First Line Non-Small Cell Lung CancerPhase 3NCT02576574
Avelumab in First-line NSCLC (JAVELIN Lung 100)
A Phase 3 study testing Avelumab, Pemetrexed and Paclitaxel in people with First Line Non-Small Cell Lung Cancer, run by EMD Serono Research & Development Institute, Inc. at 349 sites in 42 countries.
Trial 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+)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- First Line Non-Small Cell Lung Cancer
- What is being tested?
- Avelumab, Pemetrexed and Paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,214 participants
- Where
- 349 sitesin 42 countries
- Study dates
- 29 Oct 2015to 29 Jan 2024
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Subjects whose disease harbors a EGFR mutation, or anaplastic lymphoma kinase (ALK) rearrangement are not eligible.
- Other exclusion criteria include prior therapy with any antibody or drug targeting T cell coregulatory proteins, concurrent anticancer treatment, or immunosuppressive agents
- 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
Trial locations and contacts
349 sites in 42 countries.
349 sites in 42 countries
Russia24 sites
SBIH of Arkhangelsk region "Arkhangelsk Clinical Oncological Dispensary"
Arkhangelsk, 163045
LLC Evimed
Chelyabinsk, 454048
Chelyabinsk Regional Oncology Dispensary
Chelyabinsk, 454087
Irkutsk Regional Oncology Dispensary
Irkutsk, 664035
RBIH "Ivanovo Regional Oncological Dispensary"
Ivanovo, 153040
SBHI of Kaluga Region "Kaluga regional clinical oncology dispensary"
Kaluga, 248007
SAIH "Republican Clinical Oncological Dispensary of the Ministry of Healthcare of Republic Tatarstan
Kazan', 420029
Kemerovo SPI Regional Clinical Oncology Dispensary
Kemerovo, 650036
SBHI "Krasnoyarsk Regional Oncology Dispensary n.a. A.I. Kryzhanovsky"
Krasnoyarsk, 660133
RBIH "Kursk regional clinical oncology dispensary" of Kursk Region Healthcare Committee
Kursk, 305035
FSBSI "Russian Oncological Scientific Center n.a. N.N. Blokhin"
Moscow, 115478
Murmansk Regional Clinical Hospital named after Bayandin
Murmansk, 183047
SBHI of Novosibirsk region "Novosibirsk Regional Oncological Dispensary"
Novosibirsk, 630108
SBIH of Stavropol territory "Pyatigorsk Oncological Dispensary"
Pyatigorsk, 357502
FSBHI Clinical research institute of phthisiopulmonology
Saint Petersburg, 191036
SBIH "Leningrad Regional Oncological Dispensary"
Saint Petersburg, 191104
"Bio Eq" LLC
Saint Petersburg, 197342
FBI "Scientific Research Institute of Oncology n. a. N. N. Petrov"
Saint Petersburg, 197758
SBIH "Samara Regional Clinical Oncological Dispensary"
Samara, 443031
SBIH "Oncological Dispensary # 2" of the MoH of Krasnodar territory
Sochi, 354057
Tomsk Research Instutite of Oncology
Tomsk, 634028
BHI of Omsk region "Clinical Oncology Dispensary"
Tomsk, 644013
Medicinskiy gorod
Tyumen, 625041
SBIH of Yaroslavl region "Regional Clinical Oncological Hospital"
Yaroslavl, 150054
United States21 sites
St. Vincent Frontier Cancer Center
Billings, Montana, 59102
University Cancer Institute
Boynton Beach, Florida, 33426
University of Vermont Medical Center
Burlington, Vermont, 05401-1473
Cheyenne Regional Medical Center
Cheyenne, Wyoming, 82001
Cookeville Regional Medical Center
Cookeville, Tennessee, 38501
Coastal Bend Cancer Center
Corpus Christi, Texas, 78404
Henry Ford Hospital
Detroit, Michigan, 48202
San Juan Oncology Associates
Farmington, New Mexico, 87401
Oncology Consultants, P.A.
