Avelumab in First-line NSCLC (JAVELIN Lung 100)

NCT ID: NCT02576574

Last Updated: 2025-01-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1214 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-29
• Study Completion Date: 2024-01-29

Brief Summary

The purpose of this study was to demonstrate superiority with regard to Overall Survival (OS) or Progression Free Survival (PFS) of avelumab versus platinum-based doublet, based on an Independent Review Committee assessment, in Non-small cell lung cancer (NSCLC) participants with Programmed death ligand 1+ (PD-L1+) tumors.

Conditions

First Line Non-Small Cell Lung Cancer

Study Design

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

Study Groups

Avelumab Biweekly

Group Type: EXPERIMENTAL

Avelumab

Intervention Type: DRUG

Participants received Avelumab at a dose of 10 milligrams per kilogram (mg/kg) as a 1-hour (-10/+20 minutes) intravenous (IV) infusion once every 2 weeks until disease progression or unacceptable toxicities.

Avelumab Weekly

Group Type: EXPERIMENTAL

Cisplatin

Intervention Type: DRUG

Participants received Cisplatin 75 mg/m\^2 by IV infusion in 3-Week cycle up to a maximum of 6 cycles of IV injection until disease progression or unacceptable toxicities.

Avelumab Weekly

Intervention Type: DRUG

Participants received Avelumab at a dose of 10 mg/kg as a 1-hour (-10/+20 minutes) IV infusion every week for 12 consecutive weeks.

Chemotherapy

Group Type: ACTIVE_COMPARATOR

Pemetrexed

Intervention Type: DRUG

Participants received Pemetrexed 500 milligrams per square meter (mg/m\^2) by IV infusion on Day 1 of 3-Week cycle up to a maximum of 6 cycles of IV injection until disease progression or unacceptable toxicities.

Paclitaxel

Intervention Type: DRUG

Participants received Paclitaxel 200 mg/m\^2 by IV infusion on Day 1 of 3-Week cycle up to a maximum of 6 cycles of IV injection until disease progression or unacceptable toxicities.

Gemcitabine

Intervention Type: DRUG

Participants received Gemcitabine 1250 mg/m\^2 on Day 1 and Day 8 by IV infusion in 3-Week cycle up to a maximum of 6 cycles when combined with cisplatin of IV injection until disease progression or unacceptable toxicities.

Gemcitabine

Intervention Type: DRUG

Participants received Gemcitabine 1000 mg/m\^2 on Day 1 and Day 8 by IV infusion in 3-Week cycle up to a maximum of 6 cycles of IV injection when combined with carboplatin until disease progression or unacceptable toxicities.

Carboplatin

Intervention Type: DRUG

Participants received Carboplatin area under concentration curve (AUC) 5 mg/mL\*min in 3-Week cycle up to a maximum of 6 cycles of IV injection when combined with gemcitabine until disease progression or unacceptable toxicities.

Carboplatin

Intervention Type: DRUG

Carboplatin AUC 6 mg/mL\*min by IV infusion in 3-Week cycle up to a maximum of 6 cycles of IV injection when combined with pemetrexed, or paclitaxel until disease progression or unacceptable toxicities.

Interventions

Avelumab

Participants received Avelumab at a dose of 10 milligrams per kilogram (mg/kg) as a 1-hour (-10/+20 minutes) intravenous (IV) infusion once every 2 weeks until disease progression or unacceptable toxicities.

Intervention Type: DRUG

Pemetrexed

Participants received Pemetrexed 500 milligrams per square meter (mg/m\^2) by IV infusion on Day 1 of 3-Week cycle up to a maximum of 6 cycles of IV injection until disease progression or unacceptable toxicities.

Intervention Type: DRUG

Paclitaxel

Participants received Paclitaxel 200 mg/m\^2 by IV infusion on Day 1 of 3-Week cycle up to a maximum of 6 cycles of IV injection until disease progression or unacceptable toxicities.

Intervention Type: DRUG

Gemcitabine

Participants received Gemcitabine 1250 mg/m\^2 on Day 1 and Day 8 by IV infusion in 3-Week cycle up to a maximum of 6 cycles when combined with cisplatin of IV injection until disease progression or unacceptable toxicities.

