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

• ClinicalTrials.gov Identifier: NCT02395172
• Recruitment Status: Completed
• First Posted: March 20, 2015
• Results First Posted: December 13, 2018
• Last Update Posted: August 3, 2020
• Sponsor: EMD Serono Research & Development Institute, Inc.
• Collaborator: Merck KGaA, Darmstadt, Germany
• Information provided by (Responsible Party): EMD Serono ( EMD Serono Research & Development Institute, Inc. )

Study Description

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.

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

Study Design

• 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
• Actual Study Completion Date: December 3, 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: Avelumab	Drug: Avelumab; Participants received 10 milligrams per kilogram (mg/kg) of avelumab as a 1-hour intravenous infusion once every 2 weeks until confirmed disease progression, significant clinical deterioration, unacceptable toxicity, or any criterion for withdrawal from the study or Investigational Medicinal Product (IMP) as defined in the study protocol was fulfilled.
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, significant clinical deterioration, unacceptable toxicity, or any criterion for withdrawal from the study or Investigational Medicinal Product (IMP) as defined in the study protocol was fulfilled.

Outcome Measures

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 1420 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 1420 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 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 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) as Assessed by an Independent Endpoint Review Committee (IERC) in Full Analysis Set Population [ Time Frame: Time from date of randomization up to 907 days ]
   Confirmed BOR was determined according to RECIST v1.1 and as adjudicated by an IERC. Confirmed BOR was defined as the best response of any of the complete response (CR), partial response (PR), stable disease (SD) and progressive disease (PD) recorded from the date of randomization until disease progression or recurrence (taking the smallest measurement recorded since the start of treatment as reference). CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions. SD: Neither sufficient increase to qualify for PD nor sufficient shrinkage to qualify for PR. PD was defined as at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions and unequivocal progression of non-target lesions. Number of participants with best overall response in each category (CR, PR, SD, PD) was reported.
5. Number of Participants With Confirmed Best Overall Response (BOR) as Assessed by Independent Endpoint Review Committee (IERC) in PD-L1+ Full Analysis Set Population [ Time Frame: Time from date of randomization up to 907 days ]
   Confirmed BOR was determined according to RECIST v1.1 and as adjudicated by an IERC. Confirmed BOR was defined as the best response of any of the complete response (CR), partial response (PR), stable disease (SD) and progressive disease (PD) recorded from the date of randomization until disease progression or recurrence (taking the smallest measurement recorded since the start of treatment as reference). CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions. SD: Neither sufficient increase to qualify for PD nor sufficient shrinkage to qualify for PR. PD was defined as at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions and unequivocal progression of non-target lesions. Number of participants with best overall response in each category (CR, PR, SD, PD) was reported.
6. Percentage of Participants With Objective Response as Assessed by Independent Endpoint Review Committee (IERC) in Full Analysis Set Population [ Time Frame: Time from date of randomization up to 907 days ]
   Percentage of participants with objective response (CR plus PR) according to RECIST v1.1 was reported. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions.
7. Percentage of Participants With Objective Response as Assessed by Independent Endpoint Review Committee (IERC) in PD-L1+ Full Analysis Set Population [ Time Frame: Time from date of randomization up to 907 days ]
   Percentage of participants with objective response (CR plus PR) according to RECIST v1.1 was reported. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions.
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 were combined to generate health profiles. These profiles were converted to a continuous single index score. The lowest possible score was -0.59 (unable to walk, unable to self-care, unable to do usual activities, extreme pain or discomfort, extreme anxiety or depression) and the highest was 1.00 (no problems in all 5 dimensions).
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 was comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension had 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses were used to derive overall score using a visual analog scale (VAS) that ranged from 0 to 100 millimeter (mm), where 0 was the worst health you can imagine and 100 was the best health you can imagine.
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 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 1420 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 events were the events between first dose of study drug that were absent before treatment or that worsened relative to pre-treatment state up to 30 days after last administration. TEAEs included both Serious TEAEs and non-serious TEAEs.
13. Number of Participants With Treatment Emergent Adverse Events (TEAEs) by Severity [ Time Frame: Time from date of randomization up to 1420 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 1420 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 Positive Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs) for Avelumab [ Time Frame: Time from date of randomization up to 1420 days ]
    Serum samples were analyzed by a validated electrochemiluminesce immunoassay to detect the presence of antidrug antibodies (ADA). Samples that screened positive were subsequently tested in a confirmatory assay were tested for neutralizing antibodies (nAb). Number of participants with ADA or nAb positive results for Avelumab were reported.

Eligibility Criteria

• 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

Contacts and Locations

Locations

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

• 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

More Information

Additional Information:

Trial Awareness and Transparency website 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

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.

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. Erratum In: Lancet Oncol. 2018 Nov;19(11):e581.

• Responsible Party: EMD Serono Research & Development Institute, Inc.
• ClinicalTrials.gov Identifier: NCT02395172
• Other Study ID Numbers: 100070-004; 2014-005060-15 ( EudraCT Number )
• First Posted: March 20, 2015
• Results First Posted: December 13, 2018
• Last Update Posted: August 3, 2020
• Last Verified: July 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: Per company policy, following approval of a new product or a new indication for an approved product in both the EU and the US, EMD Serono will share study protocols, anonymized patient level and study level data and redacted clinical study reports from clinical trials in patients with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website https://www.emdgroup.com/en/research/our-approach-to-research-and-development/healthcare/clinical-trials/commitment-responsible-data-sharing.html

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:

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; Avelumab; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents, Immunological