Clinical trial NCT02395172: Avelumab in Non-Small Cell Lung Cancer (JAVELIN Lung 200)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Carcinoma, Non-Small-Cell Lung
Keywords: Avelumab
MSB0010718C
Non-Small Cell Lung Cancer
Anti-PD-L1
Lead sponsor: EMD Serono
Sponsor class: INDUSTRY
Collaborators: name: Merck KGaA, Darmstadt, Germany
First posted: 2015-03-20
Enrollment: 792
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria

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

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

Other protocol defined inclusion criteria could apply

Exclusion criteria

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

  1. Brain metastases have been treated locally, and
  2. No ongoing neurological symptoms that are related to the brain localization of the disease
* Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent:

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

Other protocol defined exclusion criteria could apply

Primary outcomes:
measure: Overall Survival (OS) Time in Programmed Death Ligand 1 (PD-L1) + Full Analysis Set Population (FAS)
timeFrame: Time from date of randomization up to 1420 days
Secondary outcomes:
measure: Overall Survival (OS) Time in Full Analysis Set Population
timeFrame: Time from date of randomization up to 1420 days
measure: Progression-Free Survival (PFS) Time in PD-L1+ Full Analysis Set Population
timeFrame: Time from date of randomization up to 907 days
measure: Progression-Free Survival (PFS) Time in Full Analysis Set Population
timeFrame: Time from date of randomization up to 907 days
measure: Number of Participants With Confirmed Best Overall Response (BOR) as Assessed by an Independent Endpoint Review Committee (IERC) in Full Analysis Set Population
timeFrame: Time from date of randomization up to 907 days
measure: Number of Participants With Confirmed Best Overall Response (BOR) as Assessed by Independent Endpoint Review Committee (IERC) in PD-L1+ Full Analysis Set Population
timeFrame: Time from date of randomization up to 907 days
measure: Percentage of Participants With Objective Response as Assessed by Independent Endpoint Review Committee (IERC) in Full Analysis Set Population
timeFrame: Time from date of randomization up to 907 days
measure: Percentage of Participants With Objective Response as Assessed by Independent Endpoint Review Committee (IERC) in PD-L1+ Full Analysis Set Population
timeFrame: Time from date of randomization up to 907 days
measure: 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)
timeFrame: Baseline, End of treatment visit (up to Week 124)
measure: 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)
timeFrame: Baseline, End of treatment visit (up to Week 124)
measure: 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)
timeFrame: Baseline, End of treatment visit (up to Week 124)
measure: 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)
timeFrame: Baseline, End of treatment visit (up to Week 124)
measure: 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
timeFrame: Time from date of randomization up to 1420 days
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs) by Severity
timeFrame: Time from date of randomization up to 1420 days
measure: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance: Baseline Score vs. Worst Post-baseline Score
timeFrame: Time from date of randomization up to 1420 days
measure: Number of Participants With Positive Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs) for Avelumab
timeFrame: Time from date of randomization up to 1420 days
Other outcomes:
Locations:
city: Tuscaloosa
country: United States
facility: University of Alabama
state: Alabama
city: Scottsdale , Phoenix
country: United States
facility: Mayo Clinic
state: Arizona
city: Anaheim
country: United States
facility: Pacific Cancer Medical Center, Inc.
state: California
city: Lawndale
country: United States
facility: Healing Hands Oncology and Medical Care
state: California
city: Modesto
country: United States
facility: Sutter Gould Medical Foundation
state: California
city: San Diego
country: United States
facility: Sharp Memorial Hospital
state: California
city: Boca Raton
country: United States
facility: Lynn Cancer Institute Center
state: Florida
city: Boynton Beach
country: United States
facility: University Cancer Institute
state: Florida
city: Fort Lauderdale
country: United States
facility: Holy Cross Hospital Inc.
state: Florida
city: Fort Myers
country: United States
facility: Florida Cancer Specialists-Broadway
state: Florida
city: Saint Petersburg
country: United States
facility: Florida Cancer Specialists
state: Florida
city: West Palm Beach
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Athens
country: United States
facility: Northeast Georgia Cancer Care, LLC
state: Georgia
city: Metairie
country: United States
facility: Metairie Oncologist, LLC
state: Louisiana
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Nyack
country: United States
facility: Hematology Oncology Associates of Rockland
state: New York
city: Winston-Salem
country: United States
facility: Novant Health Oncology Specialists
state: North Carolina
city: Cincinnati
country: United States
facility: Oncology Hematology Care
state: Ohio
city: Middletown
country: United States
facility: Signal Point Clinical Research Center
state: Ohio
city: Oklahoma City
country: United States
facility: Mercy Clinic Oklahoma Communities, Inc.
state: Oklahoma
city: Abington
country: United States
facility: Abington Memorial Hospital
state: Pennsylvania
city: Hershey
country: United States
facility: Penn State Univ. Milton S. Hershey Medical Center
state: Pennsylvania
city: Knoxville
country: United States
facility: Center for Biomedical Research, LLC
state: Tennessee
city: Nashville
country: United States
facility: SCRI - Tennessee Oncology
state: Tennessee
city: Fort Worth
country: United States
facility: The Center for Cancer and Blood Disorders
state: Texas
city: Tyler
country: United States
facility: University of Texas Health Science Center at Tyler
state: Texas
city: Tacoma
country: United States
facility: MultiCare Health System
state: Washington
city: Bahia Blanca
country: Argentina
facility: Hospital Italiano Regional del Sur
city: Barrio General Paz
country: Argentina
facility: Clínica Universitaria Privada Reina Fabiola
city: Berazategui
country: Argentina
facility: Centro de Oncologia e Investigacion Buenos Aires
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: Instituto Medico Especializado Alexander Fleming
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: CEMIC
city: Cordoba
country: Argentina
facility: Instituto DAMIC Fundacion Rusculleda
city: La Rioja
country: Argentina
facility: Centro Oncologico Riojano Integral (Cori)
city: Parana
country: Argentina
facility: Centro Oncologico de Parana
city: Pilar
country: Argentina
facility: Hospital Universitario Austral
city: Rosario
country: Argentina
facility: Instituto Gamma
city: Rosario
country: Argentina
facility: Sanatorio Parque S.A.
city: Rosario
country: Argentina
facility: Instituto de Oncología de Rosario
city: San Miguel de Tucuman
country: Argentina
facility: Centro Medico San Roque S.R.L.
city: Ballarat
country: Australia
facility: Ballarat Base Hospital
city: Box Hill
country: Australia
facility: Box Hill Hospital
city: Coffs Harbour
country: Australia
facility: Coffs Harbour Base Hospital
city: Elizabeth Vale
country: Australia
facility: Lyell McEwin Hospital
city: Greenslopes
country: Australia
facility: Greenslopes Private Hospital
city: Lismore
country: Australia
facility: Lismore Base Hospital
city: Parkville
country: Australia
facility: Royal Melbourne Hospital
city: Subiaco
country: Australia
facility: St John of God Hospital
city: Woolloongabba
country: Australia
facility: Princess Alexandra Hospital
city: Edegem
country: Belgium
facility: UZ Antwerpen
city: Gilly
country: Belgium
facility: Grand Hôpital de Charleroi
city: Leuven
country: Belgium
facility: UZ Leuven
city: Libramont
country: Belgium
facility: Centre Hospitalier de l'Ardenne
city: Liège
country: Belgium
facility: C. H. U. Sart Tilman
city: Roeselare
country: Belgium
facility: AZ Delta
city: Belo Horizonte
country: Brazil
facility: Cenantron - Centro Avançado de Tratamento Oncológico S/C Ltda
city: Florianópolis
country: Brazil
facility: CEPON - Centro de Pesquisas Oncológicas de Santa Catarina
city: Ijuí
country: Brazil
facility: Hospital de Caridade de Ijuí
city: Itajaí
country: Brazil
facility: Clínica de Neoplasias Litoral Ltda.