Intervention Type: DRUG

Gemcitabine

Participants received Gemcitabine 1000 mg/m\^2 on Day 1 and Day 8 by IV infusion in 3-Week cycle up to a maximum of 6 cycles of IV injection when combined with carboplatin until disease progression or unacceptable toxicities.

Intervention Type: DRUG

Carboplatin

Participants received Carboplatin area under concentration curve (AUC) 5 mg/mL\*min in 3-Week cycle up to a maximum of 6 cycles of IV injection when combined with gemcitabine until disease progression or unacceptable toxicities.

Intervention Type: DRUG

Cisplatin

Participants received Cisplatin 75 mg/m\^2 by IV infusion in 3-Week cycle up to a maximum of 6 cycles of IV injection until disease progression or unacceptable toxicities.

Intervention Type: DRUG

Carboplatin

Carboplatin AUC 6 mg/mL\*min by IV infusion in 3-Week cycle up to a maximum of 6 cycles of IV injection when combined with pemetrexed, or paclitaxel until disease progression or unacceptable toxicities.

Intervention Type: DRUG

Avelumab Weekly

Participants received Avelumab at a dose of 10 mg/kg as a 1-hour (-10/+20 minutes) IV infusion every week for 12 consecutive weeks.

Intervention Type: DRUG

Other Intervention Names

Anti-PD-L1; MSB0010718C; Anti-PD-L1; MSB0010718C

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• 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., an affiliate of Merck KGaA, Darmstadt, Germany

Locations

Clearview Cancer Institute

Huntsville, Alabama, United States

Arizona Center for Cancer Care

Surprise, Arizona, United States

Sharp Memorial Hospital

San Diego, California, United States

University Cancer Institute

Boynton Beach, Florida, United States

South Georgia Medical Center

Valdosta, Georgia, United States

Christus Cancer Treatment Center

Shreveport, Louisiana, United States

Henry Ford Hospital

Detroit, Michigan, United States

St. Vincent Frontier Cancer Center

Billings, Montana, United States

Nevada Cancer Research Foundation

Las Vegas, Nevada, United States

San Juan Oncology Associates

Farmington, New Mexico, United States

Novant Health Oncology Specialists

Kernersville, North Carolina, United States

Mercy Research

Oklahoma City, Oklahoma, United States

Kaiser Permanente Northwest

Portland, Oregon, United States

Lancaster Cancer Center

Lancaster, Pennsylvania, United States

Cookeville Regional Medical Center

Cookeville, Tennessee, United States

Thompson Cancer Survival Center

Knoxville, Tennessee, United States

Coastal Bend Cancer Center

Corpus Christi, Texas, United States

Oncology Consultants, P.A.

