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

NCT ID: NCT02395172

Last Updated: 2020-08-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 792 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-24
• Study Completion Date: 2019-12-03

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.

Conditions

Carcinoma, Non-Small-Cell Lung

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Avelumab

Group Type: EXPERIMENTAL

Avelumab

Intervention Type: DRUG

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.

Docetaxel

Group Type: ACTIVE_COMPARATOR

Docetaxel

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

1. Participants must have progressed during or after a minimum of 2 cycles of 1 course of a platinum based combination therapy administered for the treatment of a metastatic disease. A history of continuation (use of a non platinum agent from initial combination) or switch (use of a different agent) maintenance therapy is permitted provided there was no progression after the initial combination. A switch of agents during treatment for the management of toxicities is also permitted provided there was no progression after the initial combination OR

2. Participants must have progressed within 6 months of completion of a platinum-based adjuvant, neoadjuvant, or definitive chemotherapy, or concomitant chemoradiation regimen for locally advanced disease

• Participants with non-squamous cell NSCLC of unknown epidermal growth factor receptor (EGFR) mutation status will require testing (local laboratory, or central laboratory if local testing is not available). Participants with a tumor that harbors an activating EGFR mutation will not be eligible
• Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 1 at trial entry
• Estimated life expectancy of more than 12 weeks
• Adequate hematological function defined by White Blood Cell (WBC) count >= 2.5 × 10^9/L with absolute neutrophil count (ANC) >= 1.5 × 10^9/L, lymphocyte count >=0.5 × 10^9/L, platelet count >= 100 × 10^9/L, and hemoglobin >= 9 gram per deciliter (g/dL) (may have been transfused)
• Adequate hepatic function defined by a total bilirubin level less than or equal to (<=) 1.5 × the upper limit of normal (ULN) range and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels <= 2.5 × ULN for all participants
• Adequate renal function defined by an estimated creatinine clearance > 30 milliliter per minute (mL/min) according to the Cockcroft-Gault formula (or local institutional standard method).

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck KGaA, Darmstadt, Germany

INDUSTRY

Sponsor Role: collaborator

EMD Serono Research & Development Institute, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Responsible

Role: STUDY_DIRECTOR

EMD Serono Inc., a business of Merck KGaA, Darmstadt, Germany

Locations

University of Alabama

Tuscaloosa, Alabama, United States

Mayo Clinic

Scottsdale , Phoenix, Arizona, United States

Pacific Cancer Medical Center, Inc.

Anaheim, California, United States

Healing Hands Oncology and Medical Care

Lawndale, California, United States

Sutter Gould Medical Foundation

Modesto, California, United States

Sharp Memorial Hospital

San Diego, California, United States

Lynn Cancer Institute Center

Boca Raton, Florida, United States

University Cancer Institute

Boynton Beach, Florida, United States

Holy Cross Hospital Inc.

Fort Lauderdale, Florida, United States

Florida Cancer Specialists-Broadway

Fort Myers, Florida, United States

Florida Cancer Specialists

St. Petersburg, Florida, United States

Florida Cancer Specialists

West Palm Beach, Florida, United States

Northeast Georgia Cancer Care, LLC

Athens, Georgia, United States

Metairie Oncologist, LLC

Metairie, Louisiana, United States

Henry Ford Health System

Detroit, Michigan, United States

Hematology Oncology Associates of Rockland

Nyack, New York, United States

Novant Health Oncology Specialists

Winston-Salem, North Carolina, United States

Oncology Hematology Care

Cincinnati, Ohio, United States

Signal Point Clinical Research Center

Middletown, Ohio, United States

Mercy Clinic Oklahoma Communities, Inc.

Oklahoma City, Oklahoma, United States

Abington Memorial Hospital

Abington, Pennsylvania, United States

Penn State Univ. Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

Center for Biomedical Research, LLC

Knoxville, Tennessee, United States

SCRI - Tennessee Oncology

Nashville, Tennessee, United States

The Center for Cancer and Blood Disorders

Fort Worth, Texas, United States

University of Texas Health Science Center at Tyler

Tyler, Texas, United States

MultiCare Health System

Tacoma, Washington, United States

Hospital Italiano Regional del Sur

Bahía Blanca, , Argentina

Clínica Universitaria Privada Reina Fabiola

Barrio General Paz, , Argentina

Centro de Oncologia e Investigacion Buenos Aires

Berazategui, , Argentina

Instituto Medico Especializado Alexander Fleming

Ciudad Autonoma Buenos Aires, , Argentina

CEMIC

Ciudad Autonoma Buenos Aires, , Argentina

Instituto DAMIC Fundacion Rusculleda

Córdoba, , Argentina

Centro Oncologico Riojano Integral (Cori)

La Rioja, , Argentina

Centro Oncologico de Parana

Paraná, , Argentina

Hospital Universitario Austral

Pilar, , Argentina

Instituto Gamma

Rosario, , Argentina

Sanatorio Parque S.A.

