Avelumab in First-line NSCLC (JAVELIN Lung 100)

January 20, 2025 updated by: EMD Serono Research & Development Institute, Inc.

A Phase III, Open-label, Multicenter Trial of Avelumab (MSB0010718C) Versus Platinum-based Doublet as a First-line Treatment of Recurrent or Stage IV PD-L1+NSCLC

The purpose of this study was to demonstrate superiority with regard to Overall Survival (OS) or Progression Free Survival (PFS) of avelumab versus platinum-based doublet, based on an Independent Review Committee assessment, in Non-small cell lung cancer (NSCLC) participants with Programmed death ligand 1+ (PD-L1+) tumors.

Study Overview

Status

Completed

Conditions

First Line Non-Small Cell Lung Cancer

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1214

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

Australia
- New South Wales
  - Albury, New South Wales, Australia, 2640
    - Albury Wodonga Regional Cancer Centre
  - Coffs Harbour, New South Wales, Australia, 2450
    - Coffs Harbour Health Campus
  - Kogarah, New South Wales, Australia, 2217
    - St George Private Hospital
  - Lismore, New South Wales, Australia, 2480
    - Lismore Base Hospital
  - Orange, New South Wales, Australia, 2800
    - Orange Health Service
  - St Leonards, New South Wales, Australia, 2065
    - Royal North Shore Hospital
  - Waratah, New South Wales, Australia, 2298
    - Calvary Mater Newcastle
- Queensland
  - Greenslopes, Queensland, Australia, 4120
    - Gallipoli Medical Research Foundation Ltd
  - Southport, Queensland, Australia, 4215
    - Gold Coast University Hospital
- South Australia
  - Woodville South, South Australia, Australia, 5011
    - The Queen Elizabeth Hospital
- Victoria
  - Ballarat, Victoria, Australia, 3350
    - Ballarat Base Hospital
  - Bendigo, Victoria, Australia, 3550
    - Bendigo Hospital
  - Warrnambool, Victoria, Australia, 3280
    - South West Healthcare
- Western Australia
  - Murdoch, Western Australia, Australia, 6150
    - Fiona Stanley Hospital
Belgium
- - Antwerpen, Belgium, 2020
    - ZNA Middelheim
  - Brasschaat, Belgium, 2930
    - A.Z. Klina
  - Mons, Belgium, 7000
    - CHU Ambroise Pare
Brazil
- - Rio de Janeiro, Brazil, 20230-230
    - INCA - Instituto Nacional de Cancer
- Bahia
  - Salvador, Bahia, Brazil, 40170-110
    - NOB - Nucleo de Oncologia da Bahia
- Ceará
  - Fortaleza, Ceará, Brazil, 60336-045
    - Crio - Centro Regional Integrado de Oncologia
- Goiás
  - Goiânia, Goiás, Brazil, 74605-030
    - CEBROM - Centro Brasileiro de Radioterapia, Oncologia e Mastologia
- Paraná
  - Curitiba, Paraná, Brazil, 81520-060
    - Hospital Erasto Gaertner - Liga Paranaense de Combate Ao Cancer
- Rio Grande Do Sul
  - Ijuí, Rio Grande Do Sul, Brazil, 98700-000
    - Hospital de Caridade de Ijui
  - Lajeado, Rio Grande Do Sul, Brazil, 95900-000
    - Hospital Bruno Born
  - Passo Fundo, Rio Grande Do Sul, Brazil, 99010-080
    - Hospital São Vicente de Paulo
  - Porto Alegre, Rio Grande Do Sul, Brazil, 91350-200
    - Hospital Nossa Senhora da Conceicao
  - Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903
    - Hospital De Clinicas De Porto Alegre
  - Porto Alegre, Rio Grande Do Sul, Brazil, 90610-000
    - Hospital Sao Lucas da PUCRS
  - Porto Alegre, Rio Grande Do Sul, Brazil, 90470-340
    - IMV-Pesquisa Cardiologica Sociedade Simples - HMD - COR
- Santa Catarina
  - Florianópolis, Santa Catarina, Brazil, 88034-000
    - CEPON - Centro de Pesquisas Oncológicas de Santa Catarina
  - Itajaí, Santa Catarina, Brazil, 88301-220
    - Clínica de Neoplasias Litoral Ltda.
- Sao Paulo
  - Barretos, Sao Paulo, Brazil, 14784-400
    - Hospital de Cancer de Barretos - Fundacao Pio XII
  - Jaú, Sao Paulo, Brazil, 17210-120
    - Fundacao Doutor Amaral Carvalho
  - Santo Andre, Sao Paulo, Brazil, 09060-650
    - CEPHO - Centro de Estudos e Pesquisas em Hematologia e Oncologia
  - São José do Rio Preto, Sao Paulo, Brazil, 15090-000
    - Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto
  - São Paulo, Sao Paulo, Brazil, 01246-000
    - ICESP - Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira
  - São Paulo, Sao Paulo, Brazil, 03102-002
    - IBCC - Instituto Brasileiro de Controle do Cancer
Bulgaria
- - Ruse, Bulgaria, 7002
    - Complex Oncological Center - Ruse, EODD
  - Sofia, Bulgaria, 1431
    - UMHAT "Sv. Ivan Rilski", EAD