Houston, Texas, United States

University of Vermont Medical Center

Burlington, Vermont, United States

Northwest Medical Specialties, PLLC

Tacoma, Washington, United States

Cheyenne Regional Medical Center

Cheyenne, Wyoming, United States

Albury Wodonga Regional Cancer Centre

Albury, New South Wales, Australia

Coffs Harbour Health Campus

Coffs Harbour, New South Wales, Australia

St George Private Hospital

Kogarah, New South Wales, Australia

Lismore Base Hospital

Lismore, New South Wales, Australia

Orange Health Service

Orange, New South Wales, Australia

Royal North Shore Hospital

St Leonards, New South Wales, Australia

Calvary Mater Newcastle

Waratah, New South Wales, Australia

Gallipoli Medical Research Foundation Ltd

Greenslopes, Queensland, Australia

Gold Coast University Hospital

Southport, Queensland, Australia

The Queen Elizabeth Hospital

Woodville South, South Australia, Australia

Ballarat Base Hospital

Ballarat, Victoria, Australia

Bendigo Hospital

Bendigo, Victoria, Australia

South West Healthcare

Warrnambool, Victoria, Australia

Fiona Stanley Hospital

Murdoch, Western Australia, Australia

ZNA Middelheim

Antwerp, , Belgium

A.Z. Klina

Brasschaat, , Belgium

CHU Ambroise Paré

Mons, , Belgium

CRIO - Centro Regional Integrado de Oncologia

Fortaleza, Ceará, Brazil

NOB - Núcleo de Oncologia da Bahia

Salvador, Estado de Bahia, Brazil

CEBROM - Centro Brasileiro de Radioterapia, Oncologia e Mastologia

Goiânia, Goiás, Brazil

Hospital Erasto Gaertner - Liga Paranaense de Combate ao Câncer

Curitiba, Paraná, Brazil

Hospital de Caridade de Ijuí

Ijuí, Rio Grande do Sul, Brazil

Hospital Bruno Born

Lajeado, Rio Grande do Sul, Brazil

Hospital São Vicente de Paulo

Passo Fundo, Rio Grande do Sul, Brazil

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

IMV-Pesquisa Cardiologica Sociedade Simples - HMD - COR

Porto Alegre, Rio Grande do Sul, Brazil

Hospital São Lucas da PUCRS

Porto Alegre, Rio Grande do Sul, Brazil

Hospital Nossa Senhora da Conceição

Porto Alegre, Rio Grande do Sul, Brazil

CEPON - Centro de Pesquisas Oncológicas de Santa Catarina

Florianópolis, Santa Catarina, Brazil

Clínica de Neoplasias Litoral Ltda.

Itajaí, Santa Catarina, Brazil

Hospital de Câncer de Barretos - Fundação Pio XII

Barretos, São Paulo, Brazil

Fundação Doutor Amaral Carvalho

Jaú, São Paulo, Brazil

CEPHO - Centro de Estudos e Pesquisas em Hematologia e Oncologia

Santo André, São Paulo, Brazil

Fundação Faculdade Regional de Medicina de São José do Rio Preto

São José do Rio Preto, São Paulo, Brazil

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

São Paulo, São Paulo, Brazil

IBCC - Instituto Brasileiro de Controle do Câncer

São Paulo, São Paulo, Brazil

INCA - Instituto Nacional de Câncer

Rio de Janeiro, , Brazil

Complex Oncological Center - Ruse, EODD

Rousse, , Bulgaria

MHAT for women's health - Nadezhda, OOD

Sofia, , Bulgaria

UMHAT "Sv. Ivan Rilski", EAD

Sofia, , Bulgaria

Shato, Ead

Sofia, , Bulgaria

The Moncton Hospital

Moncton, New Brunswick, Canada

Mount Sinai Hospital

Toronto, Ontario, Canada

FALP - Fundación Arturo López Pérez

Santiago, , Chile

Clinica Santa Maria

Santiago, , Chile

IRAM - Instituto de Radio Medicina

Santiago, , Chile

Hospital Militar de Santiago

Santiago, , Chile

Hospital Clínico San Borja Arriaran

Santiago, , Chile

Hospital Clínico Universidad de Chile

Santiago, , Chile

Hospital Clinico Viña del Mar

Viña del Mar, , Chile

Centro de Investigaciones Clinicas Viña del Mar

Viña del Mar, , Chile

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Guangdong General Hospital

Guangzhou, Guangdong, China

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

Liaoning Cancer Hospital & Institute

Shenyang, Liaoning, China

Linyi Cancer Hospital

Linyi, Shandong, China

Administradora Country S.A.

Bogotá, , Colombia

Fundación Oftalmológica de Santander - FOSCAL

Floridablanca, , Colombia

Hospital Pablo Tobón Uribe

Medellín, , Colombia

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

Montería, , Colombia

University Clinic for Pulmonary Diseases

Zagreb, , Croatia

University Hospital Centre "Sestre Milosrdnice"

Zagreb, , Croatia

Bank of Cyprus Oncology Center

Nicosia, , Cyprus

Krajska nemocnice Liberec, a.s.

Liberec, , Czechia

Nemocnice Na Plesi s.r.o.

Nová Ves pod Pleší, , Czechia

Fakultni nemocnice Olomouc

Olomouc, , Czechia

Vitkovicka nemocnice a.s

Ostrava - Vitkovice, , Czechia

Thomayerova nemocnice

Praha 4 - Krc, , Czechia

Krajska zdravotni, a.s. - Masarykova nemocnice v Usti nad Labem, o.z.