Rosario, , Argentina

Instituto de Oncología de Rosario

Rosario, , Argentina

Centro Medico San Roque S.R.L.

San Miguel de Tucumán, , Argentina

Ballarat Base Hospital

Ballarat, , Australia

Box Hill Hospital

Box Hill, , Australia

Coffs Harbour Base Hospital

Coffs Harbour, , Australia

Lyell McEwin Hospital

Elizabeth Vale, , Australia

Greenslopes Private Hospital

Greenslopes, , Australia

Lismore Base Hospital

Lismore, , Australia

Royal Melbourne Hospital

Parkville, , Australia

St John of God Hospital

Subiaco, , Australia

Princess Alexandra Hospital

Woolloongabba, , Australia

UZ Antwerpen

Edegem, , Belgium

Grand Hôpital de Charleroi

Gilly, , Belgium

UZ Leuven

Leuven, , Belgium

Centre Hospitalier de l'Ardenne

Libramont, , Belgium

C. H. U. Sart Tilman

Liège, , Belgium

AZ Delta

Roeselare, , Belgium

Cenantron - Centro Avançado de Tratamento Oncológico S/C Ltda

Belo Horizonte, , Brazil

CEPON - Centro de Pesquisas Oncológicas de Santa Catarina

Florianópolis, , Brazil

Hospital de Caridade de Ijuí

Ijuí, , Brazil

Clínica de Neoplasias Litoral Ltda.

Itajaí, , Brazil

CMiP - Centro Mineiro de Pesquisa

Juiz de Fora, , Brazil

Hospital Bruno Born

Lajeado, , Brazil

Liga Norte-Rio-Grandense Contra o Câncer

Natal, , Brazil

Oncosinos - Clínica de Oncologia - Hospital Regina

Novo Hamburgo, , Brazil

CITO - Centro Integrado de Terapia Onco-Hematológica - Hospital da Cidade de Passo Fundo

Passo Fundo, , Brazil

Hospital Mãe de Deus

Porto Alegre, , Brazil

Hospital São Lucas da PUCRS

Porto Alegre, , Brazil

COI - Clínicas Oncológicas Integradas

Rio de Janeiro, , Brazil

CEPHO - Centro de Estudos e Pesquisas em Hematologia e Oncologia

Santo André, , Brazil

Fundação Faculdade Regional de Medicina de São José do Rio Preto

São José do Rio Preto, , Brazil

ICESP - Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira

São Paulo, , Brazil

IOS - Instituto de Oncologia de Sorocaba "Dr. Gilson Delgado"

Sorocaba, , Brazil

UMHAT 'Dr. Georgi Stranski', EAD

Pleven, , Bulgaria

Complex Oncological Center - Plovdiv, EOOD

Plovdiv, , Bulgaria

MHAT "Serdika", EOOD

Sofia, , Bulgaria

MHAT 'Tokuda Hospital Sofia', AD

Sofia, , Bulgaria

Shato, Ead

Sofia, , Bulgaria

MHAT 'Sv. Marina', EAD

Varna, , Bulgaria

Instituto de Terapias Oncologicas Providencia

Santiago, , Chile

FALP - Fundación Arturo López Pérez

Santiago, , Chile

CIEC - Centro Internacional de Estudios Clínicos

Santiago, , Chile

Instituto Clinico Oncologico del Sur (ICOS)

Temuco, , Chile

Centro de Investigaciones Clinicas Viña del Mar

Viña del Mar, , Chile

Hospital Clinico Viña del Mar

Viña del Mar, , Chile

Fundacion Cardioinfantil Instituto de Cardiologia

Bogotá, , Colombia

Instituto Nacional de Cancerologia E.S.E.

Bogotá, , Colombia

Administradora Country S.A.

Bogotá, , Colombia

Clinica Colsanitas S.A. sede Clinica Universitaria Colombia

Bogotá, , Colombia

Fundación Valle del Lilí

Cali, , Colombia

Centro Medico Imbanaco

Cali, , Colombia

Hemato Oncologos S.A.

Cali, , Colombia

Hospital Pablo Tobón Uribe

Medellín, , Colombia

Instituto de Cancerologia S.A.

Medellín, , Colombia

IPS IMAT- Instituto Medico de Alta Tecnologia - Oncomedica S.A.

