Avelumab in First-line NSCLC (JAVELIN Lung 100)

NCT02576574 | Completed Phase 3 Results DMC

• 2 other identifiers: EMR 100070-0052015-001537-24
• Study Type: interventional
• Target: 1,214
• Locations: 41 countries
• Sites: 331

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

Keywords

Avelumab; MSB0010718C; Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (4)

• Progression Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Assessed by Independent Review Committee (IRC) in High Programmed Death Ligand 1 (PD-L1) + Full Analysis Set (FAS)

  PFS is 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. PD is defined as at least a 20 percent (%) increase in the sum of the longest diameter (SLD), taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. PFS was measured using Kaplan-Meier (KM) estimates.

  Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)

• Progression Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Assessed by Independent Review Committee (IRC) in High Programmed Death Ligand 1 (PD-L1) + Modified Full Analysis Set (mFAS)

  PFS is 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. PD is defined as at least a 20 percent (%) increase in the sum of the longest diameter (SLD), taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. PFS was measured using Kaplan-Meier (KM) estimates.

  Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)

• Overall Survival (OS) in High Programmed Death Ligand 1 (PD-L1) + Full Analysis Set (FAS)

  OS is defined as the time from randomization to the date of death, regardless of the actual cause of the participant's 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.

  Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)

• Overall Survival (OS) in High Programmed Death Ligand 1 (PD-L1)+ Modified Full Analysis Set (mFAS)

  OS is defined as the time from randomization to the date of death, regardless of the actual cause of the participant's 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.

  Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)

Secondary Outcomes (28)

• Progression Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Assessed by Independent Review Committee (IRC) in Moderate and High Programmed Death Ligand 1 (PD-L1)+ Full Analysis Set (FAS)

  Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)

• Progression Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Assessed by Independent Review Committee (IRC) in Moderate and High Programmed Death Ligand 1 (PD-L1)+ Modified Full Analysis Set (mFAS)

  Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)

• Overall Survival (OS) in Moderate and High Programmed Death Ligand 1 (PD-L1)+ Full Analysis Set (FAS)

  Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)

• Overall Survival (OS) in Moderate and High Programmed Death Ligand 1 (PD-L1)+ Modified Full Analysis Set (mFAS)

  Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)

• Overall Survival (OS) in Full Analysis Set (FAS)

  Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)

Study Arms (3)

Avelumab Biweekly

EXPERIMENTAL

Drug: Avelumab

Avelumab Weekly

EXPERIMENTAL

Drug: Cisplatin; Drug: Avelumab Weekly

Chemotherapy

ACTIVE COMPARATOR

Drug: Pemetrexed; Drug: Paclitaxel; Drug: Gemcitabine; Drug: Carboplatin

Interventions

Avelumab 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.

Also known as: Anti-PD-L1, MSB0010718C

Avelumab Biweekly

Pemetrexed 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.

Chemotherapy

Paclitaxel 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.

Chemotherapy

Gemcitabine 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.

Chemotherapy

Carboplatin 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.

Chemotherapy

Cisplatin 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

Avelumab Weekly 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.

Also known as: Anti-PD-L1, MSB0010718C

Avelumab Weekly

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• EMD Serono Research & Development Institute, Inc.: lead
• Merck KGaA, Darmstadt, Germany: collaborator

Study Sites (349)

Clearview Cancer Institute

Huntsville, Alabama, 35805, United States

Location

Arizona Center for Cancer Care

Surprise, Arizona, 85374, United States

Location

Sharp Memorial Hospital

San Diego, California, 92123, United States

Location

University Cancer Institute

Boynton Beach, Florida, 33426, United States

Location

South Georgia Medical Center

Valdosta, Georgia, 31602, United States

Location

Christus Cancer Treatment Center

Shreveport, Louisiana, 71105, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

St. Vincent Frontier Cancer Center

Billings, Montana, 59102, United States

Location

Nevada Cancer Research Foundation

Las Vegas, Nevada, 89106, United States

Location

San Juan Oncology Associates

Farmington, New Mexico, 87401, United States

Location

Novant Health Oncology Specialists

Kernersville, North Carolina, 27284, United States

Location

Mercy Research

Oklahoma City, Oklahoma, 73120, United States

Location

Kaiser Permanente Northwest

Portland, Oregon, 97227, United States

Location

Lancaster Cancer Center

Lancaster, Pennsylvania, 17605, United States

Location

Cookeville Regional Medical Center

Cookeville, Tennessee, 38501, United States

Location

Thompson Cancer Survival Center

Knoxville, Tennessee, 37916, United States

Location

Coastal Bend Cancer Center

Corpus Christi, Texas, 78404, United States

Location

Oncology Consultants, P.A.