  - Sofia, Bulgaria, 1330
    - MHAT for women's health - Nadezhda, OOD
  - Sofia, Bulgaria, 1756
    - Shato, Ead
Canada
- New Brunswick
  - Moncton, New Brunswick, Canada, E1C 6Z8
    - The Moncton Hospital
- Ontario
  - Toronto, Ontario, Canada, M5G 1X5
    - Mount Sinai Hospital
Chile
- - Santiago, Chile, 8380456
    - Hospital Clínico Universidad de Chile
  - Santiago, Chile, 7500921
    - FALP - Fundación Arturo López Pérez
  - Santiago, Chile, 7520378
    - Clinica Santa Maria
  - Santiago, Chile, 7630370
    - IRAM - Instituto de Radio Medicina
  - Santiago, Chile, 7850000
    - Hospital Militar de Santiago
  - Santiago, Chile, 8360160
    - Hospital Clinico San Borja Arriaran
  - Viña del Mar, Chile, 2520612
    - Hospital Clinico Vina del Mar
  - Viña del Mar, Chile, 2540364
    - Centro de Investigaciones Clinicas Viña del Mar
China
- Beijing
  - Beijing, Beijing, China, 100142
    - Beijing Cancer Hospital
- Guangdong
  - Guangzhou, Guangdong, China, 510080
    - Guangdong General Hospital
- Heilongjiang
  - Harbin, Heilongjiang, China, 150081
    - Harbin medical university cancer hospital
- Liaoning
  - Shenyang, Liaoning, China, 110042
    - Liaoning Cancer Hospital & Institute
- Shandong
  - Linyi, Shandong, China, 276001
    - Linyi Cancer Hospital
Colombia
- - Bogotá, Colombia, 00000
    - Administradora Country S.A.
  - Floridablanca, Colombia, 6810002
    - Fundacion Oftalmologica de Santander - FOSCAL
  - Medellín, Colombia, 050034
    - Hospital Pablo Tobon Uribe
  - Monteria, Colombia, 230002
    - IPS IMAT- Instituto Medico de Alta Tecnologia - Oncomedica S.A.
Croatia
- - Zagreb, Croatia, 10000
    - University Hospital Centre "Sestre Milosrdnice"
  - Zagreb, Croatia, 10 000
    - University Clinic for Pulmonary Diseases
Cyprus
- - Nicosia, Cyprus, 2006
    - Bank of Cyprus Oncology Center
Czechia
- - Liberec, Czechia, 460 63
    - Krajska nemocnice Liberec, a.s.
  - Nova Ves pod Plesi, Czechia, 26204
    - Nemocnice Na Pleši s.r.o.
  - Olomouc, Czechia, 775 20
    - Fakultni nemocnice Olomouc
  - Ostrava - Vitkovice, Czechia, 703 84
    - Vitkovicka nemocnice a.s
  - Praha 4 - Krc, Czechia, 140 59
    - Thomayerova nemocnice
  - Usti nad Labem, Czechia, 40113
    - Krajská zdravotní, a.s. - Masarykova nemocnice v Ústí nad Labem, o.z.
Denmark
- - Herning, Denmark, 7400
    - Herning Sygehus
  - Roskilde, Denmark, 4000
    - Roskilde Sygehus
Estonia
- - Tallinn, Estonia, 13419
    - North Estonia Medical Centre Foundation
France
- - Paris Cedex 10, France
    - Hôpital Saint-Louis - Paris
- Alpes Maritimes
  - Nice cedex 02, Alpes Maritimes, France, 06189
    - Centre Antoine Lacassagne
- Bas Rhin
  - Strasbourg, Bas Rhin, France, 67091
    - CHU de Strasbourg - Nouvel Hôpital Civil
- Bouches-du-Rhône
  - Marseille, Bouches-du-Rhône, France, 13009
    - Hopital Prive Clairval
  - Marseille cedex 20, Bouches-du-Rhône, France, 13915
    - Hôpital Nord - AP-HM Marseille#
- Doubs
  - Besancon Cedex, Doubs, France, 25030
    - CHU Besancon - Hôpital Jean Minjoz
- Finistere
  - Brest Cedex, Finistere, France, 29609
    - CHU Brest - Hopital Morvan
- Gironde
  - Pessac, Gironde, France, 33604
    - Groupe Hospitalier Sud - Hôpital Haut-Lévêque
- Maine Et Loire
  - Angers Cedex 9, Maine Et Loire, France, 49933
    - CHU Angers - Hôpital Hôtel Dieu#
- Paris
  - Paris cedex 14, Paris, France, 75679
    - Hopital Cochin
- Pyrenees Atlantiques
  - Bayonne, Pyrenees Atlantiques, France, 64100
    - Centre Hospitalier de la Cote Basque
- Rhone
  - Lyon cedex 04, Rhone, France, 69317
    - Centre Hospitalier de la Croix Rousse
- Sarthe
  - Le Mans Cedex 02, Sarthe, France, 72015
    - Clinique Victor Hugo - Centre Jean Bernard
- Vaculuse
  - Avignon Cedex 9, Vaculuse, France, 84918
    - Institut Sainte Catherine
- Val De Marne
  - Creteil cedex, Val De Marne, France, 94010
    - Centre Hospitalier Intercommunal de Creteil
Germany
- Baden Wuerttemberg
  - Heidelberg, Baden Wuerttemberg, Germany, 69126
    - Universitaetsklinikum Heidelberg
- Schleswig Holstein
  - Grosshansdorf, Schleswig Holstein, Germany, 22927
    - LungenClinic Grosshansdorf GmbH
Greece
- - Athens, Greece, 11527
    - General Hospital of Athens of Chest Diseases "SOTIRIA"
  - Athens, Greece, 12462
    - University General Hospital "Attikon"
  - Athens, Greece, 14564
