Avelumab in Non-Small Cell Lung Cancer (JAVELIN Lung 200)
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
2 other identifiers
interventional
792
29 countries
260
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Mar 2015
Longer than P75 for phase_3
260 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 27, 2015
CompletedFirst Posted
Study publicly available on registry
March 20, 2015
CompletedStudy Start
First participant enrolled
March 24, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 22, 2017
CompletedResults Posted
Study results publicly available
December 13, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 3, 2019
CompletedAugust 3, 2020
July 1, 2020
2.7 years
February 27, 2015
November 20, 2018
July 20, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
Time from date of randomization up to 1420 days
Secondary Outcomes (15)
Overall Survival (OS) Time in Full Analysis Set Population
Time from date of randomization up to 1420 days
Progression-Free Survival (PFS) Time in PD-L1+ Full Analysis Set Population
Time from date of randomization up to 907 days
Progression-Free Survival (PFS) Time in Full Analysis Set Population
Time from date of randomization up to 907 days
Number of Participants With Confirmed Best Overall Response (BOR) as Assessed by an Independent Endpoint Review Committee (IERC) in Full Analysis Set Population
Time from date of randomization up to 907 days
Number of Participants With Confirmed Best Overall Response (BOR) as Assessed by Independent Endpoint Review Committee (IERC) in PD-L1+ Full Analysis Set Population
Time from date of randomization up to 907 days
- +10 more secondary outcomes
Study Arms (2)
Avelumab
EXPERIMENTALDocetaxel
ACTIVE COMPARATORInterventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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:
- 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).
You may not qualify if:
- In the United States only, participants with a squamous cell histology will be excluded
- Systemic anticancer therapy administered after disease progression during or following a platinum based combination
- Participants with non-squamous cell NSCLC whose disease harbors EGFR mutation(s) and/or anaplastic lymphoma kinase (ALK) rearrangement will not be eligible for this trial. Participants of unknown ALK and/or EGFR mutation status will require testing at screening (local laboratory, or central laboratory if local testing is not available)
- Prior therapy with any antibody/drug targeting T cell coregulatory proteins (immune checkpoints) such as PD-1, PD L1, or cytotoxic T lymphocyte antigen-4 (CTLA-4).
- Concurrent anticancer treatment
- Major surgery for any reason, except diagnostic biopsy, within 4 weeks of randomization and/or if the participant has not fully recovered from the surgery within 4 weeks of randomization
- Participants receiving immunosuppressive agents (such as steroids) for any reason should be tapered off these drugs before initiation of the trial treatment.
- All participants with brain metastases, except those meeting the following criteria:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (260)
University of Alabama
Tuscaloosa, Alabama, 35401, United States
Mayo Clinic
Scottsdale , Phoenix, Arizona, 85259-5499, United States
Pacific Cancer Medical Center, Inc.
Anaheim, California, 92801, United States
Healing Hands Oncology and Medical Care
Lawndale, California, 90260, United States
Sutter Gould Medical Foundation
Modesto, California, 95355, United States
Sharp Memorial Hospital
San Diego, California, 92123, United States
Lynn Cancer Institute Center
Boca Raton, Florida, 33486, United States
University Cancer Institute
Boynton Beach, Florida, 33426, United States
Holy Cross Hospital Inc.
Fort Lauderdale, Florida, 33308, United States
Florida Cancer Specialists-Broadway
Fort Myers, Florida, 33916, United States
Florida Cancer Specialists
St. Petersburg, Florida, 33705, United States
Florida Cancer Specialists
West Palm Beach, Florida, 33401, United States
Northeast Georgia Cancer Care, LLC
Athens, Georgia, 30607, United States
Metairie Oncologist, LLC
Metairie, Louisiana, 70006, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
Hematology Oncology Associates of Rockland
Nyack, New York, 10960, United States
Novant Health Oncology Specialists
Winston-Salem, North Carolina, 27103, United States
Oncology Hematology Care
Cincinnati, Ohio, 45242, United States
Signal Point Clinical Research Center
Middletown, Ohio, 45042, United States
Mercy Clinic Oklahoma Communities, Inc.
Oklahoma City, Oklahoma, 73120-9309, United States
Abington Memorial Hospital
Abington, Pennsylvania, 19001, United States
Penn State Univ. Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
Center for Biomedical Research, LLC
Knoxville, Tennessee, 37909, United States
SCRI - Tennessee Oncology
Nashville, Tennessee, 37203, United States
The Center for Cancer and Blood Disorders
Fort Worth, Texas, 76104, United States
University of Texas Health Science Center at Tyler
Tyler, Texas, 75708, United States
MultiCare Health System
Tacoma, Washington, 98405, United States
Hospital Italiano Regional del Sur
Bahía Blanca, B8001HXM, Argentina
Clínica Universitaria Privada Reina Fabiola
Barrio General Paz, X5004FHP, Argentina
Centro de Oncologia e Investigacion Buenos Aires
Berazategui, B1880BBF, Argentina
Instituto Medico Especializado Alexander Fleming
Ciudad Autonoma Buenos Aires, C1426ANZ, Argentina
CEMIC
Ciudad Autonoma Buenos Aires, C1431FWO, Argentina
Instituto DAMIC Fundacion Rusculleda
Córdoba, X5003DCE, Argentina
Centro Oncologico Riojano Integral (Cori)
La Rioja, F5300COE, Argentina
Centro Oncologico de Parana
Paraná, 3100, Argentina
Hospital Universitario Austral
Pilar, B1629ODT, Argentina
Instituto Gamma
Rosario, S2000CRF, Argentina
Sanatorio Parque S.A.
Rosario, S2000DSV, Argentina
Instituto de Oncología de Rosario
Rosario, S2000KZE, Argentina
Centro Medico San Roque S.R.L.
San Miguel de Tucumán, 4000, Argentina
Ballarat Base Hospital
Ballarat, 3350, Australia
Box Hill Hospital
Box Hill, 3128, Australia
Coffs Harbour Base Hospital
Coffs Harbour, 2450, Australia
Lyell McEwin Hospital
Elizabeth Vale, 5112, Australia
Greenslopes Private Hospital
Greenslopes, 4120, Australia
Lismore Base Hospital
Lismore, 2480, Australia
Royal Melbourne Hospital
Parkville, 3050, Australia
St John of God Hospital
Subiaco, 6008, Australia
Princess Alexandra Hospital
Woolloongabba, 4102, Australia
UZ Antwerpen
Edegem, 2650, Belgium
Grand Hôpital de Charleroi
Gilly, 6060, Belgium
UZ Leuven
Leuven, 3000, Belgium
Centre Hospitalier de l'Ardenne
Libramont, 6800, Belgium
C. H. U. Sart Tilman
Liège, 4000, Belgium
AZ Delta
Roeselare, 8800, Belgium
Cenantron - Centro Avançado de Tratamento Oncológico S/C Ltda
Belo Horizonte, 30110-921, Brazil
CEPON - Centro de Pesquisas Oncológicas de Santa Catarina
Florianópolis, 88034-000, Brazil
Hospital de Caridade de Ijuí
Ijuí, 98700-000, Brazil
Clínica de Neoplasias Litoral Ltda.
Itajaí, 88310-110, Brazil
CMiP - Centro Mineiro de Pesquisa
Juiz de Fora, 36010-570, Brazil
Hospital Bruno Born
Lajeado, 95900-000, Brazil
Liga Norte-Rio-Grandense Contra o Câncer
Natal, 59075-740, Brazil
Oncosinos - Clínica de Oncologia - Hospital Regina
Novo Hamburgo, 93510-250, Brazil
CITO - Centro Integrado de Terapia Onco-Hematológica - Hospital da Cidade de Passo Fundo
Passo Fundo, 99010-260, Brazil
Hospital Mãe de Deus
Porto Alegre, 90110-270, Brazil
Hospital São Lucas da PUCRS
Porto Alegre, 90610-000, Brazil
COI - Clínicas Oncológicas Integradas
Rio de Janeiro, 22793-080, Brazil
CEPHO - Centro de Estudos e Pesquisas em Hematologia e Oncologia
Santo André, 09060-650, Brazil
Fundação Faculdade Regional de Medicina de São José do Rio Preto
São José do Rio Preto, 15090-000, Brazil
ICESP - Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira
São Paulo, 01246-000, Brazil
IOS - Instituto de Oncologia de Sorocaba "Dr. Gilson Delgado"
Sorocaba, 18030-075, Brazil
UMHAT 'Dr. Georgi Stranski', EAD
Pleven, 5800, Bulgaria
Complex Oncological Center - Plovdiv, EOOD
Plovdiv, 4004, Bulgaria
MHAT "Serdika", EOOD
Sofia, 1303, Bulgaria
MHAT 'Tokuda Hospital Sofia', AD
Sofia, 1407, Bulgaria
Shato, Ead
Sofia, 1756, Bulgaria
MHAT 'Sv. Marina', EAD
Varna, 9010, Bulgaria
Instituto de Terapias Oncologicas Providencia
Santiago, 7500000, Chile
FALP - Fundación Arturo López Pérez
Santiago, 7500921, Chile
CIEC - Centro Internacional de Estudios Clínicos
Santiago, 8420383, Chile
Instituto Clinico Oncologico del Sur (ICOS)
Temuco, Chile
Centro de Investigaciones Clinicas Viña del Mar
Viña del Mar, 2540364, Chile
Hospital Clinico Viña del Mar
Viña del Mar, Chile
Fundacion Cardioinfantil Instituto de Cardiologia
Bogotá, 110131, Colombia
Instituto Nacional de Cancerologia E.S.E.
Bogotá, 111511, Colombia
Administradora Country S.A.
Bogotá, Colombia
Clinica Colsanitas S.A. sede Clinica Universitaria Colombia
Bogotá, Colombia
Fundación Valle del Lilí
Cali, 760032, Colombia
Centro Medico Imbanaco
Cali, 760042, Colombia
Hemato Oncologos S.A.
Cali, Colombia
Hospital Pablo Tobón Uribe
Medellín, 050034, Colombia
Instituto de Cancerologia S.A.
Medellín, Colombia
IPS IMAT- Instituto Medico de Alta Tecnologia - Oncomedica S.A.
Montería, Colombia
General Hospital Dubrovnik
Dubrovnik, 20000, Croatia
General Hospital Zadar
Zadar, 23000, Croatia
Clinical Hospital Centar "Sestre Milosrdnice"
Zagreb, 10000, Croatia
University Clinic for Pulmonary Diseases
Zagreb, 10000, Croatia
Masarykuv onkologicky ustav
Brno, 65653, Czechia
Nemocnice Novy Jicin a.s.
Nový Jičín, 74101, Czechia
Multiscan s.r.o.
Pardubice, 53203, Czechia
Vseobecna fakultni nemocnice V Praze
Prague, 12808, Czechia
Thomayerova nemocnice
Prague, 14059, Czechia
Herlev Hospital
Herlev, 2730, Denmark
Odense Universitetshospital
Odense C, 5000, Denmark
ICO - Site Paul Papin
Angers, 49933, France
CHU Besançon - Hôpital Jean Minjoz
Besançon, 25030, France
Clinique Victor Hugo - Centre Jean Bernard
Le Mans, 72000, France
Hôpital Nord - AP-HM Marseille#
Marseille, 13915, France
Centre Catherine de Sienne
Nantes, 44202, France
Centre Antoine Lacassagne
Nice, 06189, France
Groupe Hospitalier Sud - Hôpital Haut-Lévêque
Pessac, 33604, France
CHU Poitiers - Hôpital la Milétrie
Poitiers, 86021, France
ICO - Site René Gauducheau
Saint-Herblain, 44805, France
CHU Strasbourg - Nouvel Hôpital Civil
Strasbourg, 67091, France
CHU de Toulouse - Hôpital Larrey
Toulouse, 31059, France
Semmelweis Egyetem AOK
Budapest, 1125, Hungary
