Avelumab in Non-Small Cell Lung Cancer (JAVELIN Lung 200)

July 20, 2020 updated by: EMD Serono Research & Development Institute, Inc.

A Phase III Open-Label, Multicenter Trial of Avelumab (MSB0010718C) Versus Docetaxel in Subjects With Non-Small Cell Lung Cancer That Has Progressed After a Platinum-Containing Doublet

The main purpose of this study was to demonstrate superiority with regard to overall survival of avelumab versus docetaxel in participants with programmed death ligand 1 (PD-L1) positive, non-small cell lung cancer (NSCLC) after failure of a platinum-based doublet.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

792

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Bahia Blanca, Argentina, B8001HXM
        • Hospital Italiano Regional del Sur
      • Barrio General Paz, Argentina, X5004FHP
        • Clinica Universitaria Privada Reina Fabiola
      • Berazategui, Argentina, B1880BBF
        • Centro de Oncologia e Investigacion Buenos Aires
      • Ciudad Autonoma Buenos Aires, Argentina, C1426ANZ
        • Instituto Médico Especializado Alexander Fleming
      • Ciudad Autonoma Buenos Aires, Argentina, C1431FWO
        • Cemic
      • Cordoba, Argentina, X5003DCE
        • Instituto DAMIC Fundacion Rusculleda
      • La Rioja, Argentina, F5300COE
        • Centro Oncologico Riojano Integral (Cori)
      • Parana, Argentina, 3100
        • Centro Oncologico de Parana
      • Pilar, Argentina, B1629ODT
        • Hospital Universitario Austral
      • Rosario, Argentina, S2000KZE
        • Instituto de Oncología de Rosario
      • Rosario, Argentina, S2000CRF
        • Instituto Gamma
      • Rosario, Argentina, S2000DSV
        • Sanatorio Parque S.A.
      • San Miguel de Tucuman, Argentina, 4000
        • Centro Medico San Roque S.R.L.
  • Australia
      • Ballarat, Australia, 3350
        • Ballarat Base Hospital
      • Box Hill, Australia, 3128
        • Box Hill Hospital
      • Coffs Harbour, Australia, 2450
        • Coffs Harbour Base Hospital
      • Elizabeth Vale, Australia, 5112
        • Lyell McEwin Hospital
      • Greenslopes, Australia, 4120
        • Greenslopes Private Hospital
      • Lismore, Australia, 2480
        • Lismore Base Hospital
      • Parkville, Australia, 3050
        • Royal Melbourne Hospital
      • Subiaco, Australia, 6008
        • St John of God Hospital
      • Woolloongabba, Australia, 4102
        • Princess Alexandra Hospital
  • Belgium
      • Edegem, Belgium, 2650
        • UZ Antwerpen
      • Gilly, Belgium, 6060
        • Grand Hôpital de Charleroi
      • Leuven, Belgium, 3000
        • UZ Leuven
      • Libramont, Belgium, 6800
        • Centre Hospitalier De L'Ardenne
      • Liège, Belgium, 4000
        • C. H. U. Sart Tilman
      • Roeselare, Belgium, 8800
        • AZ Delta
  • Brazil
      • Belo Horizonte, Brazil, 30110-921
        • Cenantron - Centro Avançado de Tratamento Oncológico S/C Ltda
      • Florianópolis, Brazil, 88034-000
        • CEPON - Centro de Pesquisas Oncológicas de Santa Catarina
      • Ijuí, Brazil, 98700-000
        • Hospital de Caridade de Ijui
      • Itajaí, Brazil, 88310-110
        • Clínica de Neoplasias Litoral Ltda.
      • Juiz de Fora, Brazil, 36010-570
        • CMiP - Centro Mineiro de Pesquisa
      • Lajeado, Brazil, 95900-000
        • Hospital Bruno Born
      • Natal, Brazil, 59075-740
        • Liga Norte-Rio-Grandense Contra O Câncer
      • Novo Hamburgo, Brazil, 93510-250
        • Oncosinos - Clínica de Oncologia - Hospital Regina
      • Passo Fundo, Brazil, 99010-260
        • CITO - Centro Integrado de Terapia Onco-Hematológica - Hospital da Cidade de Passo Fundo
      • Porto Alegre, Brazil, 90610-000
        • Hospital Sao Lucas da PUCRS
      • Porto Alegre, Brazil, 90110-270
        • Hospital Mae de Deus
      • Rio de Janeiro, Brazil, 22793-080
        • COI - Clínicas Oncológicas Integradas
      • Santo André, Brazil, 09060-650
        • CEPHO - Centro de Estudos e Pesquisas em Hematologia e Oncologia
      • Sorocaba, Brazil, 18030-075
        • IOS - Instituto de Oncologia de Sorocaba "Dr. Gilson Delgado"
      • São José do Rio Preto, Brazil, 15090-000
        • Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto
      • São Paulo, Brazil, 01246-000
        • ICESP - Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira
  • Bulgaria
      • Pleven, Bulgaria, 5800
        • UMHAT 'Dr. Georgi Stranski', EAD
      • Plovdiv, Bulgaria, 4004
        • Complex Oncological Center - Plovdiv, EOOD
      • Sofia, Bulgaria, 1756
        • Shato, Ead
      • Sofia, Bulgaria, 1303
        • MHAT "Serdika", EOOD
      • Sofia, Bulgaria, 1407
        • MHAT 'Tokuda Hospital Sofia', AD
      • Varna, Bulgaria, 9010
        • MHAT 'Sv. Marina', EAD
  • Chile
      • Santiago, Chile, 7500921
        • FALP - Fundación Arturo López Pérez
      • Santiago, Chile, 7500000
        • Instituto de Terapias Oncologicas Providencia
      • Santiago, Chile, 8420383
        • CIEC - Centro Internacional de Estudios Clínicos
      • Temuco, Chile
        • Instituto Clinico Oncologico del Sur (ICOS)
      • Viña del Mar, Chile, 2540364
        • Centro de Investigaciones Clinicas Vina Del Mar
      • Viña del Mar, Chile
        • Hospital Clinico Vina del Mar
  • Colombia
      • Bogota, Colombia, 110131
        • Fundación Cardioinfantil Instituto de Cardiología
      • Bogota, Colombia, 111511
        • Instituto Nacional de Cancerologia E.S.E.
      • Bogota, Colombia
        • Clinica Colsanitas S.A. sede Clinica Universitaria Colombia
      • Bogotá, Colombia
        • Administradora Country S.A.
      • Cali, Colombia, 760032
        • Fundacion Valle Del Lili
      • Cali, Colombia
        • Hemato Oncologos S.A.
      • Cali, Colombia, 760042
        • Centro Médico Imbanaco
      • Medellin, Colombia
        • Instituto de Cancerologia S.A.
      • Medellín, Colombia, 050034
        • Hospital Pablo Tobón Uribe
      • Monteria, Colombia
        • IPS IMAT- Instituto Medico de Alta Tecnologia - Oncomedica S.A.
  • Croatia
      • Dubrovnik, Croatia, 20000
        • General Hospital Dubrovnik
      • Zadar, Croatia, 23000
        • General Hospital Zadar
      • Zagreb, Croatia, 10000
        • Clinical Hospital Centar "Sestre Milosrdnice"
      • Zagreb, Croatia, 10000
        • University Clinic for Pulmonary Diseases
  • Czechia
      • Brno, Czechia, 65653
        • Masarykuv onkologicky ustav
      • Novy Jicin, Czechia, 74101
        • Nemocnice Novy Jicin a.s.
      • Pardubice, Czechia, 53203
        • Multiscan s.r.o.
      • Praha 2, Czechia, 12808
        • Vseobecna fakultni nemocnice v Praze
      • Praha 4, Czechia, 14059
        • Thomayerova nemocnice
  • Denmark
      • Herlev, Denmark, 2730
        • Herlev Hospital
      • Odense C, Denmark, 5000
        • Odense Universitetshospital
  • France
      • Angers Cedex 9, France, 49933
        • ICO - Site Paul Papin
      • Besancon Cedex, France, 25030
        • CHU Besançon - Hôpital Jean Minjoz
      • Le Mans Cedex 02, France, 72000
        • Clinique Victor Hugo - Centre Jean Bernard
      • Marseille cedex 20, France, 13915
        • Hôpital Nord - AP-HM Marseille#
      • Nantes, France, 44202
        • Centre Catherine de Sienne
      • Nice cedex 02, France, 06189
        • Centre Antoine Lacassagne
      • Pessac, France, 33604
        • Groupe Hospitalier Sud - Hôpital Haut-Lévêque
      • Poitiers, France, 86021
        • CHU Poitiers - Hôpital la Milétrie
      • Saint Herblain, France, 44805
        • ICO - Site René Gauducheau
      • Strasbourg, France, 67091
        • CHU Strasbourg - Nouvel Hopital Civil
      • Toulouse, France, 31059
        • CHU de Toulouse - Hôpital Larrey
  • Hungary
      • Budapest, Hungary, 1145
        • Uzsoki Utcai Kórház
      • Budapest, Hungary, 1125
        • Semmelweis Egyetem AOK
      • Györ, Hungary, 9024
        • Petz Aladár Megyei Oktató Kórház
      • Miskolc, Hungary, 3529
        • Miskolci Semmelweis Kórház és Egyetemi Oktatókórház
      • Torokbalint, Hungary, 2045
        • Tudogyogyintezet Torokbalint
  • Israel
      • Beer Sheva, Israel, 84101
        • Soroka Medical Center
      • Beer Yaakov, Israel, 70300
        • Assaf Harofeh Medical Center
      • Haifa, Israel, 3109601
        • Rambam Health Care Campus
      • Haifa, Israel, 34361
        • The Lady Davis Carmel Medical Center
      • Jerusalem, Israel, 9112001
        • Hadassah University Hospital - Ein Kerem
      • Kfar-Saba, Israel, 4428164
        • Sapir Medical Center, Meir Hospital
      • Petach Tikva, Israel, 4941492
        • Rabin Medical Center-Beilinson Campus
      • Ramat-Gan, Israel, 52621
        • Chaim Sheba Medical Center
      • Tel Aviv, Israel, 64239
        • Tel Aviv Sourasky Medical Center
  • Italy
      • Cremona, Italy, 26100
        • Azienda Ospedaliera Istituti Ospitalieri di Cremona
      • Legnago (VR), Italy, 37045
        • Ospedale Mater Salutis
      • Lido di Camaiore, Italy, 55043
        • Ospedale Versilia
      • Milano, Italy, 20133
        • Fondazione IRCCS Istituto Nazionale dei Tumori
      • Milano, Italy, 20141
        • IEO Istituto Europeo di Oncologia
      • Napoli, Italy, 80131
        • Seconda Università degli Studi di Napoli
      • Pisa, Italy, 56124
        • Azienda Ospedaliero Universitaria Pisana
      • Roma, Italy, 00189
        • Azienda Ospedaliera Sant'Andrea-Università di Roma La Sapienza
      • Roma, Italy, 00168
        • Policlinico Universitario Agostino Gemelli
      • Roma, Italy, 00144
        • Istituto Nazionale Tumori Regina Elena Irccs
      • Roma, Italy, 00128
        • Università Campus Bio-Medico di Roma
      • Siena, Italy, 53100
        • A.O.U. Senese Policlinico Santa Maria alle Scotte
      • Treviglio, Italy, 24047
        • Azienda Ospedaliera Ospedale Treviglio-Caravaggio di Treviglio
  • Japan
      • Chuo-ku, Japan, 104-0045
        • National Cancer Center Hospital
      • Fukuoka-shi, Japan, 811-1395
        • Nho Kyushu Cancer Center
      • Habikino-shi, Japan, 583-8588
        • Osaka Prefectural Medical Center for Respiratory and Allergic Diseases
      • Hiroshima-shi, Japan, 730-8518
        • Hiroshima City Hiroshima Citizens Hospital
      • Kashiwa-shi, Japan, 277-8577
        • National Cancer Center Hospital East
      • Kitaadachi-gun, Japan, 362-0806
        • Saitama Cancer Center
      • Kobe-shi, Japan, 650-0047
        • Kobe City Hospital Organization Kobe City Medical Center General Hospital
      • Kobe-shi, Japan, 650-0047
        • Institute of Biomedical Research and Innovation Hospital
      • Koto-ku, Japan, 135-8550
        • Cancer Institute Hospital Of JFCR
      • Kurume-shi, Japan, 830-0011
        • Kurume University Hospital
      • Natori-shi, Japan, 981-1293
        • Miyagi Cancer Center
      • Okazaki-shi, Japan, 444-0011
        • Aichi Cancer Center Hospital
      • Osaka-shi, Japan, 534-0021
        • Osaka City General Hospital
      • Osaka-shi, Japan, 537-8511
        • Osaka Medical Center for Cancer and Cardiovascular Diseases
      • Osakasayama-shi, Japan, 589-8511
        • Kinki University Hospital
      • Sagamihara-shi, Japan, 252-0375
        • Kitasato University Hospital
      • Sapporo-shi, Japan, 060-8648
        • Hokkaido University Hospital
      • Sapporo-shi, Japan, 003-0804
        • NHO Hokkaido Cancer Center
      • Shinjuku-ku, Japan, 160-0023
        • Tokyo Medical University Hospital
      • Toyama-shi, Japan, 930-0194
        • Toyama University Hospital
      • Wakayama-shi, Japan, 641-8510
        • Wakayama Medical University Hospital
      • Yokohama-shi, Japan, 241-8515
        • Kanagawa Cancer Center
      • Yokohama-shi, Japan, 240-8555
        • Yokohama Municipal Citizen's Hospital
  • Korea, Republic of
      • Cheongju-si, Korea, Republic of, 28644
        • Chungbuk National University Hospital
      • Hwasun-gun, Korea, Republic of, 519-763
        • Chonnam National University Hwasun Hospital
      • Incheon, Korea, Republic of, 21565
        • Gachon University Gil Medical Center
      • Seongnam-si, Korea, Republic of, 13620
        • Seoul National University Bundang Hospital
      • Seoul, Korea, Republic of, 05505
        • Asan Medical Center
      • Seoul, Korea, Republic of, 136-705
        • Korea University Anam Hospital
      • Seoul, Korea, Republic of, 08308
        • Korea University Guro Hospital
      • Seoul, Korea, Republic of, 06351
        • Samsung Medical Center
      • Seoul, Korea, Republic of, 137-701
        • The Catholic University of Korea, Seoul St. Mary's Hospital
      • Suwon-si, Korea, Republic of, 16247
        • The Catholic university of Korea, St. Vincent's Hospital
  • Mexico
      • Cuautitlan Izcalli, Mexico, 54769
        • Phylasis Clinicas Research S de RL de CV
      • Durango, Mexico, 34000
        • Instituto de Investigaciones Aplicadas a la Neurociencia A.C.
      • Leon, Mexico, 37000
        • Fundacion Rodolfo Padilla Padilla, A.C.
      • Mexico, Mexico, 03810
        • Health Pharma Professional Research S.A. de C.V.
      • Monterrey, Mexico, 64060
        • Winsett Rethman S.A. de C.V.
      • Morelia, Mexico, 58260
        • Centro de Investigación Clínica Chapultepec S.A. de C.V.
      • Oaxaca, Mexico, 68000
        • Oaxaca Site Management Organization S.C.
      • Toluca, Mexico, 50180
        • Centro Oncologico Estatal ISSEMYM
  • Peru
      • Arequipa, Peru, 04000
        • Clinica Monte Carmelo
      • Chiclayo, Peru, 14001
        • Hospital Nacional Almanzor Aguinaga Asenjo
      • Cusco, Peru
        • Hospital Nacional Adolfo Guevara Velasco
      • Lima, Peru, Lima 27
        • Clinica Ricardo Palma
      • Lima, Peru, Lima 34
        • Instituto Nacional de Enfermedades Neoplasicas
      • Lima, Peru, 15000
        • Clinica San Borja
      • Lima, Peru, LIMA 13
        • Hospital Nacional Guillermo Almenara Irigoyen
  • Poland
      • Brzozow, Poland, 36-200
        • Szpital Specjalistyczny W Brzozowie, Podkarpacki Osrodek Onkologiczny Im.Ks.B.Markiewicza
      • Jelenia Gora, Poland, 58-506
        • Wojewódzkie Centrum Szpitalne Kotliny Jeleniogórskiej
      • Katowice, Poland, 40-514
        • Samodzielny Publiczny Szpital Kliniczny nr 5 SUM
      • Lodz, Poland, 90-242
        • Centrum Terapii Wspolczesnej J.M. Jasnorzewska Sp. Komandytowo-Akcyjna
      • Lublin, Poland, 20-362
        • KO-MED Centra Kliniczne Lublin II
      • Mrozy, Poland, 05-320
        • SSZZOZ im. Dr Teodora Dunina w Rudce
      • Otwock, Poland, 05-400
        • Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy
  • Romania
      • Alba Iulia, Romania, 510077
        • Spitalul Judetean de Urgenta Alba Iulia
      • Baia Mare, Romania, 430031
        • Spitalul Judetean de Urgenta "Dr. Constantin Opris" Baia Mare
      • Brasov, Romania, 500152
        • Policlinica de Diagnostic Rapid SRL
      • Oradea, Romania, 410469
        • Spitalul Clinic Municipal "Dr. Gavril Curteanu" Oradea
      • Ploiesti, Romania, 100011
        • Spital Lotus SRL
      • Timisoara, Romania, 300210
        • S.C Oncocenter Oncologie Clinica S.R.L
  • Russian Federation
      • Kazan, Russian Federation, 420029
        • SHI "Republican Clinical Oncological Dispensary of HM RT"
      • Moscow, Russian Federation, 111123
        • SHBI Moscow Clinical Scientific Center of Department of Healthcare of Moscow
      • Saint Petersburg, Russian Federation, 197022
        • Pavlov First Saint Petersburg State Medical University
      • Saint Petersburg, Russian Federation, 191036
        • FSBHI Clinical research institute of phthisiopulmonology
      • St. Petersburg, Russian Federation, 197022
        • St. Petersburg SHI "City Clinical Oncology Dispensary"
      • St. Petersburg, Russian Federation, 197758
        • FBI "Scientific Research Institute of Oncology n. a. N. N. Petrov"
  • Slovakia
      • Bardejov, Slovakia, 08501
        • Nemocnica s poliklinikou Sv. Jakuba, n.o. Bardejov
      • Bratislava, Slovakia, 82606
        • Univerzitna nemocnica Bratislava, Nemocnica Ruzinov
      • Ruzomberok, Slovakia, 03426
        • Ustredna vojenska nemocnica SNP Ruzomberok- Fakultna nemocnica
      • Trnava, Slovakia, 91708
        • Fakultna nemocnica Trnava
  • South Africa
      • Cape Town, South Africa, 7570
        • GVI Cape Gate Oncology Centre
      • Cape town, South Africa, 7700
        • GVI Rondebosch Oncology Centre
      • Port Elizabeth, South Africa, 6045
        • GVI Langenhoven Drive Oncology Centre
      • Pretoria, South Africa, 0181
        • Mary Potter Oncology Centre
      • Pretoria, South Africa, 0002
        • University of Pretoria Oncology Department
  • Spain
      • Alicante, Spain, 03010
        • Hospital General Universitario de Alicante
      • Badalona, Spain, 08916
        • ICO Badalona - Hospital Germans Trias I Pujol
      • Barcelona, Spain, 08035
        • Hospital Universitari Vall d'Hebron
      • Barcelona, Spain, 08036
        • Hospital Clinic i Provincial de Barcelona
      • Barcelona, Spain, 08028
        • Hospital Universitari Quiron Dexeus
      • L'Hospitalet de Llobregat, Spain, 08908
        • ICO l´Hospitalet - Hospital Duran i Reynals
      • Las Palmas de Gran Canaria, Spain, 35016
        • Hospital Universitario Materno-Infantil de Canarias
      • Madrid, Spain, 28034
        • Hospital Universitario Ramón y Cajal
      • Madrid, Spain, 28050
        • Centro Integral Oncologico Clara Campal
      • Malaga, Spain, 29010
        • Hospital Clinico Universitario Virgen de La Victoria
      • Mataro, Spain, 08304
        • Hospital de Mataró
      • Santiago de Compostela, Spain, 15706
        • Complejo Hospitalario Universitario de Santiago
      • Sevilla, Spain, 41009
        • Hospital Universitario Virgen Macarena
      • Sevilla, Spain, 41013
        • Hospital Universitario Virgen del Rocio
      • Valencia, Spain, 46026
        • Hospital Universitari i Politècnic La Fe
  • Switzerland
      • Chur, Switzerland, 7000
        • Kantonsspital Graubuenden
  • Taiwan
      • Taichung, Taiwan, 40705
        • Taichung Veterans General Hospital
      • Tainan, Taiwan, 704
        • National Cheng Kung University Hospital
      • Taipei, Taiwan, 100
        • National Taiwan University Hospital
      • Taipei, Taiwan, 11490
        • Tri-Service General Hospital
      • Taipei, Taiwan, 112
        • Taipei Veterans General Hospital
      • Taoyuan County, Taiwan, 333
        • Chang Gung Memorial Hospital, Linkou
  • Turkey
      • Ankara, Turkey, 06100
        • Hacettepe University Medical Faculty
      • Ankara, Turkey
        • Ankara University Medical Faculty
      • Ankara, Turkey, 06500
        • Baskent University Ankara Hospital
      • Edirne, Turkey, 22030
        • Trakya University Medical Faculty
      • Istanbul, Turkey, 34098
        • Istanbul University Cerrahpasa Medical Faculty
      • Istanbul, Turkey, 34093
        • Bezmi Alem Foundation University Medical Faculty Hospital
      • Istanbul, Turkey, 34500
        • Fatih Universitesi Tip Fakultesi
      • Istanbul, Turkey, 34899
        • Marmara University Pendik Research and Training Center
      • Izmir, Turkey, 35100
        • Ege University Medical Faculty
      • Izmir, Turkey, 35340
        • Dokuz Eylul University Medicine Faculty
      • Konya, Turkey, 42080
        • Konya Necmettin Erbakan University Meram Faculty of Medicine
  • United Kingdom
      • Bournemouth, United Kingdom, BH7 7DW
        • Royal Bournemouth General Hospital
      • Bristol, United Kingdom, BS2 8ED
        • Bristol Haematology & Oncology Centre
      • Exeter, United Kingdom, EX2 5DW
        • Royal Devon and Exeter Hospital (Wonford)
      • Glasgow, United Kingdom, G12 OYN
        • Beatson West of Scotland Cancer Centre
      • Leeds, United Kingdom, LS9 7TF
        • St James's University Hospital
      • London, United Kingdom, NW1 2BU
        • University College London Hospital
      • Plymouth, United Kingdom, PL6 8BQ
        • Derriford Hospital
      • Stevenage, United Kingdom, SG1 4AB
        • Mount Vernon Hospital
      • Wirral, United Kingdom, CH63 4JY
        • The Clatterbridge Cancer Centre
  • United States
    • Alabama
      • Tuscaloosa, Alabama, United States, 35401
        • University of Alabama
    • Arizona
      • Scottsdale , Phoenix, Arizona, United States, 85259-5499
        • Mayo Clinic
    • California
      • Anaheim, California, United States, 92801
        • Pacific Cancer Medical Center, Inc.
      • Lawndale, California, United States, 90260
        • Healing Hands Oncology and Medical Care
      • Modesto, California, United States, 95355
        • Sutter Gould Medical Foundation
      • San Diego, California, United States, 92123
        • Sharp Memorial Hospital
    • Florida
      • Boca Raton, Florida, United States, 33486
        • Lynn Cancer Institute Center
      • Boynton Beach, Florida, United States, 33426
        • University Cancer Institute
      • Fort Lauderdale, Florida, United States, 33308
        • Holy Cross Hospital Inc.
      • Fort Myers, Florida, United States, 33916
        • Florida Cancer Specialists-Broadway
      • Saint Petersburg, Florida, United States, 33705
        • Florida Cancer Specialists
      • West Palm Beach, Florida, United States, 33401
        • Florida Cancer Specialists
    • Georgia
      • Athens, Georgia, United States, 30607
        • Northeast Georgia Cancer Care, LLC
    • Louisiana
      • Metairie, Louisiana, United States, 70006
        • Metairie Oncologist, LLC
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Health System
    • New York
      • Nyack, New York, United States, 10960
        • Hematology Oncology Associates of Rockland
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27103
        • Novant Health Oncology Specialists
    • Ohio
      • Cincinnati, Ohio, United States, 45242
        • Oncology Hematology Care
      • Middletown, Ohio, United States, 45042
        • Signal Point Clinical Research Center
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73120-9309
        • Mercy Clinic Oklahoma Communities, Inc.
    • Pennsylvania
      • Abington, Pennsylvania, United States, 19001
        • Abington Memorial Hospital
      • Hershey, Pennsylvania, United States, 17033
        • Penn State Univ. Milton S. Hershey Medical Center
    • Tennessee
      • Knoxville, Tennessee, United States, 37909
        • Center for Biomedical Research, LLC
      • Nashville, Tennessee, United States, 37203
        • SCRI - Tennessee Oncology
    • Texas
      • Fort Worth, Texas, United States, 76104
        • The Center for Cancer and Blood Disorders
      • Tyler, Texas, United States, 75708
        • University of Texas Health Science Center at Tyler
    • Washington
      • Tacoma, Washington, United States, 98405
        • MultiCare Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

  • Signed written informed consent before any trial related procedure
  • Male or female participants aged greater than or equal to (>=) 18 years
  • Availability of a formalin-fixed, paraffin-embedded block containing tumor tissue or 7 unstained tumor slides suitable for PD-L1 expression assessment
  • Tumor determined to be evaluable for PD-L1 expression per the evaluation of a central laboratory
  • Participants with histologically confirmed Stage IIIb/IV or recurrent NSCLC who have experienced disease progression

  • Participants must have progressed after an acceptable therapy defined as follows:

    1. Participants must have progressed during or after a minimum of 2 cycles of 1 course of a platinum based combination therapy administered for the treatment of a metastatic disease. A history of continuation (use of a non platinum agent from initial combination) or switch (use of a different agent) maintenance therapy is permitted provided there was no progression after the initial combination. A switch of agents during treatment for the management of toxicities is also permitted provided there was no progression after the initial combination OR
    2. Participants must have progressed within 6 months of completion of a platinum-based adjuvant, neoadjuvant, or definitive chemotherapy, or concomitant chemoradiation regimen for locally advanced disease
  • Participants with non-squamous cell NSCLC of unknown epidermal growth factor receptor (EGFR) mutation status will require testing (local laboratory, or central laboratory if local testing is not available). Participants with a tumor that harbors an activating EGFR mutation will not be eligible
  • Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 1 at trial entry
  • Estimated life expectancy of more than 12 weeks
  • Adequate hematological function defined by White Blood Cell (WBC) count >= 2.5 × 10^9/L with absolute neutrophil count (ANC) >= 1.5 × 10^9/L, lymphocyte count >=0.5 × 10^9/L, platelet count >= 100 × 10^9/L, and hemoglobin >= 9 gram per deciliter (g/dL) (may have been transfused)
  • Adequate hepatic function defined by a total bilirubin level less than or equal to (<=) 1.5 × the upper limit of normal (ULN) range and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels <= 2.5 × ULN for all participants
  • Adequate renal function defined by an estimated creatinine clearance > 30 milliliter per minute (mL/min) according to the Cockcroft-Gault formula (or local institutional standard method).

Other protocol defined inclusion criteria could apply

Exclusion criteria

  • In the United States only, participants with a squamous cell histology will be excluded
  • Systemic anticancer therapy administered after disease progression during or following a platinum based combination
  • Participants with non-squamous cell NSCLC whose disease harbors EGFR mutation(s) and/or anaplastic lymphoma kinase (ALK) rearrangement will not be eligible for this trial. Participants of unknown ALK and/or EGFR mutation status will require testing at screening (local laboratory, or central laboratory if local testing is not available)
  • Prior therapy with any antibody/drug targeting T cell coregulatory proteins (immune checkpoints) such as PD-1, PD L1, or cytotoxic T lymphocyte antigen-4 (CTLA-4).
  • Concurrent anticancer treatment
  • Major surgery for any reason, except diagnostic biopsy, within 4 weeks of randomization and/or if the participant has not fully recovered from the surgery within 4 weeks of randomization
  • Participants receiving immunosuppressive agents (such as steroids) for any reason should be tapered off these drugs before initiation of the trial treatment.

  • All participants with brain metastases, except those meeting the following criteria:

    1. Brain metastases have been treated locally, and
    2. No ongoing neurological symptoms that are related to the brain localization of the disease

  • Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent:

    1. Participants with diabetes type I, vitiligo, psoriasis, hypo- or hyperthyroid disease not requiring immunosuppressive treatment are eligible
    2. Participants requiring hormone replacement with corticosteroids are eligible if the steroids are administered only for the purpose of hormonal replacement and at doses less than or equal to (<=)10 milligram (mg) or equivalent prednisone per day
    3. Administration of steroids through a route known to result in a minimal systemic exposure are acceptable
  • Previous or ongoing administration of systemic steroids for the management of an acute allergic phenomenon is acceptable as long as it is anticipated that the administration of steroids will be completed in 14 days, or that the daily dose after 14 days will be <=10 mg per day of equivalent prednisone

Other protocol defined exclusion criteria could apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Docetaxel
Drug: Docetaxel
Participants received 75 mg per square meter (m^2) (per label) of docetaxel by intravenous infusion once every 3 weeks until confirmed disease progression, significant clinical deterioration, unacceptable toxicity, or any criterion for withdrawal from the study or Investigational Medicinal Product (IMP) as defined in the study protocol was fulfilled.
Experimental: Avelumab
Drug: Avelumab
Participants received 10 milligrams per kilogram (mg/kg) of avelumab as a 1-hour intravenous infusion once every 2 weeks until confirmed disease progression, significant clinical deterioration, unacceptable toxicity, or any criterion for withdrawal from the study or Investigational Medicinal Product (IMP) as defined in the study protocol was fulfilled.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS) Time in Programmed Death Ligand 1 (PD-L1) + Full Analysis Set Population (FAS)
Time Frame: Time from date of randomization up to 1420 days
The OS time was defined as the time from randomization to the date of death. The participants who were still alive at the time of data analysis or who were lost to follow-up OS time was censored at the last recorded date that the participant was known to be alive before the data cutoff date. OS was measured using Kaplan-Meier (KM) estimates.
Time from date of randomization up to 1420 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS) Time in Full Analysis Set Population
Time Frame: Time from date of randomization up to 1420 days
The OS time was defined as the time from randomization to the date of death. The participants who were still alive at the time of data analysis or who were lost to follow-up OS time was censored at the last recorded date that the participant was known to be alive before the data cutoff date. OS was measured using Kaplan-Meier (KM) estimates.
Time from date of randomization up to 1420 days
Progression-Free Survival (PFS) Time in PD-L1+ Full Analysis Set Population
Time Frame: Time from date of randomization up to 907 days
PFS was defined as the time from date of randomization until date of the first documentation of progressive disease (PD) or death due to any cause in the absence of documented PD, whichever occurs first. PFS was assessed as per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) as adjudicated by independent endpoint review committee (IERC). PD was defined as at least a 20 percent (%) increase in the sum of longest diameter (SLD), taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions and unequivocal progression of non-target lesions. PFS was measured using Kaplan-Meier (KM) estimates.
Time from date of randomization up to 907 days
Progression-Free Survival (PFS) Time in Full Analysis Set Population
Time Frame: Time from date of randomization up to 907 days
PFS was defined as the time from date of randomization until date of the first documentation of progressive disease (PD) or death due to any cause in the absence of documented PD, whichever occurs first. PFS was assessed as per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) as adjudicated by independent endpoint review committee (IERC). PD was defined as at least a 20 percent (%) increase in the sum of longest diameter (SLD), taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions and unequivocal progression of non-target lesions. PFS was measured using Kaplan-Meier (KM) estimates.
Time from date of randomization up to 907 days
Number of Participants With Confirmed Best Overall Response (BOR) as Assessed by an Independent Endpoint Review Committee (IERC) in Full Analysis Set Population
Time Frame: Time from date of randomization up to 907 days
Confirmed BOR was determined according to RECIST v1.1 and as adjudicated by an IERC. Confirmed BOR was defined as the best response of any of the complete response (CR), partial response (PR), stable disease (SD) and progressive disease (PD) recorded from the date of randomization until disease progression or recurrence (taking the smallest measurement recorded since the start of treatment as reference). CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions. SD: Neither sufficient increase to qualify for PD nor sufficient shrinkage to qualify for PR. PD was defined as at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions and unequivocal progression of non-target lesions. Number of participants with best overall response in each category (CR, PR, SD, PD) was reported.
Time from date of randomization up to 907 days
Number of Participants With Confirmed Best Overall Response (BOR) as Assessed by Independent Endpoint Review Committee (IERC) in PD-L1+ Full Analysis Set Population
Time Frame: Time from date of randomization up to 907 days
Confirmed BOR was determined according to RECIST v1.1 and as adjudicated by an IERC. Confirmed BOR was defined as the best response of any of the complete response (CR), partial response (PR), stable disease (SD) and progressive disease (PD) recorded from the date of randomization until disease progression or recurrence (taking the smallest measurement recorded since the start of treatment as reference). CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions. SD: Neither sufficient increase to qualify for PD nor sufficient shrinkage to qualify for PR. PD was defined as at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions and unequivocal progression of non-target lesions. Number of participants with best overall response in each category (CR, PR, SD, PD) was reported.
Time from date of randomization up to 907 days
Percentage of Participants With Objective Response as Assessed by Independent Endpoint Review Committee (IERC) in Full Analysis Set Population
Time Frame: Time from date of randomization up to 907 days
Percentage of participants with objective response (CR plus PR) according to RECIST v1.1 was reported. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions.
Time from date of randomization up to 907 days
Percentage of Participants With Objective Response as Assessed by Independent Endpoint Review Committee (IERC) in PD-L1+ Full Analysis Set Population
Time Frame: Time from date of randomization up to 907 days
Percentage of participants with objective response (CR plus PR) according to RECIST v1.1 was reported. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions.
Time from date of randomization up to 907 days
Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Health Outcome Questionnaire Through Composite Index Score at End of Treatment (EOT)
Time Frame: Baseline, End of treatment visit (up to Week 124)
The EQ-5D-5L health outcome questionnaire was a measure of health status that provides a simple descriptive profile and a single index value. The EQ-5D-5L defined health in terms of mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The 5 items were combined to generate health profiles. These profiles were converted to a continuous single index score. The lowest possible score was -0.59 (unable to walk, unable to self-care, unable to do usual activities, extreme pain or discomfort, extreme anxiety or depression) and the highest was 1.00 (no problems in all 5 dimensions).
Baseline, End of treatment visit (up to Week 124)
Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Health Outcome Questionnaire Through Visual Analogue Scale (VAS) at End of Treatment (EOT)
Time Frame: Baseline, End of treatment visit (up to Week 124)
EQ-5D-5L was comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension had 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses were used to derive overall score using a visual analog scale (VAS) that ranged from 0 to 100 millimeter (mm), where 0 was the worst health you can imagine and 100 was the best health you can imagine.
Baseline, End of treatment visit (up to Week 124)
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) Global Health Status at End of Treatment (EOT)
Time Frame: Baseline, End of treatment visit (up to Week 124)
EORTC QLQ-C30 was a 30-question tool used to assess the overall quality of life (QoL) in cancer participants. It consisted of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, role, cognitive, emotional, social), and 9 symptom scales/items (Fatigue, nausea and vomiting, pain, dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, financial impact). The EORTC QLQ-C30 GHS/QoL score ranged from 0 to 100; High score indicated better GHS/QoL. Score 0 represents: very poor physical condition and QoL. Score 100 represents: excellent overall physical condition and QoL.
Baseline, End of treatment visit (up to Week 124)
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) at End of Treatment (EOT)
Time Frame: Baseline, End of treatment visit (up to Week 124)
EORTC QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy. The EORTC QLQ-LC13 module generated one multiple-item score assessing dyspnea and a series of single item scores assessing coughing, hemoptysis, sore mouth, dysphagia, neuropathy, alopecia, pain in chest, pain in arms or shoulder and pain in other parts. Score range: 0 (no burden of symptom domain or single symptom item) to 100 (highest burden of symptoms for symptom domains and single items).
Baseline, End of treatment visit (up to Week 124)
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), Drug Related Treatment Emergent Adverse Events and Treatment Emergent Adverse Events Leading to Death
Time Frame: Time from date of randomization up to 1420 days
An Adverse event (AE) was defined as any unfavorable and unintended sign (including clinically significant abnormal laboratory, vital signs and 12-lead Electrocardiogram findings), symptom, or disease temporally associated with the use of study drug or worsening of pre-existing medical condition, whether or not related to study drug. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. Treatment-emergent events were the events between first dose of study drug that were absent before treatment or that worsened relative to pre-treatment state up to 30 days after last administration. TEAEs included both Serious TEAEs and non-serious TEAEs.
Time from date of randomization up to 1420 days
Number of Participants With Treatment Emergent Adverse Events (TEAEs) by Severity
Time Frame: Time from date of randomization up to 1420 days
Treatment Emergent Adverse Events were graded as per National Cancer Institute Common Terminology Criteria for Adverse Experience version 4.03 (NCI-CTCAE v 4.03). Grade 3 refers to severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care and Activity of daily living (ADL), Grade 4 refers to Life-threatening consequences; where urgent intervention indicated, Grade 5 refers to the death related to adverse event.
Time from date of randomization up to 1420 days
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance: Baseline Score vs. Worst Post-baseline Score
Time Frame: Time from date of randomization up to 1420 days
ECOG performance status measured to assess participant's performance status on a scale of 0 to 5, where 0 = Fully active, able to carry on all pre-disease activities without restriction; 1 = Restricted in physically strenuous activity, ambulatory and able to carry out light or sedentary work; 2 = Ambulatory and capable of all selfcare but unable to carry out any work activities; 3 = Capable of only limited self-care, confined to bed/chair for more than 50 percent of waking hours; 4 = Completely disabled, cannot carry on any self-care, totally confined to bed/chair; 5 = dead. The participants with missing worst post baseline score were also reported. ECOG performance status was reported in terms of number of participants with Baseline value vs. worst post-baseline value (i.e. highest score) combination.
Time from date of randomization up to 1420 days
Number of Participants With Positive Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs) for Avelumab
Time Frame: Time from date of randomization up to 1420 days
Serum samples were analyzed by a validated electrochemiluminesce immunoassay to detect the presence of antidrug antibodies (ADA). Samples that screened positive were subsequently tested in a confirmatory assay were tested for neutralizing antibodies (nAb). Number of participants with ADA or nAb positive results for Avelumab were reported.
Time from date of randomization up to 1420 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

EMD Serono Research & Development Institute, Inc.

Collaborators

Merck KGaA, Darmstadt, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 24, 2015

Primary Completion (Actual)

November 22, 2017

Study Completion (Actual)

December 3, 2019

Study Registration Dates

First Submitted

February 27, 2015

First Submitted That Met QC Criteria

March 19, 2015

First Posted (Estimate)

March 20, 2015

Study Record Updates

Last Update Posted (Actual)

August 3, 2020

Last Update Submitted That Met QC Criteria

July 20, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 100070-004
  • 2014-005060-15 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Per company policy, following approval of a new product or a new indication for an approved product in both the EU and the US, EMD Serono will share study protocols, anonymized patient level and study level data and redacted clinical study reports from clinical trials in patients with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website https://www.emdgroup.com/en/research/our-approach-to-research-and-development/healthcare/clinical-trials/commitment-responsible-data-sharing.html

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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