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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02395172
Recruitment Status : Active, not recruiting
First Posted : March 20, 2015
Results First Posted : December 13, 2018
Last Update Posted : December 13, 2018
Sponsor:
Collaborator:
Merck KGaA, Darmstadt, Germany
Information provided by (Responsible Party):
EMD Serono ( EMD Serono Research & Development Institute, Inc. )

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Carcinoma, Non-Small-Cell Lung Drug: Avelumab Drug: Docetaxel Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 792 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : March 24, 2015
Actual Primary Completion Date : November 22, 2017
Estimated Study Completion Date : January 16, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: Avelumab Drug: Avelumab
Participants received 10 milligram per kilogram (mg/kg) of avelumab as a 1-hour intravenous infusion once every 2 weeks until confirmed disease progression.

Active Comparator: Docetaxel Drug: Docetaxel
Participants received 75 mg per square meter (m^2) (per label) of docetaxel by intravenous infusion once every 3 weeks until confirmed disease progression.




Primary Outcome Measures :
  1. Overall Survival (OS) Time in Programmed Death Ligand 1 (PD-L1) + Full Analysis Set Population (FAS) [ Time Frame: Time from date of randomization up to data cutoff (assessed up to 907 days) ]
    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.


Secondary Outcome Measures :
  1. Overall Survival (OS) Time in Full Analysis Set Population [ Time Frame: Time from date of randomization up to data cutoff (assessed up to 907 days) ]
    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.

  2. Progression-Free Survival (PFS) Time in PD-L1+ Full Analysis Set Population [ Time Frame: Time from date of randomization up to data cutoff (assessed up to 907 days) ]
    PFS was defined as the time from date of randomization until date of the first documentation of progressive disease (PD) or death due to any cause in the absence of documented PD, whichever occurs first. PFS was assessed as per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) as adjudicated by independent endpoint review committee (IERC). PD was defined as at least a 20 percent (%) increase in the sum of longest diameter (SLD), taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions and unequivocal progression of non-target lesions. PFS was measured using Kaplan-Meier (KM) estimates.

  3. Progression-Free Survival (PFS) Time in Full Analysis Set Population [ Time Frame: Time from date of randomization up to data cutoff (assessed up to 907 days) ]
    PFS was defined as the time from date of randomization until date of the first documentation of progressive disease (PD) or death due to any cause in the absence of documented PD, whichever occurs first. PFS was assessed as per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) as adjudicated by independent endpoint review committee (IERC). PD was defined as at least a 20 percent (%) increase in the sum of longest diameter (SLD), taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions and unequivocal progression of non-target lesions. PFS was measured using Kaplan-Meier (KM) estimates.

  4. Number of Participants With Confirmed Best Overall Response (BOR) in Full Analysis Set Population [ Time Frame: Time from date of randomization up to data cutoff (assessed up to 907 days) ]
    Confirmed BOR was determined according to RECIST 1.1 and as adjudicated by an IERC. Confirmed BOR was defined as the best response of any of the complete response (CR), partial response (PR), stable disease (SD) and progressive disease (PD) recorded from the date of randomization until disease progression or recurrence (taking the smallest measurement recorded since the start of treatment as reference). CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions. SD: Neither sufficient increase to qualify for PD nor sufficient shrinkage to qualify for PR. PD was defined as at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions and unequivocal progression of non-target lesions. Number of participants with best overall response in each category (CR, PR, SD, PD) was reported.

  5. Number of Participants With Confirmed Best Overall Response (BOR) in PD-L1+ Full Analysis Set Population [ Time Frame: Time from date of randomization up to data cutoff (assessed up to 907 days) ]
    Confirmed BOR was determined according to RECIST 1.1 and as adjudicated by an IERC. Confirmed BOR was defined as the best response of any of the complete response (CR), partial response (PR), stable disease (SD) and progressive disease (PD) recorded from the date of randomization until disease progression or recurrence (taking the smallest measurement recorded since the start of treatment as reference). CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions. SD: Neither sufficient increase to qualify for PD nor sufficient shrinkage to qualify for PR. PD was defined as at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions and unequivocal progression of non-target lesions. Number of participants with best overall response in each category (CR, PR, SD, PD) was reported.

  6. Percentage of Participants With Objective Response in Full Analysis Set Population [ Time Frame: Time from date of randomization up to data cutoff (assessed up to 907 days) ]
    Percentage of participants with objective response (CR plus PR) according to RECIST Version 1.1 was reported. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions.

  7. Percentage of Participants With Objective Response in PD-L1+ Full Analysis Set Population [ Time Frame: Time from date of randomization up to data cutoff (assessed up to 907 days) ]
    Percentage of participants with objective response (CR plus PR) according to RECIST Version 1.1 was reported. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions.

  8. Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Health Outcome Questionnaire Through Composite Index Score at End of Treatment (EOT) [ Time Frame: Baseline, End of treatment visit (up to Week 124) ]
    The EQ-5D-5L health outcome questionnaire was a measure of health status that provides a simple descriptive profile and a single index value. The EQ-5D-5L defined health in terms of mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The 5 items are combined to generate health profiles. These profiles were converted to a continuous single index score. The lowest possible score is -0.59 (unable to walk, unable to self-care, unable to do usual activities, extreme pain or discomfort, extreme anxiety or depression) and the highest is 1.00 (no problems in all 5 dimensions).

  9. Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Health Outcome Questionnaire Through Visual Analogue Scale (VAS) at End of Treatment (EOT) [ Time Frame: Baseline, End of treatment visit (up to Week 124) ]
    EQ-5D-5L is comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive overall score using a visual analog scale (VAS) that ranged from 0 to 100 millimeter (mm), where 0 is the worst health you can imagine and 100 is the best health you can imagine.

  10. Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) Global Health Status at End of Treatment (EOT) [ Time Frame: Baseline, End of treatment visit (up to Week 124) ]
    EORTC QLQ-C30 was a 30-question tool used to assess the overall quality of life (QoL) in cancer participants. It consisted of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, role, cognitive, emotional, social), and 9 symptom scales/items (Fatigue, nausea and vomiting, pain, dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, financial impact). The EORTC QLQ-C30 GHS/QoL score ranged from 0 to 100; High score indicated better GHS/QoL. Score 0 represents: very poor physical condition and QoL. Score 100 represents: excellent overall physical condition and QoL.

  11. Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) at End of Treatment (EOT) [ Time Frame: Baseline, End of treatment visit (up to Week 124) ]
    EORTC QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy. The EORTC QLQ-LC13 module generated one multiple-item scale score assessing dyspnea and a series of single item scores assessing coughing, hemoptysis, sore mouth, dysphagia, neuropathy, alopecia, pain in chest, pain in arms or shoulder and pain in other parts. Score range: 0 (no burden of symptom domain or single symptom item) to 100 (highest burden of symptoms for symptom domains and single items).

  12. Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), Drug Related Treatment Emergent Adverse Events and Treatment Emergent Adverse Events Leading to Death [ Time Frame: Time from date of randomization up to data cutoff (assessed up to 907 days) ]
    An Adverse event (AE) was defined as any unfavorable and unintended sign (including clinically significant abnormal laboratory, vital signs and 12-lead Electrocardiogram findings), symptom, or disease temporally associated with the use of study drug or worsening of pre-existing medical condition, whether or not related to study drug. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. Treatment-emergent are events between first dose of study drug that were absent before treatment or that worsened relative to pre-treatment state up to 30 days after last administration. TEAEs included both Serious TEAEs and non-serious TEAEs.

  13. Number of Participants With Treatment Emergent Adverse Events (TEAEs) by Severity [ Time Frame: Time from date of randomization up to data cutoff (assessed up to 907 days) ]
    Treatment Emergent Adverse Events were graded as per National Cancer Institute Common Terminology Criteria for Adverse Experience version 4.03 (NCI-CTCAE v 4.03). Grade 3 refers to severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care and Activity of daily living (ADL), Grade 4 refers to Life-threatening consequences; where urgent intervention indicated, Grade 5 refers to the death related to adverse event.

  14. Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance: Baseline Score vs. Worst Post-baseline Score [ Time Frame: Time from date of randomization up to data cutoff (assessed up to 907 days) ]
    ECOG performance status measured to assess participant's performance status on a scale of 0 to 5, where 0=Fully active, able to carry on all pre-disease activities without restriction; 1=Restricted in physically strenuous activity, ambulatory and able to carry out light or sedentary work; 2=Ambulatory and capable of all selfcare but unable to carry out any work activities; 3=Capable of only limited self-care, confined to bed/chair for more than 50 percent of waking hours; 4=Completely disabled, cannot carry on any self-care, totally confined to bed/chair; 5=dead. The participants with missing worst post baseline score were also reported. ECOG performance status was reported in terms of number of participants with Baseline value vs. worst post-baseline value (i.e. highest score) combination.

  15. Number of Participants With Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs) for Avelumab [ Time Frame: Time from date of randomization up to data cutoff (assessed up to 907 days) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02395172


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Locations
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United States, Alabama
University of Alabama
Tuscaloosa, Alabama, United States, 35401
United States, Arizona
Mayo Clinic
Scottsdale , Phoenix, Arizona, United States, 85259-5499
United States, California
Pacific Cancer Medical Center, Inc.
Anaheim, California, United States, 92801
Healing Hands Oncology and Medical Care
Lawndale, California, United States, 90260
Sutter Gould Medical Foundation
Modesto, California, United States, 95355
Sharp Memorial Hospital
San Diego, California, United States, 92123
United States, Florida
Lynn Cancer Institute Center
Boca Raton, Florida, United States, 33486
University Cancer Institute
Boynton Beach, Florida, United States, 33426
Holy Cross Hospital Inc.
Fort Lauderdale, Florida, United States, 33308
Florida Cancer Specialists-Broadway
Fort Myers, Florida, United States, 33916
Florida Cancer Specialists
Saint Petersburg, Florida, United States, 33705
Florida Cancer Specialists
West Palm Beach, Florida, United States, 33401
United States, Georgia
Northeast Georgia Cancer Care, LLC
Athens, Georgia, United States, 30607
United States, Louisiana
Metairie Oncologist, LLC
Metairie, Louisiana, United States, 70006
United States, Michigan
Henry Ford Health System
Detroit, Michigan, United States, 48202
United States, New York
Hematology Oncology Associates of Rockland
Nyack, New York, United States, 10960
United States, North Carolina
Novant Health Oncology Specialists
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Oncology Hematology Care
Cincinnati, Ohio, United States, 45242
Signal Point Clinical Research Center
Middletown, Ohio, United States, 45042
United States, Oklahoma
Mercy Clinic Oklahoma Communities, Inc.
Oklahoma City, Oklahoma, United States, 73120-9309
United States, Pennsylvania
Abington Memorial Hospital
Abington, Pennsylvania, United States, 19001
Penn State Univ. Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
United States, Tennessee
Center for Biomedical Research, LLC
Knoxville, Tennessee, United States, 37909