    - General Oncology Hospital of Kifissia " Agioi Anargyroi"
  - Athens, Greece, 115 25
    - 251 General Air Force Hospital
  - Athens, Greece, 15562
    - Metropolitan General Hospital
  - Heraklion, Greece, 71110
    - University General Hospital of Heraklion
  - Patras, Greece, 26504
    - University General Hospital of Patra
  - Thessaloniki, Greece, 54645
    - Euromedica General Clinic Thessaloniki
Hungary
- - Budapest, Hungary, 1122
    - Orszagos Onkologiai Intezet
  - Budapest, Hungary, 1125
    - Semmelweis Egyetem
  - Budapest, Hungary, 1121
    - Orszagos Koranyi Pulmonologiai Intezet
  - Budapest, Hungary
    - Orszagos Koranyi Pulmonologiai Intezet
  - Deszk, Hungary, 6772
    - Csongrad Megyei Mellkasi Betegsegek Szakkorhaza
  - Györ, Hungary, 9024
    - Petz Aladar Megyei Oktato Korhaz
  - Miskolc, Hungary, 3529
    - Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Oktatókórház
  - Nyiregyhaza, Hungary, 4400
    - SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz
  - Szekszard, Hungary, 7100
    - Tolna Megyei Balassa Janos Korhaz
  - Torokbalint, Hungary, 2045
    - Tudogyogyintezet Torokbalint
  - Zalaegerszeg, Hungary, 8900
    - Zala Megyei Szent Rafael Kórház
Ireland
- - Cork, Ireland
    - Cork University Hospital
Israel
- - Beer Sheva, Israel, 8410101
    - Soroka University Medical Center
  - Haifa, Israel, 3109601
    - Rambam Health Care Center
  - Jerusalem, Israel, 9112001
    - Hadassah University Hospital - Ein Kerem
  - Kfar-Saba, Israel, 4428164
    - Sapir Medical Center, Meir Hospital
  - Petach Tikva, Israel, 49100
    - Rabin Medical Center-Beilinson Campus
  - Ramat Gan, Israel, 5265601
    - Chaim Sheba Medical Center
  - Rechovot, Israel, 7610001
    - Kaplan Medical Center
  - Rishon Lezion, Israel, 75141
    - Assaf Harofeh
  - Tel Aviv, Israel, 6423906
    - Tel Aviv Sourasky Medical Center
Italy
- - Brescia, Italy, 25124
    - Fondazione Poliambulanza Istituto Ospedaliero
  - Catania, Italy, 95100
    - Presidio Ospedaliero Garibaldi Nesima
  - Genova, Italy, 16132
    - Azienda Ospedaliero Universitaria San Martino
  - Napoli, Italy, 80131
    - Seconda Università degli Studi di Napoli
  - Parma, Italy, 43100
    - Azienda Ospedaliero Universitaria di Parma
  - Pisa, Italy, 56126
    - Azienda Ospedaliero Universitaria Pisana
- Verona
  - Legnago, Verona, Italy, 37045
    - Ospedale Mater Salutis
Japan
- - Kobe-shi, Japan, 650-0047
    - Kobe City Hospital Organization Kobe City Medical Center General Hospital
- Chiba-Ken
  - Kashiwa-shi, Chiba-Ken, Japan, 277-8577
    - National Cancer Center Hospital East
- Fukuoka-Ken
  - Kurume-shi, Fukuoka-Ken, Japan, 830-0011
    - Kurume University Hospital
- Hokkaido
  - Sapporo-shi, Hokkaido, Japan, 003-0804
    - NHO Hokkaido Cancer Center
- Hyogo-Ken
  - Kobe-shi, Hyogo-Ken, Japan, 650-0047
    - Institute of Biomedical Research and Innovation Hospital
  - Kobe-shi, Hyogo-Ken, Japan, 650-0047
    - Kobe City Hospital Organization Kobe City Medical Center General Hospital
- Kanagawa-Ken
  - Yokohama-shi, Kanagawa-Ken, Japan, 241-8515
    - Kanagawa Cancer Center
  - Yokohama-shi, Kanagawa-Ken, Japan, 240-8555
    - Yokohama Municipal Citizen's Hospital
- Osaka-Fu
  - Hirakata-shi, Osaka-Fu, Japan, 573-1191
    - Kansai Medical University Hospital
  - Takatsuki-shi, Osaka-Fu, Japan, 569-8686
    - Osaka Medical College Hospital
- Tokyo-To
  - Chuo-ku, Tokyo-To, Japan, 104-0045
    - National Cancer Center Hospital
  - Shinjuku-ku, Tokyo-To, Japan, 160-0023
    - Tokyo Medical University Hospital
- Toyama-Ken
  - Toyama-shi, Toyama-Ken, Japan, 930-0194
    - Toyama University Hospital
Korea, Republic of
- - Daegu, Korea, Republic of, 41404
    - Kyungpook National University Chilgok Hospital
  - Incheon, Korea, Republic of, 21565
    - Gachon University Gil Medical Center
  - Seoul, Korea, Republic of, 03080
    - Seoul National University Hospital
  - Seoul, Korea, Republic of, 05505
    - Asan Medical Center
  - Seoul, Korea, Republic of, 02841
    - Korea University Anam Hospital
  - Seoul, Korea, Republic of, 06591
    - The Catholic University of Korea, Seoul St. Mary's Hospital
  - Seoul, Korea, Republic of, 08308
    - Korea University Guro Hospital
  - Seoul, Korea, Republic of, 06351
    - Samsung Medical Center
  - Seoul, Korea, Republic of, 03722