Houston, Texas, 77030, United States

Location

University of Vermont Medical Center

Burlington, Vermont, 05401-1473, United States

Location

Northwest Medical Specialties, PLLC

Tacoma, Washington, 98405, United States

Location

Cheyenne Regional Medical Center

Cheyenne, Wyoming, 82001, United States

Location

Albury Wodonga Regional Cancer Centre

Albury, New South Wales, 2640, Australia

Location

Coffs Harbour Health Campus

Coffs Harbour, New South Wales, 2450, Australia

Location

St George Private Hospital

Kogarah, New South Wales, 2217, Australia

Location

Lismore Base Hospital

Lismore, New South Wales, 2480, Australia

Location

Orange Health Service

Orange, New South Wales, 2800, Australia

Location

Royal North Shore Hospital

St Leonards, New South Wales, 2065, Australia

Location

Calvary Mater Newcastle

Waratah, New South Wales, 2298, Australia

Location

Gallipoli Medical Research Foundation Ltd

Greenslopes, Queensland, 4120, Australia

Location

Gold Coast University Hospital

Southport, Queensland, 4215, Australia

Location

The Queen Elizabeth Hospital

Woodville South, South Australia, 5011, Australia

Location

Ballarat Base Hospital

Ballarat, Victoria, 3350, Australia

Location

Bendigo Hospital

Bendigo, Victoria, 3550, Australia

Location

South West Healthcare

Warrnambool, Victoria, 3280, Australia

Location

Fiona Stanley Hospital

Murdoch, Western Australia, 6150, Australia

Location

ZNA Middelheim

Antwerp, 2020, Belgium

Location

A.Z. Klina

Brasschaat, 2930, Belgium

Location

CHU Ambroise Paré

Mons, 7000, Belgium

Location

CRIO - Centro Regional Integrado de Oncologia

Fortaleza, Ceará, 60336-045, Brazil

Location

NOB - Núcleo de Oncologia da Bahia

Salvador, Estado de Bahia, 40170-110, Brazil

Location

CEBROM - Centro Brasileiro de Radioterapia, Oncologia e Mastologia

Goiânia, Goiás, 74605-030, Brazil

Location

Hospital Erasto Gaertner - Liga Paranaense de Combate ao Câncer

Curitiba, Paraná, 81520-060, Brazil

Location

Hospital de Caridade de Ijuí

Ijuí, Rio Grande do Sul, 98700-000, Brazil

Location

Hospital Bruno Born

Lajeado, Rio Grande do Sul, 95900-000, Brazil

Location

Hospital São Vicente de Paulo

Passo Fundo, Rio Grande do Sul, 99010-080, Brazil

Location

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

Location

IMV-Pesquisa Cardiologica Sociedade Simples - HMD - COR

Porto Alegre, Rio Grande do Sul, 90470-340, Brazil

Location

Hospital São Lucas da PUCRS

Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

Location

Hospital Nossa Senhora da Conceição

Porto Alegre, Rio Grande do Sul, 91350-200, Brazil

Location

CEPON - Centro de Pesquisas Oncológicas de Santa Catarina

Florianópolis, Santa Catarina, 88034-000, Brazil

Location

Clínica de Neoplasias Litoral Ltda.

