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

PHASE3CompletedINTERVENTIONAL
Enrollment

792

Participants

Timeline

Start Date

March 24, 2015

Primary Completion Date

November 22, 2017

Study Completion Date

December 3, 2019

Conditions
Carcinoma, Non-Small-Cell Lung
Interventions
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.

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.

Trial Locations (260)

100

National Taiwan University Hospital, Taipei

112

Taipei Veterans General Hospital, Taipei

333

Chang Gung Memorial Hospital, Linkou, Taoyuan

704

National Cheng Kung University Hospital, Tainan City

1125

Semmelweis Egyetem AOK, Budapest

1145

Uzsoki Utcai Korhaz, Budapest

1303

"MHAT Serdika, EOOD", Sofia

1407

MHAT 'Tokuda Hospital Sofia', AD, Sofia

1756

Shato, Ead, Sofia

2045

Tudogyogyintezet Torokbalint, Törökbálint

2450

Coffs Harbour Base Hospital, Coffs Harbour

2480

Lismore Base Hospital, Lismore

2650

UZ Antwerpen, Edegem

2730

Herlev Hospital, Herlev

3000

UZ Leuven, Leuven

3050

Royal Melbourne Hospital, Parkville

3100

Centro Oncologico de Parana, Paraná

3128

Box Hill Hospital, Box Hill

3350

Ballarat Base Hospital, Ballarat

3529

Miskolci Semmelweis Korhaz es Egyetemi Oktatokorhaz, Miskolc

4000

Centro Medico San Roque S.R.L., San Miguel de Tucumán

C. H. U. Sart Tilman, Liège

4004

Complex Oncological Center - Plovdiv, EOOD, Plovdiv

4102

Princess Alexandra Hospital, Woolloongabba

4120

Greenslopes Private Hospital, Greenslopes

5000

Odense Universitetshospital, Odense C

5112

Lyell McEwin Hospital, Elizabeth Vale

5800

UMHAT 'Dr. Georgi Stranski', EAD, Pleven

6008

St John of God Hospital, Subiaco

6045

GVI Langenhoven Drive Oncology Centre, Port Elizabeth

6060

Grand Hôpital de Charleroi, Gilly

6800

Centre Hospitalier de l'Ardenne, Libramont

7000

Kantonsspital Graubuenden, Chur

7570

GVI Cape Gate Oncology Centre, Cape Town

7700

GVI Rondebosch Oncology Centre, Cape Town

8800

AZ Delta, Roeselare

9010

MHAT 'Sv. Marina', EAD, Varna

9024

Petz Aladar Megyei Oktato Korhaz, Győr

10000

"Clinical Hospital Centar Sestre Milosrdnice", Zagreb

University Clinic for Pulmonary Diseases, Zagreb

10960

Hematology Oncology Associates of Rockland, Nyack

11490

Tri-Service General Hospital, Taipei

12808

Vseobecna fakultni nemocnice V Praze, Prague

13620

Seoul National University Bundang Hospital, Seongnam-si

13915

Hôpital Nord - AP-HM Marseille#, Marseille

14001

Hospital Nacional Almanzor Aguinaga Asenjo, Chiclayo

14059

Thomayerova nemocnice, Prague

15000

Clinica San Borja, Lima

15706

Complejo Hospitalario Universitario de Santiago, Santiago de Compostela

16247

The Catholic University of Korea, St. Vincent's Hospital, Suwon

17033

Penn State Univ. Milton S. Hershey Medical Center, Hershey

19001

Abington Memorial Hospital, Abington

20000

General Hospital Dubrovnik, Dubrovnik

20133

Fondazione IRCCS Istituto Nazionale dei Tumori, Milan

20141

IEO Istituto Europeo di Oncologia, Milan

21565

Gachon University Gil Medical Center, Incheon

22030

Trakya University Medical Faculty, Edirne

23000

General Hospital Zadar, Zadar

24047

Azienda Ospedaliera Ospedale Treviglio-Caravaggio di Treviglio, Treviglio

25030

CHU Besançon - Hôpital Jean Minjoz, Besançon

26100

Azienda Ospedaliera Istituti Ospitalieri di Cremona, Cremona

27103

Novant Health Oncology Specialists, Winston-Salem

28034

Hospital Universitario Ramon y Cajal, Madrid

28050

Centro Integral Oncologico Clara Campal, Madrid

28644

Chungbuk National University Hospital, Cheongju-si

29010

Hospital Clinico Universitario Virgen de la Victoria, Málaga

30607

Northeast Georgia Cancer Care, LLC, Athens

31059

CHU de Toulouse - Hôpital Larrey, Toulouse

33308

Holy Cross Hospital Inc., Fort Lauderdale

33401