Ústí nad Labem, , Czechia

Herning Sygehus

Herning, , Denmark

Roskilde Sygehus

Roskilde, , Denmark

North Estonia Medical Centre Foundation

Tallinn, , Estonia

Centre Antoine Lacassagne

Nice, Alpes Maritimes, France

CHU de Strasbourg - Nouvel Hôpital Civil

Strasbourg, Bas Rhin, France

Hôpital privé Clairval

Marseille, Bouches-du-Rhône, France

Hôpital Nord - AP-HM Marseille#

Marseille, Bouches-du-Rhône, France

CHU Besançon - Hôpital Jean Minjoz

Besançon, Doubs, France

CHU Brest - Hôpital Morvan

Brest, Finistere, France

Groupe Hospitalier Sud - Hôpital Haut-Lévêque

Pessac, Gironde, France

CHU Angers - Hôpital Hôtel Dieu#

Angers, Maine Et Loire, France

Hôpital Cochin

Paris, Paris, France

Centre Hospitalier de la Côte Basque

Bayonne, Pyrenees Atlantiques, France

Centre Hospitalier de la Croix Rousse

Lyon, Rhone, France

Clinique Victor Hugo - Centre Jean Bernard

Le Mans, Sarthe, France

Institut Sainte Catherine

Avignon, Vaculuse, France

Centre Hospitalier Intercommunal de Créteil

Créteil, Val De Marne, France

Hôpital Saint-Louis - Paris

Paris, , France

Universitaetsklinikum Heidelberg

Heidelberg, Baden-Wurttemberg, Germany

LungenClinic Grosshansdorf GmbH

Großhansdorf, Schleswig-Holstein, Germany

251 General Air Force Hospital

Athens, , Greece

General Hospital of Athens of Chest Diseases "SOTIRIA"

Athens, , Greece

University General Hospital "Attikon"

Athens, , Greece

General Oncology Hospital of Kifissia " Agioi Anargyroi"