Itajaí, Santa Catarina, 88301-220, Brazil

Location

Hospital de Câncer de Barretos - Fundação Pio XII

Barretos, São Paulo, 14784-400, Brazil

Location

Fundação Doutor Amaral Carvalho

Jaú, São Paulo, 17210-120, Brazil

Location

CEPHO - Centro de Estudos e Pesquisas em Hematologia e Oncologia

Santo André, São Paulo, 09060-650, Brazil

Location

Fundação Faculdade Regional de Medicina de São José do Rio Preto

São José do Rio Preto, São Paulo, 15090-000, Brazil

Location

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

São Paulo, São Paulo, 01246-000, Brazil

Location

IBCC - Instituto Brasileiro de Controle do Câncer

São Paulo, São Paulo, 03102-002, Brazil

Location

INCA - Instituto Nacional de Câncer

Rio de Janeiro, 20230-230, Brazil

Location

Complex Oncological Center - Ruse, EODD

Rousse, 7002, Bulgaria

Location

MHAT for women's health - Nadezhda, OOD

Sofia, 1330, Bulgaria

Location

UMHAT "Sv. Ivan Rilski", EAD

Sofia, 1431, Bulgaria

Location

Shato, Ead

Sofia, 1756, Bulgaria

Location

The Moncton Hospital

Moncton, New Brunswick, E1C 6Z8, Canada

Location

Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

Location

FALP - Fundación Arturo López Pérez

Santiago, 7500921, Chile

Location

Clinica Santa Maria

Santiago, 7520378, Chile

Location

IRAM - Instituto de Radio Medicina

Santiago, 7630370, Chile

Location

Hospital Militar de Santiago

Santiago, 7850000, Chile

Location

Hospital Clínico San Borja Arriaran

Santiago, 8360160, Chile

Location

Hospital Clínico Universidad de Chile

Santiago, 8380456, Chile

Location

Hospital Clinico Viña del Mar

Viña del Mar, 2520612, Chile

Location

Centro de Investigaciones Clinicas Viña del Mar

Viña del Mar, 2540364, Chile

Location

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location

Guangdong General Hospital

Guangzhou, Guangdong, 510080, China

Location

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, 150081, China

Location

Liaoning Cancer Hospital & Institute

Shenyang, Liaoning, 110042, China

Location

Linyi Cancer Hospital

Linyi, Shandong, 276001, China

Location

Administradora Country S.A.

Bogotá, 00000, Colombia

Location

Fundación Oftalmológica de Santander - FOSCAL

Floridablanca, 6810002, Colombia

Location

Hospital Pablo Tobón Uribe

Medellín, 050034, Colombia

Location

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

Montería, 230002, Colombia

Location

University Clinic for Pulmonary Diseases

Zagreb, 10 000, Croatia

Location

University Hospital Centre "Sestre Milosrdnice"

Zagreb, 10000, Croatia

Location

Bank of Cyprus Oncology Center

Nicosia, 2006, Cyprus

Location

Krajska nemocnice Liberec, a.s.

Liberec, 460 63, Czechia

Location

Nemocnice Na Plesi s.r.o.

Nová Ves pod Pleší, 26204, Czechia

Location

Fakultni nemocnice Olomouc

Olomouc, 775 20, Czechia

Location

Vitkovicka nemocnice a.s

Ostrava - Vitkovice, 703 84, Czechia

Location

Thomayerova nemocnice

Praha 4 - Krc, 140 59, Czechia

Location

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

Ústí nad Labem, 40113, Czechia

Location

Herning Sygehus

Herning, 7400, Denmark

Location

Roskilde Sygehus

Roskilde, 4000, Denmark

Location

North Estonia Medical Centre Foundation

Tallinn, 13419, Estonia

Location

Centre Antoine Lacassagne

Nice, Alpes Maritimes, 06189, France

Location

CHU de Strasbourg - Nouvel Hôpital Civil

Strasbourg, Bas Rhin, 67091, France

Location

Hôpital privé Clairval

Marseille, Bouches-du-Rhône, 13009, France

Location

Hôpital Nord - AP-HM Marseille#

Marseille, Bouches-du-Rhône, 13915, France

Location

CHU Besançon - Hôpital Jean Minjoz

Besançon, Doubs, 25030, France

Location

CHU Brest - Hôpital Morvan

Brest, Finistere, 29609, France

Location

Groupe Hospitalier Sud - Hôpital Haut-Lévêque

Pessac, Gironde, 33604, France

Location

CHU Angers - Hôpital Hôtel Dieu#

Angers, Maine Et Loire, 49933, France

Location

Hôpital Cochin

Paris, Paris, 75679, France

Location

Centre Hospitalier de la Côte Basque

Bayonne, Pyrenees Atlantiques, 64100, France

Location

Centre Hospitalier de la Croix Rousse

Lyon, Rhone, 69317, France

Location

Clinique Victor Hugo - Centre Jean Bernard

Le Mans, Sarthe, 72015, France

Location

Institut Sainte Catherine

Avignon, Vaculuse, 84918, France

Location

Centre Hospitalier Intercommunal de Créteil

Créteil, Val De Marne, 94010, France

Location

Hôpital Saint-Louis - Paris

Paris, France

Location

Universitaetsklinikum Heidelberg

Heidelberg, Baden-Wurttemberg, 69126, Germany

Location

LungenClinic Grosshansdorf GmbH

Großhansdorf, Schleswig-Holstein, 22927, Germany

Location

251 General Air Force Hospital

Athens, 115 25, Greece

Location

General Hospital of Athens of Chest Diseases "SOTIRIA"