    - Severance Hospital, Yonsei University
  - Seoul, Korea, Republic of, 07345
    - The Catholic University of Korea, Yeouido St. Mary's Hospital
  - Ulsan, Korea, Republic of, 44033
    - Ulsan University Hospital
- Chungcheongbuk-do
  - Cheongju-si, Chungcheongbuk-do, Korea, Republic of, 28644
    - Chungbuk National University Hospital
- Gangwon-do
  - Wonju-si, Gangwon-do, Korea, Republic of, 26426
    - Yonsei University Wonju Severance Christian Hospital
- Gyeonggi-do
  - Busan, Gyeonggi-do, Korea, Republic of, 48108
    - Inje University Haeundae Paik Hospital
  - Goyang-si, Gyeonggi-do, Korea, Republic of, 10408
    - National Cancer Center
  - Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
    - Seoul National University Bundang Hospital
  - Seongnam-si, Gyeonggi-do, Korea, Republic of, 13496
    - CHA Bundang Medical Center, CHA University
  - Suwon-si, Gyeonggi-do, Korea, Republic of, 16247
    - The Catholic university of Korea, St. Vincent's Hospital
  - Suwon-si, Gyeonggi-do, Korea, Republic of, 443-380
    - Ajou University Hospital
Lebanon
- - Beirut, Lebanon, 1107 2020
    - American University of Beirut Medical Center
  - Beirut, Lebanon, 166830
    - Hotel Dieu de France Hospital
  - Beirut, Lebanon, 113-6044
    - Rafik Hariri University Hospital
  - Beirut, Lebanon, 470
    - Mount Lebanon Hospital
  - Saida, Lebanon, 652
    - Hammoud Hospital University Medical Center
Lithuania
- - Kaunas, Lithuania, 50009
    - Hospital of Lithuanian University of Health Sciences Kaunas Clinics
Netherlands
- - Groningen, Netherlands, 9728 NT
    - Martini Ziekenhuis
  - Hoorn, Netherlands, 1624 NP
    - Westfriesgasthuis - PARENT
  - Tilburg, Netherlands, 5022 GC
    - ETZ Elisabeth
New Zealand
- - Auckland, New Zealand, 1010
    - Auckland City Hospital
  - Dunedin, New Zealand, 9016
    - Dunedin Public Hospital
  - Hamilton, New Zealand, 3200
    - Waikato Hospital
  - Palmerston North, New Zealand, 4414
    - Palmerston North Hospital
  - Tauranga, New Zealand, 3143
    - Tauranga Hospital
  - Wellington, New Zealand, 6021
    - Wellington Hospital
Peru
- - Lima, Peru, Lima 41
    - Oncosalud
  - Lima, Peru, Lima 34
    - Instituto Nacional de Enfermedades Neoplasicas
  - Lima, Peru, Lima 41
    - Clinica Internacional Sede San Borja
Poland
- - Lodz, Poland, 93-513
    - Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Łodzi
  - Lodz, Poland, 90-242
    - Centrum Terapii Wspolczesnej J.M. Jasnorzewska Sp. Komandytowo-Akcyjna
  - Lodz, Poland, 90-302
    - Instytut MSF Sp. o.o
  - Lublin, Poland, 20-362
    - KO-MED Centra Kliniczne Lublin II
  - Mrozy, Poland, 05-320
    - SSZZOZ im. Dr Teodora Dunina w Rudce
  - Olsztyn, Poland, 10-357
    - SP Zespol Gruzlicy i Chorob Pluc w Olsztynie
  - Otwock, Poland
    - Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy
  - Poznan, Poland, 60-569
    - Szpital Kliniczny Przemienienia Pańskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego
  - Szklarska Poręba, Poland, 58-580
    - Izerskie Centrum Pulmonologii i Chemioterapii "IZER-MED" Spolka z o.o.
  - Warszawa, Poland, 02-781
    - Centrum Onkologii-Instytut im. M. Sklodowskiej Curie
  - Wieliszew, Poland, 05-135
    - Mazowiecki Szpital Onkologiczny
Portugal
- - Almada, Portugal, 2801-915
    - Hospital Garcia de Orta, EPE
  - Amadora-Lisbon, Portugal, 2610-276
    - Hospital Professor Doutor Fernando Fonseca, E.P.E.
  - Coimbra, Portugal, 3041-801
    - Centro Hospitalar De Coimbra-CHUC
  - Coimbra, Portugal, 3041-801
    - Centro Hospitalar e Universitário de Coimbra, E.P.E (CHC)
  - Lisboa, Portugal, 1769-001
    - Centro Hospitalar de Lisboa Norte, E.P.E. - Hospital Pulido Valente
  - Lisboa, Portugal, 1849-017
    - Centro Hospitalar de Lisboa Central, E.P.E. - Hospital de Santo Antonio dos Capuchos
  - Porto, Portugal, 4200-319
    - Centro Hospitalar de São João, E.P.E.
  - Porto, Portugal, 4100-180
    - Hospital Cuf porto
  - Porto, Portugal, 4200-072
    - Instituto Português de Oncologia do Porto Francisco Gentil, EPE
  - Porto, Portugal, 4099-001
    - Centro Hospitalar Do Porto, E.P.E. - Hospital de Santo António
  - Santa Maria da Feira, Portugal, 4520-211
    - Centro Hospitalar de Entre o Douro e Vouga, E.P.E - Hospital de São Sebastião
  - Vila Nova de Gaia, Portugal, 4434-502
