AzTrials
AzTrials

Carcinoma, Non-Small-Cell LungPhase 3NCT02395172

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

A Phase 3 study testing Avelumab and Docetaxel in people with Carcinoma, Non-Small-Cell Lung, run by EMD Serono Research & Development Institute, Inc. at 260 sites in 29 countries.

Completed

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

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carcinoma, Non-Small-Cell Lung
What is being tested?
Avelumab and Docetaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
792 participants
Where
260 sitesin 29 countries
Study dates
24 Mar 2015to 3 Dec 2019
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

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

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

Who may be able to join

  • 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:
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  • 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
  • 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

Who cannot join

  • 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
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  • 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:
  • Brain metastases have been treated locally, and
  • 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:
  • Participants with diabetes type I, vitiligo, psoriasis, hypo- or hyperthyroid disease not requiring immunosuppressive treatment are eligible
  • 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
  • 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

Trial locations and contacts

260 sites in 29 countries.

260 sites in 29 countries

United States27 sites

  • Abington Memorial Hospital

    Abington, Pennsylvania, 19001

  • Pacific Cancer Medical Center, Inc.

    Anaheim, California, 92801

  • Northeast Georgia Cancer Care, LLC

    Athens, Georgia, 30607

  • Lynn Cancer Institute Center

    Boca Raton, Florida, 33486

  • University Cancer Institute

    Boynton Beach, Florida, 33426

  • Oncology Hematology Care

    Cincinnati, Ohio, 45242

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • Holy Cross Hospital Inc.

    Fort Lauderdale, Florida, 33308

  • Florida Cancer Specialists-Broadway

    Fort Myers, Florida, 33916

  • The Center for Cancer and Blood Disorders

    Fort Worth, Texas, 76104

  • Penn State Univ. Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033

  • Center for Biomedical Research, LLC

    Knoxville, Tennessee, 37909

  • Healing Hands Oncology and Medical Care

    Lawndale, California, 90260

  • Metairie Oncologist, LLC

    Metairie, Louisiana, 70006

  • Signal Point Clinical Research Center

    Middletown, Ohio, 45042

  • Sutter Gould Medical Foundation

    Modesto, California, 95355

  • SCRI - Tennessee Oncology

    Nashville, Tennessee, 37203

  • Hematology Oncology Associates of Rockland

    Nyack, New York, 10960

  • Mercy Clinic Oklahoma Communities, Inc.

    Oklahoma City, Oklahoma, 73120-9309

  • Sharp Memorial Hospital

    San Diego, California, 92123

  • Mayo Clinic

    Scottsdale , Phoenix, Arizona, 85259-5499

  • Florida Cancer Specialists

    St. Petersburg, Florida, 33705

  • MultiCare Health System

    Tacoma, Washington, 98405

  • University of Alabama

    Tuscaloosa, Alabama, 35401

  • University of Texas Health Science Center at Tyler

    Tyler, Texas, 75708

  • Florida Cancer Specialists

    West Palm Beach, Florida, 33401

  • Novant Health Oncology Specialists

    Winston-Salem, North Carolina, 27103

Other trials in United States

Japan23 sites

  • National Cancer Center Hospital

    Chūōku, 104-0045

  • NHO Kyushu Cancer Center

    Fukuoka, 811-1395

  • Osaka Prefectural Medical Center for Respiratory and Allergic Diseases

    Habikino-shi, 583-8588

  • Hiroshima City Hiroshima Citizens Hospital

    Hiroshima, 730-8518

  • National Cancer Center Hospital East

    Kashiwa-shi, 277-8577

  • Saitama Cancer Center

    Kitaadachi-gun, 362-0806

  • Institute of Biomedical Research and Innovation Hospital

    Kobe, 650-0047

  • Kobe City Hospital Organization Kobe City Medical Center General Hospital

    Kobe, 650-0047

  • Cancer Institute Hospital of JFCR

    Kōtoku, 135-8550

  • Kurume University Hospital

    Kurume-shi, 830-0011

  • Miyagi Cancer Center

    Natori-shi, 981-1293

  • Aichi Cancer Center Hospital

    Okazaki-shi, 444-0011

  • Osaka City General Hospital

    Osaka, 534-0021

  • Osaka Medical Center for Cancer and Cardiovascular Diseases

    Osaka, 537-8511

  • Kinki University Hospital

    Osakasayama-shi, 589-8511

  • Kitasato University Hospital

    Sagamihara-shi, 252-0375

  • NHO Hokkaido Cancer Center

    Sapporo, 003-0804

  • Hokkaido University Hospital

    Sapporo, 060-8648

  • Tokyo Medical University Hospital

    Shinjuku-ku, 160-0023

  • Toyama University Hospital

    Toyama, 930-0194

  • Wakayama Medical University Hospital

    Wakayama, 641-8510

  • Yokohama Municipal Citizen's Hospital

    Yokohama, 240-8555

  • Kanagawa Cancer Center

    Yokohama, 241-8515

Other trials in Japan

Brazil16 sites

  • Cenantron - Centro Avançado de Tratamento Oncológico S/C Ltda

    Belo Horizonte, 30110-921

  • CEPON - Centro de Pesquisas Oncológicas de Santa Catarina

    Florianópolis, 88034-000

  • Hospital de Caridade de Ijuí

    Ijuí, 98700-000

  • Clínica de Neoplasias Litoral Ltda.

    Itajaí, 88310-110

  • CMiP - Centro Mineiro de Pesquisa

    Juiz de Fora, 36010-570

  • Hospital Bruno Born

    Lajeado, 95900-000

  • Liga Norte-Rio-Grandense Contra o Câncer

    Natal, 59075-740

  • Oncosinos - Clínica de Oncologia - Hospital Regina

    Novo Hamburgo, 93510-250

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

    Passo Fundo, 99010-260

  • Hospital Mãe de Deus

    Porto Alegre, 90110-270

  • Hospital São Lucas da PUCRS

    Porto Alegre, 90610-000

  • COI - Clínicas Oncológicas Integradas

    Rio de Janeiro, 22793-080

  • CEPHO - Centro de Estudos e Pesquisas em Hematologia e Oncologia

    Santo André, 09060-650

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

    São José do Rio Preto, 15090-000

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

    São Paulo, 01246-000

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

    Sorocaba, 18030-075

Other trials in Brazil

Spain15 sites

  • Hospital General Universitario de Alicante

    Alicante, 03010

  • ICO Badalona - Hospital Germans Trias i Pujol

    Badalona, 08916

  • Hospital Universitari Quiron Dexeus

    Barcelona, 08028

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

  • Hospital Clinic i Provincial de Barcelona

    Barcelona, 08036

  • ICO l´Hospitalet - Hospital Duran i Reynals

    L'Hospitalet de Llobregat, 08908

  • Hospital Universitario Materno-Infantil de Canarias

    Las Palmas de Gran Canaria, 35016

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034

  • Centro Integral Oncologico Clara Campal

    Madrid, 28050

  • Hospital Clinico Universitario Virgen de la Victoria

    Málaga, 29010

  • Hospital de Mataro

    Mataró, 08304

  • Complejo Hospitalario Universitario de Santiago

    Santiago de Compostela, 15706

  • Hospital Universitario Virgen Macarena

    Seville, 41009

  • Hospital Universitario Virgen del Rocio

    Seville, 41013

  • Hospital Universitari i Politecnic La Fe

    Valencia, 46026

Other trials in Spain

Argentina13 sites

  • Hospital Italiano Regional del Sur

    Bahía Blanca, B8001HXM

  • Clínica Universitaria Privada Reina Fabiola

    Barrio General Paz, X5004FHP

  • Centro de Oncologia e Investigacion Buenos Aires

    Berazategui, B1880BBF

  • Instituto Medico Especializado Alexander Fleming

    Ciudad Autonoma Buenos Aires, C1426ANZ

  • CEMIC

    Ciudad Autonoma Buenos Aires, C1431FWO

  • Instituto DAMIC Fundacion Rusculleda

    Córdoba, X5003DCE

  • Centro Oncologico Riojano Integral (Cori)

    La Rioja, F5300COE

  • Centro Oncologico de Parana

    Paraná, 3100

  • Hospital Universitario Austral

    Pilar, B1629ODT

  • Instituto Gamma

    Rosario, S2000CRF

  • Sanatorio Parque S.A.

    Rosario, S2000DSV

  • Instituto de Oncología de Rosario

    Rosario, S2000KZE

  • Centro Medico San Roque S.R.L.

    San Miguel de Tucumán, 4000

Other trials in Argentina

Italy13 sites

  • Azienda Ospedaliera Istituti Ospitalieri di Cremona

    Cremona, 26100

  • Ospedale Mater Salutis

    Legnago (VR), 37045

  • Ospedale Versilia

    Lido di Camaiore, 55043

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, 20133

  • IEO Istituto Europeo di Oncologia

    Milan, 20141

  • Seconda Università degli Studi di Napoli

    Naples, 80131

  • Azienda Ospedaliero Universitaria Pisana

    Pisa, 56124

  • Università Campus Bio-Medico di Roma

    Roma, 00128

  • Istituto Nazionale Tumori Regina Elena IRCCS

    Roma, 00144

  • Policlinico Universitario Agostino Gemelli

    Roma, 00168

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

    Roma, 00189

  • A.O.U. Senese Policlinico Santa Maria alle Scotte

    Siena, 53100

  • Azienda Ospedaliera Ospedale Treviglio-Caravaggio di Treviglio

    Treviglio, 24047

Other trials in Italy

France11 sites

  • ICO - Site Paul Papin

    Angers, 49933

  • CHU Besançon - Hôpital Jean Minjoz

    Besançon, 25030

  • Clinique Victor Hugo - Centre Jean Bernard

    Le Mans, 72000

  • Hôpital Nord - AP-HM Marseille#

    Marseille, 13915

  • Centre Catherine de Sienne

    Nantes, 44202

  • Centre Antoine Lacassagne

    Nice, 06189

  • Groupe Hospitalier Sud - Hôpital Haut-Lévêque

    Pessac, 33604

  • CHU Poitiers - Hôpital la Milétrie

    Poitiers, 86021

  • ICO - Site René Gauducheau

    Saint-Herblain, 44805

  • CHU Strasbourg - Nouvel Hôpital Civil

    Strasbourg, 67091

  • CHU de Toulouse - Hôpital Larrey

    Toulouse, 31059

Other trials in France

Turkey (Türkiye)11 sites

  • Hacettepe University Medical Faculty

    Ankara, 06100

  • Baskent University Ankara Hospital

    Ankara, 06500

  • Ankara University Medical Faculty

    Ankara

  • Trakya University Medical Faculty

    Edirne, 22030

  • Bezmi Alem Foundation University Medical Faculty Hospital

    Istanbul, 34093

  • Istanbul University Cerrahpasa Medical Faculty

    Istanbul, 34098

  • Fatih Universitesi Tip Fakultesi

    Istanbul, 34500

  • Marmara University Pendik Research and Training Center

    Istanbul, 34899

  • Ege University Medical Faculty

    Izmir, 35100

  • Dokuz Eylul University Medicine Faculty

    Izmir, 35340

  • Konya Necmettin Erbakan University Meram Faculty of Medicine

    Konya, 42080

Other trials in Turkey (Türkiye)

Colombia10 sites

  • Fundacion Cardioinfantil Instituto de Cardiologia

    Bogotá, 110131

  • Instituto Nacional de Cancerologia E.S.E.

    Bogotá, 111511

  • Administradora Country S.A.

    Bogotá

  • Clinica Colsanitas S.A. sede Clinica Universitaria Colombia

    Bogotá

  • Fundación Valle del Lilí

    Cali, 760032

  • Centro Medico Imbanaco

    Cali, 760042

  • Hemato Oncologos S.A.