Houston, Texas, 77030
Clearview Cancer Institute
Huntsville, Alabama, 35805
Novant Health Oncology Specialists
Kernersville, North Carolina, 27284
Thompson Cancer Survival Center
Knoxville, Tennessee, 37916
Lancaster Cancer Center
Lancaster, Pennsylvania, 17605
Nevada Cancer Research Foundation
Las Vegas, Nevada, 89106
Mercy Research
Oklahoma City, Oklahoma, 73120
Kaiser Permanente Northwest
Portland, Oregon, 97227
Sharp Memorial Hospital
San Diego, California, 92123
Christus Cancer Treatment Center
Shreveport, Louisiana, 71105
Arizona Center for Cancer Care
Surprise, Arizona, 85374
Northwest Medical Specialties, PLLC
Tacoma, Washington, 98405
South Georgia Medical Center
Valdosta, Georgia, 31602
Brazil20 sites
Hospital de Câncer de Barretos - Fundação Pio XII
Barretos, São Paulo, 14784-400
Hospital Erasto Gaertner - Liga Paranaense de Combate ao Câncer
Curitiba, Paraná, 81520-060
CEPON - Centro de Pesquisas Oncológicas de Santa Catarina
Florianópolis, Santa Catarina, 88034-000
CRIO - Centro Regional Integrado de Oncologia
Fortaleza, Ceará, 60336-045
CEBROM - Centro Brasileiro de Radioterapia, Oncologia e Mastologia
Goiânia, Goiás, 74605-030
Hospital de Caridade de Ijuí
Ijuí, Rio Grande do Sul, 98700-000
Clínica de Neoplasias Litoral Ltda.
Itajaí, Santa Catarina, 88301-220
Fundação Doutor Amaral Carvalho
Jaú, São Paulo, 17210-120
Hospital Bruno Born
Lajeado, Rio Grande do Sul, 95900-000
Hospital São Vicente de Paulo
Passo Fundo, Rio Grande do Sul, 99010-080
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-903
IMV-Pesquisa Cardiologica Sociedade Simples - HMD - COR
Porto Alegre, Rio Grande do Sul, 90470-340
Hospital São Lucas da PUCRS
Porto Alegre, Rio Grande do Sul, 90610-000
Hospital Nossa Senhora da Conceição
Porto Alegre, Rio Grande do Sul, 91350-200
INCA - Instituto Nacional de Câncer
Rio de Janeiro, 20230-230
NOB - Núcleo de Oncologia da Bahia
Salvador, Estado de Bahia, 40170-110
CEPHO - Centro de Estudos e Pesquisas em Hematologia e Oncologia
Santo André, São Paulo, 09060-650
Fundação Faculdade Regional de Medicina de São José do Rio Preto
São José do Rio Preto, São Paulo, 15090-000
ICESP - Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira
São Paulo, São Paulo, 01246-000
IBCC - Instituto Brasileiro de Controle do Câncer
São Paulo, São Paulo, 03102-002
South Korea19 sites
Inje University Haeundae Paik Hospital
Busan, Gyeonggi-do, 48108
Chungbuk National University Hospital
Cheongju-si, North Chungcheong, 28644
Kyungpook National University Chilgok Hospital
Daegu, 41404
National Cancer Center
Goyang-si, Gyeonggi-do, 10408
Gachon University Gil Medical Center
Incheon, 21565
CHA Bundang Medical Center, CHA University
Seongnam-si, Gyeonggi-do, 13496
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620
Korea University Anam Hospital
Seoul, 02841
Seoul National University Hospital
Seoul, 03080
Severance Hospital, Yonsei University
Seoul, 03722
Asan Medical Center
Seoul, 05505
Samsung Medical Center
Seoul, 06351
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, 06591
The Catholic University of Korea, Yeouido St. Mary's Hospital
Seoul, 07345
Korea University Guro Hospital
Seoul, 08308
The Catholic University of Korea, St. Vincent's Hospital
Suwon, Gyeonggi-do, 16247
Ajou University Hospital
Suwon, Gyeonggi-do, 443-380
Ulsan University Hospital
Ulsan, 44033
Yonsei University Wonju Severance Christian Hospital
Wŏnju, Gangwon-do, 26426
Turkey (Türkiye)19 sites
Acibadem Adana Hospital
Adana, 01130
Baskent University Adana Application and Research Center
Adana, 01220
Adana Numune Training and Research Hospital
Adana, 01240
Cukurova University Medical Faculty
Adana, 01330
Adana City Hospital
Adana, 01370
Ankara University Medical Faculty
Ankara, 06100
Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
Ankara, 06100
Hacettepe University Medical Faculty
Ankara, 06100
Memorial Antalya Hastanesi
Antalya, 07020
Okmeydani Research and Training Hospital
Istanbul, 34000
Istanbul University Cerrahpasa Medical Faculty
Istanbul, 34098
Bakirkoy Dr. Sadi Konuk Teaching and Research Hospital
Istanbul, 34147
Medipol University Medical Faculty
Istanbul, 34214
Kartal Lutfi Kirdar Research and Training Hospital
Istanbul, 34890
Ege University Medical Faculty
Izmir, 35100
Inonu Uni. Med. Fac.