Florida Cancer Specialists, West Palm Beach

33426

University Cancer Institute, Boynton Beach

33486

Lynn Cancer Institute Center, Boca Raton

33604

Groupe Hospitalier Sud - Hôpital Haut-Lévêque, Pessac

33705

Florida Cancer Specialists, St. Petersburg

33916

Florida Cancer Specialists-Broadway, Fort Myers

34000

Instituto de Investigaciones Aplicadas a la Neurociencia A.C., Durango

34093

Bezmi Alem Foundation University Medical Faculty Hospital, Istanbul

34098

Istanbul University Cerrahpasa Medical Faculty, Istanbul

34361

The Lady Davis Carmel Medical Center, Haifa

34500

Fatih Universitesi Tip Fakultesi, Istanbul

34899

Marmara University Pendik Research and Training Center, Istanbul

35016

Hospital Universitario Materno-Infantil de Canarias, Las Palmas de Gran Canaria

35100

Ege University Medical Faculty, Izmir

35340

Dokuz Eylul University Medicine Faculty, Izmir

35401

University of Alabama, Tuscaloosa

37000

Fundacion Rodolfo Padilla Padilla, A.C., León

37045

Ospedale Mater Salutis, Legnago (VR)

37203

SCRI - Tennessee Oncology, Nashville

37909

Center for Biomedical Research, LLC, Knoxville

40705

Taichung Veterans General Hospital, Taichung

41009

Hospital Universitario Virgen Macarena, Seville

41013

Hospital Universitario Virgen del Rocio, Seville

42080

Konya Necmettin Erbakan University Meram Faculty of Medicine, Konya

44202

Centre Catherine de Sienne, Nantes

44805

ICO - Site René Gauducheau, Saint-Herblain

45042

Signal Point Clinical Research Center, Middletown

45242

Oncology Hematology Care, Cincinnati

46026

Hospital Universitari i Politecnic La Fe, Valencia

48202

Henry Ford Health System, Detroit

49933

ICO - Site Paul Papin, Angers

50180

Centro Oncologico Estatal ISSEMyM, Toluca

52621

Chaim Sheba Medical Center, Ramat Gan

53100

A.O.U. Senese Policlinico Santa Maria alle Scotte, Siena

53203

Multiscan s.r.o., Pardubice

54769

Phylasis Clinicas Research S de RL de CV, Cuautitlán Izcalli

55043

Ospedale Versilia, Lido di Camaiore

56124

Azienda Ospedaliero Universitaria Pisana, Pisa

58260

Centro de Investigacion Clinica Chapultepec S.A. de C.V., Morelia

64060

Winsett Rethman S.A. de C.V., Monterrey

64239

Tel Aviv Sourasky Medical Center, Tel Aviv

65653

Masarykuv onkologicky ustav, Brno

67091

CHU Strasbourg - Nouvel Hôpital Civil, Strasbourg

68000

Oaxaca Site Management Organization S.C., Oaxaca City

70006

Metairie Oncologist, LLC, Metairie

70300

Assaf Harofeh Medical Center, Beer Yaakov

72000

Clinique Victor Hugo - Centre Jean Bernard, Le Mans

74101

Nemocnice Novy Jicin a.s., Nový Jičín

75708

University of Texas Health Science Center at Tyler, Tyler

76104

The Center for Cancer and Blood Disorders, Fort Worth

80131

Seconda Università degli Studi di Napoli, Napoli

82606

Univerzitna nemocnica Bratislava, Nemocnica Ruzinov, Bratislava

84101

Soroka Medical Center, Beersheba

86021

CHU Poitiers - Hôpital la Milétrie, Poitiers

90260

Healing Hands Oncology and Medical Care, Lawndale

91708

Fakultna nemocnica Trnava, Trnava

92123

Sharp Memorial Hospital, San Diego

92801

Pacific Cancer Medical Center, Inc., Anaheim

95355

Sutter Gould Medical Foundation, Modesto

98405

MultiCare Health System, Tacoma

100011

Spital Lotus SRL, Ploieşti

110131

Fundacion Cardioinfantil Instituto de Cardiologia, Bogotá

111123

SHBI Moscow Clinical Scientific Center of Department of Healthcare of Moscow, Moscow

111511

Instituto Nacional de Cancerologia E.S.E., Bogotá

191036

FSBHI Clinical research institute of phthisiopulmonology, Saint Petersburg

197022

Pavlov First Saint Petersburg State Medical University, Saint Petersburg

"St. Petersburg SHI City Clinical Oncology Dispensary", Saint Petersburg

197758

"FBI Scientific Research Institute of Oncology n. a. N. N. Petrov", Saint Petersburg