Athens, 11527, Greece

Location

University General Hospital "Attikon"

Athens, 12462, Greece

Location

General Oncology Hospital of Kifissia " Agioi Anargyroi"

Athens, 14564, Greece

Location

Metropolitan General Hospital

Athens, 15562, Greece

Location

University General Hospital of Heraklion

Heraklion, 71110, Greece

Location

University General Hospital of Patra

Pátrai, 26504, Greece

Location

Euromedica General Clinic Thessaloniki

Thessaloniki, 54645, Greece

Location

Orszagos Koranyi Pulmonologiai Intezet

Budapest, 1121, Hungary

Location

Orszagos Onkologiai Intezet

Budapest, 1122, Hungary

Location

Semmelweis Egyetem

Budapest, 1125, Hungary

Location

Orszagos Koranyi Pulmonologiai Intezet

Budapest, Hungary

Location

Csongrad Megyei Mellkasi Betegsegek Szakkorhaza

Deszk, 6772, Hungary

Location

Petz Aladar Megyei Oktato Korhaz

Győr, 9024, Hungary

Location

Borsod-Abauj-Zemplen Megyei Kozponti Korhaz es Egyetemi Oktatokorhaz

Miskolc, 3529, Hungary

Location

SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz

Nyíregyháza, 4400, Hungary

Location

Tolna Megyei Balassa Janos Korhaz

Szekszárd, 7100, Hungary

Location

Tudogyogyintezet Torokbalint

Törökbálint, 2045, Hungary

Location

Zala Megyei Szent Rafael Korhaz

Zalaegerszeg, 8900, Hungary

Location

Cork University Hospital

Cork, Ireland

Location

Soroka University Medical Center

Beersheba, 8410101, Israel

Location

Rambam Health Care Center

Haifa, 3109601, Israel

Location

Hadassah University Hospital - Ein Kerem

Jerusalem, 9112001, Israel

Location

Sapir Medical Center, Meir Hospital

Kfar Saba, 4428164, Israel

Location

Rabin Medical Center-Beilinson Campus

Petah Tikva, 49100, Israel

Location

Chaim Sheba Medical Center

Ramat Gan, 5265601, Israel

Location

Kaplan Medical Center

Rehovot, 7610001, Israel

Location

Assaf Harofeh

Rishon LeZiyyon, 75141, Israel

Location

Tel Aviv Sourasky Medical Center

Tel Aviv, 6423906, Israel

Location

Ospedale Mater Salutis

Legnago, Verona, 37045, Italy

Location

Fondazione Poliambulanza Istituto Ospedaliero

Brescia, 25124, Italy

Location

Presidio Ospedaliero Garibaldi Nesima

Catania, 95100, Italy

Location

Azienda Ospedaliero Universitaria San Martino

Genova, 16132, Italy

Location

Seconda Università degli Studi di Napoli

Napoli, 80131, Italy

Location

Azienda Ospedaliero Universitaria di Parma

Parma, 43100, Italy

Location

Azienda Ospedaliero Universitaria Pisana

Pisa, 56126, Italy

Location

National Cancer Center Hospital East

Kashiwa-shi, Chiba, 277-8577, Japan

Location

Kurume University Hospital

Kurume-shi, Fukuoka, 830-0011, Japan

Location

NHO Hokkaido Cancer Center

Sapporo, Hokkaido, 003-0804, Japan

Location

Institute of Biomedical Research and Innovation Hospital

Kobe, Hyōgo, 650-0047, Japan

Location

Kobe City Hospital Organization Kobe City Medical Center General Hospital

Kobe, Hyōgo, 650-0047, Japan

Location

Yokohama Municipal Citizen's Hospital

Yokohama, Kanagawa, 240-8555, Japan

Location

Kanagawa Cancer Center

Yokohama, Kanagawa, 241-8515, Japan

Location

Kansai Medical University Hospital

Hirakata-shi, Osaka, 573-1191, Japan

Location

Osaka Medical College Hospital

Takatsuki-shi, Osaka, 569-8686, Japan

Location

National Cancer Center Hospital

Chūōku, Tokyo-To, 104-0045, Japan

Location

Tokyo Medical University Hospital

Shinjuku-ku, Tokyo-To, 160-0023, Japan

Location

Toyama University Hospital

Toyama, Toyama, 930-0194, Japan

Location

Kobe City Hospital Organization Kobe City Medical Center General Hospital

Kobe, 650-0047, Japan

Location

American University of Beirut Medical Center

Beirut, 1107 2020, Lebanon

Location

Rafik Hariri University Hospital

Beirut, 113-6044, Lebanon

Location

Hotel Dieu de France Hospital

Beirut, 166830, Lebanon

Location

Mount Lebanon Hospital

Beirut, 470, Lebanon

Location

Hammoud Hospital University Medical Center

Saida, 652, Lebanon

Location

Hospital of Lithuanian University of Health Sciences Kaunas Clinics

Kaunas, 50009, Lithuania

Location

Martini Ziekenhuis