Malatya, 44280
Mersin University Medical Faculty
Mersin, 33169
Sakarya Traning and Research Hospital
Sakarya, 54187
Namik Kemal University
Tekirdağ, 59100
Spain18 sites
Specialist
Barcelona, 08006
Hospital Universitari Quiron Dexeus
Barcelona, 08028
Hospital Universitari Vall d'Hebron
Barcelona, 08035
Hospital de la Santa Creu i Sant Pau
Barcelona, 08041
Hospital Universitario Donostia
Donostia / San Sebastian, Guipuzcoa, 20014
ICO Girona - Hospital Universitari de Girona Dr. Josep Trueta
Girona, 17007
Hospital General Universitario Gregorio Marañon
Madrid, 28007
MD Anderson Cancer Centre
Madrid, 28033
Fundacion Jimenez Diaz
Madrid, 28040
Hospital Universitario La Paz
Madrid, 28046
Hospital Regional Universitario de Malaga
Málaga, 29010
Hospital de Mataro
Mataró, Barcelona, 08304
Complejo Hospitalario Universitario de Santiago
Santiago de Compostela, La Coruña, 15706
Hospital Quiron Sagrado Corazon
Seville, 41013
Hospital Universitario Virgen del Rocio
Seville, 41013
Hospital Universitario Mutua de Terrassa
Terrassa, Barcelona, 08221
Complejo Hospitalario Universitario de Vigo
Vigo, Pontevedra, 36204
Hospital Txagorritxu
Vitoria-Gasteiz, 01009
Romania17 sites
Spitalul Judetean de Urgenta "Dr. Constantin Opris" Baia Mare
Baia Mare, 430031
S.C Policlinica de Diagnostic Rapid S.A
Brasov, 500152
Institutul Oncologic "Prof. Dr. Al. Trestioreanu"
Bucharest, 022328
Spitalul Clinic Coltea
Bucharest, 030171
S.C Gral Medical S.R.L
Bucharest, 031422
Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj Napoca
Cluj-Napoca, 400015
S.C Medisprof S.R.L
Cluj-Napoca, 400058
Spitalul Militar de Urgenta "Dr.Constantin Papilian"Cluj -Napoca
Cluj-Napoca, 400132
S.C Radiotherapy Center Cluj S.R.L
Comuna Floresti, 407280
Spitalul Clinic Judetean de Urgenta "Sf. Apostol Andrei" Constanta
Constanța, 900591
S.C Centrul de Oncologie Sf. Nectarie S.R.L
Craiova, 200347
Institutul Regional de Oncologie Iasi
Iași, 700483
S.C Pelican Impex S.R.L
Oradea, 410469
Spitalul Clinic Municipal "Dr. Gavril Curteanu" Oradea
Oradea, 410469
Spitalul Judetean de Urgenta "Sf. Ioan cel Nou" Suceava
Suceava, 720201
S.C Oncocenter Oncologie Clinica S.R.L
Timișoara, 300210
S.C Oncomed S.R.L
Timișoara, 300239
Ukraine16 sites
CI Chernivtsi RC Oncological Dispensary Bukovinian SMU Ch of Oncology and Radiology
Chernivtsi, 58013
CI Dnipropetrovsk CMCH #4 of Dnipropetrovsk RC Dept of Chemotherapy SI Dnipropetrovsk MA of MOHU
Dnipro, 49102
CI Transcarpathian Cl Onc Center Dep of Surgery#1 SHEI Ivano-Frankivsk NMU
Ivano-Frankivsk, 76018
SI S.P.Grygoriev Institute of Medical Radiology of NAMSU
Kharkiv, 61024
Communal Non-profit Enterprise Regional Center of Oncology
Kharkiv, 61070
Kherson Regional Oncologic Dispensary
Kherson, 73000
Treatment-Diagnostic Center of Private Enterprise of PPC Atsynus
Kropyvnytskyi, 25006
CI Kryvyi Rih Oncological Dispensary of DRC
Kryvyi Rih, Dnipropetrovsk Region, 50048
Kyiv City Clinical Oncological Center
Kyiv, 03115
Treatment-Prevention Institution Volyn Regional Oncological Dispensary
Lutsk, 43018