    - Centro Hospitalar Vila Nova de Gaia/Espinho, E.P.E
Romania
- - Baia Mare, Romania, 430031
    - Spitalul Judetean de Urgenta "Dr. Constantin Opris" Baia Mare
  - Brasov, Romania, 500152
    - S.C Policlinica de Diagnostic Rapid S.A
  - Bucuresti, Romania, 022328
    - Institutul Oncologic "Prof. Dr. Al. Trestioreanu"
  - Bucuresti, Romania, 030171
    - Spitalul Clinic Coltea
  - Bucuresti, Romania, 031422
    - S.C Gral Medical S.R.L
  - Cluj Napoca, Romania, 400015
    - Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj Napoca
  - Cluj-Napoca, Romania, 400058
    - S.C Medisprof S.R.L
  - Cluj-Napoca, Romania, 400132
    - Spitalul Militar de Urgenta "Dr.Constantin Papilian"Cluj -Napoca
  - Comuna Floresti, Romania, 407280
    - S.C Radiotherapy Center Cluj S.R.L
  - Constanta, Romania, 900591
    - Spitalul Clinic Judetean de Urgenta "Sf. Apostol Andrei" Constanta
  - Craiova, Romania, 200347
    - S.C Centrul de Oncologie Sf. Nectarie S.R.L
  - Iasi, Romania, 700483
    - Institutul Regional de Oncologie Iasi
  - Oradea, Romania, 410469
    - Spitalul Clinic Municipal "Dr. Gavril Curteanu" Oradea
  - Oradea, Romania, 410469
    - S.C Pelican Impex S.R.L
  - Suceava, Romania, 720201
    - Spitalul Judetean de Urgenta "Sf. Ioan cel Nou" Suceava
  - Timisoara, Romania, 300210
    - S.C Oncocenter Oncologie Clinica S.R.L
  - Timisoara, Romania, 300239
    - S.C Oncomed S.R.L
Russian Federation
- - Arkhangelsk, Russian Federation, 163045
    - SBIH of Arkhangelsk region "Arkhangelsk Clinical Oncological Dispensary"
  - Chelyabinsk, Russian Federation, 454087
    - Chelyabinsk Regional Oncology Dispensary
  - Chelyabinsk, Russian Federation, 454048
    - LLC Evimed
  - Irkutsk, Russian Federation, 664035
    - Irkutsk Regional Oncology Dispensary
  - Ivanovo, Russian Federation, 153040
    - RBIH "Ivanovo Regional Oncological Dispensary"
  - Kaluga, Russian Federation, 248007
    - SBHI of Kaluga Region "Kaluga regional clinical oncology dispensary"
  - Kazan, Russian Federation, 420029
    - SAIH "Republican Clinical Oncological Dispensary of the Ministry of Healthcare of Republic Tatarstan
  - Kemerovo, Russian Federation, 650036
    - Kemerovo SPI Regional Clinical Oncology Dispensary
  - Krasnoyarsk, Russian Federation, 660133
    - SBHI "Krasnoyarsk Regional Oncology Dispensary n.a. A.I. Kryzhanovsky"
  - Kursk, Russian Federation, 305035
    - RBIH "Kursk regional clinical oncology dispensary" of Kursk Region Healthcare Committee
  - Moscow, Russian Federation, 115478
    - FSBSI "Russian Oncological Scientific Center n.a. N.N. Blokhin"
  - Murmansk, Russian Federation, 183047
    - Murmansk Regional Clinical Hospital named after Bayandin
  - Novosibirsk, Russian Federation, 630108
    - SBHI of Novosibirsk region "Novosibirsk Regional Oncological Dispensary"
  - Pyatigorsk, Russian Federation, 357502
    - SBIH of Stavropol territory "Pyatigorsk Oncological Dispensary"
  - Saint-Petersburg, Russian Federation, 197758
    - FBI "Scientific Research Institute of Oncology n. a. N. N. Petrov"
  - Saint-Petersburg, Russian Federation, 191104
    - SBIH "Leningrad Regional Oncological Dispensary"
  - Saint-Petersburg, Russian Federation, 197342
    - "Bio Eq" LLC
  - Samara, Russian Federation, 443031
    - SBIH "Samara Regional Clinical Oncological Dispensary"
  - Sochi, Russian Federation, 354057
    - SBIH "Oncological Dispensary # 2" of the MoH of Krasnodar territory
  - St. Petersburg, Russian Federation, 191036
    - FSBHI Clinical research institute of phthisiopulmonology
  - Tomsk, Russian Federation, 634028
    - Tomsk Research Instutite of Oncology
  - Tomsk, Russian Federation, 644013
    - BHI of Omsk region "Clinical Oncology Dispensary"
  - Tyumen, Russian Federation, 625041
    - Medicinskiy gorod
  - Yaroslavl, Russian Federation, 150054
    - SBIH of Yaroslavl Region "Regional Clinical Oncological Hospital"
Serbia
- - Belgrade, Serbia, 11000
    - Military Medical Academy
  - Belgrade, Serbia, 11080
    - Clinical Center Bezanijska kosa
  - Belgrade, Serbia, 11000
    - Institute of Oncology and Radiology of Serbia
  - Belgrade, Serbia, 11 000
    - Clinical Center of Serbia
  - Gornji Matejevac, Serbia, 18204
    - Clinical Center Nis, Pulmonary Diseases Clinic
  - Kragujevac, Serbia, 34000
    - Clinical Center Kragujevac