Groningen, 9728 NT, Netherlands

Location

Westfriesgasthuis - PARENT

Hoorn, 1624 NP, Netherlands

Location

ETZ Elisabeth

Tilburg, 5022 GC, Netherlands

Location

Auckland City Hospital

Auckland, 1010, New Zealand

Location

Dunedin Public Hospital

Dunedin, 9016, New Zealand

Location

Waikato Hospital

Hamilton, 3200, New Zealand

Location

Palmerston North Hospital

Palmerston North, 4414, New Zealand

Location

Tauranga Hospital

Tauranga, 3143, New Zealand

Location

Wellington Hospital

Wellington, 6021, New Zealand

Location

Instituto Nacional de Enfermedades Neoplásicas

Lima, LIMA 34, Peru

Location

Clinica Internacional Sede San Borja

Lima, LIMA 41, Peru

Location

Oncosalud

Lima, Lima 41, Peru

Location

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

Lodz, 90-242, Poland

Location

Instytut MSF Sp. o.o

Lodz, 90-302, Poland

Location

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

Lodz, 93-513, Poland

Location

KO-MED Centra Kliniczne Lublin II

Lublin, 20-362, Poland

Location

SSZZOZ im. Dr Teodora Dunina w Rudce

Mrozy, 05-320, Poland

Location

SP Zespol Gruzlicy i Chorob Pluc w Olsztynie

Olsztyn, 10-357, Poland

Location

Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy

Otwock, Poland

Location

Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego

Poznan, 60-569, Poland

Location

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

Szklarska Poręba, 58-580, Poland

Location

Centrum Onkologii-Instytut im. M. Sklodowskiej Curie

Warsaw, 02-781, Poland

Location

Mazowiecki Szpital Onkologiczny

Wieliszew, 05-135, Poland

Location

Hospital Garcia de Orta, EPE

Almada, 2801-915, Portugal

Location

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

Amadora-Lisbon, 2610-276, Portugal

Location

Centro Hospitalar De Coimbra-CHUC

Coimbra, 3041-801, Portugal

Location

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

Coimbra, 3041-801, Portugal

Location

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

Lisbon, 1769-001, Portugal

Location

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

Lisbon, 1849-017, Portugal

Location

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

Porto, 4099-001, Portugal

Location

Hospital CUF Porto

Porto, 4100-180, Portugal

Location

Instituto Português de Oncologia do Porto Francisco Gentil, EPE

Porto, 4200-072, Portugal

Location

Centro Hospitalar de São João, E.P.E.

Porto, 4200-319, Portugal

Location

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

Santa Maria da Feira, 4520-211, Portugal

Location

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

Vila Nova de Gaia, 4434-502, Portugal

Location

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

Baia Mare, 430031, Romania

Location

S.C Policlinica de Diagnostic Rapid S.A

Brasov, 500152, Romania

Location

Institutul Oncologic "Prof. Dr. Al. Trestioreanu"

Bucharest, 022328, Romania

Location

Spitalul Clinic Coltea

Bucharest, 030171, Romania

Location

S.C Gral Medical S.R.L

Bucharest, 031422, Romania

Location

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

Cluj-Napoca, 400015, Romania

Location

S.C Medisprof S.R.L

Cluj-Napoca, 400058, Romania

Location

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

Cluj-Napoca, 400132, Romania

Location

S.C Radiotherapy Center Cluj S.R.L

Comuna Floresti, 407280, Romania

Location

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

Constanța, 900591, Romania

Location

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

Craiova, 200347, Romania

Location

Institutul Regional de Oncologie Iasi

Iași, 700483, Romania

Location

S.C Pelican Impex S.R.L

Oradea, 410469, Romania

Location

Spitalul Clinic Municipal "Dr. Gavril Curteanu" Oradea

Oradea, 410469, Romania

Location

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

Suceava, 720201, Romania

Location

S.C Oncocenter Oncologie Clinica S.R.L

Timișoara, 300210, Romania

Location

S.C Oncomed S.R.L

Timișoara, 300239, Romania

Location

SBIH of Arkhangelsk region "Arkhangelsk Clinical Oncological Dispensary"