Lviv State Oncological Regional Treatment and Diagnostic Center
Lviv, 79031
Odesa Regional Oncologic Dispensary
Odesa, 65055
RCI Sumy Regional Clinical Oncological Dispensary
Sumy, 40022
CCCH City Oncological Center SHEI Uzhgorod NU
Uzhhorod, 88000
Podilskyi Regional Oncological Center
Vinnytsia, 21029
Vinnytsia Regional Clinical Oncological Dispensary
Vinnytsia, 21029
France15 sites
CHU Angers - Hôpital Hôtel Dieu#
Angers, Maine Et Loire, 49933
Institut Sainte Catherine
Avignon, Vaculuse, 84918
Centre Hospitalier de la Côte Basque
Bayonne, Pyrenees Atlantiques, 64100
CHU Besançon - Hôpital Jean Minjoz
Besançon, Doubs, 25030
CHU Brest - Hôpital Morvan
Brest, Finistere, 29609
Centre Hospitalier Intercommunal de Créteil
Créteil, Val De Marne, 94010
Clinique Victor Hugo - Centre Jean Bernard
Le Mans, Sarthe, 72015
Centre Hospitalier de la Croix Rousse
Lyon, Rhone, 69317
Hôpital privé Clairval
Marseille, Bouches-du-Rhône, 13009
Hôpital Nord - AP-HM Marseille#
Marseille, Bouches-du-Rhône, 13915
Centre Antoine Lacassagne
Nice, Alpes Maritimes, 06189
Hôpital Cochin
Paris, Paris, 75679
Hôpital Saint-Louis - Paris
Paris
Groupe Hospitalier Sud - Hôpital Haut-Lévêque
Pessac, Gironde, 33604
CHU de Strasbourg - Nouvel Hôpital Civil
Strasbourg, Bas Rhin, 67091
Australia14 sites
Albury Wodonga Regional Cancer Centre
Albury, New South Wales, 2640
Ballarat Base Hospital
Ballarat, Victoria, 3350
Bendigo Hospital
Bendigo, Victoria, 3550
Coffs Harbour Health Campus
Coffs Harbour, New South Wales, 2450
Gallipoli Medical Research Foundation Ltd
Greenslopes, Queensland, 4120
St George Private Hospital
Kogarah, New South Wales, 2217
Lismore Base Hospital
Lismore, New South Wales, 2480
Fiona Stanley Hospital
Murdoch, Western Australia, 6150
Orange Health Service
Orange, New South Wales, 2800
Gold Coast University Hospital
Southport, Queensland, 4215
Royal North Shore Hospital
St Leonards, New South Wales, 2065
Calvary Mater Newcastle
Waratah, New South Wales, 2298
South West Healthcare
Warrnambool, Victoria, 3280
The Queen Elizabeth Hospital
Woodville South, South Australia, 5011
Japan13 sites
National Cancer Center Hospital
Chūōku, Tokyo-To, 104-0045
Kansai Medical University Hospital
Hirakata-shi, Osaka, 573-1191
National Cancer Center Hospital East
Kashiwa-shi, Chiba, 277-8577
Institute of Biomedical Research and Innovation Hospital
Kobe, Hyōgo, 650-0047
Kobe City Hospital Organization Kobe City Medical Center General Hospital
Kobe, Hyōgo, 650-0047
Kobe City Hospital Organization Kobe City Medical Center General Hospital
Kobe, 650-0047
Kurume University Hospital
Kurume-shi, Fukuoka, 830-0011
NHO Hokkaido Cancer Center
Sapporo, Hokkaido, 003-0804
Tokyo Medical University Hospital
Shinjuku-ku, Tokyo-To, 160-0023
Osaka Medical College Hospital
Takatsuki-shi, Osaka, 569-8686
Toyama University Hospital
Toyama, Toyama, 930-0194
Yokohama Municipal Citizen's Hospital
Yokohama, Kanagawa, 240-8555
Kanagawa Cancer Center
Yokohama, Kanagawa, 241-8515
Portugal12 sites
Hospital Garcia de Orta, EPE
Almada, 2801-915
Hospital Professor Doutor Fernando Fonseca, E.P.E.