300210

S.C Oncocenter Oncologie Clinica S.R.L, Timișoara

410469

"Spitalul Clinic Municipal Dr. Gavril Curteanu Oradea", Oradea

420029

"SHI Republican Clinical Oncological Dispensary of HM RT", Kazan'

430031

"Spitalul Judetean de Urgenta Dr. Constantin Opris Baia Mare", Baia Mare

500152

Policlinica de Diagnostic Rapid SRL, Brasov

510077

Spitalul Judetean de Urgenta Alba Iulia, Alba Iulia

760032

Fundación Valle del Lilí, Santiago de Cali

760042

Centro Medico Imbanaco, Santiago de Cali

2540364

Centro de Investigaciones Clinicas Viña del Mar, Viña del Mar

3109601

Rambam Health Care Campus, Haifa

4428164

Sapir Medical Center, Meir Hospital, Kfar Saba

4941492

Rabin Medical Center-Beilinson Campus, Petah Tikva

7500000

Instituto de Terapias Oncologicas Providencia, Santiago

7500921

FALP - Fundación Arturo López Pérez, Santiago

8420383

CIEC - Centro Internacional de Estudios Clínicos, Santiago

9112001

Hadassah University Hospital - Ein Kerem, Jerusalem

85259-5499

Mayo Clinic, Scottsdale , Phoenix

73120-9309

Mercy Clinic Oklahoma Communities, Inc., Oklahoma City

B8001HXM

Hospital Italiano Regional del Sur, Bahía Blanca

X5004FHP

Clínica Universitaria Privada Reina Fabiola, Barrio General Paz

B1880BBF

Centro de Oncologia e Investigacion Buenos Aires, Berazategui

C1426ANZ

Instituto Medico Especializado Alexander Fleming, Ciudad Autonoma Buenos Aires

C1431FWO

CEMIC, Ciudad Autonoma Buenos Aires

X5003DCE

Instituto DAMIC Fundacion Rusculleda, Córdoba

F5300COE

Centro Oncologico Riojano Integral (Cori), La Rioja

B1629ODT

Hospital Universitario Austral, Pilar

S2000CRF

Instituto Gamma, Rosario

S2000DSV

Sanatorio Parque S.A., Rosario

S2000KZE

Instituto de Oncología de Rosario, Rosario

30110-921

Cenantron - Centro Avançado de Tratamento Oncológico S/C Ltda, Belo Horizonte

88034-000

CEPON - Centro de Pesquisas Oncológicas de Santa Catarina, Florianópolis

98700-000

Hospital de Caridade de Ijuí, Ijuí

88310-110

Clínica de Neoplasias Litoral Ltda., Itajaí

36010-570

CMiP - Centro Mineiro de Pesquisa, Juiz de Fora

95900-000

Hospital Bruno Born, Lajeado

59075-740

Liga Norte-Rio-Grandense Contra o Câncer, Natal

93510-250

Oncosinos - Clínica de Oncologia - Hospital Regina, Novo Hamburgo

99010-260

CITO - Centro Integrado de Terapia Onco-Hematológica - Hospital da Cidade de Passo Fundo, Passo Fundo

90110-270

Hospital Mãe de Deus, Porto Alegre

90610-000

Hospital São Lucas da PUCRS, Porto Alegre

22793-080

COI - Clínicas Oncológicas Integradas, Rio de Janeiro

09060-650

CEPHO - Centro de Estudos e Pesquisas em Hematologia e Oncologia, Santo André

15090-000

Fundação Faculdade Regional de Medicina de São José do Rio Preto, São José do Rio Preto

01246-000

ICESP - Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira, São Paulo

18030-075

"IOS - Instituto de Oncologia de Sorocaba Dr. Gilson Delgado", Sorocaba

Unknown

Instituto Clinico Oncologico del Sur (ICOS), Temuco

Hospital Clinico Viña del Mar, Viña del Mar

Administradora Country S.A., Bogotá

Clinica Colsanitas S.A. sede Clinica Universitaria Colombia, Bogotá

Instituto de Cancerologia S.A., Medellín

IPS IMAT- Instituto Medico de Alta Tecnologia - Oncomedica S.A., Montería

Hemato Oncologos S.A., Santiago de Cali

Hospital Nacional Adolfo Guevara Velasco, Cusco

Ankara University Medical Faculty, Ankara

050034

Hospital Pablo Tobón Uribe, Medellín

06189

Centre Antoine Lacassagne, Nice

00128

Università Campus Bio-Medico di Roma, Roma

00144

Istituto Nazionale Tumori Regina Elena IRCCS, Roma

00168

Policlinico Universitario Agostino Gemelli, Roma

00189

Azienda Ospedaliera Sant'Andrea-Università di Roma La Sapienza, Roma

104-0045

National Cancer Center Hospital, Chūōku

811-1395

NHO Kyushu Cancer Center, Fukuoka

583-8588

Osaka Prefectural Medical Center for Respiratory and Allergic Diseases, Habikino-shi