Arkhangelsk, 163045, Russia

Location

LLC Evimed

Chelyabinsk, 454048, Russia

Location

Chelyabinsk Regional Oncology Dispensary

Chelyabinsk, 454087, Russia

Location

Irkutsk Regional Oncology Dispensary

Irkutsk, 664035, Russia

Location

RBIH "Ivanovo Regional Oncological Dispensary"

Ivanovo, 153040, Russia

Location

SBHI of Kaluga Region "Kaluga regional clinical oncology dispensary"

Kaluga, 248007, Russia

Location

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

Kazan', 420029, Russia

Location

Kemerovo SPI Regional Clinical Oncology Dispensary

Kemerovo, 650036, Russia

Location

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

Krasnoyarsk, 660133, Russia

Location

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

Kursk, 305035, Russia

Location

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

Moscow, 115478, Russia

Location

Murmansk Regional Clinical Hospital named after Bayandin

Murmansk, 183047, Russia

Location

SBHI of Novosibirsk region "Novosibirsk Regional Oncological Dispensary"

Novosibirsk, 630108, Russia

Location

SBIH of Stavropol territory "Pyatigorsk Oncological Dispensary"

Pyatigorsk, 357502, Russia

Location

FSBHI Clinical research institute of phthisiopulmonology

Saint Petersburg, 191036, Russia

Location

SBIH "Leningrad Regional Oncological Dispensary"

Saint Petersburg, 191104, Russia

Location

"Bio Eq" LLC

Saint Petersburg, 197342, Russia

Location

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

Saint Petersburg, 197758, Russia

Location

SBIH "Samara Regional Clinical Oncological Dispensary"

Samara, 443031, Russia

Location

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

Sochi, 354057, Russia

Location

Tomsk Research Instutite of Oncology

Tomsk, 634028, Russia

Location

BHI of Omsk region "Clinical Oncology Dispensary"

Tomsk, 644013, Russia

Location

Medicinskiy gorod

Tyumen, 625041, Russia

Location

SBIH of Yaroslavl region "Regional Clinical Oncological Hospital"

Yaroslavl, 150054, Russia

Location

Clinical Center of Serbia

Belgrade, 11 000, Serbia

Location

Institute of Oncology and Radiology of Serbia

Belgrade, 11000, Serbia

Location

Military Medical Academy

Belgrade, 11000, Serbia

Location

Clinical Center Bezanijska Kosa

Belgrade, 11080, Serbia

Location

Clinical Center Nis, Pulmonary Diseases Clinic

Gornji Matejevac, 18204, Serbia

Location

Institute for Pulmonary Diseases of Vojvodina

Kamenitz, 21204, Serbia

Location

Clinical Center Kragujevac

Kragujevac, 34000, Serbia

Location

National University Cancer Institute

Singapore, 119074, Singapore

Location

National Cancer Centre

Singapore, 169610, Singapore

Location

Tan Tock Seng Hospital

Singapore, 308433, Singapore

Location

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

Bardejov, 08501, Slovakia

Location

Univerzitna nemocnica Bratislava, Nemocnica Ruzinov

Bratislava, 82606, Slovakia

Location

Emery Clinical Services

Alberton, Gauteng, 1449, South Africa

Location

University of Pretoria Oncology Department

Pretoria, Gauteng, 0002, South Africa

Location

Johese Clinical Research

Pretoria, Gauteng, 1692, South Africa

Location

Cape Town Oncology Trials Pty Ltd

Cape Town, Western Cape, 7570, South Africa

Location

Yonsei University Wonju Severance Christian Hospital

Wŏnju, Gangwon-do, 26426, South Korea

Location

Inje University Haeundae Paik Hospital

Busan, Gyeonggi-do, 48108, South Korea

Location

National Cancer Center

Goyang-si, Gyeonggi-do, 10408, South Korea

Location

CHA Bundang Medical Center, CHA University

Seongnam-si, Gyeonggi-do, 13496, South Korea

Location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

Location

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

Suwon, Gyeonggi-do, 16247, South Korea

Location

Ajou University Hospital

Suwon, Gyeonggi-do, 443-380, South Korea

Location

Chungbuk National University Hospital

Cheongju-si, North Chungcheong, 28644, South Korea

Location

Kyungpook National University Chilgok Hospital

Daegu, 41404, South Korea

Location

Gachon University Gil Medical Center

Incheon, 21565, South Korea

Location

Korea University Anam Hospital

Seoul, 02841, South Korea

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Severance Hospital, Yonsei University