  - Sremska Kamenica, Serbia, 21204
    - Institute for Pulmonary Diseases of Vojvodina
Singapore
- - Singapore, Singapore, 169610
    - National Cancer Centre
  - Singapore, Singapore, 308433
    - Tan Tock Seng Hospital
  - Singapore, Singapore, 119074
    - National University Cancer Institute
Slovakia
- - Bardejov, Slovakia, 08501
    - Nemocnica s poliklinikou Sv. Jakuba, n.o. Bardejov
  - Bratislava, Slovakia, 82606
    - Univerzitna nemocnica Bratislava, Nemocnica Ruzinov
South Africa
- Gauteng
  - Alberton, Gauteng, South Africa, 1449
    - Emery Clinical Services
  - Pretoria, Gauteng, South Africa, 0002
    - University of Pretoria Oncology Department
  - Pretoria, Gauteng, South Africa, 1692
    - Johese Clinical Research
- Western Cape
  - Cape Town, Western Cape, South Africa, 7570
    - Cape Town Oncology Trials Pty Ltd
Spain
- - Barcelona, Spain, 08035
    - Hospital Universitari Vall d'Hebron
  - Barcelona, Spain, 08041
    - Hospital de la Santa Creu i Sant Pau
  - Barcelona, Spain, 08028
    - Hospital Universitari Quiron Dexeus
  - Barcelona, Spain, 08006
    - specialist
  - Girona, Spain, 17007
    - ICO Girona - Hospital Universitari de Girona Dr. Josep Trueta
  - Madrid, Spain, 28040
    - Fundacion Jimenez Diaz
  - Madrid, Spain, 28046
    - Hospital Universitario La Paz
  - Madrid, Spain, 28007
    - Hospital General Universitario Gregorio Marañon
  - Madrid, Spain, 28033
    - Md Anderson Cancer Centre
  - Málaga, Spain, 29010
    - Hospital Regional Universitario de Malaga
  - Sevilla, Spain, 41013
    - Hospital Universitario Virgen del Rocio
  - Sevilla, Spain, 41013
    - Hospital Quiron Sagrado Corazon
  - Vitoria, Spain, 01009
    - Hospital Txagorritxu
- Barcelona
  - Mataro, Barcelona, Spain, 08304
    - Hospital de Mataró
  - Terrassa, Barcelona, Spain, 08221
    - Hospital Universitario Mutua de Terrassa
- Guipuzcoa
  - San Sebastian, Guipuzcoa, Spain, 20014
    - Hospital Universitario Donostia
- La Coruña
  - Santiago de Compostela, La Coruña, Spain, 15706
    - Complejo Hospitalario Universitario de Santiago
- Pontevedra
  - Vigo, Pontevedra, Spain, 36204
    - Complejo Hospitalario Universitario de Vigo
Taiwan
- - Kaohsiung, Taiwan, 83301
    - Kaohsiung Chang Gung Memorial Hospital
  - Taichung, Taiwan, 40447
    - China Medical University Hospital
  - Taichung, Taiwan, 40705
    - Taichung Veterans General Hospital
  - Taipei, Taiwan, 100
    - National Taiwan University Hospital
  - Taipei, Taiwan, 11217
    - Taipei Veterans General Hospital
  - Taipei, Taiwan, 11490
    - Tri-Service General Hospital
  - Taoyuan County, Taiwan, 333
    - Chang Gung Memorial Hospital, Linkou
Thailand
- - Bangkok, Thailand, 10700
    - Siriraj Hospital
- Bangkok
  - Patumwan, Bangkok, Thailand, 10330
    - King Chulalongkorn Memorial Hospital
  - Rajathevee, Bangkok, Thailand, 10400
    - Rajavithi Hospital
- Chiang Mai
  - Muang, Chiang Mai, Thailand, 50200
    - Maharaj Nakorn Chiang Mai Hospital
- Khon Kaen
  - Muang, Khon Kaen, Thailand, 40002
    - Srinagarind Hospital
- Phitsanulok
  - Muang, Phitsanulok, Thailand, 65000
    - Naresuan University Hospital
- Songkhla
  - Hat Yai, Songkhla, Thailand, 90110
    - Songklanagarind Hospital
Turkey
- - Adana, Turkey, 01330
    - Cukurova University Medical Faculty
  - Adana, Turkey, 01130
    - Acibadem Adana Hospital
  - Adana, Turkey, 01220
    - Baskent University Adana Application and Research Center
  - Adana, Turkey, 01240
    - Adana Numune Training and Research Hospital
  - Adana, Turkey, 01370
    - Adana City Hospital
  - Ankara, Turkey, 06100
    - Hacettepe University Medical Faculty
  - Ankara, Turkey, 06100
    - Ankara University Medical Faculty
  - Ankara, Turkey, 06100
    - Dr. Abdurrahman Yurtaslan Ankara Oncology Training And Research Hospital
  - Antalya, Turkey, 07020
    - Memorial Antalya Hastanesi
  - Istanbul, Turkey, 34098
    - Istanbul University Cerrahpasa Medical Faculty
  - Istanbul, Turkey, 34214
    - Medipol University Medical Faculty
  - Istanbul, Turkey, 34147
    - Bakirkoy Dr. Sadi Konuk Teaching and Research Hospital
  - Istanbul, Turkey, 34890
    - Kartal Lutfi Kirdar Research and Training Hospital
  - Istanbul, Turkey, 34000
    - Okmeydani Research and Training Hospital
  - Izmir, Turkey, 35100
    - Ege University Medical Faculty