730-8518

Hiroshima City Hiroshima Citizens Hospital, Hiroshima

277-8577

National Cancer Center Hospital East, Kashiwa-shi

362-0806

Saitama Cancer Center, Kitaadachi-gun

650-0047

Institute of Biomedical Research and Innovation Hospital, Kobe

Kobe City Hospital Organization Kobe City Medical Center General Hospital, Kobe

135-8550

Cancer Institute Hospital of JFCR, Kōtoku

830-0011

Kurume University Hospital, Kurume-shi

981-1293

Miyagi Cancer Center, Natori-shi

444-0011

Aichi Cancer Center Hospital, Okazaki-shi

534-0021

Osaka City General Hospital, Osaka

537-8511

Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka

589-8511

Kinki University Hospital, Osakasayama-shi

252-0375

Kitasato University Hospital, Sagamihara-shi

003-0804

NHO Hokkaido Cancer Center, Sapporo

060-8648

Hokkaido University Hospital, Sapporo

160-0023

Tokyo Medical University Hospital, Shinjuku-ku

930-0194

Toyama University Hospital, Toyama

641-8510

Wakayama Medical University Hospital, Wakayama

240-8555

Yokohama Municipal Citizen's Hospital, Yokohama

241-8515

Kanagawa Cancer Center, Yokohama

03810

Health Pharma Professional Research S.A. de C.V., México

04000

Clinica Monte Carmelo, Arequipa

Lima 13

Hospital Nacional Guillermo Almenara Irigoyen, Lima

LIMA 27

Clínica Ricardo Palma, Lima

LIMA 34

Instituto Nacional de Enfermedades Neoplásicas, Lima

36-200

Szpital Specjalistyczny W Brzozowie, Podkarpacki Osrodek Onkologiczny Im.Ks.B.Markiewicza, Brzozów

58-506

Wojewodzkie Centrum Szpitalne Kotliny Jeleniogorskiej, Jelenia Góra

40-514

Samodzielny Publiczny Szpital Kliniczny nr 5 SUM, Katowice

90-242

Centrum Terapii Wspolczesnej J.M. Jasnorzewska sp. komandytowo-akcyjna, Lodz

20-362

KO-MED Centra Kliniczne Lublin II, Lublin

05-320

SSZZOZ im. Dr Teodora Dunina w Rudce, Mrozy

05-400

Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy, Otwock

08501

Nemocnica s poliklinikou Sv. Jakuba, n.o. Bardejov, Bardejov

03426

Ustredna vojenska nemocnica SNP Ruzomberok- Fakultna nemocnica, Ružomberok

0002

University of Pretoria Oncology Department, Pretoria

0181

Mary Potter Oncology Centre, Pretoria

519-763

Chonnam National University Hwasun Hospital, Hwasun-gun

05505

Asan Medical Center, Seoul

06351

Samsung Medical Center, Seoul

08308

Korea University Guro Hospital, Seoul

136-705

Korea University Anam Hospital, Seoul

137-701

The Catholic University of Korea, Seoul St. Mary's Hospital, Seoul

03010

Hospital General Universitario de Alicante, Alicante

08916

ICO Badalona - Hospital Germans Trias i Pujol, Badalona

08028

Hospital Universitari Quiron Dexeus, Barcelona

08035

Hospital Universitari Vall d'Hebron, Barcelona

08036

Hospital Clinic i Provincial de Barcelona, Barcelona

08908

ICO l´Hospitalet - Hospital Duran i Reynals, L'Hospitalet de Llobregat

08304

Hospital de Mataro, Mataró

06100

Hacettepe University Medical Faculty, Ankara

06500

Baskent University Ankara Hospital, Ankara

BH7 7DW

Royal Bournemouth General Hospital, Bournemouth

BS2 8ED

Bristol Haematology & Oncology Centre, Bristol

EX2 5DW

Royal Devon and Exeter Hospital (Wonford), Exeter

G12 OYN

Beatson West of Scotland Cancer Centre, Glasgow

LS9 7TF

St James's University Hospital, Leeds

NW1 2BU

University College London Hospital, London

CH63 4JY

The Clatterbridge Cancer Centre, Metropolitan Borough of Wirral

PL6 8BQ

Derriford Hospital, Plymouth

SG1 4AB

Mount Vernon Hospital, Stevenage

All Listed Sponsors
collaborator

Merck KGaA, Darmstadt, Germany

INDUSTRY

lead

EMD Serono Research & Development Institute, Inc.

INDUSTRY

NCT02395172 - Avelumab in Non-Small Cell Lung Cancer (JAVELIN Lung 200) | Biotech Hunter | Biotech Hunter