Seoul, 03722, South Korea

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

Samsung Medical Center

Seoul, 06351, South Korea

Location

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

Seoul, 06591, South Korea

Location

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

Seoul, 07345, South Korea

Location

Korea University Guro Hospital

Seoul, 08308, South Korea

Location

Ulsan University Hospital

Ulsan, 44033, South Korea

Location

Hospital de Mataro

Mataró, Barcelona, 08304, Spain

Location

Hospital Universitario Mutua de Terrassa

Terrassa, Barcelona, 08221, Spain

Location

Hospital Universitario Donostia

Donostia / San Sebastian, Guipuzcoa, 20014, Spain

Location

Complejo Hospitalario Universitario de Santiago

Santiago de Compostela, La Coruña, 15706, Spain

Location

Complejo Hospitalario Universitario de Vigo

Vigo, Pontevedra, 36204, Spain

Location

Specialist

Barcelona, 08006, Spain

Location

Hospital Universitari Quiron Dexeus

Barcelona, 08028, Spain

Location

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, 08041, Spain

Location

ICO Girona - Hospital Universitari de Girona Dr. Josep Trueta

Girona, 17007, Spain

Location

Hospital General Universitario Gregorio Marañon

Madrid, 28007, Spain

Location

MD Anderson Cancer Centre

Madrid, 28033, Spain

Location

Fundacion Jimenez Diaz

Madrid, 28040, Spain

Location

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

Hospital Regional Universitario de Malaga

Málaga, 29010, Spain

Location

Hospital Quiron Sagrado Corazon

Seville, 41013, Spain

Location

Hospital Universitario Virgen del Rocio

Seville, 41013, Spain

Location

Hospital Txagorritxu

Vitoria-Gasteiz, 01009, Spain

Location

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, 83301, Taiwan

Location

China Medical University Hospital

Taichung, 40447, Taiwan

Location

Taichung Veterans General Hospital

Taichung, 40705, Taiwan

Location

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Taipei Veterans General Hospital

Taipei, 11217, Taiwan

Location

Tri-Service General Hospital

Taipei, 11490, Taiwan

Location

Chang Gung Memorial Hospital, Linkou

Taoyuan, 333, Taiwan

Location

King Chulalongkorn Memorial Hospital

Patumwan, Bangkok, 10330, Thailand

Location

Rajavithi Hospital

Rajathevee, Bangkok, 10400, Thailand

Location

Srinagarind Hospital

Muang, Changwat Khon Kaen, 40002, Thailand

Location

Naresuan University Hospital

Muang, Changwat Phitsanulok, 65000, Thailand

Location

Songklanagarind Hospital

Hat Yai, Changwat Songkhla, 90110, Thailand

Location

Maharaj Nakorn Chiang Mai Hospital

Muang, Chiang Mai, 50200, Thailand

Location

Siriraj Hospital

Bangkok, 10700, Thailand

Location

Acibadem Adana Hospital

Adana, 01130, Turkey (Türkiye)

Location

Baskent University Adana Application and Research Center

Adana, 01220, Turkey (Türkiye)

Location

Adana Numune Training and Research Hospital

Adana, 01240, Turkey (Türkiye)

Location

Cukurova University Medical Faculty

Adana, 01330, Turkey (Türkiye)

Location

Adana City Hospital

Adana, 01370, Turkey (Türkiye)

Location

Ankara University Medical Faculty

Ankara, 06100, Turkey (Türkiye)

Location

Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

Ankara, 06100, Turkey (Türkiye)

Location

Hacettepe University Medical Faculty

Ankara, 06100, Turkey (Türkiye)

Location

Memorial Antalya Hastanesi

Antalya, 07020, Turkey (Türkiye)

Location

Okmeydani Research and Training Hospital

Istanbul, 34000, Turkey (Türkiye)

Location

Istanbul University Cerrahpasa Medical Faculty

Istanbul, 34098, Turkey (Türkiye)

Location

Bakirkoy Dr. Sadi Konuk Teaching and Research Hospital

Istanbul, 34147, Turkey (Türkiye)

Location

Medipol University Medical Faculty

Istanbul, 34214, Turkey (Türkiye)

Location

Kartal Lutfi Kirdar Research and Training Hospital

Istanbul, 34890, Turkey (Türkiye)

Location

Ege University Medical Faculty

Izmir, 35100, Turkey (Türkiye)

Location

Inonu Uni. Med. Fac.

Malatya, 44280, Turkey (Türkiye)

Location

Mersin University Medical Faculty

Mersin, 33169, Turkey (Türkiye)

Location

Sakarya Traning and Research Hospital

Sakarya, 54187, Turkey (Türkiye)

Location

Namik Kemal University

Tekirdağ, 59100, Turkey (Türkiye)

Location

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

Chernivtsi, 58013, Ukraine

Location

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

Dnipro, 49102, Ukraine

Location

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

Ivano-Frankivsk, 76018, Ukraine

Location

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

Kharkiv, 61024, Ukraine

Location

Communal Non-profit Enterprise Regional Center of Oncology

Kharkiv, 61070, Ukraine

Location

Kherson Regional Oncologic Dispensary

Kherson, 73000, Ukraine

Location

Treatment-Diagnostic Center of Private Enterprise of PPC Atsynus

Kropyvnytskyi, 25006, Ukraine

Location

CI Kryvyi Rih Oncological Dispensary of DRC

Kryvyi Rih, Dnipropetrovsk Region, 50048, Ukraine

Location

Kyiv City Clinical Oncological Center

Kyiv, 03115, Ukraine

Location

Treatment-Prevention Institution Volyn Regional Oncological Dispensary

Lutsk, 43018, Ukraine

Location

Lviv State Oncological Regional Treatment and Diagnostic Center

Lviv, 79031, Ukraine

Location

Odesa Regional Oncologic Dispensary

Odesa, 65055, Ukraine

Location

RCI Sumy Regional Clinical Oncological Dispensary

Sumy, 40022, Ukraine

Location

CCCH City Oncological Center SHEI Uzhgorod NU

Uzhhorod, 88000, Ukraine

Location

Podilskyi Regional Oncological Center

Vinnytsia, 21029, Ukraine

Location

Vinnytsia Regional Clinical Oncological Dispensary

Vinnytsia, 21029, Ukraine

Location

Southend University Hospital

Westcliff-on-Sea, Essex, SS0 0RY, United Kingdom

Location

Cheltenham General Hospital

Cheltenham, Gloucestershire, GL53 7AN, United Kingdom

Location

Chelsea and Westminster Hospital

London, Greater London, SW109NH, United Kingdom

Location

Mount Vernon Hospital

Stevenage, Hertfordshire, SG1 4AB, United Kingdom

Location

The Clatterbridge Cancer Centre

Metropolitan Borough of Wirral, Merseyside, CH63 4JY, United Kingdom

Location

Royal Stoke University Hospital

Stoke-on-Trent, Staffordshire, ST4 6QG, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 37748693 RESULT

Related Links

• Trial Awareness and Transparency website
• US Medical Information website, Medical Resources

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

avelumab; Pemetrexed; Paclitaxel; Gemcitabine; Carboplatin; Cisplatin

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Coordination Complexes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Results Point of Contact

• Title: Communication Center
• Organization: Merck KGaA, Darmstadt, Germany

service@emdgroup.com

+49-6151-72-5200

Study Officials

• Medical Responsible

  EMD Serono Inc., an affiliate of Merck KGaA, Darmstadt, Germany

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2015
• First Posted: October 15, 2015
• Study Start: October 29, 2015
• Primary Completion: December 6, 2021
• Study Completion: January 29, 2024
• Last Updated: January 31, 2025
• Results First Posted: January 4, 2023

Record last verified: 2025-01

Locations

CY (1); DE (2); BU (4); UA (16); HU (11); BE (3); CN (5); ES (1); DK (2); SL (2); GB (6); NZ (6); PL (11); PE (3); CZ (6); RU (24); GR (8); US (21); CL (8); SG (3); TH (7); IE (1); JP (13); CO (4); IT (7); LI (1); NL (3); PT (12); RO (17); ZA (4); KR (19); IL (9); CA (2); LE (5); BR (20); TW (7); CR (2); SE (7); AU (14); TU (19); FR (15)