Montería, , Colombia

General Hospital Dubrovnik

Dubrovnik, , Croatia

General Hospital Zadar

Zadar, , Croatia

Clinical Hospital Centar "Sestre Milosrdnice"

Zagreb, , Croatia

University Clinic for Pulmonary Diseases

Zagreb, , Croatia

Masarykuv onkologicky ustav

Brno, , Czechia

Nemocnice Novy Jicin a.s.

Nový Jičín, , Czechia

Multiscan s.r.o.

Pardubice, , Czechia

Vseobecna fakultni nemocnice V Praze

Prague, , Czechia

Thomayerova nemocnice

Prague, , Czechia

Herlev Hospital

Herlev, , Denmark

Odense Universitetshospital

Odense C, , Denmark

ICO - Site Paul Papin

Angers, , France

CHU Besançon - Hôpital Jean Minjoz

Besançon, , France

Clinique Victor Hugo - Centre Jean Bernard

Le Mans, , France

Hôpital Nord - AP-HM Marseille#

Marseille, , France

Centre Catherine de Sienne

Nantes, , France

Centre Antoine Lacassagne

Nice, , France

Groupe Hospitalier Sud - Hôpital Haut-Lévêque

Pessac, , France

CHU Poitiers - Hôpital la Milétrie

Poitiers, , France

ICO - Site René Gauducheau

Saint-Herblain, , France

CHU Strasbourg - Nouvel Hôpital Civil

Strasbourg, , France

CHU de Toulouse - Hôpital Larrey

Toulouse, , France

Semmelweis Egyetem AOK

Budapest, , Hungary

Uzsoki Utcai Korhaz

Budapest, , Hungary

Petz Aladar Megyei Oktato Korhaz

Győr, , Hungary

Miskolci Semmelweis Korhaz es Egyetemi Oktatokorhaz

Miskolc, , Hungary

Tudogyogyintezet Torokbalint

Törökbálint, , Hungary

Assaf Harofeh Medical Center

Beer Yaakov, , Israel

Soroka Medical Center

Beersheba, , Israel

Rambam Health Care Campus

Haifa, , Israel

The Lady Davis Carmel Medical Center

Haifa, , Israel

Hadassah University Hospital - Ein Kerem

Jerusalem, , Israel

Sapir Medical Center, Meir Hospital

Kfar Saba, , Israel

Rabin Medical Center-Beilinson Campus

Petah Tikva, , Israel

Chaim Sheba Medical Center

Ramat Gan, , Israel

Tel Aviv Sourasky Medical Center

Tel Aviv, , Israel

Azienda Ospedaliera Istituti Ospitalieri di Cremona

Cremona, , Italy

Ospedale Mater Salutis

Legnago (VR), , Italy

Ospedale Versilia

Lido di Camaiore, , Italy

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, , Italy

IEO Istituto Europeo di Oncologia

Milan, , Italy

Seconda Università degli Studi di Napoli

Napoli, , Italy

Azienda Ospedaliero Universitaria Pisana

Pisa, , Italy

Università Campus Bio-Medico di Roma

Roma, , Italy

Istituto Nazionale Tumori Regina Elena IRCCS

Roma, , Italy

Policlinico Universitario Agostino Gemelli

Roma, , Italy

Azienda Ospedaliera Sant'Andrea-Università di Roma La Sapienza

Roma, , Italy

A.O.U. Senese Policlinico Santa Maria alle Scotte

Siena, , Italy

Azienda Ospedaliera Ospedale Treviglio-Caravaggio di Treviglio

Treviglio, , Italy

National Cancer Center Hospital

Chūōku, , Japan

NHO Kyushu Cancer Center

Fukuoka, , Japan

Osaka Prefectural Medical Center for Respiratory and Allergic Diseases

Habikino-shi, , Japan

Hiroshima City Hiroshima Citizens Hospital

Hiroshima, , Japan

National Cancer Center Hospital East

Kashiwa-shi, , Japan

Saitama Cancer Center

Kitaadachi-gun, , Japan

Institute of Biomedical Research and Innovation Hospital

Kobe, , Japan

Kobe City Hospital Organization Kobe City Medical Center General Hospital

Kobe, , Japan

Cancer Institute Hospital of JFCR

Kōtoku, , Japan

Kurume University Hospital

Kurume-shi, , Japan

Miyagi Cancer Center

Natori-shi, , Japan

Aichi Cancer Center Hospital

Okazaki-shi, , Japan

Osaka City General Hospital

Osaka, , Japan

Osaka Medical Center for Cancer and Cardiovascular Diseases

Osaka, , Japan

Kinki University Hospital

Osakasayama-shi, , Japan

Kitasato University Hospital

Sagamihara-shi, , Japan

NHO Hokkaido Cancer Center

Sapporo, , Japan

Hokkaido University Hospital

Sapporo, , Japan

Tokyo Medical University Hospital

Shinjuku-ku, , Japan

Toyama University Hospital

Toyama, , Japan

Wakayama Medical University Hospital

Wakayama, , Japan

Yokohama Municipal Citizen's Hospital

Yokohama, , Japan

Kanagawa Cancer Center

Yokohama, , Japan

Phylasis Clinicas Research S de RL de CV

Cuautitlán Izcalli, , Mexico

Instituto de Investigaciones Aplicadas a la Neurociencia A.C.

Durango, , Mexico

Fundacion Rodolfo Padilla Padilla, A.C.

León, , Mexico

Health Pharma Professional Research S.A. de C.V.

México, , Mexico

Winsett Rethman S.A. de C.V.

Monterrey, , Mexico

Centro de Investigacion Clinica Chapultepec S.A. de C.V.

Morelia, , Mexico

Oaxaca Site Management Organization S.C.

Oaxaca City, , Mexico

Centro Oncologico Estatal ISSEMyM

Toluca, , Mexico

Clinica Monte Carmelo

Arequipa, , Peru

Hospital Nacional Almanzor Aguinaga Asenjo

Chiclayo, , Peru

Hospital Nacional Adolfo Guevara Velasco

Cusco, , Peru

Clinica San Borja

Lima, , Peru

Hospital Nacional Guillermo Almenara Irigoyen

Lima, , Peru

Clínica Ricardo Palma

Lima, , Peru

Instituto Nacional de Enfermedades Neoplásicas

Lima, , Peru

Szpital Specjalistyczny W Brzozowie, Podkarpacki Osrodek Onkologiczny Im.Ks.B.Markiewicza

Brzozów, , Poland

Wojewodzkie Centrum Szpitalne Kotliny Jeleniogorskiej

Jelenia Góra, , Poland

Samodzielny Publiczny Szpital Kliniczny nr 5 SUM

Katowice, , Poland

Centrum Terapii Wspolczesnej J.M. Jasnorzewska sp. komandytowo-akcyjna

Lodz, , Poland

KO-MED Centra Kliniczne Lublin II

Lublin, , Poland

SSZZOZ im. Dr Teodora Dunina w Rudce

Mrozy, , Poland

Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy

Otwock, , Poland

Spitalul Judetean de Urgenta Alba Iulia

Alba Iulia, , Romania

Spitalul Judetean de Urgenta "Dr. Constantin Opris" Baia Mare

Baia Mare, , Romania

Policlinica de Diagnostic Rapid SRL

Brasov, , Romania

Spitalul Clinic Municipal "Dr. Gavril Curteanu" Oradea

Oradea, , Romania

Spital Lotus SRL

Ploieşti, , Romania

S.C Oncocenter Oncologie Clinica S.R.L

Timișoara, , Romania

SHI "Republican Clinical Oncological Dispensary of HM RT"

Kazan', , Russia

SHBI Moscow Clinical Scientific Center of Department of Healthcare of Moscow

Moscow, , Russia

FSBHI Clinical research institute of phthisiopulmonology

Saint Petersburg, , Russia

Pavlov First Saint Petersburg State Medical University

Saint Petersburg, , Russia

St. Petersburg SHI "City Clinical Oncology Dispensary"

Saint Petersburg, , Russia

FBI "Scientific Research Institute of Oncology n. a. N. N. Petrov"