    Cali

  • Hospital Pablo Tobón Uribe

    Medellín, 050034

  • Instituto de Cancerologia S.A.

    Medellín

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

    Montería

Other trials in Colombia

South Korea10 sites

  • Chungbuk National University Hospital

    Cheongju-si, 28644

  • Chonnam National University Hwasun Hospital

    Hwasun-gun, 519-763

  • Gachon University Gil Medical Center

    Incheon, 21565

  • Seoul National University Bundang Hospital

    Seongnam-si, 13620

  • Asan Medical Center

    Seoul, 05505

  • Samsung Medical Center

    Seoul, 06351

  • Korea University Guro Hospital

    Seoul, 08308

  • Korea University Anam Hospital

    Seoul, 136-705

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

    Seoul, 137-701

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

    Suwon, 16247

Other trials in South Korea

Australia9 sites

  • Ballarat Base Hospital

    Ballarat, 3350

  • Box Hill Hospital

    Box Hill, 3128

  • Coffs Harbour Base Hospital

    Coffs Harbour, 2450

  • Lyell McEwin Hospital

    Elizabeth Vale, 5112

  • Greenslopes Private Hospital

    Greenslopes, 4120

  • Lismore Base Hospital

    Lismore, 2480

  • Royal Melbourne Hospital

    Parkville, 3050

  • St John of God Hospital

    Subiaco, 6008

  • Princess Alexandra Hospital

    Woolloongabba, 4102

Other trials in Australia

Israel9 sites

  • Assaf Harofeh Medical Center

    Beer Yaakov, 70300

  • Soroka Medical Center

    Beersheba, 84101

  • Rambam Health Care Campus

    Haifa, 3109601

  • The Lady Davis Carmel Medical Center

    Haifa, 34361

  • Hadassah University Hospital - Ein Kerem

    Jerusalem, 9112001

  • Sapir Medical Center, Meir Hospital

    Kfar Saba, 4428164

  • Rabin Medical Center-Beilinson Campus

    Petah Tikva, 4941492

  • Chaim Sheba Medical Center

    Ramat Gan, 52621

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 64239

Other trials in Israel

United Kingdom9 sites

  • Royal Bournemouth General Hospital

    Bournemouth, BH7 7DW

  • Bristol Haematology & Oncology Centre

    Bristol, BS2 8ED

  • Royal Devon and Exeter Hospital (Wonford)

    Exeter, EX2 5DW

  • Beatson West of Scotland Cancer Centre

    Glasgow, G12 OYN

  • St James's University Hospital

    Leeds, LS9 7TF

  • University College London Hospital

    London, NW1 2BU

  • The Clatterbridge Cancer Centre

    Metropolitan Borough of Wirral, CH63 4JY

  • Derriford Hospital

    Plymouth, PL6 8BQ

  • Mount Vernon Hospital

    Stevenage, SG1 4AB

Other trials in United Kingdom

Mexico8 sites

  • Phylasis Clinicas Research S de RL de CV

    Cuautitlán Izcalli, 54769

  • Instituto de Investigaciones Aplicadas a la Neurociencia A.C.

    Durango, 34000

  • Fundacion Rodolfo Padilla Padilla, A.C.

    León, 37000

  • Health Pharma Professional Research S.A. de C.V.

    México, 03810

  • Winsett Rethman S.A. de C.V.

    Monterrey, 64060

  • Centro de Investigacion Clinica Chapultepec S.A. de C.V.

    Morelia, 58260

  • Oaxaca Site Management Organization S.C.