Amadora-Lisbon, 2610-276
Centro Hospitalar De Coimbra-CHUC
Coimbra, 3041-801
Centro Hospitalar e Universitário de Coimbra, E.P.E (CHC)
Coimbra, 3041-801
Centro Hospitalar de Lisboa Norte, E.P.E. - Hospital Pulido Valente
Lisbon, 1769-001
Centro Hospitalar de Lisboa Central, E.P.E. - Hospital de Santo António dos Capuchos
Lisbon, 1849-017
Centro Hospitalar do Porto, E.P.E. - Hospital de Santo António
Porto, 4099-001
Hospital CUF Porto
Porto, 4100-180
Instituto Português de Oncologia do Porto Francisco Gentil, EPE
Porto, 4200-072
Centro Hospitalar de São João, E.P.E.
Porto, 4200-319
Centro Hospitalar de Entre o Douro e Vouga, E.P.E - Hospital de São Sebastião
Santa Maria da Feira, 4520-211
Centro Hospitalar Vila Nova de Gaia/Espinho, E.P.E
Vila Nova de Gaia, 4434-502
Hungary11 sites
Orszagos Koranyi Pulmonologiai Intezet
Budapest, 1121
Orszagos Onkologiai Intezet
Budapest, 1122
Semmelweis Egyetem
Budapest, 1125
Orszagos Koranyi Pulmonologiai Intezet
Budapest
Csongrad Megyei Mellkasi Betegsegek Szakkorhaza
Deszk, 6772
Petz Aladar Megyei Oktato Korhaz
Győr, 9024
Borsod-Abauj-Zemplen Megyei Kozponti Korhaz es Egyetemi Oktatokorhaz
Miskolc, 3529
SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz
Nyíregyháza, 4400
Tolna Megyei Balassa Janos Korhaz
Szekszárd, 7100
Tudogyogyintezet Torokbalint
Törökbálint, 2045
Zala Megyei Szent Rafael Korhaz
Zalaegerszeg, 8900
Poland11 sites
Centrum Terapii Wspolczesnej J.M. Jasnorzewska sp. komandytowo-akcyjna
Lodz, 90-242
Instytut MSF Sp. o.o
Lodz, 90-302
Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Łodzi
Lodz, 93-513
KO-MED Centra Kliniczne Lublin II
Lublin, 20-362
SSZZOZ im. Dr Teodora Dunina w Rudce
Mrozy, 05-320
SP Zespol Gruzlicy i Chorob Pluc w Olsztynie
Olsztyn, 10-357
Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy
Otwock
Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego
Poznan, 60-569
Izerskie Centrum Pulmonologii i Chemioterapii "IZER-MED" Spolka z o.o.
Szklarska Poręba, 58-580
Centrum Onkologii-Instytut im. M. Sklodowskiej Curie
Warsaw, 02-781
Mazowiecki Szpital Onkologiczny
Wieliszew, 05-135
Israel9 sites
Soroka University Medical Center
Beersheba, 8410101
Rambam Health Care Center
Haifa, 3109601
Hadassah University Hospital - Ein Kerem
Jerusalem, 9112001
Sapir Medical Center, Meir Hospital
Kfar Saba, 4428164
Rabin Medical Center-Beilinson Campus
Petah Tikva, 49100
Chaim Sheba Medical Center
Ramat Gan, 5265601
Kaplan Medical Center
Rehovot, 7610001
Assaf Harofeh
Rishon LeZiyyon, 75141
Tel Aviv Sourasky Medical Center
Tel Aviv, 6423906
Chile8 sites
FALP - Fundación Arturo López Pérez
Santiago, 7500921
Clinica Santa Maria
Santiago, 7520378
IRAM - Instituto de Radio Medicina
Santiago, 7630370
Hospital Militar de Santiago
Santiago, 7850000
Hospital Clínico San Borja Arriaran
Santiago, 8360160
Hospital Clínico Universidad de Chile
Santiago, 8380456
Hospital Clinico Viña del Mar
Viña del Mar, 2520612
Centro de Investigaciones Clinicas Viña del Mar
Viña del Mar, 2540364
Greece8 sites
251 General Air Force Hospital
Athens, 115 25
General Hospital of Athens of Chest Diseases "SOTIRIA"
Athens, 11527
University General Hospital "Attikon"
Athens, 12462
General Oncology Hospital of Kifissia " Agioi Anargyroi"
Athens, 14564
Metropolitan General Hospital
Athens, 15562
University General Hospital of Heraklion
Heraklion, 71110
University General Hospital of Patra
Pátrai, 26504
Euromedica General Clinic Thessaloniki
Thessaloniki, 54645
Italy7 sites