city: Juiz de Fora
country: Brazil
facility: CMiP - Centro Mineiro de Pesquisa
city: Lajeado
country: Brazil
facility: Hospital Bruno Born
city: Natal
country: Brazil
facility: Liga Norte-Rio-Grandense Contra o Câncer
city: Novo Hamburgo
country: Brazil
facility: Oncosinos - Clínica de Oncologia - Hospital Regina
city: Passo Fundo
country: Brazil
facility: CITO - Centro Integrado de Terapia Onco-Hematológica - Hospital da Cidade de Passo Fundo
city: Porto Alegre
country: Brazil
facility: Hospital Mãe de Deus
city: Porto Alegre
country: Brazil
facility: Hospital São Lucas da PUCRS
city: Rio de Janeiro
country: Brazil
facility: COI - Clínicas Oncológicas Integradas
city: Santo André
country: Brazil
facility: CEPHO - Centro de Estudos e Pesquisas em Hematologia e Oncologia
city: Sorocaba
country: Brazil
facility: IOS - Instituto de Oncologia de Sorocaba "Dr. Gilson Delgado"
city: São José do Rio Preto
country: Brazil
facility: Fundação Faculdade Regional de Medicina de São José do Rio Preto
city: São Paulo
country: Brazil
facility: ICESP - Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira
city: Pleven
country: Bulgaria
facility: UMHAT 'Dr. Georgi Stranski', EAD
city: Plovdiv
country: Bulgaria
facility: Complex Oncological Center - Plovdiv, EOOD
city: Sofia
country: Bulgaria
facility: MHAT "Serdika", EOOD
city: Sofia
country: Bulgaria
facility: MHAT 'Tokuda Hospital Sofia', AD
city: Sofia
country: Bulgaria
facility: Shato, Ead
city: Varna
country: Bulgaria
facility: MHAT 'Sv. Marina', EAD
city: Santiago
country: Chile
facility: Instituto de Terapias Oncologicas Providencia
city: Santiago
country: Chile
facility: FALP - Fundación Arturo López Pérez
city: Santiago
country: Chile
facility: CIEC - Centro Internacional de Estudios Clínicos
city: Temuco
country: Chile
facility: Instituto Clinico Oncologico del Sur (ICOS)
city: Viña del Mar
country: Chile
facility: Centro de Investigaciones Clinicas Viña del Mar
city: Viña del Mar
country: Chile
facility: Hospital Clinico Viña del Mar
city: Bogota
country: Colombia
facility: Fundacion Cardioinfantil Instituto de Cardiologia
city: Bogota
country: Colombia
facility: Instituto Nacional de Cancerologia E.S.E.
city: Bogota
country: Colombia
facility: Clinica Colsanitas S.A. sede Clinica Universitaria Colombia
city: Bogotá
country: Colombia
facility: Administradora Country S.A.
city: Cali
country: Colombia
facility: Fundación Valle del Lilí
city: Cali
country: Colombia
facility: Centro Medico Imbanaco
city: Cali
country: Colombia
facility: Hemato Oncologos S.A.
city: Medellin
country: Colombia
facility: Instituto de Cancerologia S.A.
city: Medellín
country: Colombia
facility: Hospital Pablo Tobón Uribe
city: Monteria
country: Colombia
facility: IPS IMAT- Instituto Medico de Alta Tecnologia - Oncomedica S.A.
city: Dubrovnik
country: Croatia
facility: General Hospital Dubrovnik
city: Zadar
country: Croatia
facility: General Hospital Zadar
city: Zagreb
country: Croatia
facility: Clinical Hospital Centar "Sestre Milosrdnice"
city: Zagreb
country: Croatia
facility: University Clinic for Pulmonary Diseases
city: Brno
country: Czechia
facility: Masarykuv onkologicky ustav
city: Novy Jicin
country: Czechia
facility: Nemocnice Novy Jicin a.s.
city: Pardubice
country: Czechia
facility: Multiscan s.r.o.
city: Praha 2
country: Czechia
facility: Vseobecna fakultni nemocnice V Praze
city: Praha 4
country: Czechia
facility: Thomayerova nemocnice
city: Herlev
country: Denmark
facility: Herlev Hospital
city: Odense C
country: Denmark
facility: Odense Universitetshospital
city: Angers Cedex 9
country: France
facility: ICO - Site Paul Papin
city: Besancon Cedex
country: France
facility: CHU Besançon - Hôpital Jean Minjoz
city: Le Mans Cedex 02
country: France
facility: Clinique Victor Hugo - Centre Jean Bernard
city: Marseille cedex 20
country: France
facility: Hôpital Nord - AP-HM Marseille#
city: Nantes
country: France
facility: Centre Catherine de Sienne
city: Nice cedex 02
country: France
facility: Centre Antoine Lacassagne
city: Pessac
country: France
facility: Groupe Hospitalier Sud - Hôpital Haut-Lévêque
city: Poitiers
country: France
facility: CHU Poitiers - Hôpital la Milétrie
city: Saint Herblain
country: France
facility: ICO - Site René Gauducheau
city: Strasbourg
country: France
facility: CHU Strasbourg - Nouvel Hôpital Civil
city: Toulouse
country: France
facility: CHU de Toulouse - Hôpital Larrey
city: Budapest
country: Hungary
facility: Semmelweis Egyetem AOK
city: Budapest
country: Hungary
facility: Uzsoki Utcai Korhaz
city: Györ
country: Hungary
facility: Petz Aladar Megyei Oktato Korhaz
city: Miskolc
country: Hungary
facility: Miskolci Semmelweis Korhaz es Egyetemi Oktatokorhaz
city: Torokbalint
country: Hungary
facility: Tudogyogyintezet Torokbalint
city: Beer Sheva
country: Israel
facility: Soroka Medical Center
city: Beer Yaakov
country: Israel
facility: Assaf Harofeh Medical Center
city: Haifa
country: Israel
facility: Rambam Health Care Campus
city: Haifa
country: Israel
facility: The Lady Davis Carmel Medical Center
city: Jerusalem
country: Israel
facility: Hadassah University Hospital - Ein Kerem
city: Kfar-Saba
country: Israel
facility: Sapir Medical Center, Meir Hospital
city: Petach Tikva
country: Israel
facility: Rabin Medical Center-Beilinson Campus
city: Ramat-Gan
country: Israel
facility: Chaim Sheba Medical Center
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center
city: Cremona
country: Italy
facility: Azienda Ospedaliera Istituti Ospitalieri di Cremona
city: Legnago (VR)
country: Italy
facility: Ospedale Mater Salutis
city: Lido di Camaiore
country: Italy
facility: Ospedale Versilia
city: Milano
country: Italy
facility: Fondazione IRCCS Istituto Nazionale dei Tumori
city: Milano
country: Italy
facility: IEO Istituto Europeo di Oncologia
city: Napoli
country: Italy
facility: Seconda Università degli Studi di Napoli
city: Pisa
country: Italy
facility: Azienda Ospedaliero Universitaria Pisana
city: Roma
country: Italy
facility: Università Campus Bio-Medico di Roma
city: Roma
country: Italy
facility: Istituto Nazionale Tumori Regina Elena IRCCS
city: Roma
country: Italy
facility: Policlinico Universitario Agostino Gemelli
city: Roma
country: Italy
facility: Azienda Ospedaliera Sant'Andrea-Università di Roma La Sapienza
city: Siena
country: Italy
facility: A.O.U. Senese Policlinico Santa Maria alle Scotte
city: Treviglio
country: Italy
facility: Azienda Ospedaliera Ospedale Treviglio-Caravaggio di Treviglio
city: Chuo-ku
country: Japan
facility: National Cancer Center Hospital
city: Fukuoka-shi
country: Japan
facility: NHO Kyushu Cancer Center
city: Habikino-shi
country: Japan
facility: Osaka Prefectural Medical Center for Respiratory and Allergic Diseases
city: Hiroshima-shi
country: Japan
facility: Hiroshima City Hiroshima Citizens Hospital
city: Kashiwa-shi
country: Japan
facility: National Cancer Center Hospital East
city: Kitaadachi-gun
country: Japan
facility: Saitama Cancer Center
city: Kobe-shi
country: Japan
facility: Institute of Biomedical Research and Innovation Hospital
city: Kobe-shi
country: Japan
facility: Kobe City Hospital Organization Kobe City Medical Center General Hospital
city: Koto-ku
country: Japan
facility: Cancer Institute Hospital of JFCR
city: Kurume-shi
country: Japan
facility: Kurume University Hospital
city: Natori-shi
country: Japan
facility: Miyagi Cancer Center
city: Okazaki-shi
country: Japan
facility: Aichi Cancer Center Hospital
city: Osaka-shi
country: Japan
facility: Osaka City General Hospital
city: Osaka-shi
country: Japan
facility: Osaka Medical Center for Cancer and Cardiovascular Diseases
city: Osakasayama-shi
country: Japan
facility: Kinki University Hospital
city: Sagamihara-shi
country: Japan
facility: Kitasato University Hospital
city: Sapporo-shi
country: Japan
facility: NHO Hokkaido Cancer Center
city: Sapporo-shi
country: Japan
facility: Hokkaido University Hospital
city: Shinjuku-ku
country: Japan
facility: Tokyo Medical University Hospital
city: Toyama-shi
country: Japan
facility: Toyama University Hospital
city: Wakayama-shi
country: Japan
facility: Wakayama Medical University Hospital
city: Yokohama-shi
country: Japan
facility: Yokohama Municipal Citizen's Hospital
city: Yokohama-shi
country: Japan
facility: Kanagawa Cancer Center
city: Cheongju-si
country: Korea, Republic of
facility: Chungbuk National University Hospital
city: Hwasun-gun
country: Korea, Republic of
facility: Chonnam National University Hwasun Hospital
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Seoul St. Mary's Hospital
city: Suwon-si
country: Korea, Republic of
facility: The Catholic University of Korea, St. Vincent's Hospital
city: Cuautitlan Izcalli
country: Mexico
facility: Phylasis Clinicas Research S de RL de CV
city: Durango
country: Mexico
facility: Instituto de Investigaciones Aplicadas a la Neurociencia A.C.
city: Leon
country: Mexico
facility: Fundacion Rodolfo Padilla Padilla, A.C.
city: Mexico
country: Mexico
facility: Health Pharma Professional Research S.A. de C.V.
city: Monterrey
country: Mexico
facility: Winsett Rethman S.A. de C.V.
city: Morelia
country: Mexico
facility: Centro de Investigacion Clinica Chapultepec S.A. de C.V.
city: Oaxaca
country: Mexico
facility: Oaxaca Site Management Organization S.C.
city: Toluca
country: Mexico
facility: Centro Oncologico Estatal ISSEMyM
city: Arequipa
country: Peru
facility: Clinica Monte Carmelo
city: Chiclayo
country: Peru
facility: Hospital Nacional Almanzor Aguinaga Asenjo
city: Cusco
country: Peru
facility: Hospital Nacional Adolfo Guevara Velasco
city: Lima
country: Peru
facility: Clinica San Borja
city: Lima
country: Peru
facility: Hospital Nacional Guillermo Almenara Irigoyen
city: Lima
country: Peru
facility: Clínica Ricardo Palma
city: Lima
country: Peru
facility: Instituto Nacional de Enfermedades Neoplásicas
city: Brzozow
country: Poland
facility: Szpital Specjalistyczny W Brzozowie, Podkarpacki Osrodek Onkologiczny Im.Ks.B.Markiewicza
city: Jelenia Gora
country: Poland
facility: Wojewodzkie Centrum Szpitalne Kotliny Jeleniogorskiej
city: Katowice
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny nr 5 SUM
city: Lodz
country: Poland
facility: Centrum Terapii Wspolczesnej J.M. Jasnorzewska sp. komandytowo-akcyjna
city: Lublin
country: Poland
facility: KO-MED Centra Kliniczne Lublin II
city: Mrozy
country: Poland
facility: SSZZOZ im. Dr Teodora Dunina w Rudce
city: Otwock
country: Poland
facility: Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy
city: Alba Iulia
country: Romania
facility: Spitalul Judetean de Urgenta Alba Iulia
city: Baia Mare
country: Romania
facility: Spitalul Judetean de Urgenta "Dr. Constantin Opris" Baia Mare
city: Brasov
country: Romania
facility: Policlinica de Diagnostic Rapid SRL
city: Oradea
country: Romania
facility: Spitalul Clinic Municipal "Dr. Gavril Curteanu" Oradea
city: Ploiesti
country: Romania
facility: Spital Lotus SRL
city: Timisoara
country: Romania
facility: S.C Oncocenter Oncologie Clinica S.R.L
city: Kazan
country: Russian Federation
facility: SHI "Republican Clinical Oncological Dispensary of HM RT"
city: Moscow
country: Russian Federation
facility: SHBI Moscow Clinical Scientific Center of Department of Healthcare of Moscow
city: Saint Petersburg
country: Russian Federation
facility: FSBHI Clinical research institute of phthisiopulmonology
city: Saint Petersburg
country: Russian Federation
facility: Pavlov First Saint Petersburg State Medical University
city: St. Petersburg
country: Russian Federation
facility: St. Petersburg SHI "City Clinical Oncology Dispensary"
city: St. Petersburg
country: Russian Federation
facility: FBI "Scientific Research Institute of Oncology n. a. N. N. Petrov"
city: Bardejov
country: Slovakia
facility: Nemocnica s poliklinikou Sv. Jakuba, n.o. Bardejov
city: Bratislava
country: Slovakia
facility: Univerzitna nemocnica Bratislava, Nemocnica Ruzinov
city: Ruzomberok
country: Slovakia
facility: Ustredna vojenska nemocnica SNP Ruzomberok- Fakultna nemocnica
city: Trnava
country: Slovakia
facility: Fakultna nemocnica Trnava
city: Cape Town
country: South Africa
facility: GVI Cape Gate Oncology Centre
city: Cape town
country: South Africa
facility: GVI Rondebosch Oncology Centre
city: Port Elizabeth
country: South Africa
facility: GVI Langenhoven Drive Oncology Centre
city: Pretoria
country: South Africa
facility: University of Pretoria Oncology Department
city: Pretoria
country: South Africa
facility: Mary Potter Oncology Centre
city: Alicante
country: Spain
facility: Hospital General Universitario de Alicante
city: Badalona
country: Spain
facility: ICO Badalona - Hospital Germans Trias i Pujol
city: Barcelona
country: Spain
facility: Hospital Universitari Quiron Dexeus
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Barcelona
country: Spain
facility: Hospital Clinic i Provincial de Barcelona
city: L'Hospitalet de Llobregat
country: Spain
facility: ICO l´Hospitalet - Hospital Duran i Reynals
city: Las Palmas de Gran Canaria
country: Spain
facility: Hospital Universitario Materno-Infantil de Canarias
city: Madrid
country: Spain
facility: Hospital Universitario Ramon y Cajal
city: Madrid
country: Spain
facility: Centro Integral Oncologico Clara Campal
city: Malaga
country: Spain
facility: Hospital Clinico Universitario Virgen de la Victoria
city: Mataro
country: Spain
facility: Hospital de Mataro
city: Santiago de Compostela
country: Spain
facility: Complejo Hospitalario Universitario de Santiago
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio
city: Valencia
country: Spain
facility: Hospital Universitari i Politecnic La Fe
city: Chur
country: Switzerland
facility: Kantonsspital Graubuenden
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Taipei
country: Taiwan
facility: Tri-Service General Hospital
city: Taoyuan County
country: Taiwan
facility: Chang Gung Memorial Hospital, Linkou
city: Ankara
country: Turkey
facility: Hacettepe University Medical Faculty
city: Ankara
country: Turkey
facility: Baskent University Ankara Hospital
city: Ankara
country: Turkey
facility: Ankara University Medical Faculty
city: Edirne
country: Turkey
facility: Trakya University Medical Faculty
city: Istanbul
country: Turkey
facility: Bezmi Alem Foundation University Medical Faculty Hospital
city: Istanbul
country: Turkey
facility: Istanbul University Cerrahpasa Medical Faculty
city: Istanbul
country: Turkey
facility: Fatih Universitesi Tip Fakultesi
city: Istanbul
country: Turkey
facility: Marmara University Pendik Research and Training Center
city: Izmir
country: Turkey
facility: Ege University Medical Faculty
city: Izmir
country: Turkey
facility: Dokuz Eylul University Medicine Faculty
city: Konya
country: Turkey
facility: Konya Necmettin Erbakan University Meram Faculty of Medicine
city: Bournemouth
country: United Kingdom
facility: Royal Bournemouth General Hospital
city: Bristol
country: United Kingdom
facility: Bristol Haematology & Oncology Centre
city: Exeter
country: United Kingdom
facility: Royal Devon and Exeter Hospital (Wonford)
city: Glasgow
country: United Kingdom
facility: Beatson West of Scotland Cancer Centre
city: Leeds
country: United Kingdom
facility: St James's University Hospital
city: London
country: United Kingdom
facility: University College London Hospital
city: Plymouth
country: United Kingdom
facility: Derriford Hospital
city: Stevenage
country: United Kingdom
facility: Mount Vernon Hospital
city: Wirral
country: United Kingdom
facility: The Clatterbridge Cancer Centre
Study officials:
affiliation: EMD Serono Inc., a business of Merck KGaA, Darmstadt, Germany
name: Medical Responsible
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.