Saint Petersburg, , Russia

Nemocnica s poliklinikou Sv. Jakuba, n.o. Bardejov

Bardejov, , Slovakia

Univerzitna nemocnica Bratislava, Nemocnica Ruzinov

Bratislava, , Slovakia

Ustredna vojenska nemocnica SNP Ruzomberok- Fakultna nemocnica

Ružomberok, , Slovakia

Fakultna nemocnica Trnava

Trnava, , Slovakia

GVI Cape Gate Oncology Centre

Cape Town, , South Africa

GVI Rondebosch Oncology Centre

Cape Town, , South Africa

GVI Langenhoven Drive Oncology Centre

Port Elizabeth, , South Africa

University of Pretoria Oncology Department

Pretoria, , South Africa

Mary Potter Oncology Centre

Pretoria, , South Africa

Chungbuk National University Hospital

Cheongju-si, , South Korea

Chonnam National University Hwasun Hospital

Hwasun-gun, , South Korea

Gachon University Gil Medical Center

Incheon, , South Korea

Seoul National University Bundang Hospital

Seongnam-si, , South Korea

Asan Medical Center

Seoul, , South Korea

Samsung Medical Center

Seoul, , South Korea

Korea University Guro Hospital

Seoul, , South Korea

Korea University Anam Hospital

Seoul, , South Korea

The Catholic University of Korea, Seoul St. Mary's Hospital

Seoul, , South Korea

The Catholic University of Korea, St. Vincent's Hospital

Suwon, , South Korea

Hospital General Universitario de Alicante

Alicante, , Spain

ICO Badalona - Hospital Germans Trias i Pujol

Badalona, , Spain

Hospital Universitari Quiron Dexeus

Barcelona, , Spain

Hospital Universitari Vall d'Hebron

Barcelona, , Spain

Hospital Clinic i Provincial de Barcelona

Barcelona, , Spain

ICO l´Hospitalet - Hospital Duran i Reynals

L'Hospitalet de Llobregat, , Spain

Hospital Universitario Materno-Infantil de Canarias

Las Palmas de Gran Canaria, , Spain

Hospital Universitario Ramon y Cajal

Madrid, , Spain

Centro Integral Oncologico Clara Campal

Madrid, , Spain

Hospital de Mataro

Mataró, , Spain

Hospital Clinico Universitario Virgen de la Victoria

Málaga, , Spain

Complejo Hospitalario Universitario de Santiago

Santiago de Compostela, , Spain

Hospital Universitario Virgen Macarena

Seville, , Spain

Hospital Universitario Virgen del Rocio

Seville, , Spain

Hospital Universitari i Politecnic La Fe

Valencia, , Spain

Kantonsspital Graubuenden

Chur, , Switzerland

Taichung Veterans General Hospital

Taichung, , Taiwan

National Cheng Kung University Hospital

Tainan City, , Taiwan

National Taiwan University Hospital

Taipei, , Taiwan

Taipei Veterans General Hospital

Taipei, , Taiwan

Tri-Service General Hospital

Taipei, , Taiwan

Chang Gung Memorial Hospital, Linkou

Taoyuan, , Taiwan

Hacettepe University Medical Faculty

Ankara, , Turkey (Türkiye)

Baskent University Ankara Hospital

Ankara, , Turkey (Türkiye)

Ankara University Medical Faculty

Ankara, , Turkey (Türkiye)

Trakya University Medical Faculty

Edirne, , Turkey (Türkiye)

Bezmi Alem Foundation University Medical Faculty Hospital

Istanbul, , Turkey (Türkiye)

Istanbul University Cerrahpasa Medical Faculty

Istanbul, , Turkey (Türkiye)

Fatih Universitesi Tip Fakultesi

Istanbul, , Turkey (Türkiye)

Marmara University Pendik Research and Training Center

Istanbul, , Turkey (Türkiye)

Ege University Medical Faculty

Izmir, , Turkey (Türkiye)

Dokuz Eylul University Medicine Faculty

Izmir, , Turkey (Türkiye)

Konya Necmettin Erbakan University Meram Faculty of Medicine

Konya, , Turkey (Türkiye)

Royal Bournemouth General Hospital

Bournemouth, , United Kingdom

Bristol Haematology & Oncology Centre

Bristol, , United Kingdom

Royal Devon and Exeter Hospital (Wonford)

Exeter, , United Kingdom

Beatson West of Scotland Cancer Centre

Glasgow, , United Kingdom

St James's University Hospital

Leeds, , United Kingdom

University College London Hospital

London, , United Kingdom

The Clatterbridge Cancer Centre

Metropolitan Borough of Wirral, , United Kingdom

Derriford Hospital

Plymouth, , United Kingdom

Mount Vernon Hospital

Stevenage, , United Kingdom

Countries

United States; Argentina; Australia; Belgium; Brazil; Bulgaria; Chile; Colombia; Croatia; Czechia; Denmark; France; Hungary; Israel; Italy; Japan; Mexico; Peru; Poland; Romania; Russia; Slovakia; South Africa; South Korea; Spain; Switzerland; Taiwan; Turkey (Türkiye); United Kingdom

References

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.

Reference Type: DERIVED

PMID: 35771392 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 35144482 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33636453 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 30262187 (View on PubMed)

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

Related Links

http://clinicaltrials.emdgroup.com/en/trial-details/?id=EMR100070_004

Trial Awareness and Transparency website

http://medical.emdserono.com/en_US/home.html

US Medical Information website, Medical Resources

http://www.merckgroup.com/en/company/contact-us/medinfo-contact-map.html

Medical Information Location Map - Med Info Contacts

Other Identifiers

2014-005060-15

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

100070-004

Identifier Type: -

Identifier Source: org_study_id