Fondazione Poliambulanza Istituto Ospedaliero
Brescia, 25124
Presidio Ospedaliero Garibaldi Nesima
Catania, 95100
Azienda Ospedaliero Universitaria San Martino
Genova, 16132
Ospedale Mater Salutis
Legnago, Verona, 37045
Seconda Università degli Studi di Napoli
Naples, 80131
Azienda Ospedaliero Universitaria di Parma
Parma, 43100
Azienda Ospedaliero Universitaria Pisana
Pisa, 56126
Serbia7 sites
Clinical Center of Serbia
Belgrade, 11 000
Institute of Oncology and Radiology of Serbia
Belgrade, 11000
Military Medical Academy
Belgrade, 11000
Clinical Center Bezanijska Kosa
Belgrade, 11080
Clinical Center Nis, Pulmonary Diseases Clinic
Gornji Matejevac, 18204
Institute for Pulmonary Diseases of Vojvodina
Kamenitz, 21204
Clinical Center Kragujevac
Kragujevac, 34000
Taiwan7 sites
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, 83301
China Medical University Hospital
Taichung, 40447
Taichung Veterans General Hospital
Taichung, 40705
National Taiwan University Hospital
Taipei, 100
Taipei Veterans General Hospital
Taipei, 11217
Tri-Service General Hospital
Taipei, 11490
Chang Gung Memorial Hospital, Linkou
Taoyuan County, 333
Thailand7 sites
Siriraj Hospital
Bangkok, 10700
Songklanagarind Hospital
Hat Yai, Changwat Songkhla, 90110
Srinagarind Hospital
Muang, Changwat Khon Kaen, 40002
Naresuan University Hospital
Muang, Changwat Phitsanulok, 65000
Maharaj Nakorn Chiang Mai Hospital
Muang, Chiang Mai, 50200
King Chulalongkorn Memorial Hospital
Patumwan, Bangkok, 10330
Rajavithi Hospital
Rajathevee, Bangkok, 10400
Czechia6 sites
Krajska nemocnice Liberec, a.s.
Liberec, 460 63
Nemocnice Na Plesi s.r.o.
Nová Ves pod Pleší, 26204
Fakultni nemocnice Olomouc
Olomouc, 775 20
Vitkovicka nemocnice a.s
Ostrava - Vitkovice, 703 84
Thomayerova nemocnice
Praha 4 - Krc, 140 59
Krajska zdravotni, a.s. - Masarykova nemocnice v Usti nad Labem, o.z.
Ústí nad Labem, 40113
New Zealand6 sites
Auckland City Hospital
Auckland, 1010
Dunedin Public Hospital
Dunedin, 9016
Waikato Hospital
Hamilton, 3200
Palmerston North Hospital
Palmerston North, 4414
Tauranga Hospital
Tauranga, 3143
Wellington Hospital
Wellington, 6021
United Kingdom6 sites
Cheltenham General Hospital
Cheltenham, Gloucestershire, GL53 7AN
Chelsea and Westminster Hospital
London, Greater London, SW109NH
The Clatterbridge Cancer Centre
Metropolitan Borough of Wirral, Merseyside, CH63 4JY
Mount Vernon Hospital
Stevenage, Hertfordshire, SG1 4AB
Royal Stoke University Hospital
Stoke-on-Trent, Staffordshire, ST4 6QG
Southend University Hospital
Westcliff-on-Sea, Essex, SS0 0RY
China5 sites
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
Guangdong General Hospital
Guangzhou, Guangdong, 510080
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150081
Linyi Cancer Hospital
Linyi, Shandong, 276001
Liaoning Cancer Hospital & Institute
Shenyang, Liaoning, 110042
Lebanon5 sites
American University of Beirut Medical Center
Beirut, 1107 2020
Rafik Hariri University Hospital
Beirut, 113-6044
Hotel Dieu de France Hospital
Beirut, 166830
Mount Lebanon Hospital
Beirut, 470
Hammoud Hospital University Medical Center
Saida, 652
Bulgaria4 sites
Complex Oncological Center - Ruse, EODD
Rousse, 7002
MHAT for women's health - Nadezhda, OOD
Sofia, 1330
UMHAT "Sv. Ivan Rilski", EAD
Sofia, 1431
Shato, Ead
Sofia, 1756
Colombia4 sites
Administradora Country S.A.
Bogotá, 00000
Fundación Oftalmológica de Santander - FOSCAL
Floridablanca, 6810002
Hospital Pablo Tobón Uribe
Medellín, 050034
IPS IMAT- