Clinical trial NCT02576574: Avelumab in First-line NSCLC (JAVELIN Lung 100)
Official title: A Phase III, Open-label, Multicenter Trial of Avelumab (MSB0010718C) Versus Platinum-based Doublet as a First-line Treatment of Recurrent or Stage IV PD-L1+NSCLC
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: First Line Non-Small Cell Lung Cancer
Keywords: Avelumab
MSB0010718C
Non-Small Cell Lung Cancer
Lead sponsor: EMD Serono
Sponsor class: INDUSTRY
Collaborators: name: Merck KGaA, Darmstadt, Germany
First posted: 2015-10-15
Enrollment: 1214
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 purpose of this study was to demonstrate superiority with regard to Overall Survival (OS) or Progression Free Survival (PFS) of avelumab versus platinum-based doublet, based on an Independent Review Committee assessment, in Non-small cell lung cancer (NSCLC) participants with Programmed death ligand 1+ (PD-L1+) tumors.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Progression Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Assessed by Independent Review Committee (IRC) in High Programmed Death Ligand 1 (PD-L1) + Full Analysis Set (FAS)
timeFrame: Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)
measure: Progression Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Assessed by Independent Review Committee (IRC) in High Programmed Death Ligand 1 (PD-L1) + Modified Full Analysis Set (mFAS)
timeFrame: Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)
measure: Overall Survival (OS) in High Programmed Death Ligand 1 (PD-L1) + Full Analysis Set (FAS)
timeFrame: Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)
measure: Overall Survival (OS) in High Programmed Death Ligand 1 (PD-L1)+ Modified Full Analysis Set (mFAS)
timeFrame: Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)
Secondary outcomes:
measure: Progression Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Assessed by Independent Review Committee (IRC) in Moderate and High Programmed Death Ligand 1 (PD-L1)+ Full Analysis Set (FAS)
timeFrame: Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)
measure: Progression Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Assessed by Independent Review Committee (IRC) in Moderate and High Programmed Death Ligand 1 (PD-L1)+ Modified Full Analysis Set (mFAS)
timeFrame: Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)
measure: Overall Survival (OS) in Moderate and High Programmed Death Ligand 1 (PD-L1)+ Full Analysis Set (FAS)
timeFrame: Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)
measure: Overall Survival (OS) in Moderate and High Programmed Death Ligand 1 (PD-L1)+ Modified Full Analysis Set (mFAS)
timeFrame: Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)
measure: Overall Survival (OS) in Full Analysis Set (FAS)
timeFrame: Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)
measure: Overall Survival (OS) in Modified Full Analysis Set (mFAS)
timeFrame: Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)
measure: Percentage of Participants With Confirmed Objective Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Independent Review Committee (IRC) in High PD-L1+ Full Analysis Set
timeFrame: Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)
measure: Percentage of Participants With Confirmed Objective Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Independent Review Committee (IRC) in High PD-L1+ Modified Full Analysis Set
timeFrame: Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)
measure: Percentage of Participants With Confirmed Objective Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Independent Review Committee (IRC) in Moderate and High PD-L1+ Full Analysis Set
timeFrame: Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)
measure: Percentage of Participants With Confirmed Objective Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Independent Review Committee (IRC) in Moderate and High PD-L1+ Modified Full Analysis Set
timeFrame: Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)
measure: Duration of Response (DOR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Independent Review Committee (IRC) in High Programmed Death Ligand 1 (PD-L1)+ Full Analysis Set (FAS)
timeFrame: Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)
measure: Duration of Response (DOR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Independent Review Committee (IRC) in High Programmed Death Ligand 1 (PD-L1)+ Modified Full Analysis Set (mFAS)
timeFrame: Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)
measure: Change From Baseline in European Quality Of Life 5-dimensions (EQ-5D-5L) Visual Analog Scale (VAS) in High PD-L1+ Health-related Quality of Life (HRQoL) Analysis Set at End of Treatment
timeFrame: Baseline, End of treatment (up to Week 283.9)
measure: Change From Baseline in European Quality Of Life 5-dimensions (EQ-5D-5L) Visual Analog Scale (VAS) in High Programmed Death Ligand 1 (PD-L1)+ Modified HRQoL Analysis Set
timeFrame: Baseline, End of treatment (Week 283.9)
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) in High Programmed Death Ligand 1 (PD-L1)+ HRQoL Analysis Set
timeFrame: Baseline, End of treatment (up to Week 283.9)
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) in High Programmed Death Ligand 1 (PD-L1)+ Modified HRQoL Analysis Set
timeFrame: Baseline, End of treatment (Week 283.9)
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) in High Programmed Death Ligand 1 (PD-L1)+ HRQoL Analysis Set
timeFrame: Baseline, End of treatment (up to Week 283.9)
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) in High Programmed Death Ligand 1 (PD-L1)+ Modified HRQoL Analysis Set
timeFrame: Baseline, End of treatment (up to Week 283.9)
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and AEs of Special Interest (AESIs)
timeFrame: Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)
measure: Number of Participants With Shift From Baseline to Greater Than or Equal to (>=) Grade 3 in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03
timeFrame: Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)
measure: Number of Participants With Maximal On-Treatment Changes From Baseline in Vital Signs - Maximal Body Temperature Increase
timeFrame: Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)
measure: Number of Participants With Maximal On-Treatment Changes From Baseline in Vital Signs - Maximal Weight Increase/Decrease
timeFrame: Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)
measure: Number of Participants With Maximal On-Treatment Changes From Baseline in Vital Signs - Maximal Heart Rate Increase/Decrease
timeFrame: Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)
measure: Number of Participants With Maximal On-Treatment Changes From Baseline in Vital Signs - Maximal Systolic Blood Pressure Increase/Decrease and Maximal Diastolic Blood Pressure Increase/Decrease
timeFrame: Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)
measure: Number of Participants With Maximal On-Treatment Changes From Baseline in Vital Signs - Maximal Respiration Rate Increase/Decrease
timeFrame: Time from date of randomization up to data cutoff (assessed up to 71.5 months)
measure: Number of Participants With Potentially Clinically Significant Abnormalities (PCSA) in Electrocardiogram (ECG) Parameters
timeFrame: Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)
measure: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance: Baseline Score Versus (Vs) Worst Post-baseline Score
timeFrame: Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)
measure: Number of Participants With At Least One Positive Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs) for Avelumab
timeFrame: Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Clearview Cancer Institute
state: Alabama
city: Surprise
country: United States
facility: Arizona Center for Cancer Care
state: Arizona
city: San Diego
country: United States
facility: Sharp Memorial Hospital
state: California
city: Boynton Beach
country: United States
facility: University Cancer Institute
state: Florida
city: Valdosta
country: United States
facility: South Georgia Medical Center
state: Georgia
city: Shreveport
country: United States
facility: Christus Cancer Treatment Center
state: Louisiana
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Billings
country: United States
facility: St. Vincent Frontier Cancer Center
state: Montana
city: Las Vegas
country: United States
facility: Nevada Cancer Research Foundation
state: Nevada
city: Farmington
country: United States
facility: San Juan Oncology Associates
state: New Mexico
city: Kernersville
country: United States
facility: Novant Health Oncology Specialists
state: North Carolina
city: Oklahoma City
country: United States
facility: Mercy Research
state: Oklahoma
city: Portland
country: United States
facility: Kaiser Permanente Northwest
state: Oregon
city: Lancaster
country: United States
facility: Lancaster Cancer Center
state: Pennsylvania
city: Cookeville
country: United States
facility: Cookeville Regional Medical Center
state: Tennessee
city: Knoxville
country: United States
facility: Thompson Cancer Survival Center
state: Tennessee
city: Corpus Christi
country: United States
facility: Coastal Bend Cancer Center
state: Texas
city: Houston
country: United States
facility: Oncology Consultants, P.A.
state: Texas
city: Burlington
country: United States
facility: University of Vermont Medical Center
state: Vermont
city: Tacoma
country: United States
facility: Northwest Medical Specialties, PLLC
state: Washington
city: Cheyenne
country: United States
facility: Cheyenne Regional Medical Center
state: Wyoming
city: Albury
country: Australia
facility: Albury Wodonga Regional Cancer Centre
state: New South Wales
city: Coffs Harbour
country: Australia
facility: Coffs Harbour Health Campus
state: New South Wales
city: Kogarah
country: Australia
facility: St George Private Hospital
state: New South Wales
city: Lismore
country: Australia
facility: Lismore Base Hospital
state: New South Wales
city: Orange
country: Australia
facility: Orange Health Service
state: New South Wales
city: St Leonards
country: Australia
facility: Royal North Shore Hospital
state: New South Wales
city: Waratah
country: Australia
facility: Calvary Mater Newcastle
state: New South Wales
city: Greenslopes
country: Australia
facility: Gallipoli Medical Research Foundation Ltd
state: Queensland
city: Southport
country: Australia
facility: Gold Coast University Hospital
state: Queensland
city: Woodville South
country: Australia
facility: The Queen Elizabeth Hospital
state: South Australia
city: Ballarat
country: Australia
facility: Ballarat Base Hospital
state: Victoria
city: Bendigo
country: Australia
facility: Bendigo Hospital
state: Victoria
city: Warrnambool
country: Australia
facility: South West Healthcare
state: Victoria
city: Murdoch
country: Australia
facility: Fiona Stanley Hospital
state: Western Australia
city: Antwerpen
country: Belgium
facility: ZNA Middelheim
city: Brasschaat
country: Belgium
facility: A.Z. Klina
city: Mons
country: Belgium
facility: CHU Ambroise Paré
city: Salvador
country: Brazil
facility: NOB - Núcleo de Oncologia da Bahia
state: Bahia
city: Fortaleza
country: Brazil
facility: CRIO - Centro Regional Integrado de Oncologia
state: Ceará
city: Goiânia
country: Brazil
facility: CEBROM - Centro Brasileiro de Radioterapia, Oncologia e Mastologia
state: Goiás
city: Curitiba
country: Brazil
facility: Hospital Erasto Gaertner - Liga Paranaense de Combate ao Câncer
state: Paraná
city: Ijuí
country: Brazil
facility: Hospital de Caridade de Ijuí
state: Rio Grande Do Sul
city: Lajeado
country: Brazil
facility: Hospital Bruno Born
state: Rio Grande Do Sul
city: Passo Fundo
country: Brazil
facility: Hospital São Vicente de Paulo
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: IMV-Pesquisa Cardiologica Sociedade Simples - HMD - COR
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Hospital São Lucas da PUCRS
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Hospital Nossa Senhora da Conceição
state: Rio Grande Do Sul
city: Florianópolis
country: Brazil
facility: CEPON - Centro de Pesquisas Oncológicas de Santa Catarina
state: Santa Catarina
city: Itajaí
country: Brazil
facility: Clínica de Neoplasias Litoral Ltda.
state: Santa Catarina
city: Barretos
country: Brazil
facility: Hospital de Câncer de Barretos - Fundação Pio XII
state: Sao Paulo
city: Jaú
country: Brazil
facility: Fundação Doutor Amaral Carvalho
state: Sao Paulo
city: Santo Andre
country: Brazil
facility: CEPHO - Centro de Estudos e Pesquisas em Hematologia e Oncologia
state: Sao Paulo
city: São José do Rio Preto
country: Brazil
facility: Fundação Faculdade Regional de Medicina de São José do Rio Preto
state: Sao Paulo
city: São Paulo
country: Brazil
facility: ICESP - Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira
state: Sao Paulo
city: São Paulo
country: Brazil
facility: IBCC - Instituto Brasileiro de Controle do Câncer
state: Sao Paulo
city: Rio de Janeiro
country: Brazil
facility: INCA - Instituto Nacional de Câncer
city: Ruse
country: Bulgaria
facility: Complex Oncological Center - Ruse, EODD
city: Sofia
country: Bulgaria
facility: MHAT for women's health - Nadezhda, OOD
city: Sofia
country: Bulgaria
facility: UMHAT "Sv. Ivan Rilski", EAD
city: Sofia
country: Bulgaria
facility: Shato, Ead
city: Moncton
country: Canada
facility: The Moncton Hospital
state: New Brunswick
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
city: Santiago
country: Chile
facility: FALP - Fundación Arturo López Pérez
city: Santiago
country: Chile
facility: Clinica Santa Maria
city: Santiago
country: Chile
facility: IRAM - Instituto de Radio Medicina
city: Santiago
country: Chile
facility: Hospital Militar de Santiago
city: Santiago
country: Chile
facility: Hospital Clínico San Borja Arriaran
city: Santiago
country: Chile
facility: Hospital Clínico Universidad de Chile
city: Viña del Mar
country: Chile
facility: Hospital Clinico Viña del Mar
city: Viña del Mar
country: Chile
facility: Centro de Investigaciones Clinicas Viña del Mar
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
city: Guangzhou
country: China
facility: Guangdong General Hospital
state: Guangdong
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital
state: Heilongjiang
city: Shenyang
country: China
facility: Liaoning Cancer Hospital & Institute
state: Liaoning
city: Linyi
country: China
facility: Linyi Cancer Hospital
state: Shandong
city: Bogotá
country: Colombia
facility: Administradora Country S.A.
city: Floridablanca
country: Colombia
facility: Fundación Oftalmológica de Santander - FOSCAL
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: Zagreb
country: Croatia
facility: University Clinic for Pulmonary Diseases
city: Zagreb
country: Croatia
facility: University Hospital Centre "Sestre Milosrdnice"
city: Nicosia
country: Cyprus
facility: Bank of Cyprus Oncology Center
city: Liberec
country: Czechia
facility: Krajska nemocnice Liberec, a.s.
city: Nova Ves pod Plesi
country: Czechia
facility: Nemocnice Na Plesi s.r.o.
city: Olomouc
country: Czechia
facility: Fakultni nemocnice Olomouc
city: Ostrava - Vitkovice
country: Czechia
facility: Vitkovicka nemocnice a.s
city: Praha 4 - Krc
country: Czechia
facility: Thomayerova nemocnice
city: Usti nad Labem
country: Czechia
facility: Krajska zdravotni, a.s. - Masarykova nemocnice v Usti nad Labem, o.z.
city: Herning
country: Denmark
facility: Herning Sygehus
city: Roskilde
country: Denmark
facility: Roskilde Sygehus
city: Tallinn
country: Estonia
facility: North Estonia Medical Centre Foundation
city: Nice cedex 02
country: France
facility: Centre Antoine Lacassagne
state: Alpes Maritimes
city: Strasbourg
country: France
facility: CHU de Strasbourg - Nouvel Hôpital Civil
state: Bas Rhin
city: Marseille cedex 20
country: France
facility: Hôpital Nord - AP-HM Marseille#
state: Bouches-du-Rhône
city: Marseille
country: France
facility: Hôpital privé Clairval
state: Bouches-du-Rhône
city: Besancon Cedex
country: France
facility: CHU Besançon - Hôpital Jean Minjoz
state: Doubs
city: Brest Cedex
country: France
facility: CHU Brest - Hôpital Morvan
state: Finistere
city: Pessac
country: France
facility: Groupe Hospitalier Sud - Hôpital Haut-Lévêque
state: Gironde
city: Angers Cedex 9
country: France
facility: CHU Angers - Hôpital Hôtel Dieu#
state: Maine Et Loire
city: Paris cedex 14
country: France
facility: Hôpital Cochin
state: Paris
city: Bayonne
country: France
facility: Centre Hospitalier de la Côte Basque
state: Pyrenees Atlantiques
city: Lyon cedex 04
country: France
facility: Centre Hospitalier de la Croix Rousse
state: Rhone
city: Le Mans Cedex 02
country: France
facility: Clinique Victor Hugo - Centre Jean Bernard
state: Sarthe
city: Avignon Cedex 9
country: France
facility: Institut Sainte Catherine
state: Vaculuse
city: Creteil cedex
country: France
facility: Centre Hospitalier Intercommunal de Créteil
state: Val De Marne
city: Paris Cedex 10
country: France
facility: Hôpital Saint-Louis - Paris
city: Heidelberg
country: Germany
facility: Universitaetsklinikum Heidelberg
state: Baden Wuerttemberg
city: Grosshansdorf
country: Germany
facility: LungenClinic Grosshansdorf GmbH
state: Schleswig Holstein
city: Athens
country: Greece
facility: 251 General Air Force Hospital
city: Athens
country: Greece
facility: General Hospital of Athens of Chest Diseases "SOTIRIA"
city: Athens
country: Greece
facility: University General Hospital "Attikon"
city: Athens
country: Greece
facility: General Oncology Hospital of Kifissia " Agioi Anargyroi"
city: Athens
country: Greece
facility: Metropolitan General Hospital
city: Heraklion
country: Greece
facility: University General Hospital of Heraklion
city: Patras
country: Greece
facility: University General Hospital of Patra
city: Thessaloniki
country: Greece
facility: Euromedica General Clinic Thessaloniki
city: Budapest
country: Hungary
facility: Orszagos Koranyi Pulmonologiai Intezet
city: Budapest
country: Hungary
facility: Orszagos Onkologiai Intezet
city: Budapest
country: Hungary
facility: Semmelweis Egyetem
city: Budapest
country: Hungary
facility: Orszagos Koranyi Pulmonologiai Intezet
city: Deszk
country: Hungary
facility: Csongrad Megyei Mellkasi Betegsegek Szakkorhaza
city: Györ
country: Hungary
facility: Petz Aladar Megyei Oktato Korhaz
city: Miskolc
country: Hungary
facility: Borsod-Abauj-Zemplen Megyei Kozponti Korhaz es Egyetemi Oktatokorhaz
city: Nyiregyhaza
country: Hungary
facility: SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz
city: Szekszard
country: Hungary
facility: Tolna Megyei Balassa Janos Korhaz
city: Torokbalint
country: Hungary
facility: Tudogyogyintezet Torokbalint
city: Zalaegerszeg
country: Hungary
facility: Zala Megyei Szent Rafael Korhaz
city: Cork
country: Ireland
facility: Cork University Hospital
city: Beer Sheva
country: Israel
facility: Soroka University Medical Center
city: Haifa
country: Israel
facility: Rambam Health Care 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: Rechovot
country: Israel
facility: Kaplan Medical Center
city: Rishon Lezion
country: Israel
facility: Assaf Harofeh
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center
city: Legnago
country: Italy
facility: Ospedale Mater Salutis
state: Verona
city: Brescia
country: Italy
facility: Fondazione Poliambulanza Istituto Ospedaliero
city: Catania
country: Italy
facility: Presidio Ospedaliero Garibaldi Nesima
city: Genova
country: Italy
facility: Azienda Ospedaliero Universitaria San Martino
city: Napoli
country: Italy
facility: Seconda Università degli Studi di Napoli
city: Parma
country: Italy
facility: Azienda Ospedaliero Universitaria di Parma
city: Pisa
country: Italy
facility: Azienda Ospedaliero Universitaria Pisana
city: Kashiwa-shi
country: Japan
facility: National Cancer Center Hospital East
state: Chiba-Ken
city: Kurume-shi
country: Japan
facility: Kurume University Hospital
state: Fukuoka-Ken
city: Sapporo-shi
country: Japan
facility: NHO Hokkaido Cancer Center
state: Hokkaido
city: Kobe-shi
country: Japan
facility: Institute of Biomedical Research and Innovation Hospital
state: Hyogo-Ken
city: Kobe-shi
country: Japan
facility: Kobe City Hospital Organization Kobe City Medical Center General Hospital
state: Hyogo-Ken
city: Yokohama-shi
country: Japan
facility: Yokohama Municipal Citizen's Hospital
state: Kanagawa-Ken
city: Yokohama-shi
country: Japan
facility: Kanagawa Cancer Center
state: Kanagawa-Ken
city: Hirakata-shi
country: Japan
facility: Kansai Medical University Hospital
state: Osaka-Fu
city: Takatsuki-shi
country: Japan
facility: Osaka Medical College Hospital
state: Osaka-Fu
city: Chuo-ku
country: Japan
facility: National Cancer Center Hospital
state: Tokyo-To
city: Shinjuku-ku
country: Japan
facility: Tokyo Medical University Hospital
state: Tokyo-To
city: Toyama-shi
country: Japan
facility: Toyama University Hospital
state: Toyama-Ken
city: Kobe-shi
country: Japan
facility: Kobe City Hospital Organization Kobe City Medical Center General Hospital
city: Cheongju-si
country: Korea, Republic of
facility: Chungbuk National University Hospital
state: Chungcheongbuk-do
city: Wonju-si
country: Korea, Republic of
facility: Yonsei University Wonju Severance Christian Hospital
state: Gangwon-do
city: Busan
country: Korea, Republic of
facility: Inje University Haeundae Paik Hospital
state: Gyeonggi-do
city: Goyang-si
country: Korea, Republic of
facility: National Cancer Center
state: Gyeonggi-do
city: Seongnam-si
country: Korea, Republic of
facility: CHA Bundang Medical Center, CHA University
state: Gyeonggi-do
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
city: Suwon-si
country: Korea, Republic of
facility: The Catholic University of Korea, St. Vincent's Hospital
state: Gyeonggi-do
city: Suwon-si
country: Korea, Republic of
facility: Ajou University Hospital
state: Gyeonggi-do
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Chilgok Hospital
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University
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: The Catholic University of Korea, Seoul St. Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Yeouido St. Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hospital
city: Beirut
country: Lebanon
facility: American University of Beirut Medical Center
city: Beirut
country: Lebanon
facility: Rafik Hariri University Hospital
city: Beirut
country: Lebanon
facility: Hotel Dieu de France Hospital
city: Beirut
country: Lebanon
facility: Mount Lebanon Hospital
city: Saida
country: Lebanon
facility: Hammoud Hospital University Medical Center
city: Kaunas
country: Lithuania
facility: Hospital of Lithuanian University of Health Sciences Kaunas Clinics
city: Groningen
country: Netherlands
facility: Martini Ziekenhuis
city: Hoorn
country: Netherlands
facility: Westfriesgasthuis - PARENT
city: Tilburg
country: Netherlands
facility: ETZ Elisabeth
city: Auckland
country: New Zealand
facility: Auckland City Hospital
city: Dunedin
country: New Zealand
facility: Dunedin Public Hospital
city: Hamilton
country: New Zealand
facility: Waikato Hospital
city: Palmerston North
country: New Zealand
facility: Palmerston North Hospital
city: Tauranga
country: New Zealand
facility: Tauranga Hospital
city: Wellington
country: New Zealand
facility: Wellington Hospital
city: Lima
country: Peru
facility: Instituto Nacional de Enfermedades Neoplásicas
city: Lima
country: Peru
facility: Clinica Internacional Sede San Borja
city: Lima
country: Peru
facility: Oncosalud
city: Lodz
country: Poland
facility: Centrum Terapii Wspolczesnej J.M. Jasnorzewska sp. komandytowo-akcyjna
city: Lodz
country: Poland
facility: Instytut MSF Sp. o.o
city: Lodz
country: Poland
facility: Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Łodzi
city: Lublin
country: Poland
facility: KO-MED Centra Kliniczne Lublin II
city: Mrozy
country: Poland
facility: SSZZOZ im. Dr Teodora Dunina w Rudce
city: Olsztyn
country: Poland
facility: SP Zespol Gruzlicy i Chorob Pluc w Olsztynie
city: Otwock
country: Poland
facility: Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy
city: Poznan
country: Poland
facility: Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego
city: Szklarska Poręba
country: Poland
facility: Izerskie Centrum Pulmonologii i Chemioterapii "IZER-MED" Spolka z o.o.
city: Warszawa
country: Poland
facility: Centrum Onkologii-Instytut im. M. Sklodowskiej Curie
city: Wieliszew
country: Poland
facility: Mazowiecki Szpital Onkologiczny
city: Almada
country: Portugal
facility: Hospital Garcia de Orta, EPE
city: Amadora-Lisbon
country: Portugal
facility: Hospital Professor Doutor Fernando Fonseca, E.P.E.
city: Coimbra
country: Portugal
facility: Centro Hospitalar De Coimbra-CHUC
city: Coimbra
country: Portugal
facility: Centro Hospitalar e Universitário de Coimbra, E.P.E (CHC)
city: Lisboa
country: Portugal
facility: Centro Hospitalar de Lisboa Norte, E.P.E. - Hospital Pulido Valente
city: Lisboa
country: Portugal
facility: Centro Hospitalar de Lisboa Central, E.P.E. - Hospital de Santo António dos Capuchos
city: Porto
country: Portugal
facility: Centro Hospitalar do Porto, E.P.E. - Hospital de Santo António
city: Porto
country: Portugal
facility: Hospital CUF Porto
city: Porto
country: Portugal
facility: Instituto Português de Oncologia do Porto Francisco Gentil, EPE
city: Porto
country: Portugal
facility: Centro Hospitalar de São João, E.P.E.
city: Santa Maria da Feira
country: Portugal
facility: Centro Hospitalar de Entre o Douro e Vouga, E.P.E - Hospital de São Sebastião
city: Vila Nova de Gaia
country: Portugal
facility: Centro Hospitalar Vila Nova de Gaia/Espinho, E.P.E
city: Baia Mare
country: Romania
facility: Spitalul Judetean de Urgenta "Dr. Constantin Opris" Baia Mare
city: Brasov
country: Romania
facility: S.C Policlinica de Diagnostic Rapid S.A
city: Bucuresti
country: Romania
facility: Institutul Oncologic "Prof. Dr. Al. Trestioreanu"
city: Bucuresti
country: Romania
facility: Spitalul Clinic Coltea
city: Bucuresti
country: Romania
facility: S.C Gral Medical S.R.L
city: Cluj Napoca
country: Romania
facility: Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj Napoca
city: Cluj-Napoca
country: Romania
facility: S.C Medisprof S.R.L
city: Cluj-Napoca
country: Romania
facility: Spitalul Militar de Urgenta "Dr.Constantin Papilian"Cluj -Napoca
city: Comuna Floresti
country: Romania
facility: S.C Radiotherapy Center Cluj S.R.L
city: Constanta
country: Romania
facility: Spitalul Clinic Judetean de Urgenta "Sf. Apostol Andrei" Constanta
city: Craiova
country: Romania
facility: S.C Centrul de Oncologie Sf. Nectarie S.R.L
city: Iasi
country: Romania
facility: Institutul Regional de Oncologie Iasi
city: Oradea
country: Romania
facility: S.C Pelican Impex S.R.L
city: Oradea
country: Romania
facility: Spitalul Clinic Municipal "Dr. Gavril Curteanu" Oradea
city: Suceava
country: Romania
facility: Spitalul Judetean de Urgenta "Sf. Ioan cel Nou" Suceava
city: Timisoara
country: Romania
facility: S.C Oncocenter Oncologie Clinica S.R.L
city: Timisoara
country: Romania
facility: S.C Oncomed S.R.L
city: Arkhangelsk
country: Russian Federation
facility: SBIH of Arkhangelsk region "Arkhangelsk Clinical Oncological Dispensary"
city: Chelyabinsk
country: Russian Federation
facility: LLC Evimed
city: Chelyabinsk
country: Russian Federation
facility: Chelyabinsk Regional Oncology Dispensary
city: Irkutsk
country: Russian Federation
facility: Irkutsk Regional Oncology Dispensary
city: Ivanovo
country: Russian Federation
facility: RBIH "Ivanovo Regional Oncological Dispensary"
city: Kaluga
country: Russian Federation
facility: SBHI of Kaluga Region "Kaluga regional clinical oncology dispensary"
city: Kazan
country: Russian Federation
facility: SAIH "Republican Clinical Oncological Dispensary of the Ministry of Healthcare of Republic Tatarstan
city: Kemerovo
country: Russian Federation
facility: Kemerovo SPI Regional Clinical Oncology Dispensary
city: Krasnoyarsk
country: Russian Federation
facility: SBHI "Krasnoyarsk Regional Oncology Dispensary n.a. A.I. Kryzhanovsky"
city: Kursk
country: Russian Federation
facility: RBIH "Kursk regional clinical oncology dispensary" of Kursk Region Healthcare Committee
city: Moscow
country: Russian Federation
facility: FSBSI "Russian Oncological Scientific Center n.a. N.N. Blokhin"
city: Murmansk
country: Russian Federation
facility: Murmansk Regional Clinical Hospital named after Bayandin
city: Novosibirsk
country: Russian Federation
facility: SBHI of Novosibirsk region "Novosibirsk Regional Oncological Dispensary"
city: Pyatigorsk
country: Russian Federation
facility: SBIH of Stavropol territory "Pyatigorsk Oncological Dispensary"
city: Saint-Petersburg
country: Russian Federation
facility: SBIH "Leningrad Regional Oncological Dispensary"
city: Saint-Petersburg
country: Russian Federation
facility: "Bio Eq" LLC
city: Saint-Petersburg
country: Russian Federation
facility: FBI "Scientific Research Institute of Oncology n. a. N. N. Petrov"
city: Samara
country: Russian Federation
facility: SBIH "Samara Regional Clinical Oncological Dispensary"
city: Sochi
country: Russian Federation
facility: SBIH "Oncological Dispensary # 2" of the MoH of Krasnodar territory
city: St. Petersburg
country: Russian Federation