Uzsoki Utcai Korhaz
Budapest, 1145, Hungary
Petz Aladar Megyei Oktato Korhaz
Győr, 9024, Hungary
Miskolci Semmelweis Korhaz es Egyetemi Oktatokorhaz
Miskolc, 3529, Hungary
Tudogyogyintezet Torokbalint
Törökbálint, 2045, Hungary
Assaf Harofeh Medical Center
Beer Yaakov, 70300, Israel
Soroka Medical Center
Beersheba, 84101, Israel
Rambam Health Care Campus
Haifa, 3109601, Israel
The Lady Davis Carmel Medical Center
Haifa, 34361, Israel
Hadassah University Hospital - Ein Kerem
Jerusalem, 9112001, Israel
Sapir Medical Center, Meir Hospital
Kfar Saba, 4428164, Israel
Rabin Medical Center-Beilinson Campus
Petah Tikva, 4941492, Israel
Chaim Sheba Medical Center
Ramat Gan, 52621, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, 64239, Israel
Azienda Ospedaliera Istituti Ospitalieri di Cremona
Cremona, 26100, Italy
Ospedale Mater Salutis
Legnago (VR), 37045, Italy
Ospedale Versilia
Lido di Camaiore, 55043, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, 20133, Italy
IEO Istituto Europeo di Oncologia
Milan, 20141, Italy
Seconda Università degli Studi di Napoli
Napoli, 80131, Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, 56124, Italy
Università Campus Bio-Medico di Roma
Roma, 00128, Italy
Istituto Nazionale Tumori Regina Elena IRCCS
Roma, 00144, Italy
Policlinico Universitario Agostino Gemelli
Roma, 00168, Italy
Azienda Ospedaliera Sant'Andrea-Università di Roma La Sapienza
Roma, 00189, Italy
A.O.U. Senese Policlinico Santa Maria alle Scotte
Siena, 53100, Italy
Azienda Ospedaliera Ospedale Treviglio-Caravaggio di Treviglio
Treviglio, 24047, Italy
National Cancer Center Hospital
Chūōku, 104-0045, Japan
NHO Kyushu Cancer Center
Fukuoka, 811-1395, Japan
Osaka Prefectural Medical Center for Respiratory and Allergic Diseases
Habikino-shi, 583-8588, Japan
Hiroshima City Hiroshima Citizens Hospital
Hiroshima, 730-8518, Japan
National Cancer Center Hospital East
Kashiwa-shi, 277-8577, Japan
Saitama Cancer Center
Kitaadachi-gun, 362-0806, Japan
Institute of Biomedical Research and Innovation Hospital
Kobe, 650-0047, Japan
Kobe City Hospital Organization Kobe City Medical Center General Hospital
Kobe, 650-0047, Japan
Cancer Institute Hospital of JFCR
Kōtoku, 135-8550, Japan
Kurume University Hospital
Kurume-shi, 830-0011, Japan
Miyagi Cancer Center
Natori-shi, 981-1293, Japan
Aichi Cancer Center Hospital
Okazaki-shi, 444-0011, Japan
Osaka City General Hospital
Osaka, 534-0021, Japan
Osaka Medical Center for Cancer and Cardiovascular Diseases
Osaka, 537-8511, Japan
Kinki University Hospital
Osakasayama-shi, 589-8511, Japan
Kitasato University Hospital
Sagamihara-shi, 252-0375, Japan
NHO Hokkaido Cancer Center
Sapporo, 003-0804, Japan
Hokkaido University Hospital
Sapporo, 060-8648, Japan
Tokyo Medical University Hospital
Shinjuku-ku, 160-0023, Japan
Toyama University Hospital
Toyama, 930-0194, Japan
Wakayama Medical University Hospital
Wakayama, 641-8510, Japan
Yokohama Municipal Citizen's Hospital
Yokohama, 240-8555, Japan
Kanagawa Cancer Center
Yokohama, 241-8515, Japan
Phylasis Clinicas Research S de RL de CV
Cuautitlán Izcalli, 54769, Mexico
Instituto de Investigaciones Aplicadas a la Neurociencia A.C.
Durango, 34000, Mexico
Fundacion Rodolfo Padilla Padilla, A.C.
León, 37000, Mexico
Health Pharma Professional Research S.A. de C.V.
México, 03810, Mexico
Winsett Rethman S.A. de C.V.
Monterrey, 64060, Mexico
Centro de Investigacion Clinica Chapultepec S.A. de C.V.
Morelia, 58260, Mexico
Oaxaca Site Management Organization S.C.
Oaxaca City, 68000, Mexico
Centro Oncologico Estatal ISSEMyM
Toluca, 50180, Mexico
Clinica Monte Carmelo
Arequipa, 04000, Peru
Hospital Nacional Almanzor Aguinaga Asenjo
Chiclayo, 14001, Peru
Hospital Nacional Adolfo Guevara Velasco
Cusco, Peru
Clinica San Borja
Lima, 15000, Peru
Hospital Nacional Guillermo Almenara Irigoyen
Lima, Lima 13, Peru
Clínica Ricardo Palma
Lima, LIMA 27, Peru
Instituto Nacional de Enfermedades Neoplásicas
Lima, LIMA 34, Peru
Szpital Specjalistyczny W Brzozowie, Podkarpacki Osrodek Onkologiczny Im.Ks.B.Markiewicza
Brzozów, 36-200, Poland
Wojewodzkie Centrum Szpitalne Kotliny Jeleniogorskiej
Jelenia Góra, 58-506, Poland
Samodzielny Publiczny Szpital Kliniczny nr 5 SUM
Katowice, 40-514, Poland
Centrum Terapii Wspolczesnej J.M. Jasnorzewska sp. komandytowo-akcyjna
Lodz, 90-242, Poland
KO-MED Centra Kliniczne Lublin II
Lublin, 20-362, Poland
SSZZOZ im. Dr Teodora Dunina w Rudce
Mrozy, 05-320, Poland
Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy
Otwock, 05-400, Poland
Spitalul Judetean de Urgenta Alba Iulia
Alba Iulia, 510077, Romania
Spitalul Judetean de Urgenta "Dr. Constantin Opris" Baia Mare
Baia Mare, 430031, Romania
Policlinica de Diagnostic Rapid SRL
Brasov, 500152, Romania
Spitalul Clinic Municipal "Dr. Gavril Curteanu" Oradea
Oradea, 410469, Romania
Spital Lotus SRL
Ploieşti, 100011, Romania
S.C Oncocenter Oncologie Clinica S.R.L
Timișoara, 300210, Romania
SHI "Republican Clinical Oncological Dispensary of HM RT"
Kazan', 420029, Russia
SHBI Moscow Clinical Scientific Center of Department of Healthcare of Moscow
Moscow, 111123, Russia
FSBHI Clinical research institute of phthisiopulmonology
Saint Petersburg, 191036, Russia
Pavlov First Saint Petersburg State Medical University
Saint Petersburg, 197022, Russia
St. Petersburg SHI "City Clinical Oncology Dispensary"
Saint Petersburg, 197022, Russia
FBI "Scientific Research Institute of Oncology n. a. N. N. Petrov"
Saint Petersburg, 197758, Russia
Nemocnica s poliklinikou Sv. Jakuba, n.o. Bardejov
Bardejov, 08501, Slovakia
Univerzitna nemocnica Bratislava, Nemocnica Ruzinov
Bratislava, 82606, Slovakia
Ustredna vojenska nemocnica SNP Ruzomberok- Fakultna nemocnica
Ružomberok, 03426, Slovakia
Fakultna nemocnica Trnava
Trnava, 91708, Slovakia
GVI Cape Gate Oncology Centre
Cape Town, 7570, South Africa
GVI Rondebosch Oncology Centre
Cape Town, 7700, South Africa
GVI Langenhoven Drive Oncology Centre
Port Elizabeth, 6045, South Africa
University of Pretoria Oncology Department
Pretoria, 0002, South Africa
Mary Potter Oncology Centre
Pretoria, 0181, South Africa
Chungbuk National University Hospital
Cheongju-si, 28644, South Korea
Chonnam National University Hwasun Hospital
Hwasun-gun, 519-763, South Korea
Gachon University Gil Medical Center
Incheon, 21565, South Korea
Seoul National University Bundang Hospital
Seongnam-si, 13620, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
Korea University Guro Hospital
Seoul, 08308, South Korea
Korea University Anam Hospital
Seoul, 136-705, South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, 137-701, South Korea
The Catholic University of Korea, St. Vincent's Hospital
Suwon, 16247, South Korea
Hospital General Universitario de Alicante
Alicante, 03010, Spain
ICO Badalona - Hospital Germans Trias i Pujol
Badalona, 08916, Spain
Hospital Universitari Quiron Dexeus
Barcelona, 08028, Spain
Hospital Universitari Vall d'Hebron
Barcelona, 08035, Spain
Hospital Clinic i Provincial de Barcelona
Barcelona, 08036, Spain
ICO l´Hospitalet - Hospital Duran i Reynals
L'Hospitalet de Llobregat, 08908, Spain
Hospital Universitario Materno-Infantil de Canarias
Las Palmas de Gran Canaria, 35016, Spain
Hospital Universitario Ramon y Cajal
Madrid, 28034, Spain
Centro Integral Oncologico Clara Campal
Madrid, 28050, Spain
Hospital de Mataro
Mataró, 08304, Spain
Hospital Clinico Universitario Virgen de la Victoria
Málaga, 29010, Spain
Complejo Hospitalario Universitario de Santiago
Santiago de Compostela, 15706, Spain
Hospital Universitario Virgen Macarena
Seville, 41009, Spain
Hospital Universitario Virgen del Rocio
Seville, 41013, Spain
Hospital Universitari i Politecnic La Fe
Valencia, 46026, Spain
Kantonsspital Graubuenden
Chur, 7000, Switzerland
Taichung Veterans General Hospital
Taichung, 40705, Taiwan
National Cheng Kung University Hospital
Tainan, 704, Taiwan
National Taiwan University Hospital
Taipei, 100, Taiwan
Taipei Veterans General Hospital
Taipei, 112, Taiwan
Tri-Service General Hospital
Taipei, 11490, Taiwan
Chang Gung Memorial Hospital, Linkou
Taoyuan, 333, Taiwan
Hacettepe University Medical Faculty
Ankara, 06100, Turkey (Türkiye)
Baskent University Ankara Hospital
Ankara, 06500, Turkey (Türkiye)
Ankara University Medical Faculty
Ankara, Turkey (Türkiye)
Trakya University Medical Faculty
Edirne, 22030, Turkey (Türkiye)
Bezmi Alem Foundation University Medical Faculty Hospital
Istanbul, 34093, Turkey (Türkiye)
Istanbul University Cerrahpasa Medical Faculty
Istanbul, 34098, Turkey (Türkiye)
Fatih Universitesi Tip Fakultesi
Istanbul, 34500, Turkey (Türkiye)
Marmara University Pendik Research and Training Center
Istanbul, 34899, Turkey (Türkiye)
Ege University Medical Faculty
Izmir, 35100, Turkey (Türkiye)
Dokuz Eylul University Medicine Faculty
Izmir, 35340, Turkey (Türkiye)
Konya Necmettin Erbakan University Meram Faculty of Medicine
Konya, 42080, Turkey (Türkiye)
Royal Bournemouth General Hospital
Bournemouth, BH7 7DW, United Kingdom
Bristol Haematology & Oncology Centre
Bristol, BS2 8ED, United Kingdom
Royal Devon and Exeter Hospital (Wonford)
Exeter, EX2 5DW, United Kingdom
Beatson West of Scotland Cancer Centre
Glasgow, G12 OYN, United Kingdom
St James's University Hospital
Leeds, LS9 7TF, United Kingdom
University College London Hospital
London, NW1 2BU, United Kingdom
The Clatterbridge Cancer Centre
Metropolitan Borough of Wirral, CH63 4JY, United Kingdom
Derriford Hospital
Plymouth, PL6 8BQ, United Kingdom
Mount Vernon Hospital
Stevenage, SG1 4AB, United Kingdom
Related Publications (4)
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.
PMID: 35771392DERIVEDHrinczenko 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.
PMID: 35144482DERIVEDPark 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.
PMID: 33636453DERIVEDBarlesi 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.
PMID: 30262187DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Communication Center
- Organization
- Merck KGaA, Darmstadt, Germany
Study Officials
- STUDY DIRECTOR
Medical Responsible
EMD Serono Inc., a business of Merck KGaA, Darmstadt, Germany
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 27, 2015
First Posted
March 20, 2015
Study Start
March 24, 2015
Primary Completion
November 22, 2017
Study Completion
December 3, 2019
Last Updated
August 3, 2020
Results First Posted
December 13, 2018
Record last verified: 2020-07
Data Sharing
- IPD Sharing
- Will share
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