    Oaxaca City, 68000

  • Centro Oncologico Estatal ISSEMyM

    Toluca, 50180

Other trials in Mexico

Peru7 sites

  • Clinica Monte Carmelo

    Arequipa, 04000

  • Hospital Nacional Almanzor Aguinaga Asenjo

    Chiclayo, 14001

  • Hospital Nacional Adolfo Guevara Velasco

    Cusco

  • Clinica San Borja

    Lima, 15000

  • Hospital Nacional Guillermo Almenara Irigoyen

    Lima, Lima 13

  • Clínica Ricardo Palma

    Lima, LIMA 27

  • Instituto Nacional de Enfermedades Neoplásicas

    Lima, LIMA 34

Other trials in Peru

Poland7 sites

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

    Brzozów, 36-200

  • Wojewodzkie Centrum Szpitalne Kotliny Jeleniogorskiej

    Jelenia Góra, 58-506

  • Samodzielny Publiczny Szpital Kliniczny nr 5 SUM

    Katowice, 40-514

  • Centrum Terapii Wspolczesnej J.M. Jasnorzewska sp. komandytowo-akcyjna

    Lodz, 90-242

  • KO-MED Centra Kliniczne Lublin II

    Lublin, 20-362

  • SSZZOZ im. Dr Teodora Dunina w Rudce

    Mrozy, 05-320

  • Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy

    Otwock, 05-400

Other trials in Poland

Belgium6 sites

  • UZ Antwerpen

    Edegem, 2650

  • Grand Hôpital de Charleroi

    Gilly, 6060

  • UZ Leuven

    Leuven, 3000

  • Centre Hospitalier de l'Ardenne

    Libramont, 6800

  • C. H. U. Sart Tilman

    Liège, 4000

  • AZ Delta

    Roeselare, 8800

Other trials in Belgium

Bulgaria6 sites

  • UMHAT 'Dr. Georgi Stranski', EAD

    Pleven, 5800

  • Complex Oncological Center - Plovdiv, EOOD

    Plovdiv, 4004

  • MHAT "Serdika", EOOD

    Sofia, 1303

  • MHAT 'Tokuda Hospital Sofia', AD

    Sofia, 1407

  • Shato, Ead

    Sofia, 1756

  • MHAT 'Sv. Marina', EAD

    Varna, 9010

Other trials in Bulgaria

Chile6 sites

  • Instituto de Terapias Oncologicas Providencia

    Santiago, 7500000

  • FALP - Fundación Arturo López Pérez

    Santiago, 7500921

  • CIEC - Centro Internacional de Estudios Clínicos

    Santiago, 8420383

  • Instituto Clinico Oncologico del Sur (ICOS)

    Temuco

  • Centro de Investigaciones Clinicas Viña del Mar

    Viña del Mar, 2540364

  • Hospital Clinico Viña del Mar

    Viña del Mar

Other trials in Chile

Romania6 sites

  • Spitalul Judetean de Urgenta Alba Iulia

    Alba Iulia, 510077

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

    Baia Mare, 430031

  • Policlinica de Diagnostic Rapid SRL

    Brasov, 500152

  • Spitalul Clinic Municipal "Dr. Gavril Curteanu" Oradea

    Oradea, 410469

  • Spital Lotus SRL

    Ploieşti, 100011

  • S.C Oncocenter Oncologie Clinica S.R.L

    Timișoara, 300210

Other trials in Romania

Russia6 sites

  • SHI "Republican Clinical Oncological Dispensary of HM RT"

    Kazan', 420029

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

    Moscow, 111123

  • FSBHI Clinical research institute of phthisiopulmonology

    Saint Petersburg, 191036

  • Pavlov First Saint Petersburg State Medical University

    Saint Petersburg, 197022

  • St. Petersburg SHI "City Clinical Oncology Dispensary"

    Saint Petersburg, 197022

  • FBI "Scientific Research Institute of Oncology n. a. N. N. Petrov"

    Saint Petersburg, 197758

Other trials in Russia

Taiwan6 sites

  • Taichung Veterans General Hospital

    Taichung, 40705

  • National Cheng Kung University Hospital

    Tainan, 704

  • National Taiwan University Hospital

    Taipei, 100

  • Taipei Veterans General Hospital

    Taipei, 112

  • Tri-Service General Hospital

    Taipei, 11490

  • Chang Gung Memorial Hospital, Linkou

    Taoyuan County, 333

Other trials in Taiwan

Czechia5 sites

  • Masarykuv onkologicky ustav

    Brno, 65653

  • Nemocnice Novy Jicin a.s.

    Nový Jičín, 74101

  • Multiscan s.r.o.

    Pardubice, 53203

  • Vseobecna fakultni nemocnice V Praze

    Prague, 12808

  • Thomayerova nemocnice

    Prague, 14059

Other trials in Czechia

Hungary5 sites

  • Semmelweis Egyetem AOK

    Budapest, 1125

  • Uzsoki Utcai Korhaz

    Budapest, 1145

  • Petz Aladar Megyei Oktato Korhaz

    Győr, 9024

  • Miskolci Semmelweis Korhaz es Egyetemi Oktatokorhaz

    Miskolc, 3529

  • Tudogyogyintezet Torokbalint

    Törökbálint, 2045

Other trials in Hungary

South Africa5 sites

  • GVI Cape Gate Oncology Centre

    Cape Town, 7570

  • GVI Rondebosch Oncology Centre

    Cape Town, 7700

  • GVI Langenhoven Drive Oncology Centre

    Port Elizabeth, 6045

  • University of Pretoria Oncology Department

    Pretoria, 0002

  • Mary Potter Oncology Centre

    Pretoria, 0181

Other trials in South Africa

Croatia4 sites

  • General Hospital Dubrovnik

    Dubrovnik, 20000

  • General Hospital Zadar

    Zadar, 23000

  • Clinical Hospital Centar "Sestre Milosrdnice"

    Zagreb, 10000

  • University Clinic for Pulmonary Diseases

    Zagreb, 10000

Other trials in Croatia

Slovakia4 sites

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

    Bardejov, 08501

  • Univerzitna nemocnica Bratislava, Nemocnica Ruzinov

    Bratislava, 82606

  • Ustredna vojenska nemocnica SNP Ruzomberok- Fakultna nemocnica

    Ružomberok, 03426

  • Fakultna nemocnica Trnava

    Trnava, 91708

Other trials in Slovakia

Denmark2 sites

  • Herlev Hospital

    Herlev, 2730

  • Odense Universitetshospital

    Odense C, 5000

Other trials in Denmark

Switzerland1 site

  • Kantonsspital Graubuenden

    Chur, 7000

Other trials in Switzerland

About this study

Official title: 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.

Being tested
Avelumab, Docetaxel
Keywords
Avelumab, MSB0010718C, Non-Small Cell Lung Cancer, Anti-PD-L1
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

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

  • AvelumabDrug

    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.

  • DocetaxelDrug

    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.

Study groups in NCT02395172
Study groupRoleWhat they receive
AvelumabExperimentalNot described
Receives: Drug: Avelumab
DocetaxelActive comparatorNot described
Receives: Drug: Docetaxel

What is being measured

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

  1. Overall Survival (OS) Time in Programmed Death Ligand 1 (PD-L1) + Full Analysis Set Population (FAS)

    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.

    Measured: Time from date of randomization up to 1420 days

Secondary outcomes (15)

  1. Overall Survival (OS) Time in Full Analysis Set Population

    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.

    Measured: Time from date of randomization up to 1420 days

  2. Progression-Free Survival (PFS) Time in PD-L1+ Full Analysis Set Population

    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.

    Measured: Time from date of randomization up to 907 days

  3. Progression-Free Survival (PFS) Time in Full Analysis Set Population

    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.

    Measured: Time from date of randomization up to 907 days

  4. Number of Participants With Confirmed Best Overall Response (BOR) as Assessed by an Independent Endpoint Review Committee (IERC) in Full Analysis Set Population

    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.

    Measured: Time from date of randomization up to 907 days

  5. Number of Participants With Confirmed Best Overall Response (BOR) as Assessed by Independent Endpoint Review Committee (IERC) in PD-L1+ Full Analysis Set Population

    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.

    Measured: Time from date of randomization up to 907 days

  6. Percentage of Participants With Objective Response as Assessed by Independent Endpoint Review Committee (IERC) in Full Analysis Set Population

    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.

    Measured: Time from date of randomization up to 907 days

  7. Percentage of Participants With Objective Response as Assessed by Independent Endpoint Review Committee (IERC) in PD-L1+ Full Analysis Set Population

    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.

    Measured: Time from date of randomization up to 907 days

  8. 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)

    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).

    Measured: Baseline, End of treatment visit (up to Week 124)

  9. 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)

    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.

    Measured: Baseline, End of treatment visit (up to Week 124)

  10. 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)

    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.

    Measured: Baseline, End of treatment visit (up to Week 124)

  11. 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)

    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).

    Measured: Baseline, End of treatment visit (up to Week 124)

  12. 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

    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.

    Measured: Time from date of randomization up to 1420 days

  13. Number of Participants With Treatment Emergent Adverse Events (TEAEs) by Severity

    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.

    Measured: Time from date of randomization up to 1420 days

  14. Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance: Baseline Score vs. Worst Post-baseline Score

    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.

    Measured: Time from date of randomization up to 1420 days

  15. Number of Participants With Positive Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs) for Avelumab

    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.

    Measured: Time from date of randomization up to 1420 days

Timeline

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

  1. First posted20 Mar 2015 (estimated)
  2. Study start24 Mar 2015
  3. Primary completion22 Nov 2017
  4. Study completion3 Dec 2019

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
792 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02395172
Sponsor's protocol ID
100070-004
Other IDs
2014-005060-15, 2014
Status last verified
Jul 2020
First submitted
27 Feb 2015
Last updated
3 Aug 2020
Data monitoring committee
Yes
Individual data sharing
Yes: 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

Publications

  • Coon CD, Schlichting M, Zhang X. Interpreting Within-Patient Changes on the EORTC QLQ-C30 and EORTC QLQ-LC13. Patient. 2022 Nov;15(6):691-702. doi: 10.1007/s40271-022-00584-w. Epub 2022 Jun 30.

    PubMed 35771392

  • Hrinczenko B, Iannotti N, Goel S, Spigel D, Safran H, Taylor MH, Bennouna J, Wong DJ, Kelly K, Verschraegen C, Bajars M, Manitz J, Ruisi M, Gulley JL. Long-term avelumab in advanced non-small-cell lung cancer: summaries and post hoc analyses from JAVELIN Solid Tumor. Future Oncol. 2022 Apr;18(11):1333-1342. doi: 10.2217/fon-2021-0930. Epub 2022 Feb 11.

    PubMed 35144482

  • Park K, Ozguroglu M, Vansteenkiste J, Spigel D, Yang JC, Bajars M, Ruisi M, Manitz J, Barlesi F. Impact of subsequent immune checkpoint inhibitor treatment on overall survival with avelumab vs docetaxel in platinum-treated advanced NSCLC: Post hoc analyses from the phase 3 JAVELIN Lung 200 trial. Lung Cancer. 2021 Apr;154:92-98. doi: 10.1016/j.lungcan.2021.01.026. Epub 2021 Feb 6.

    PubMed 33636453

  • Barlesi F, Vansteenkiste J, Spigel D, Ishii H, Garassino M, de Marinis F, Ozguroglu M, Szczesna A, Polychronis A, Uslu R, Krzakowski M, Lee JS, Calabro L, Aren Frontera O, Ellers-Lenz B, Bajars M, Ruisi M, Park K. Avelumab versus docetaxel in patients with platinum-treated advanced non-small-cell lung cancer (JAVELIN Lung 200): an open-label, randomised, phase 3 study. Lancet Oncol. 2018 Nov;19(11):1468-1479. doi: 10.1016/S1470-2045(18)30673-9. Epub 2018 Sep 24.

    PubMed 30262187

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Avelumab and Docetaxel in people with Carcinoma, Non-Small-Cell Lung, run by EMD Serono Research & Development Institute, Inc. at 260 sites in 29 countries.

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

Who may be eligible to take part?

The sponsor lists 15 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 260 sites in United States, Japan, Brazil, Spain, Argentina and 24 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

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

What does this phase mean?

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

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Dec 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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

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

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02395172, which also lists 4 linked publications.

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

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

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2020.

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