facility: FSBHI Clinical research institute of phthisiopulmonology
city: Tomsk
country: Russian Federation
facility: Tomsk Research Instutite of Oncology
city: Tomsk
country: Russian Federation
facility: BHI of Omsk region "Clinical Oncology Dispensary"
city: Tyumen
country: Russian Federation
facility: Medicinskiy gorod
city: Yaroslavl
country: Russian Federation
facility: SBIH of Yaroslavl region "Regional Clinical Oncological Hospital"
city: Belgrade
country: Serbia
facility: Clinical Center of Serbia
city: Belgrade
country: Serbia
facility: Institute of Oncology and Radiology of Serbia
city: Belgrade
country: Serbia
facility: Military Medical Academy
city: Belgrade
country: Serbia
facility: Clinical Center Bezanijska Kosa
city: Gornji Matejevac
country: Serbia
facility: Clinical Center Nis, Pulmonary Diseases Clinic
city: Kragujevac
country: Serbia
facility: Clinical Center Kragujevac
city: Sremska Kamenica
country: Serbia
facility: Institute for Pulmonary Diseases of Vojvodina
city: Singapore
country: Singapore
facility: National University Cancer Institute
city: Singapore
country: Singapore
facility: National Cancer Centre
city: Singapore
country: Singapore
facility: Tan Tock Seng Hospital
city: Bardejov
country: Slovakia
facility: Nemocnica s poliklinikou Sv. Jakuba, n.o. Bardejov
city: Bratislava
country: Slovakia
facility: Univerzitna nemocnica Bratislava, Nemocnica Ruzinov
city: Alberton
country: South Africa
facility: Emery Clinical Services
state: Gauteng
city: Pretoria
country: South Africa
facility: University of Pretoria Oncology Department
state: Gauteng
city: Pretoria
country: South Africa
facility: Johese Clinical Research
state: Gauteng
city: Cape Town
country: South Africa
facility: Cape Town Oncology Trials Pty Ltd
state: Western Cape
city: Mataro
country: Spain
facility: Hospital de Mataro
state: Barcelona
city: Terrassa
country: Spain
facility: Hospital Universitario Mutua de Terrassa
state: Barcelona
city: San Sebastian
country: Spain
facility: Hospital Universitario Donostia
state: Guipuzcoa
city: Santiago de Compostela
country: Spain
facility: Complejo Hospitalario Universitario de Santiago
state: La Coruña
city: Vigo
country: Spain
facility: Complejo Hospitalario Universitario de Vigo
state: Pontevedra
city: Barcelona
country: Spain
facility: Specialist
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 de la Santa Creu i Sant Pau
city: Girona
country: Spain
facility: ICO Girona - Hospital Universitari de Girona Dr. Josep Trueta
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañon
city: Madrid
country: Spain
facility: MD Anderson Cancer Centre
city: Madrid
country: Spain
facility: Fundacion Jimenez Diaz
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Málaga
country: Spain
facility: Hospital Regional Universitario de Malaga
city: Sevilla
country: Spain
facility: Hospital Quiron Sagrado Corazon
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio
city: Vitoria
country: Spain
facility: Hospital Txagorritxu
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Taichung
country: Taiwan
facility: Taichung Veterans General 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: Patumwan
country: Thailand
facility: King Chulalongkorn Memorial Hospital
state: Bangkok
city: Rajathevee
country: Thailand
facility: Rajavithi Hospital
state: Bangkok
city: Muang
country: Thailand
facility: Maharaj Nakorn Chiang Mai Hospital
state: Chiang Mai
city: Muang
country: Thailand
facility: Srinagarind Hospital
state: Khon Kaen
city: Muang
country: Thailand
facility: Naresuan University Hospital
state: Phitsanulok
city: Hat Yai
country: Thailand
facility: Songklanagarind Hospital
state: Songkhla
city: Bangkok
country: Thailand
facility: Siriraj Hospital
city: Adana
country: Turkey
facility: Acibadem Adana Hospital
city: Adana
country: Turkey
facility: Baskent University Adana Application and Research Center
city: Adana
country: Turkey
facility: Adana Numune Training and Research Hospital
city: Adana
country: Turkey
facility: Cukurova University Medical Faculty
city: Adana
country: Turkey
facility: Adana City Hospital
city: Ankara
country: Turkey
facility: Ankara University Medical Faculty
city: Ankara
country: Turkey
facility: Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
city: Ankara
country: Turkey
facility: Hacettepe University Medical Faculty
city: Antalya
country: Turkey
facility: Memorial Antalya Hastanesi
city: Istanbul
country: Turkey
facility: Okmeydani Research and Training Hospital
city: Istanbul
country: Turkey
facility: Istanbul University Cerrahpasa Medical Faculty
city: Istanbul
country: Turkey
facility: Bakirkoy Dr. Sadi Konuk Teaching and Research Hospital
city: Istanbul
country: Turkey
facility: Medipol University Medical Faculty
city: Istanbul
country: Turkey
facility: Kartal Lutfi Kirdar Research and Training Hospital
city: Izmir
country: Turkey
facility: Ege University Medical Faculty
city: Malatya
country: Turkey
facility: Inonu Uni. Med. Fac.
city: Mersin
country: Turkey
facility: Mersin University Medical Faculty
city: Sakarya
country: Turkey
facility: Sakarya Traning and Research Hospital
city: Tekirdag
country: Turkey
facility: Namik Kemal University
city: Chernivtsi
country: Ukraine
facility: CI Chernivtsi RC Oncological Dispensary Bukovinian SMU Ch of Oncology and Radiology
city: Dnipro
country: Ukraine
facility: CI Dnipropetrovsk CMCH #4 of Dnipropetrovsk RC Dept of Chemotherapy SI Dnipropetrovsk MA of MOHU
city: Ivano-Frankivsk
country: Ukraine
facility: CI Transcarpathian Cl Onc Center Dep of Surgery#1 SHEI Ivano-Frankivsk NMU
city: Kharkiv
country: Ukraine
facility: SI S.P.Grygoriev Institute of Medical Radiology of NAMSU
city: Kharkiv
country: Ukraine
facility: Communal Non-profit Enterprise Regional Center of Oncology
city: Kherson
country: Ukraine
facility: Kherson Regional Oncologic Dispensary
city: Kropyvnytskyi
country: Ukraine
facility: Treatment-Diagnostic Center of Private Enterprise of PPC Atsynus
city: Kryvyi Rih, Dnipropetrovsk Region
country: Ukraine
facility: CI Kryvyi Rih Oncological Dispensary of DRC
city: Kyiv
country: Ukraine
facility: Kyiv City Clinical Oncological Center
city: Lutsk
country: Ukraine
facility: Treatment-Prevention Institution Volyn Regional Oncological Dispensary
city: Lviv
country: Ukraine
facility: Lviv State Oncological Regional Treatment and Diagnostic Center
city: Odesa
country: Ukraine
facility: Odesa Regional Oncologic Dispensary
city: Sumy
country: Ukraine
facility: RCI Sumy Regional Clinical Oncological Dispensary
city: Uzhgorod
country: Ukraine
facility: CCCH City Oncological Center SHEI Uzhgorod NU
city: Vinnytsia
country: Ukraine
facility: Podilskyi Regional Oncological Center
city: Vinnytsia
country: Ukraine
facility: Vinnytsia Regional Clinical Oncological Dispensary
city: Westcliff on Sea
country: United Kingdom
facility: Southend University Hospital
state: Essex
city: Cheltenham
country: United Kingdom
facility: Cheltenham General Hospital
state: Gloucestershire
city: London
country: United Kingdom
facility: Chelsea and Westminster Hospital
state: Greater London
city: Stevenage
country: United Kingdom
facility: Mount Vernon Hospital
state: Hertfordshire
city: Wirral
country: United Kingdom
facility: The Clatterbridge Cancer Centre
state: Merseyside
city: Stoke on Trent
country: United Kingdom
facility: Royal Stoke University Hospital
state: Staffordshire
Study officials:
affiliation: EMD Serono Inc., an affiliate of Merck KGaA, Darmstadt, Germany
name: Medical Responsible
role: STUDY_DIRECTOR
References:
citation: Reck M, Barlesi F, Yang JC, Westeel V, Felip E, Ozguroglu M, Dols MC, Sullivan R, Kowalski DM, Andric Z, Lee DH, Sezer A, Hu P, Wang X, von Heydebreck A, Jacob N, Mehr KT, Park K. Avelumab Versus Platinum-Based Doublet Chemotherapy as First-Line Treatment for Patients With High-Expression Programmed Death-Ligand 1-Positive Metastatic NSCLC: Primary Analysis From the Phase 3 JAVELIN Lung 100 Trial. J Thorac Oncol. 2024 Feb;19(2):297-313. doi: 10.1016/j.jtho.2023.09.1445. Epub 2023 Sep 24.