  - Malatya, Turkey, 44280
    - Inonu Uni. Med. Fac.
  - Mersin, Turkey, 33169
    - Mersin University Medical Faculty
  - Sakarya, Turkey, 54187
    - Sakarya Traning and Research Hospital
  - Tekirdag, Turkey, 59100
    - Namik Kemal University
Ukraine
- - Chernivtsi, Ukraine, 58013
    - CI Chernivtsi RC Oncological Dispensary Bukovinian SMU Ch of Oncology and Radiology
  - Dnipro, Ukraine, 49102
    - CI Dnipropetrovsk CMCH #4 of Dnipropetrovsk RC Dept of Chemotherapy SI Dnipropetrovsk MA of MOHU
  - Ivano-Frankivsk, Ukraine, 76018
    - CI Transcarpathian Cl Onc Center Dep of Surgery#1 SHEI Ivano-Frankivsk NMU
  - Kharkiv, Ukraine, 61070
    - Communal Non-Profit Enterprise Regional Center of Oncology
  - Kharkiv, Ukraine, 61024
    - SI S.P.Grygoriev Institute of Medical Radiology of NAMSU
  - Kherson, Ukraine, 73000
    - Kherson Regional Oncologic Dispensary
  - Kropyvnytskyi, Ukraine, 25006
    - Treatment-Diagnostic Center of Private Enterprise of PPC Atsynus
  - Kryvyi Rih, Dnipropetrovsk Region, Ukraine, 50048
    - CI Kryvyi Rih Oncological Dispensary of DRC
  - Kyiv, Ukraine, 03115
    - Kyiv City Clinical Oncological Center
  - Lutsk, Ukraine, 43018
    - Treatment-Prevention Institution Volyn Regional Oncological Dispensary
  - Lviv, Ukraine, 79031
    - Lviv State Oncological Regional Treatment and Diagnostic Center
  - Odesa, Ukraine, 65055
    - Odesa Regional Oncologic Dispensary
  - Sumy, Ukraine, 40022
    - RCI Sumy Regional Clinical Oncological Dispensary
  - Uzhgorod, Ukraine, 88000
    - CCCH City Oncological Center SHEI Uzhgorod NU
  - Vinnytsia, Ukraine, 21029
    - Vinnytsia Regional Clinical Oncological Dispensary
  - Vinnytsia, Ukraine, 21029
    - Podilskyi Regional Oncological Center
United Kingdom
- Essex
  - Westcliff on Sea, Essex, United Kingdom, SS0 0RY
    - Southend University Hospital
- Gloucestershire
  - Cheltenham, Gloucestershire, United Kingdom, GL53 7AN
    - Cheltenham General Hospital
- Greater London
  - London, Greater London, United Kingdom, SW109NH
    - Chelsea and Westminster Hospital
- Hertfordshire
  - Stevenage, Hertfordshire, United Kingdom, SG1 4AB
    - Mount Vernon Hospital
- Merseyside
  - Wirral, Merseyside, United Kingdom, CH63 4JY
    - The Clatterbridge Cancer Centre
- Staffordshire
  - Stoke on Trent, Staffordshire, United Kingdom, ST4 6QG
    - Royal Stoke University Hospital
United States
- Alabama
  - Huntsville, Alabama, United States, 35805
    - Clearview Cancer Institute
- Arizona
  - Surprise, Arizona, United States, 85374
    - Arizona Center for Cancer Care
- California
  - San Diego, California, United States, 92123
    - Sharp Memorial Hospital
- Florida
  - Boynton Beach, Florida, United States, 33426
    - University Cancer Institute
- Georgia
  - Valdosta, Georgia, United States, 31602
    - South Georgia Medical Center
- Louisiana
  - Shreveport, Louisiana, United States, 71105
    - Christus Cancer Treatment Center
- Michigan
  - Detroit, Michigan, United States, 48202
    - Henry Ford Hospital
- Montana
  - Billings, Montana, United States, 59102
    - St. Vincent Frontier Cancer Center
- Nevada
  - Las Vegas, Nevada, United States, 89106
    - Nevada Cancer Research Foundation
- New Mexico
  - Farmington, New Mexico, United States, 87401
    - San Juan Oncology Associates
- North Carolina
  - Kernersville, North Carolina, United States, 27284
    - Novant Health Oncology Specialists
- Oklahoma
  - Oklahoma City, Oklahoma, United States, 73120
    - Mercy Research
- Oregon
  - Portland, Oregon, United States, 97227
    - Kaiser Permanente Northwest
- Pennsylvania
  - Lancaster, Pennsylvania, United States, 17605
    - Lancaster Cancer Center
- Tennessee
  - Cookeville, Tennessee, United States, 38501
    - Cookeville Regional Medical Center
  - Knoxville, Tennessee, United States, 37916
    - Thompson Cancer Survival Center
- Texas
  - Corpus Christi, Texas, United States, 78404
    - Coastal Bend Cancer Center
  - Houston, Texas, United States, 77030
    - Oncology Consultants, P.A.
- Vermont
  - Burlington, Vermont, United States, 05401-1473
    - University of Vermont Medical Center
- Washington
  - Tacoma, Washington, United States, 98405
    - NorthWest Medical Specialties, PLLC
- Wyoming
  - Cheyenne, Wyoming, United States, 82001
    - Cheyenne Regional Medical Center

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

Description

Inclusion Criteria:

Male or female subjects aged greater than or equal to (>=) 18 years
With Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 1 at trial entry
At least 1 measurable tumor lesion
With histologically confirmed metastatic or recurrent (Stage IV) non-small cell lung cancer (NSCLC)
With availability of a recently-obtained, formalin-fixed, paraffin-embedded (FFPE) tissue sample containing tumor (biopsy from a non-irradiated area preferably within 6 months) or a minimum number of 10 (preferably 25) unstained tumor slides cut within 1 week, and suitable for PD-L1 expression assessment
Subjects must not have received any treatment for systemic lung cancer, and have an estimated life expectancy of more than 12 weeks
Other protocol defined criteria could apply

Exclusion Criteria:

Subjects whose disease harbors a EGFR mutation, or anaplastic lymphoma kinase (ALK) rearrangement are not eligible.
Other exclusion criteria include prior therapy with any antibody or drug targeting T cell coregulatory proteins, concurrent anticancer treatment, or immunosuppressive agents
Known severe hypersensitivity reactions to monoclonal antibodies (Grade >= 3 NCI CTCAE v 4.03), history of anaphylaxis, or uncontrolled asthma (that is, 3 or more features of partially controlled asthma), and persisting toxicity related to prior therapy of Grade > 1 NCI-CTCAE v 4.03.
Subjects with brain metastases are excluded, except those meeting the following criteria: brain metastases that have been treated locally and are clinically stable for at least 2 weeks prior to randomization, subjects must be either off steroids or on a stable or decreasing dose of <= 10 mg daily prednisone (or equivalent), and do not have ongoing neurological symptoms that are related to the brain localization of the disease.
Other protocol defined 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)

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Chemotherapy	Drug: Pemetrexed Participants received Pemetrexed 500 milligrams per square meter (mg/m^2) by IV infusion on Day 1 of 3-Week cycle up to a maximum of 6 cycles of IV injection until disease progression or unacceptable toxicities. Drug: Paclitaxel Participants received Paclitaxel 200 mg/m^2 by IV infusion on Day 1 of 3-Week cycle up to a maximum of 6 cycles of IV injection until disease progression or unacceptable toxicities. Drug: Gemcitabine Participants received Gemcitabine 1250 mg/m^2 on Day 1 and Day 8 by IV infusion in 3-Week cycle up to a maximum of 6 cycles when combined with cisplatin of IV injection until disease progression or unacceptable toxicities. Drug: Gemcitabine Participants received Gemcitabine 1000 mg/m^2 on Day 1 and Day 8 by IV infusion in 3-Week cycle up to a maximum of 6 cycles of IV injection when combined with carboplatin until disease progression or unacceptable toxicities. Drug: Carboplatin Participants received Carboplatin area under concentration curve (AUC) 5 mg/mLmin in 3-Week cycle up to a maximum of 6 cycles of IV injection when combined with gemcitabine until disease progression or unacceptable toxicities. Drug: Carboplatin Carboplatin AUC 6 mg/mLmin by IV infusion in 3-Week cycle up to a maximum of 6 cycles of IV injection when combined with pemetrexed, or paclitaxel until disease progression or unacceptable toxicities.
Experimental: Avelumab Biweekly	Drug: Avelumab Participants received Avelumab at a dose of 10 milligrams per kilogram (mg/kg) as a 1-hour (-10/+20 minutes) intravenous (IV) infusion once every 2 weeks until disease progression or unacceptable toxicities. Other Names: MSB0010718C Anti-PD-L1
Experimental: Avelumab Weekly	Drug: Cisplatin Participants received Cisplatin 75 mg/m^2 by IV infusion in 3-Week cycle up to a maximum of 6 cycles of IV injection until disease progression or unacceptable toxicities. Drug: Avelumab Weekly Participants received Avelumab at a dose of 10 mg/kg as a 1-hour (-10/+20 minutes) IV infusion every week for 12 consecutive weeks. Other Names: MSB0010718C Anti-PD-L1

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Assessed by Independent Review Committee (IRC) in High Programmed Death Ligand 1 (PD-L1) + Full Analysis Set (FAS) Time Frame: Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)	PFS is 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. PD is defined as at least a 20 percent (%) increase in the sum of the longest diameter (SLD), taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. PFS was measured using Kaplan-Meier (KM) estimates.	Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)
Progression Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Assessed by Independent Review Committee (IRC) in High Programmed Death Ligand 1 (PD-L1) + Modified Full Analysis Set (mFAS) Time Frame: Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)	PFS is 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. PD is defined as at least a 20 percent (%) increase in the sum of the longest diameter (SLD), taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. PFS was measured using Kaplan-Meier (KM) estimates.	Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)
Overall Survival (OS) in High Programmed Death Ligand 1 (PD-L1) + Full Analysis Set (FAS) Time Frame: Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)	OS is defined as the time from randomization to the date of death, regardless of the actual cause of the participant's 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 data cutoff (assessed up to approximately 71.5 months)
Overall Survival (OS) in High Programmed Death Ligand 1 (PD-L1)+ Modified Full Analysis Set (mFAS) Time Frame: Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)	OS is defined as the time from randomization to the date of death, regardless of the actual cause of the participant's 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 data cutoff (assessed up to approximately 71.5 months)

Secondary Outcome Measures

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

Investigators

Study Director: Medical Responsible, EMD Serono Inc., an affiliate of 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

Reck M, Barlesi F, Yang JC, Westeel V, Felip E, Ozguroglu M, Dols MC, Sullivan R, Kowalski DM, Andric Z, Lee DH, Sezer A, Hu P, Wang X, von Heydebreck A, Jacob N, Mehr KT, Park K. Avelumab Versus Platinum-Based Doublet Chemotherapy as First-Line Treatment for Patients With High-Expression Programmed Death-Ligand 1-Positive Metastatic NSCLC: Primary Analysis From the Phase 3 JAVELIN Lung 100 Trial. J Thorac Oncol. 2024 Feb;19(2):297-313. doi: 10.1016/j.jtho.2023.09.1445. Epub 2023 Sep 24.

Helpful Links

Trial Awareness and Transparency website

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)

October 29, 2015

Primary Completion (Actual)

December 6, 2021

Study Completion (Actual)

January 29, 2024

Study Registration Dates

First Submitted

October 13, 2015

First Submitted That Met QC Criteria

October 14, 2015

First Posted (Estimated)

October 15, 2015

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 20, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

EMR 100070-005
2015-001537-24 (EudraCT Number)

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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Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Actual)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Collaborators

Investigators

Publications and helpful links

General Publications

Helpful Links

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Actual)

Study Completion (Actual)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Estimated)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Clinical Trials on First Line Non-Small Cell Lung Cancer

Clinical Trials on Avelumab

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