SCRI - Tennessee Oncology
Nashville, Tennessee, United States, 37203
United States, Texas
The Center for Cancer and Blood Disorders
Fort Worth, Texas, United States, 76104
University of Texas Health Science Center at Tyler
Tyler, Texas, United States, 75708
United States, Washington
MultiCare Health System
Tacoma, Washington, United States, 98405
Argentina
Hospital Italiano Regional del Sur
Bahia Blanca, Argentina, B8001HXM
Clínica Universitaria Privada Reina Fabiola
Barrio General Paz, Argentina, X5004FHP
Centro de Oncologia e Investigacion Buenos Aires
Berazategui, Argentina, B1880BBF
Instituto Medico Especializado Alexander Fleming
Ciudad Autonoma Buenos Aires, Argentina, C1426ANZ
CEMIC
Ciudad Autonoma Buenos Aires, Argentina, C1431FWO
Instituto DAMIC Fundacion Rusculleda
Cordoba, Argentina, X5003DCE
Centro Oncologico Riojano Integral (Cori)
La Rioja, Argentina, F5300COE
Centro Oncologico de Parana
Parana, Argentina, 3100
Hospital Universitario Austral
Pilar, Argentina, B1629ODT
Instituto Gamma
Rosario, Argentina, S2000CRF
Sanatorio Parque S.A.
Rosario, Argentina, S2000DSV
Instituto de Oncología de Rosario
Rosario, Argentina, S2000KZE
Centro Medico San Roque S.R.L.
San Miguel de Tucuman, Argentina, 4000
Australia
Ballarat Base Hospital
Ballarat, Australia, 3350
Box Hill Hospital
Box Hill, Australia, 3128
Coffs Harbour Base Hospital
Coffs Harbour, Australia, 2450
Lyell McEwin Hospital
Elizabeth Vale, Australia, 5112
Greenslopes Private Hospital
Greenslopes, Australia, 4120
Lismore Base Hospital
Lismore, Australia, 2480
Royal Melbourne Hospital
Parkville, Australia, 3050
St John of God Hospital
Subiaco, Australia, 6008
Princess Alexandra Hospital
Woolloongabba, Australia, 4102
Belgium
UZ Antwerpen
Edegem, Belgium, 2650
Grand Hôpital de Charleroi
Gilly, Belgium, 6060
UZ Leuven
Leuven, Belgium, 3000
Centre Hospitalier de l'Ardenne
Libramont, Belgium, 6800
C. H. U. Sart Tilman
Liège, Belgium, 4000
AZ Delta
Roeselare, Belgium, 8800
Brazil
Cenantron - Centro Avançado de Tratamento Oncológico S/C Ltda
Belo Horizonte, Brazil, 30110-921
CEPON - Centro de Pesquisas Oncológicas de Santa Catarina
Florianópolis, Brazil, 88034-000
Hospital de Caridade de Ijuí
Ijuí, Brazil, 98700-000
Clínica de Neoplasias Litoral Ltda.
Itajaí, Brazil, 88310-110
CMiP - Centro Mineiro de Pesquisa
Juiz de Fora, Brazil, 36010-570
Hospital Bruno Born
Lajeado, Brazil, 95900-000
Liga Norte-Rio-Grandense Contra o Câncer
Natal, Brazil, 59075-740
Oncosinos - Clínica de Oncologia - Hospital Regina
Novo Hamburgo, Brazil, 93510-250
CITO - Centro Integrado de Terapia Onco-Hematológica - Hospital da Cidade de Passo Fundo
Passo Fundo, Brazil, 99010-260
Hospital Mãe de Deus
Porto Alegre, Brazil, 90110-270
Hospital São Lucas da PUCRS
Porto Alegre, Brazil, 90610-000
COI - Clínicas Oncológicas Integradas
Rio de Janeiro, Brazil, 22793-080
CEPHO - Centro de Estudos e Pesquisas em Hematologia e Oncologia
Santo André, Brazil, 09060-650
IOS - Instituto de Oncologia de Sorocaba "Dr. Gilson Delgado"
Sorocaba, Brazil, 18030-075
Fundação Faculdade Regional de Medicina de São José do Rio Preto
São José do Rio Preto, Brazil, 15090-000
ICESP - Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira
São Paulo, Brazil, 01246-000
Bulgaria
UMHAT 'Dr. Georgi Stranski', EAD
Pleven, Bulgaria, 5800
Complex Oncological Center - Plovdiv, EOOD
Plovdiv, Bulgaria, 4004
MHAT "Serdika", EOOD
Sofia, Bulgaria, 1303
MHAT 'Tokuda Hospital Sofia', AD
Sofia, Bulgaria, 1407
Shato, Ead
Sofia, Bulgaria, 1756
MHAT 'Sv. Marina', EAD
Varna, Bulgaria, 9010
Chile
Instituto de Terapias Oncologicas Providencia
Santiago, Chile, 7500000
FALP - Fundación Arturo López Pérez
Santiago, Chile, 7500921
CIEC - Centro Internacional de Estudios Clínicos
Santiago, Chile, 8420383
Instituto Clinico Oncologico del Sur (ICOS)
Temuco, Chile
Centro de Investigaciones Clinicas Viña del Mar
Viña del Mar, Chile, 2540364
Hospital Clinico Viña del Mar
Viña del Mar, Chile
Colombia
Fundacion Cardioinfantil Instituto de Cardiologia
Bogota, Colombia, 110131
Instituto Nacional de Cancerologia E.S.E.
Bogota, Colombia, 111511
Clinica Colsanitas S.A. sede Clinica Universitaria Colombia
Bogota, Colombia
Administradora Country S.A.
Bogotá, Colombia
Fundación Valle del Lilí
Cali, Colombia, 760032
Centro Medico Imbanaco
Cali, Colombia, 760042
Hemato Oncologos S.A.
Cali, Colombia
Instituto de Cancerologia S.A.
Medellin, Colombia
Hospital Pablo Tobón Uribe
Medellín, Colombia, 050034
IPS IMAT- Instituto Medico de Alta Tecnologia - Oncomedica S.A.
Monteria, Colombia
Croatia
General Hospital Dubrovnik
Dubrovnik, Croatia, 20000
General Hospital Zadar
Zadar, Croatia, 23000
Clinical Hospital Centar "Sestre Milosrdnice"
Zagreb, Croatia, 10000
University Clinic for Pulmonary Diseases
Zagreb, Croatia, 10000
Czechia
Masarykuv onkologicky ustav
Brno, Czechia, 65653
Nemocnice Novy Jicin a.s.
Novy Jicin, Czechia, 74101
Multiscan s.r.o.
Pardubice, Czechia, 53203
Vseobecna fakultni nemocnice V Praze
Praha 2, Czechia, 12808
Thomayerova nemocnice
Praha 4, Czechia, 14059
Denmark
Herlev Hospital
Herlev, Denmark, 2730
Odense Universitetshospital
Odense C, Denmark, 5000
France
ICO - Site Paul Papin
Angers Cedex 9, France, 49933
CHU Besançon - Hôpital Jean Minjoz
Besancon Cedex, France, 25030
Clinique Victor Hugo - Centre Jean Bernard
Le Mans Cedex 02, France, 72000
Hôpital Nord - AP-HM Marseille#
Marseille cedex 20, France, 13915
Centre Catherine de Sienne
Nantes, France, 44202
Centre Antoine Lacassagne
Nice cedex 02, France, 06189
Groupe Hospitalier Sud - Hôpital Haut-Lévêque
Pessac, France, 33604
CHU Poitiers - Hôpital la Milétrie
Poitiers, France, 86021
ICO - Site René Gauducheau
Saint Herblain, France, 44805
CHU Strasbourg - Nouvel Hôpital Civil
Strasbourg, France, 67091
CHU de Toulouse - Hôpital Larrey
Toulouse, France, 31059
Hungary
Semmelweis Egyetem AOK
Budapest, Hungary, 1125
Uzsoki Utcai Korhaz
Budapest, Hungary, 1145
Petz Aladar Megyei Oktato Korhaz
Györ, Hungary, 9024
Miskolci Semmelweis Korhaz es Egyetemi Oktatokorhaz
Miskolc, Hungary, 3529
Tudogyogyintezet Torokbalint
Torokbalint, Hungary, 2045
Israel
Soroka Medical Center
Beer Sheva, Israel, 84101
Assaf Harofeh Medical Center
Beer Yaakov, Israel, 70300
Rambam Health Care Campus
Haifa, Israel, 3109601
The Lady Davis Carmel Medical Center
Haifa, Israel, 34361
Hadassah University Hospital - Ein Kerem
Jerusalem, Israel, 9112001
Sapir Medical Center, Meir Hospital
Kfar-Saba, Israel, 4428164
Rabin Medical Center-Beilinson Campus
Petach Tikva, Israel, 4941492
Chaim Sheba Medical Center
Ramat-Gan, Israel, 52621
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel, 64239
Italy
Azienda Ospedaliera Istituti Ospitalieri di Cremona
Cremona, Italy, 26100
Ospedale Mater Salutis
Legnago (VR), Italy, 37045
Ospedale Versilia
Lido di Camaiore, Italy, 55043
Fondazione IRCCS Istituto Nazionale dei Tumori
Milano, Italy, 20133
IEO Istituto Europeo di Oncologia
Milano, Italy, 20141
Seconda Università degli Studi di Napoli
Napoli, Italy, 80131
Azienda Ospedaliero Universitaria Pisana
Pisa, Italy, 56124
Università Campus Bio-Medico di Roma
Roma, Italy, 00128
Istituto Nazionale Tumori Regina Elena IRCCS
Roma, Italy, 00144
Policlinico Universitario Agostino Gemelli
Roma, Italy, 00168
Azienda Ospedaliera Sant'Andrea-Università di Roma La Sapienza
Roma, Italy, 00189
A.O.U. Senese Policlinico Santa Maria alle Scotte
Siena, Italy, 53100
Azienda Ospedaliera Ospedale Treviglio-Caravaggio di Treviglio
Treviglio, Italy, 24047
Japan
National Cancer Center Hospital
Chuo-ku, Japan, 104-0045
NHO Kyushu Cancer Center
Fukuoka-shi, Japan, 811-1395
Osaka Prefectural Medical Center for Respiratory and Allergic Diseases
Habikino-shi, Japan, 583-8588
Hiroshima City Hiroshima Citizens Hospital
Hiroshima-shi, Japan, 730-8518
National Cancer Center Hospital East
Kashiwa-shi, Japan, 277-8577
Saitama Cancer Center
Kitaadachi-gun, Japan, 362-0806
Institute of Biomedical Research and Innovation Hospital
Kobe-shi, Japan, 650-0047
Kobe City Hospital Organization Kobe City Medical Center General Hospital
Kobe-shi, Japan, 650-0047
Cancer Institute Hospital of JFCR
Koto-ku, Japan, 135-8550
Kurume University Hospital
Kurume-shi, Japan, 830-0011
Miyagi Cancer Center
Natori-shi, Japan, 981-1293
Aichi Cancer Center Hospital
Okazaki-shi, Japan, 444-0011
Osaka City General Hospital
Osaka-shi, Japan, 534-0021
Osaka Medical Center for Cancer and Cardiovascular Diseases
Osaka-shi, Japan, 537-8511
Kinki University Hospital
Osakasayama-shi, Japan, 589-8511
Kitasato University Hospital
Sagamihara-shi, Japan, 252-0375
NHO Hokkaido Cancer Center
Sapporo-shi, Japan, 003-0804
Hokkaido University Hospital
Sapporo-shi, Japan, 060-8648
Tokyo Medical University Hospital
Shinjuku-ku, Japan, 160-0023
Toyama University Hospital
Toyama-shi, Japan, 930-0194
Wakayama Medical University Hospital
Wakayama-shi, Japan, 641-8510
Yokohama Municipal Citizen's Hospital
Yokohama-shi, Japan, 240-8555
Kanagawa Cancer Center
Yokohama-shi, Japan, 241-8515
Korea, Republic of
Chungbuk National University Hospital
Cheongju-si, Korea, Republic of, 28644
Chonnam National University Hwasun Hospital
Hwasun-gun, Korea, Republic of, 519-763
Gachon University Gil Medical Center
Incheon, Korea, Republic of, 21565
Seoul National University Bundang Hospital
Seongnam-si, Korea, Republic of, 13620
Asan Medical Center
Seoul, Korea, Republic of, 05505
Samsung Medical Center
Seoul, Korea, Republic of, 06351
Korea University Guro Hospital
Seoul, Korea, Republic of, 08308
Korea University Anam Hospital
Seoul, Korea, Republic of, 136-705
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, Korea, Republic of, 137-701
The Catholic University of Korea, St. Vincent's Hospital
Suwon-si, Korea, Republic of, 16247
Mexico
Phylasis Clinicas Research S de RL de CV
Cuautitlan Izcalli, Mexico, 54769
Instituto de Investigaciones Aplicadas a la Neurociencia A.C.
Durango, Mexico, 34000
Fundacion Rodolfo Padilla Padilla, A.C.
Leon, Mexico, 37000
Health Pharma Professional Research S.A. de C.V.
Mexico, Mexico, 03810
Winsett Rethman S.A. de C.V.
Monterrey, Mexico, 64060
Centro de Investigacion Clinica Chapultepec S.A. de C.V.
Morelia, Mexico, 58260
Oaxaca Site Management Organization S.C.
Oaxaca, Mexico, 68000
Centro Oncologico Estatal ISSEMyM
Toluca, Mexico, 50180
Peru
Clinica Monte Carmelo
Arequipa, Peru, 04000
Hospital Nacional Almanzor Aguinaga Asenjo
Chiclayo, Peru, 14001
Hospital Nacional Adolfo Guevara Velasco
Cusco, Peru
Clinica San Borja
Lima, Peru, 15000
Hospital Nacional Guillermo Almenara Irigoyen
Lima, Peru, Lima 13
Clínica Ricardo Palma
Lima, Peru, LIMA 27
Instituto Nacional de Enfermedades Neoplásicas
Lima, Peru, LIMA 34
Poland
Szpital Specjalistyczny W Brzozowie, Podkarpacki Osrodek Onkologiczny Im.Ks.B.Markiewicza
Brzozow, Poland, 36-200
Wojewodzkie Centrum Szpitalne Kotliny Jeleniogorskiej
Jelenia Gora, Poland, 58-506
Samodzielny Publiczny Szpital Kliniczny nr 5 SUM
Katowice, Poland, 40-514
Centrum Terapii Wspolczesnej J.M. Jasnorzewska sp. komandytowo-akcyjna
Lodz, Poland, 90-242
KO-MED Centra Kliniczne Lublin II
Lublin, Poland, 20-362
SSZZOZ im. Dr Teodora Dunina w Rudce
Mrozy, Poland, 05-320
Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy
Otwock, Poland, 05-400
Romania
Spitalul Judetean de Urgenta Alba Iulia
Alba Iulia, Romania, 510077
Spitalul Judetean de Urgenta "Dr. Constantin Opris" Baia Mare
Baia Mare, Romania, 430031
Policlinica de Diagnostic Rapid SRL
Brasov, Romania, 500152
Spitalul Clinic Municipal "Dr. Gavril Curteanu" Oradea
Oradea, Romania, 410469
Spital Lotus SRL
Ploiesti, Romania, 100011
S.C Oncocenter Oncologie Clinica S.R.L
Timisoara, Romania, 300210
Russian Federation
SHI "Republican Clinical Oncological Dispensary of HM RT"
Kazan, Russian Federation, 420029
SHBI Moscow Clinical Scientific Center of Department of Healthcare of Moscow
Moscow, Russian Federation, 111123
FSBHI Clinical research institute of phthisiopulmonology
Saint Petersburg, Russian Federation, 191036
Pavlov First Saint Petersburg State Medical University
Saint Petersburg, Russian Federation, 197022
St. Petersburg SHI "City Clinical Oncology Dispensary"
St. Petersburg, Russian Federation, 197022
FBI "Scientific Research Institute of Oncology n. a. N. N. Petrov"
St. Petersburg, Russian Federation, 197758
Slovakia
Nemocnica s poliklinikou Sv. Jakuba, n.o. Bardejov
Bardejov, Slovakia, 08501
Univerzitna nemocnica Bratislava, Nemocnica Ruzinov
Bratislava, Slovakia, 82606
Ustredna vojenska nemocnica SNP Ruzomberok- Fakultna nemocnica
Ruzomberok, Slovakia, 03426
Fakultna nemocnica Trnava
Trnava, Slovakia, 91708
South Africa
GVI Cape Gate Oncology Centre
Cape Town, South Africa, 7570
GVI Rondebosch Oncology Centre
Cape town, South Africa, 7700
GVI Langenhoven Drive Oncology Centre
Port Elizabeth, South Africa, 6045
University of Pretoria Oncology Department
Pretoria, South Africa, 0002
Mary Potter Oncology Centre
Pretoria, South Africa, 0181
Spain
Hospital General Universitario de Alicante
Alicante, Spain, 03010
ICO Badalona - Hospital Germans Trias i Pujol
Badalona, Spain, 08916
Hospital Universitari Quiron Dexeus
Barcelona, Spain, 08028
Hospital Universitari Vall d'Hebron
Barcelona, Spain, 08035
Hospital Clinic i Provincial de Barcelona
Barcelona, Spain, 08036
ICO l´Hospitalet - Hospital Duran i Reynals
L'Hospitalet de Llobregat, Spain, 08908
Hospital Universitario Materno-Infantil de Canarias
Las Palmas de Gran Canaria, Spain, 35016
Hospital Universitario Ramon y Cajal
Madrid, Spain, 28034
Centro Integral Oncologico Clara Campal
Madrid, Spain, 28050
Hospital Clinico Universitario Virgen de la Victoria
Malaga, Spain, 29010
Hospital de Mataro
Mataro, Spain, 08304
Complejo Hospitalario Universitario de Santiago
Santiago de Compostela, Spain, 15706
Hospital Universitario Virgen Macarena
Sevilla, Spain, 41009
Hospital Universitario Virgen del Rocio
Sevilla, Spain, 41013
Hospital Universitari i Politecnic La Fe
Valencia, Spain, 46026
Switzerland
Kantonsspital Graubuenden
Chur, Switzerland, 7000
Taiwan
Taichung Veterans General Hospital
Taichung, Taiwan, 40705
National Cheng Kung University Hospital
Tainan, Taiwan, 704
National Taiwan University Hospital
Taipei, Taiwan, 100
Taipei Veterans General Hospital
Taipei, Taiwan, 112
Tri-Service General Hospital
Taipei, Taiwan, 11490
Chang Gung Memorial Hospital, Linkou
Taoyuan County, Taiwan, 333
Turkey
Hacettepe University Medical Faculty
Ankara, Turkey, 06100
Baskent University Ankara Hospital
Ankara, Turkey, 06500
Ankara University Medical Faculty
Ankara, Turkey
Trakya University Medical Faculty
Edirne, Turkey, 22030
Bezmi Alem Foundation University Medical Faculty Hospital
Istanbul, Turkey, 34093
Istanbul University Cerrahpasa Medical Faculty
Istanbul, Turkey, 34098
Fatih Universitesi Tip Fakultesi
Istanbul, Turkey, 34500
Marmara University Pendik Research and Training Center
Istanbul, Turkey, 34899
Ege University Medical Faculty
Izmir, Turkey, 35100
Dokuz Eylul University Medicine Faculty
Izmir, Turkey, 35340
Konya Necmettin Erbakan University Meram Faculty of Medicine
Konya, Turkey, 42080
United Kingdom
Royal Bournemouth General Hospital
Bournemouth, United Kingdom, BH7 7DW
Bristol Haematology & Oncology Centre
Bristol, United Kingdom, BS2 8ED
Royal Devon and Exeter Hospital (Wonford)
Exeter, United Kingdom, EX2 5DW
Beatson West of Scotland Cancer Centre
Glasgow, United Kingdom, G12 OYN
St James's University Hospital
Leeds, United Kingdom, LS9 7TF
University College London Hospital
London, United Kingdom, NW1 2BU
Derriford Hospital
Plymouth, United Kingdom, PL6 8BQ
Mount Vernon Hospital
Stevenage, United Kingdom, SG1 4AB
The Clatterbridge Cancer Centre
Wirral, United Kingdom, CH63 4JY
Sponsors and Collaborators
EMD Serono Research & Development Institute, Inc.
Merck KGaA, Darmstadt, Germany
Investigators
Layout table for investigator information
Study Director: Medical Responsible EMD Serono Inc., a business of Merck KGaA, Darmstadt, Germany
  Study Documents (Full-Text)

Documents provided by EMD Serono ( EMD Serono Research & Development Institute, Inc. ):
Statistical Analysis Plan  [PDF] December 11, 2017
Study Protocol  [PDF] January 10, 2017


Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: EMD Serono Research & Development Institute, Inc.
ClinicalTrials.gov Identifier: NCT02395172     History of Changes
Other Study ID Numbers: 100070-004
2014-005060-15 ( EudraCT Number )
First Posted: March 20, 2015    Key Record Dates
Results First Posted: December 13, 2018
Last Update Posted: December 13, 2018
Last Verified: November 2018

Keywords provided by EMD Serono ( EMD Serono Research & Development Institute, Inc. ):
Avelumab
MSB0010718C
Non-Small Cell Lung Cancer
Anti-PD-L1

Additional relevant MeSH terms:
Layout table for MeSH terms
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Docetaxel
Antibodies, Monoclonal
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs