response (CR or PR) in the ITT population.	Up to approximately 30 months after first participant enrolled
Duration of Response as Determined by the Investigator Using RECIST v1.1 in the ITT Population	Duration of response is defined as the time from the first documented objective response to documented PD or death from any cause, whichever occurred first, in the ITT Population.	Up to approximately 30 months after first participant enrolled
Event Free Rate at 1 and 2 Years in the ITT Population	Event free rate at 1 and 2 years is defined as the proportion of participants alive at 1 and 2 years after randomization estimated using Kaplan-Meier (KM) methodology for the ITT population.	1 and 2 years
Time to Deterioration (TTD) in Patient-reported Lung Cancer Symptoms Using EORTC QLQ-C30 Symptom Subscales in the ITT Population	TTD in Patient-reported Lung Cancer Symptoms Using EORTC QLQ-C30 Symptom Subscales in the ITT Population. The EORTC QLQ-C30 is a validated and reliable self-report measure that consists of 30 questions that assess five aspects of patient functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, pain), global health/quality of life, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). EORTC scales and single-item measures will be linearly transformed so that each score has a range of 0-100. A high score for a functional scale represents a high or healthy level of functioning, and a high score for the global health status and HRQoL represents a high HRQoL; however, a high score for a symptom scale or item represents a high level of symptomatology or problems.	Up to approximately 30 months after first participant enrolled
TTD in Patient-reported Lung Cancer Symptoms Using EORTC QLQ-LC13 Symptom Subscales in the ITT Population	TTD was documented for a 3-symptom composite endpoint using the following EORTC QLQ-LC13 symptom scores: cough, chest pain, and dyspnea multi--item scale. In this instance, symptom deterioration will be determined as a >= 10-point increase above baseline in any of the listed symptom scores, whichever occurs first (cough, chest pain, and dyspnea multi-item scale). Confirmed clinically meaningful symptom deterioration will need to be held for the original symptom; a >= 10-point increase above baseline in a symptom score must be held for at least two consecutive assessments or an initial>=10-point increase above baseline followed by death within 3 weeks from the last assessment. A >= 10-point change in the EORTC scale score is perceived by patients as clinically significant.	Up to approximately 30 months after the first participant enrolled
Change From Baseline in Patient-reported Lung Cancer Symptoms Score Using the SILC Scale Symptom Severity Score in the ITT Population	Change from baseline per SILC scale will be analyzed for each lung cancer symptoms scores. SILC questionnaire comprises 3 individual symptoms & are scored at individual symptom level, thus have a dyspnea score, chest pain score, & cough score. There are a total of 9 questions in SILC questionnaire, each question has a minimum value of 0 & maximum value of 4. Each individual symptom score is calculated as average of responses for symptom items. 'Chest pain' score is mean of question 1 & 2, 'Cough' score is mean of question 3 & 4 and 'Dyspnea' score is mean of question 5 to 9 in SILC questionnaire. An increase in score is suggestive of a worsening in symptomology. A score change of ≥0.3 points for dyspnea & cough symptom scores is considered to be clinically significant; whereas a score change of ≥0.5 points for chest pain score is considered to be clinically significant. (Note: PD=progression of disease)	Baseline up to approximately 30 months after first participant enrolled
PFS as Determined by the Investigator Using RECIST v1.1 in the ITT Population (Arm A and Arm B)	PFS is defined as the time between the date of randomization and the date of first documented disease progression or death, whichever occurs first, in the ITT Population Arm A and Arm B.	Up to approximately 30 months after first participant enrolled
OS in the ITT Population (Arm A and Arm B)	OS is defined as the time between the date of randomization and date of death from any cause in the ITT Population, Arm A and Arm B.	Up to approximately 39 months after first participant enrolled
Percentage of Participants With Adverse Events	Percentage of participants with at least one adverse event.	Up to approximately 68 months after first participant enrolled
Percentage of Participants With Anti-therapeutic Antibody (ATA) Response to Atezolizumab	Percentage of participants with Anti-therapeutic Antibody (ATA) response to atezolizumab.	Up to approximately 30 months after first participant enrolled
Maximum Observed Serum Atezolizumab Concentration (Cmax)	Maximum observed serum atezolizumab concentration (Cmax). The predose samples will be collected on the same day of treatment administration. The infusion duration of atezolizumab will be of 30-60 minutes.	Cycle 1 Day 1 and Cycle 3 Day 1 (Cycle length = 21 days)
Minimum Observed Serum Atezolizumab Concentration (Cmin)	Minimum observed serum atezolizumab concentration (Cmin). The predose samples will be collected on the same day of treatment administration.	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)
Plasma Concentrations for Paclitaxel	Plasma concentrations for paclitaxel.	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)
Plasma Concentrations for Nab-Paclitaxel	Plasma concentrations for nab-paclitaxel.	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)
Plasma Concentrations for Carboplatin	Plasma concentrations for carboplatin.	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)

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 11, 2015
• Primary Completion (Actual): October 3, 2018
• Study Completion (Actual): February 17, 2021

Study Registration Dates

• First Submitted: February 13, 2015
• First Submitted That Met QC Criteria: February 13, 2015
• First Posted (Estimate): February 20, 2015

Study Record Updates

• Last Update Posted (Actual): March 21, 2022
• Last Update Submitted That Met QC Criteria: March 17, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Immunologic Factors; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Carboplatin; Paclitaxel; Antibodies; Albumin-Bound Paclitaxel; Atezolizumab
• Other Study ID Numbers: GO29437; 2014-003208-59 (EudraCT Number)