Athens, , Greece

Metropolitan General Hospital

Athens, , Greece

University General Hospital of Heraklion

Heraklion, , Greece

University General Hospital of Patra

Pátrai, , Greece

Euromedica General Clinic Thessaloniki

Thessaloniki, , Greece

Orszagos Koranyi Pulmonologiai Intezet

Budapest, , Hungary

Orszagos Onkologiai Intezet

Budapest, , Hungary

Semmelweis Egyetem

Budapest, , Hungary

Orszagos Koranyi Pulmonologiai Intezet

Budapest, , Hungary

Csongrad Megyei Mellkasi Betegsegek Szakkorhaza

Deszk, , Hungary

Petz Aladar Megyei Oktato Korhaz

Győr, , Hungary

Borsod-Abauj-Zemplen Megyei Kozponti Korhaz es Egyetemi Oktatokorhaz

Miskolc, , Hungary

SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz

Nyíregyháza, , Hungary

Tolna Megyei Balassa Janos Korhaz

Szekszárd, , Hungary

Tudogyogyintezet Torokbalint

Törökbálint, , Hungary

Zala Megyei Szent Rafael Korhaz

Zalaegerszeg, , Hungary

Cork University Hospital

Cork, , Ireland

Soroka University Medical Center

Beersheba, , Israel

Rambam Health Care 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

Kaplan Medical Center

Rehovot, , Israel

Assaf Harofeh

Rishon LeZiyyon, , Israel

Tel Aviv Sourasky Medical Center

Tel Aviv, , Israel

Ospedale Mater Salutis

Legnago, Verona, Italy

Fondazione Poliambulanza Istituto Ospedaliero

Brescia, , Italy

Presidio Ospedaliero Garibaldi Nesima

Catania, , Italy

Azienda Ospedaliero Universitaria San Martino

Genova, , Italy

Seconda Università degli Studi di Napoli

Napoli, , Italy

Azienda Ospedaliero Universitaria di Parma

Parma, , Italy

Azienda Ospedaliero Universitaria Pisana

Pisa, , Italy

National Cancer Center Hospital East

Kashiwa-shi, Chiba, Japan

Kurume University Hospital

Kurume-shi, Fukuoka, Japan

NHO Hokkaido Cancer Center

Sapporo, Hokkaido, Japan

Institute of Biomedical Research and Innovation Hospital

Kobe, Hyōgo, Japan

Kobe City Hospital Organization Kobe City Medical Center General Hospital

Kobe, Hyōgo, Japan

Yokohama Municipal Citizen's Hospital

Yokohama, Kanagawa, Japan

Kanagawa Cancer Center

Yokohama, Kanagawa, Japan

Kansai Medical University Hospital

Hirakata-shi, Osaka, Japan

Osaka Medical College Hospital

Takatsuki-shi, Osaka, Japan

National Cancer Center Hospital

Chūōku, Tokyo-To, Japan

Tokyo Medical University Hospital

Shinjuku-ku, Tokyo-To, Japan

Toyama University Hospital

Toyama, Toyama, Japan

Kobe City Hospital Organization Kobe City Medical Center General Hospital

Kobe, , Japan

American University of Beirut Medical Center

Beirut, , Lebanon

Rafik Hariri University Hospital

Beirut, , Lebanon

Hotel Dieu de France Hospital

Beirut, , Lebanon

Mount Lebanon Hospital

Beirut, , Lebanon

Hammoud Hospital University Medical Center

Saida, , Lebanon

Hospital of Lithuanian University of Health Sciences Kaunas Clinics

Kaunas, , Lithuania

Martini Ziekenhuis

Groningen, , Netherlands

Westfriesgasthuis - PARENT

Hoorn, , Netherlands

ETZ Elisabeth

Tilburg, , Netherlands

Auckland City Hospital

Auckland, , New Zealand

Dunedin Public Hospital

Dunedin, , New Zealand

Waikato Hospital

Hamilton, , New Zealand

Palmerston North Hospital

Palmerston North, , New Zealand

Tauranga Hospital

Tauranga, , New Zealand

Wellington Hospital

Wellington, , New Zealand

Instituto Nacional de Enfermedades Neoplásicas

Lima, , Peru

Clinica Internacional Sede San Borja

Lima, , Peru

Oncosalud

Lima, , Peru

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

Lodz, , Poland

Instytut MSF Sp. o.o

Lodz, , Poland

Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Łodzi

Lodz, , Poland

KO-MED Centra Kliniczne Lublin II

Lublin, , Poland

SSZZOZ im. Dr Teodora Dunina w Rudce

Mrozy, , Poland

SP Zespol Gruzlicy i Chorob Pluc w Olsztynie

Olsztyn, , Poland

Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy

Otwock, , Poland

Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego

Poznan, , Poland

Izerskie Centrum Pulmonologii i Chemioterapii "IZER-MED" Spolka z o.o.

Szklarska Poręba, , Poland

Centrum Onkologii-Instytut im. M. Sklodowskiej Curie

Warsaw, , Poland

Mazowiecki Szpital Onkologiczny

Wieliszew, , Poland

Hospital Garcia de Orta, EPE

Almada, , Portugal

Hospital Professor Doutor Fernando Fonseca, E.P.E.

Amadora-Lisbon, , Portugal

Centro Hospitalar De Coimbra-CHUC

Coimbra, , Portugal

Centro Hospitalar e Universitário de Coimbra, E.P.E (CHC)

Coimbra, , Portugal

Centro Hospitalar de Lisboa Norte, E.P.E. - Hospital Pulido Valente

Lisbon, , Portugal

Centro Hospitalar de Lisboa Central, E.P.E. - Hospital de Santo António dos Capuchos

Lisbon, , Portugal

Centro Hospitalar do Porto, E.P.E. - Hospital de Santo António

Porto, , Portugal

Hospital CUF Porto

Porto, , Portugal

Instituto Português de Oncologia do Porto Francisco Gentil, EPE

Porto, , Portugal

Centro Hospitalar de São João, E.P.E.

Porto, , Portugal

Centro Hospitalar de Entre o Douro e Vouga, E.P.E - Hospital de São Sebastião

Santa Maria da Feira, , Portugal

Centro Hospitalar Vila Nova de Gaia/Espinho, E.P.E

Vila Nova de Gaia, , Portugal

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

Baia Mare, , Romania

S.C Policlinica de Diagnostic Rapid S.A

Brasov, , Romania

Institutul Oncologic "Prof. Dr. Al. Trestioreanu"

Bucharest, , Romania

Spitalul Clinic Coltea

Bucharest, , Romania

S.C Gral Medical S.R.L

Bucharest, , Romania

Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj Napoca

Cluj-Napoca, , Romania

S.C Medisprof S.R.L

Cluj-Napoca, , Romania

Spitalul Militar de Urgenta "Dr.Constantin Papilian"Cluj -Napoca

Cluj-Napoca, , Romania

S.C Radiotherapy Center Cluj S.R.L

Comuna Floresti, , Romania

Spitalul Clinic Judetean de Urgenta "Sf. Apostol Andrei" Constanta

Constanța, , Romania

S.C Centrul de Oncologie Sf. Nectarie S.R.L

Craiova, , Romania

Institutul Regional de Oncologie Iasi

Iași, , Romania

S.C Pelican Impex S.R.L

Oradea, , Romania

Spitalul Clinic Municipal "Dr. Gavril Curteanu" Oradea

Oradea, , Romania

Spitalul Judetean de Urgenta "Sf. Ioan cel Nou" Suceava

Suceava, , Romania

S.C Oncocenter Oncologie Clinica S.R.L

Timișoara, , Romania

S.C Oncomed S.R.L

Timișoara, , Romania

SBIH of Arkhangelsk region "Arkhangelsk Clinical Oncological Dispensary"

Arkhangelsk, , Russia

LLC Evimed

Chelyabinsk, , Russia

Chelyabinsk Regional Oncology Dispensary

Chelyabinsk, , Russia

Irkutsk Regional Oncology Dispensary

Irkutsk, , Russia

RBIH "Ivanovo Regional Oncological Dispensary"

Ivanovo, , Russia

SBHI of Kaluga Region "Kaluga regional clinical oncology dispensary"

Kaluga, , Russia

SAIH "Republican Clinical Oncological Dispensary of the Ministry of Healthcare of Republic Tatarstan

Kazan', , Russia

Kemerovo SPI Regional Clinical Oncology Dispensary

Kemerovo, , Russia

SBHI "Krasnoyarsk Regional Oncology Dispensary n.a. A.I. Kryzhanovsky"

Krasnoyarsk, , Russia

RBIH "Kursk regional clinical oncology dispensary" of Kursk Region Healthcare Committee

Kursk, , Russia

FSBSI "Russian Oncological Scientific Center n.a. N.N. Blokhin"

Moscow, , Russia

Murmansk Regional Clinical Hospital named after Bayandin

Murmansk, , Russia

SBHI of Novosibirsk region "Novosibirsk Regional Oncological Dispensary"

Novosibirsk, , Russia

SBIH of Stavropol territory "Pyatigorsk Oncological Dispensary"

Pyatigorsk, , Russia

FSBHI Clinical research institute of phthisiopulmonology

Saint Petersburg, , Russia

SBIH "Leningrad Regional Oncological Dispensary"

Saint Petersburg, , Russia

"Bio Eq" LLC

Saint Petersburg, , Russia

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

Saint Petersburg, , Russia

SBIH "Samara Regional Clinical Oncological Dispensary"

Samara, , Russia

SBIH "Oncological Dispensary # 2" of the MoH of Krasnodar territory

Sochi, , Russia

Tomsk Research Instutite of Oncology

Tomsk, , Russia

BHI of Omsk region "Clinical Oncology Dispensary"

Tomsk, , Russia

Medicinskiy gorod

Tyumen, , Russia

SBIH of Yaroslavl region "Regional Clinical Oncological Hospital"

Yaroslavl, , Russia

Clinical Center of Serbia

Belgrade, , Serbia

Institute of Oncology and Radiology of Serbia

Belgrade, , Serbia

Military Medical Academy

Belgrade, , Serbia

Clinical Center Bezanijska Kosa

Belgrade, , Serbia

Clinical Center Nis, Pulmonary Diseases Clinic

Gornji Matejevac, , Serbia

Institute for Pulmonary Diseases of Vojvodina

Kamenitz, , Serbia

Clinical Center Kragujevac

Kragujevac, , Serbia

National University Cancer Institute

Singapore, , Singapore

National Cancer Centre

Singapore, , Singapore

Tan Tock Seng Hospital

Singapore, , Singapore

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

Bardejov, , Slovakia

Univerzitna nemocnica Bratislava, Nemocnica Ruzinov

Bratislava, , Slovakia

Emery Clinical Services

Alberton, Gauteng, South Africa

University of Pretoria Oncology Department

Pretoria, Gauteng, South Africa

Johese Clinical Research

Pretoria, Gauteng, South Africa

Cape Town Oncology Trials Pty Ltd

Cape Town, Western Cape, South Africa

Yonsei University Wonju Severance Christian Hospital

Wŏnju, Gangwon-do, South Korea

Inje University Haeundae Paik Hospital

Busan, Gyeonggi-do, South Korea

National Cancer Center

Goyang-si, Gyeonggi-do, South Korea

CHA Bundang Medical Center, CHA University

Seongnam-si, Gyeonggi-do, South Korea

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

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

Suwon, Gyeonggi-do, South Korea

Ajou University Hospital

Suwon, Gyeonggi-do, South Korea

Chungbuk National University Hospital

Cheongju-si, North Chungcheong, South Korea

Kyungpook National University Chilgok Hospital

Daegu, , South Korea

Gachon University Gil Medical Center

Incheon, , South Korea

Korea University Anam Hospital

Seoul, , South Korea

Seoul National University Hospital

Seoul, , South Korea

Severance Hospital, Yonsei University

Seoul, , South Korea

Asan Medical Center

Seoul, , South Korea

Samsung Medical Center

Seoul, , South Korea

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

Seoul, , South Korea

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

Seoul, , South Korea

Korea University Guro Hospital

Seoul, , South Korea

Ulsan University Hospital

Ulsan, , South Korea

Hospital de Mataro

Mataró, Barcelona, Spain

Hospital Universitario Mutua de Terrassa

Terrassa, Barcelona, Spain

Hospital Universitario Donostia

Donostia / San Sebastian, Guipuzcoa, Spain

Complejo Hospitalario Universitario de Santiago

Santiago de Compostela, La Coruña, Spain

Complejo Hospitalario Universitario de Vigo

Vigo, Pontevedra, Spain

Specialist

Barcelona, , Spain

Hospital Universitari Quiron Dexeus

Barcelona, , Spain

Hospital Universitari Vall d'Hebron

Barcelona, , Spain

Hospital de la Santa Creu i Sant Pau

Barcelona, , Spain

ICO Girona - Hospital Universitari de Girona Dr. Josep Trueta

Girona, , Spain

Hospital General Universitario Gregorio Marañon

Madrid, , Spain

MD Anderson Cancer Centre

Madrid, , Spain

Fundacion Jimenez Diaz

Madrid, , Spain

Hospital Universitario La Paz

Madrid, , Spain

Hospital Regional Universitario de Malaga

Málaga, , Spain

Hospital Quiron Sagrado Corazon

Seville, , Spain

Hospital Universitario Virgen del Rocio

Seville, , Spain

Hospital Txagorritxu

Vitoria-Gasteiz, , Spain

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, , Taiwan

China Medical University Hospital

Taichung, , Taiwan

Taichung Veterans General Hospital

Taichung, , 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

King Chulalongkorn Memorial Hospital

Patumwan, Bangkok, Thailand

Rajavithi Hospital

Rajathevee, Bangkok, Thailand

Srinagarind Hospital

Muang, Changwat Khon Kaen, Thailand

Naresuan University Hospital

Muang, Changwat Phitsanulok, Thailand

Songklanagarind Hospital

Hat Yai, Changwat Songkhla, Thailand

Maharaj Nakorn Chiang Mai Hospital

Muang, Chiang Mai, Thailand

Siriraj Hospital

Bangkok, , Thailand

Acibadem Adana Hospital

Adana, , Turkey (Türkiye)

Baskent University Adana Application and Research Center

Adana, , Turkey (Türkiye)

Adana Numune Training and Research Hospital

Adana, , Turkey (Türkiye)

Cukurova University Medical Faculty

Adana, , Turkey (Türkiye)

Adana City Hospital

Adana, , Turkey (Türkiye)

Ankara University Medical Faculty

Ankara, , Turkey (Türkiye)

Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

Ankara, , Turkey (Türkiye)

Hacettepe University Medical Faculty

Ankara, , Turkey (Türkiye)

Memorial Antalya Hastanesi

Antalya, , Turkey (Türkiye)

Okmeydani Research and Training Hospital

Istanbul, , Turkey (Türkiye)

Istanbul University Cerrahpasa Medical Faculty

Istanbul, , Turkey (Türkiye)

Bakirkoy Dr. Sadi Konuk Teaching and Research Hospital

Istanbul, , Turkey (Türkiye)

Medipol University Medical Faculty

Istanbul, , Turkey (Türkiye)

Kartal Lutfi Kirdar Research and Training Hospital

Istanbul, , Turkey (Türkiye)

Ege University Medical Faculty

Izmir, , Turkey (Türkiye)

Inonu Uni. Med. Fac.

Malatya, , Turkey (Türkiye)

Mersin University Medical Faculty

Mersin, , Turkey (Türkiye)

Sakarya Traning and Research Hospital

Sakarya, , Turkey (Türkiye)

Namik Kemal University

Tekirdağ, , Turkey (Türkiye)

CI Chernivtsi RC Oncological Dispensary Bukovinian SMU Ch of Oncology and Radiology

Chernivtsi, , Ukraine

CI Dnipropetrovsk CMCH #4 of Dnipropetrovsk RC Dept of Chemotherapy SI Dnipropetrovsk MA of MOHU

Dnipro, , Ukraine

CI Transcarpathian Cl Onc Center Dep of Surgery#1 SHEI Ivano-Frankivsk NMU

Ivano-Frankivsk, , Ukraine

SI S.P.Grygoriev Institute of Medical Radiology of NAMSU

Kharkiv, , Ukraine

Communal Non-profit Enterprise Regional Center of Oncology

Kharkiv, , Ukraine

Kherson Regional Oncologic Dispensary

Kherson, , Ukraine

Treatment-Diagnostic Center of Private Enterprise of PPC Atsynus

Kropyvnytskyi, , Ukraine

CI Kryvyi Rih Oncological Dispensary of DRC

Kryvyi Rih, Dnipropetrovsk Region, , Ukraine

Kyiv City Clinical Oncological Center

Kyiv, , Ukraine

Treatment-Prevention Institution Volyn Regional Oncological Dispensary

Lutsk, , Ukraine

Lviv State Oncological Regional Treatment and Diagnostic Center

Lviv, , Ukraine

Odesa Regional Oncologic Dispensary

Odesa, , Ukraine

RCI Sumy Regional Clinical Oncological Dispensary

Sumy, , Ukraine

CCCH City Oncological Center SHEI Uzhgorod NU

Uzhhorod, , Ukraine

Podilskyi Regional Oncological Center

Vinnytsia, , Ukraine

Vinnytsia Regional Clinical Oncological Dispensary

Vinnytsia, , Ukraine

Southend University Hospital

Westcliff-on-Sea, Essex, United Kingdom

Cheltenham General Hospital

Cheltenham, Gloucestershire, United Kingdom

Chelsea and Westminster Hospital

London, Greater London, United Kingdom

Mount Vernon Hospital

Stevenage, Hertfordshire, United Kingdom

The Clatterbridge Cancer Centre

Metropolitan Borough of Wirral, Merseyside, United Kingdom

Royal Stoke University Hospital

Stoke-on-Trent, Staffordshire, United Kingdom

Countries

United States; Australia; Belgium; Brazil; Bulgaria; Canada; Chile; China; Colombia; Croatia; Cyprus; Czechia; Denmark; Estonia; France; Germany; Greece; Hungary; Ireland; Israel; Italy; Japan; Lebanon; Lithuania; Netherlands; New Zealand; Peru; Poland; Portugal; Romania; Russia; Serbia; Singapore; Slovakia; South Africa; South Korea; Spain; Taiwan; Thailand; Turkey (Türkiye); Ukraine; United Kingdom

References

Reck M, Barlesi F, Yang JC, Westeel V, Felip E, Ozguroglu M, Dols MC, Sullivan R, Kowalski DM, Andric Z, Lee DH, Sezer A, Hu P, Wang X, von Heydebreck A, Jacob N, Mehr KT, Park K. Avelumab Versus Platinum-Based Doublet Chemotherapy as First-Line Treatment for Patients With High-Expression Programmed Death-Ligand 1-Positive Metastatic NSCLC: Primary Analysis From the Phase 3 JAVELIN Lung 100 Trial. J Thorac Oncol. 2024 Feb;19(2):297-313. doi: 10.1016/j.jtho.2023.09.1445. Epub 2023 Sep 24.

Reference Type: RESULT

PMID: 37748693 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://clinicaltrials.emdgroup.com/en/trial-details/?id=EMR%20100070-005

Trial Awareness and Transparency website

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

US Medical Information website, Medical Resources

Other Identifiers

2015-001537-24

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

EMR 100070-005

Identifier Type: -

Identifier Source: org_study_id