AzTrials
AzTrials

Squamous Non-Small Cell Lung CancerPhase 3NCT02367794

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 3 study testing Atezolizumab (MPDL3280A), an engineered anti-programmed death-ligand 1 (anti-PD-L1) antibody, Carboplatin and Nab-Paclitaxel in people with Squamous Non-Small Cell Lung Cancer, run by Hoffmann-La Roche at 242 sites in 26 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Squamous Non-Small Cell Lung Cancer
What is being tested?
Atezolizumab (MPDL3280A), an engineered anti-programmed death-ligand 1 (anti-PD-L1) antibody, Carboplatin and Nab-Paclitaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,021 participants
Where
242 sitesin 26 countries
Study dates
11 Jun 2015to 17 Feb 2021
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 10Show fewer
  • 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

Trial locations and contacts

242 sites in 26 countries.

242 sites in 26 countries

United States57 sites

  • St. Joseph Mercy Health System

    Ann Arbor, Michigan, 48106

  • University Cancer & Blood Center, LLC; Research

    Athens, Georgia, 30607

  • Southern CA Permanente Med Grp

    Bellflower, California

  • St. Luke's Cancer Care Associates

    Bethlehem, Pennsylvania, 18015

  • Hematology-Oncology; Associates of the Quad Cities

    Bettendorf, Iowa, 52722

  • Billings Clinic

    Billings, Montana, 59102

  • Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital

    Carrollton, Georgia, 30117

  • Ironwood Cancer & Research Centers

    Chandler, Arizona, 85224

  • SCRI Tennessee Oncology Chattanooga

    Chattanooga, Tennessee, 37404

  • University of Chicago

    Chicago, Illinois, 60637

  • University of Cincinnati

    Cincinnati, Ohio, 45203-0542

  • Mark H. Zangmeister Center

    Columbus, Ohio, 43219

  • Danbury Hospital

    Danbury, Connecticut, 06810

  • SCRI The Center For Cancer and Blood Disorders

    Denton, Texas, 76210

  • Rocky Mountain Cancer Center

    Denver, Colorado, 80218

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • St. Luke's Regional Cancer Center

    Duluth, Minnesota, 55805

  • Providence Regional Cancer Partnership

    Everett, Washington, 98201

  • Virginia Cancer Specialists, PC

    Fairfax, Virginia, 22031

  • Southcoast Health System; Southcoast Centers For Cancer Care

    Fairhaven, Massachusetts, 02719

  • Holy Cross Hospital Inc

    Fort Lauderdale, Florida, 33308

  • SCRI Florida Cancer Specialists South

    Fort Myers, Florida, 33916

  • Fort Wayne Med Oncology & Hematology Inc

    Fort Wayne, Indiana, 46845

  • Maryland Oncology Hematology (Lanham) - USOR

    Gettysburg, Pennsylvania, 17325

  • Oncology Hematology Care, Inc.

    Hamilton, Ohio, 45103

  • Joliet Oncology-Hematology; Associates, Ltd.

    Joliet, Illinois, 60435

  • Tennessee Cancer Specialists

    Knoxville, Tennessee, 37920

  • Lahey Clinic Med Ctr

    Lexington, Kentucky, 02421

  • Longview Cancer Center

    Longview, Texas, 75601

  • Norton Cancer Institute

    Louisville, Kentucky, 40202

  • Central Georgia Cancer Care PC

    Macon, Georgia, 31201

  • Ochsner Clinic Foundation

    New Orleans, Louisiana, 70121

  • Southeastern Regional Medical Center, Inc.

    Newnan, Georgia, 30265

  • Virginia Oncology Associates

    Norfolk, Virginia, 23502

  • Kaiser Permanente Oakland Medical Center

    Oakland, California, 94611

  • Florida Cancer Specialists

    Palm Beach Gardens, Florida, 33410

  • Valley Hospital; Oncology Research

    Paramus, New Jersey, 07652

  • Allegheny Cancer Center

    Pittsburgh, Pennsylvania, 15212

  • Univ of Pittsburgh Medical Ctr

    Pittsburgh, Pennsylvania, 15232

  • Hematology Oncology Associates of the Treasure Coast

    Port Saint Lucie, Florida, 34952

  • Oregon Health & Science Uni

    Portland, Oregon, 97239

  • Quincy Medical Group

    Quincy, Illinois, 62301

  • Blue Ridge Cancer Care

    Roanoke, Virginia, 24014

  • Kaiser Permanente - Sacramento Medical Center and Medical Offices

    Sacramento, California, 95825

  • W.G. Bill Hefner VA Medical Center

    Salisbury, North Carolina

  • Kaiser Permanente - San Leandro Medical Center

    San Leandro, California, 94577

  • Kaiser Permanente - Santa Clara

    Santa Clara, California, 95051

  • New England Cancer Specialists

    Scarborough, Maine, 04074

  • Regional Cancer Care Associates LLC

    Sewell, New Jersey, 08080

  • Siouxland Hematology/Oncology

    Sioux City, Iowa, 51101

  • Medical Oncology Associates

    Spokane, Washington, 99208

  • Highlands Oncology Group

    Springdale, Arkansas, 72762

  • Florida Cancer Specialists (St. Petersburg - St. Anthony's Professional Building)

    St. Petersburg, Florida, 33705

  • Hematology and Oncology Associates at Bridgepoint

    Tupelo, Mississippi, 38801

  • Kaiser Permanente; Oncology Clinical Trials

    Vallejo, California, 94589

  • Kaiser Permanente - Walnut Creek

    Walnut Creek, California, 94596

  • Clinical Research Alliance

    Westbury, New York, 11590

Other trials in United States

Japan24 sites

  • Aichi Cancer Center Hospital; Respiratory Medicine

    Aichi, 464-8681

  • Nagoya University Hospital; Respiratory Medicine

    Aichi, 466-8560

  • National Cancer Center Hospital East; Thoracic Oncology

    Chiba, 277-8577

  • National Hospital Organization Shikoku Cancer Center; Internal Medicine

    Ehime, 791-0280

  • National Hospital Organization Kyushu Medical Center; Respiratory Internal Medicine

    Fukuoka, 810-8563

  • Kyushu University Hospital; Respiratory

    Fukuoka, 812-8582

  • Kobe City Medical Center General Hospital; Respiratory Medicine

    Hyōgo, 650-0047

  • National Hospital Organization Himeji Medical Center

    Hyōgo, 670-8520

  • Hyogo Cancer Center; Thoracic Oncology

    Hyōgo, 673-8558

  • Ibaraki Prefectural Central Hospital; Division of respiratory

    Ibaraki, 309-1793

  • Kanagawa Cancer Center;Thoracic Oncology

    Kanagawa, 241-8515

  • Kyoto University Hospital, Respiratory Medicine

    Kyoto, 606-8507

  • Sendai Kousei Hospital; Pulmonary Medicine

    Miyagi, 980-0873

  • Niigata University Medical & Dental Hospital; Respiratory Medicine and Infectious Disease

    Niigata, 951-8520

  • Okayama University Hospital; Respiratory and Allergy Medicine

    Okayama, 700-8558

  • Osaka International Cancer Institute; Thoracic Oncology

    Osaka, 541-8567

  • Osaka City Uni Hospital; Respiratory Medicine

    Osaka, 545-8586

  • Kansai Medical university Hospital; Thoracic Oncology

    Osaka, 573-1191

  • Osaka Habikino Medical Center

    Osaka, 583-8588

  • National Hospital Organization Kinki-Chuo Chest Medical Center

    Sakaishi, 591-8555

  • Saitama Cancer Center; Thoracic Oncology

    Satima, 362-0806

  • Shizuoka Cancer Center; Thoracic Oncology

    Shizuoka, 411-8777

  • National Cancer Center Hospital; Thoracic Medical Oncology

    Tokyo, 104-0045

  • Tokyo Medical University Hospital; Dept of Surgery

    Tokyo, 160-0023

Other trials in Japan

Spain24 sites

  • Complejo Hospitalario Universitario A Coruña

    A Coruña, LA Coruña, 15006

  • Hospital del Mar

    Barcelona, 08003

  • Hospital Univ Vall d'Hebron; Servicio de Oncologia

    Barcelona, 08035

  • Hospital Clinic de Barcelona

    Barcelona, 08036

  • Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia

    Barcelona, 08041

  • Hospital Universitario Reina Sofia

    Córdoba, 14008

  • Instituto Catalan de Oncologia de Hospitalet (ICO); Servicio de Farmacia

    L'Hospitalet de Llobregat, Barcelona, 08908

  • Complejo Hospitalario Universitario Insular-Materno Infantil

    Las Palmas de Gran Canaria, LAS Palmas, 35016

  • Hospital Lucus Augusti; Servicio de Oncologia

    Lugo, 27003

  • Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

    Madrid, 28007

  • Hospital Universitario La Paz

    Madrid, 280146

  • Hospital Ramon y Cajal; Servicio de Oncologia

    Madrid, 28034

  • Fundación Jimenez Díaz

    Madrid, 28040

  • Hospital Clinico San Carlos; Servicio de Oncologia

    Madrid, 28040

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio de Oncologia

    Madrid, 28050

  • Hospital Universitario Son Espases

    Palma de Mallorca, Balearic Islands, 07014

  • Hospital Universitario de Canarias

    S. Cristobal de La Laguna, Tenerife, 38320

  • Corporacio Sanitaria Parc Tauli; Servicio de Oncologia

    Sabadell, Barcelona, 8208

  • Hospital Universitario Marques de Valdecilla; Servicio de Oncologia

    Santander, Cantabria, 39008

  • Hospital Nuestra Senora de Valme

    Seville, Sevilla, 41014

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010

  • Hospital General Universitario de Valencia

    Valencia, 46014

  • Hospital Universitario Miguel Servet

    Zaragoza, 50009

Other trials in Spain

Germany20 sites

  • Charite - Universitätsmedizin Berlin

    Berlin, 12203

  • Ev.Krankenhaus Bielefeld gGmbH; Klinik für Innere Medizin und Geriatrie

    Bielefeld, 33611

  • Augusta Kranken-Anstalt gGmbH

    Bochum, 44791

  • Kliniken der Stadt Koln gGmbH

    Cologne, 51109

  • Universitätsklinikum "Carl Gustav Carus" der Technischen Universität Dresden

    Dresden, 01307

  • St. Elisabethen Krankenhaus

    Frankfurt am Main, 60487

  • Robert Bosch Krankenhaus; Pneumologie und pneumologische Onkologie

    Gerlingen, 70839

  • LungenClinic Großhansdorf GmbH

    Großhansdorf, 22927

  • Krankenhaus Martha-Maria; Halle-Dolau gGmbH

    Halle, 06120

  • Universitätsklinikum Hamburg-Eppendorf

    Hamburg, 20246

  • Asklepios Klinik Harburg

    Hamburg, 21075

  • Lungenklinik Hemer

    Hemer, 58675

  • Universität Des Saarlandes; Klinik für Innere Medizin V

    Homburg, 66421

  • Fachklinik für Lungenerkrankungen

    Immenhausen, 34376

  • Johannes Wesling Klinikum Minden; Hämatologie, Onkologie, Hämostaseologie und Palliativmedizin

    Minden, 32429

  • Klinikum Bogenhausen; Klinik für Pneumologie und Pneumologische Onkologie

    München, 81925

  • Krankenhaus Barmherzige Bruder Regensburg

    Regensburg, 93049

  • Klinikum der Universität Regensburg

    Regensburg, 93053

  • Stiftung Mathias-Spital Rheine

    Rheine, 48431

  • Schwarzwald-Baar Klinikum/VS GmbH; Onkologie/Hämatologie/Infektologie

    Villingen-Schwenningen, 78052

Other trials in Germany

Italy12 sites

  • Azienda Ospedaliera di Rilievo Nazionale e di Alta Specialita San Giuseppe Moscati

    Avellino, Campania, 83100

  • IRCCS Giovanni Paolo II Istituto Oncologico

    Bari, Apulia, 70124

  • Policlinico Vittorio Emanuele

    Catania, Sicily, 95123

  • ASL 3 Genovese; DSM

    Genoa, Liguria, 16147

  • Ospedale Civile - Livorno

    Livorno, Tuscany, 57124

  • AORN A Cardarelli

    Naples, Campania, 80131

  • Azienda Ospedaliero Universitaria Seconda Università degli Studi di Napoli; Farmacia Centralizzata

    Naples, Campania, 80131

  • Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione G. Pascale

    Naples, Campania, 80131

  • Fondazione IRCCS Policlinico San Matteo

    Pavia, Lombardy, 27100

  • Ospedale Silvestrini

    Perugia, Umbria, 06122

  • Azienda Ospedaliero Universitaria Pisana

    Pisa, Tuscany, 56100

  • Azienda Ospedaliera San Camillo Forlanini

    Rome, Lazio, 00152

Other trials in Italy

Ukraine11 sites

  • Municipal Institution Chernivtsi Regional Clinical Oncology Dispensary; Surgery Department #1

    Chernivtsi, 58013

  • Municipal Institution City Clinical Hospital #4 of Dnipro City Council - PPDS; Dept of Chemotherapy

    Dnipropetrovsk, Katerynoslav Governorate, 49102

  • Communal Non profit Enterprise Regional Center of Oncology; Oncosurgical dept of thoracic organs

    Kharkiv, Kharkiv Governorate, 61070

  • SI Institute of Medical Radiology n.a. S.P. Hryhoriev of NAMS of Ukraine

    Kharkiv, 61024

  • ME Kryviy Rih Oncology Dispensary of Dnipropetrovs'k Regional Council; Chemotherapy Department

    Kryvyi Rih, 50048

  • MI of the Lviv Regional Council Lviv Oncology Regional Treatment and Diagnostic Centre; Chemotherapy

    Lviv, Volhynian Governorate, 79031

  • Poltava Regional Clinical Oncology Dispensary of Poltava Regional Council; Thoracic department

    Poltava, 36011

  • Regional Municipal Institution Sumy Regional Clinical Oncology Dispensary

    Sumy, 40005

  • Uzhgorod Central City Clinical Hospital

    Uzhhorod, Katerynoslav Governorate, 88000

  • Communal Nonprofit Enterprise Podilsky Regional Center Of Oncology OfTheVinnytsia Regional Council

    Vinnytsia, KIEV Governorate, 21029

  • MNPE Zaporizhzhia Regional Antitumor Center ZRC

    Zaporizhzhya, Katerynoslav Governorate, 69040

Other trials in Ukraine

Australia10 sites

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

  • Chris O'Brien Lifehouse

    Camperdown, New South Wales, 2050

  • Prince Charles Hospital

    Chermside, Queensland, 4032

  • Austin Health

    Heidelberg, Victoria, 3084

  • Cabrini Hospital Malvern

    Malvern, Victoria, 3144

  • Sir Charles Gairdner Hospital

    Nedlands, Western Australia, 6009

  • Sunshine Hospital

    St Albans, Victoria, 3021

  • Townsville Hospital

    Townsville, Queensland, 4810

  • Calvary Mater Newcastle; Medical Oncology

    Waratah, New South Wales, 2298

  • Princess Alexandra Hospital

    Woolloongabba, Queensland, 4102

Other trials in Australia

Brazil10 sites

  • *X*Fundação Pio XII Hospital de Câncer de Barretos

    Barretos, São Paulo, 14784-400

  • Cenantron - Centro Avancado de Tratamento Oncologico

    Belo Horizonte, Minas Gerais, 30130-090

  • IPCEM; Instituto de Pesquisa de Estudos Multicêntricos

    Caxias do Sul, Rio Grande do Sul, 95070-560

  • Hospital Bruno Born

    Lajeado, Rio Grande do Sul, 95900-000

  • Instituto Do Cancer Delondrina_X; Unidade De Pesquisa Clinica

    Londrina, Paraná, 86 015 520

  • Liga Norte Riograndense Contra O Câncer

    Natal, Rio Grande do Norte, 59040150

  • Hospital das Clinicas - UFRGS

    Porto Alegre, Rio Grande do Sul, 90035-903

  • Hospital Mae de Deus

    Porto Alegre, Rio Grande do Sul, 90470-340

  • Hospital de Base de Sao Jose do Rio Preto

    São José do Rio Preto, São Paulo, 15090-000

  • Hospital Do Cancer A C Camargo

    São Paulo, São Paulo, 01525-001

Other trials in Brazil

France10 sites

  • CHU de Grenoble

    Grenoble, 38043

  • Ctr Jean Bernard Clin V. Hugo; Service d'Oncologie Méd

    Le Mans, 72000

  • Centre Léon Bérard Centre Régional de Lutte Contre Le Cancer Rhône Alpes

    Lyon, 69008

  • Clinique Clémentville

    Montpellier, 34070

  • Hopital de La Source

    Orléans, 45067

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69495

  • Hopital de Pontchaillou; Service de Pneumologie

    Rennes, 35033

  • Centre Hospitalier Regional Sud Reunion; Service de Pneumologie

    Saint-Pierre, 97448

  • CH de Saint Quentin

    Saint-Quentin, 2100

  • Hôpital d'Instruction des Armées de Sainte Anne; Service Pharmacie Essais Cliniques

    Toulon, 83800

Other trials in France

Israel7 sites

  • Soroka Medical Center

    Beersheba, 8410101

  • Hadassah University Hospital - Ein Kerem

    Jerusalem, 9112001

  • Meir Medical Center; Oncology

    Kfar Saba, 4428164

  • Rabin Medical Center

    Petach Tiqwa, 4941492

  • Chaim Sheba Medical Center; Oncology Dept

    Ramat Gan, 5262100

  • Rambam Health Corporation; Oncology Institute

    Rambam, 3525408

  • Tel Aviv Sourasky Medical Ctr; Oncology

    Tel Aviv, 6423906

Other trials in Israel

Taiwan7 sites

  • Changhua Christian Hospital; Hematology-Oncology

    Changhua, 500

  • Kaohsiung Medical University Hospital; Department of Urology

    Kaohsiung City, 807

  • Chi Mei Medical Center Liou Ying Campus

    Liuying Township, 736

  • Chang Gung Memorial Hospital Chiayi

    Putzu, 613

  • China Medical University Hospital

    Taichung, 40447

  • National Taiwan Uni Hospital

    Taipei, 10041

  • Mackay Memorial Hospital

    Taipei, 104

Other trials in Taiwan

Argentina6 sites

  • Fundación CENIT para la Investigación en Neurociencias

    Buenos Aires, C1125ABD

  • Sanatorio Allende

    Córdoba, X5000JHQ

  • Centro Oncologico Riojano Integral (CORI)

    La Rioja, F5300COE

  • Clínica Pergamino

    Pergamino, B2700CPM

  • Fundacion Koriza

    Santa Rosa, L6304BOC

  • Centro de Investigacion; Clinica - Clinica Viedma S.A.

    Viedma, R8500ACE

Other trials in Argentina

Canada6 sites

  • Royal Victoria Regional Health Centre

    Barrie, Ontario, L4M 6M2

  • William Osler Health Centre

    Etobicoke, Ontario, M9V 1R8

  • Cite de La Sante de Laval; Hemato-Oncologie

    Laval, Quebec, H7M 3L9

  • Hôpital du Sacré-Coeur de Montreal

    Montreal, Quebec, H4J 1C5

  • Lakeridge Health Center

    Oshawa, Ontario, L1J 2J2

  • St. Jerome Medical Research

    Saint-Jérôme, Quebec, J7Z 5T3

Other trials in Canada

Belgium5 sites

  • Cliniques Universitaires St-Luc

    Brussels, 1200

  • CHU Sart-Tilman

    Liège, 4000

  • Clinique Ste-Elisabeth

    Namur, 5000

  • Werken Glorieux VZW

    Ronse, 9600

  • GasthuisZusters Antwerpen

    Wilrijk, 2610

Other trials in Belgium

Netherlands5 sites

  • VU Medisch Centrum; VU University Medical Center

    Amsterdam, 1007 MB

  • Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis

    Amsterdam, 1066 CX

  • Ziekenhuis Gelderse Vallei

    Ede, 6716 RP

  • Catharina Hospital; Afdeling Longgeneeskunde en Tuberculose

    Eindhoven, 5623 EJ

  • St. Antonius Ziekenhuis; R&D Long

    Nieuwegein, 3435 CM

Other trials in Netherlands

Portugal5 sites

  • IPO de Lisboa; Servico de Pneumologia

    Lisbon, 1099-023

  • Hospital Pulido Valente; Servico de Pneumologia

    Lisbon, 1796-001

  • Centro Hospitalar do Porto - Hospital de Santo António

    Porto, 4099-001

  • Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe

    Porto, 4200-072

  • Hospital de Sao Joao; Servico de Pneumologia

    Porto, 4200

Other trials in Portugal

Russia5 sites

  • Moscow City Oncology Hospital #62

    Moscovskaya Oblast, Moscow Oblast, 143423

  • Russian Oncology Research Center n.a. N.N. Blokhin

    Moscow, 115478

  • Clinical Oncology Dispensary

    Omsk, 644013

  • City Clinical Oncology Dispensary

    Saint Petersburg, 197022

  • Volgograd Regional Clinical Oncology Dispensary

    Volgograd, 400138

Other trials in Russia

Peru3 sites

  • Centro Medico Monte Carmelo

    Arequipa, 04001

  • Hospital Nacional Guillermo Almenara Irigoyen ESSALUD

    Lima, Lima 13

  • Instituto Regional de Enfermedades Neoplásicas Del Norte

    Trujillo, 12345

Other trials in Peru

Slovakia3 sites

  • Univerzitna nemocnica Bratislava

    Bratislava, 813 69

  • Narodny onkologicky ustav

    Bratislava, 833 10

  • POKO Poprad s.r.o.

    Poprad, 058 01

Other trials in Slovakia

Bulgaria2 sites

  • Multiprofile Hospital for Active Treatment Central Onco Hospital OOD

    Plovdiv, 4000

  • Multiprofile Hospital for Active Treatment Serdika EOOD

    Sofia, 1303

Other trials in Bulgaria

Chile2 sites

  • Health & Care SPA

    Santiago, 7500006

  • Sociedad de Investigaciones Medicas Ltda (SIM)

    Temuco, 4810469

Other trials in Chile

Latvia2 sites

  • Pauls Stradins Clinical University Hospital

    Riga, LV-1002

  • Riga East Clinical University Hospital Latvian Oncology Centre

    Riga, LV-1079

Other trials in Latvia

Mexico2 sites

  • Centro Universitario Contra El Cancer

    Monterrey, 64020

  • Cancerología

    Querétaro, 76090

Other trials in Mexico

Singapore2 sites

  • National University Hospital

    Singapore, 119074

  • National Cancer Centre

    Singapore, 169610

Other trials in Singapore

Austria1 site

  • Paracelsus Medizinische Privatuniversität

    Salzburg, 5020

Other trials in Austria

Lithuania1 site

  • National Cancer Institute

    Vilnius, 08660

Other trials in Lithuania

About this study

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

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.

Being tested
Atezolizumab (MPDL3280A), an engineered anti-programmed death-ligand 1 (anti-PD-L1) antibody, Carboplatin, Nab-Paclitaxel, Paclitaxel

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Atezolizumab (MPDL3280A), an engineered anti-programmed death-ligand 1 (anti-PD-L1) antibodyDrug

    Also called Tecentriq

    Atezolizumab 1200 milligrams (mg) intravenous infusion (IV) on day 1 of each 21-day cycle.

  • CarboplatinDrug

    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.

  • Nab-PaclitaxelDrug

    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.

  • PaclitaxelDrug

    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.

Study groups in NCT02367794
Study groupRoleWhat they receive
Arm A: Atezolizumab + Paclitaxel + CarboplatinExperimentalThe 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.
Receives: Drug: Atezolizumab (MPDL3280A), an engineered anti-programmed death-ligand 1 (anti-PD-L1) antibody; Drug: Carboplatin; Drug: Paclitaxel
Arm B: Atezolizumab + Nab-Paclitaxel + CarboplatinExperimentalThe 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.
Receives: Drug: Atezolizumab (MPDL3280A), an engineered anti-programmed death-ligand 1 (anti-PD-L1) antibody; Drug: Carboplatin; Drug: Nab-Paclitaxel
Arm C: Nab-Paclitaxel + CarboplatinActive comparatorThe 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.
Receives: Drug: Carboplatin; Drug: Nab-Paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to approximately 30 months after first participant enrolled

  2. 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.

    Measured: Up to approximately 39 months after first participant enrolled

Secondary outcomes (21)

  1. 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.

    Measured: Up to approximately 39 months after first participant enrolled

  2. 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.

    Measured: Up to approximately 30 months after first participant enrolled

  3. 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.

    Measured: Up to approximately 30 months after first participant enrolled

  4. 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.

    Measured: Up to approximately 30 months after first participant enrolled

  5. 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.

    Measured: Up to approximately 39 months after first participant enrolled

  6. 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.

    Measured: Up to approximately 39 months after first participant enrolled

  7. 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.

    Measured: Up to approximately 30 months after first participant enrolled

  8. 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.

    Measured: Up to approximately 30 months after first participant enrolled

  9. 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.

    Measured: 1 and 2 years

  10. 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.

    Measured: Up to approximately 30 months after first participant enrolled

  11. 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.

    Measured: Up to approximately 30 months after the first participant enrolled

  12. 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)

    Measured: Baseline up to approximately 30 months after first participant enrolled

  13. 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.

    Measured: Up to approximately 30 months after first participant enrolled

  14. 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.

    Measured: Up to approximately 39 months after first participant enrolled

  15. Percentage of Participants With Adverse Events

    Percentage of participants with at least one adverse event.

    Measured: Up to approximately 68 months after first participant enrolled

  16. Percentage of Participants With Anti-therapeutic Antibody (ATA) Response to Atezolizumab

    Percentage of participants with Anti-therapeutic Antibody (ATA) response to atezolizumab.

    Measured: Up to approximately 30 months after first participant enrolled

  17. 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.

    Measured: Cycle 1 Day 1 and Cycle 3 Day 1 (Cycle length = 21 days)

  18. 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.

    Measured: 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)

  19. Plasma Concentrations for Paclitaxel

    Plasma concentrations for paclitaxel.

    Measured: 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)

  20. Plasma Concentrations for Nab-Paclitaxel

    Plasma concentrations for nab-paclitaxel.

    Measured: 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)

  21. Plasma Concentrations for Carboplatin

    Plasma concentrations for carboplatin.

    Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Feb 2015 (estimated)
  2. Study start11 Jun 2015
  3. Primary completion3 Oct 2018
  4. Study completion17 Feb 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,021 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02367794
Sponsor's protocol ID
GO29437
Other IDs
2014-003208-59, 2014
Status last verified
Mar 2022
First submitted
13 Feb 2015
Last updated
21 Mar 2022

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.

    PubMed 35511917

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Atezolizumab (MPDL3280A), an engineered anti-programmed death-ligand 1 (anti-PD-L1) antibody, Carboplatin and Nab-Paclitaxel in people with Squamous Non-Small Cell Lung Cancer, run by Hoffmann-La Roche at 242 sites in 26 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 242 sites in United States, Japan, Spain, Germany, Italy and 21 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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 (time frame: Up to approximately 30 months after first participant enrolled). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02367794, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2022.

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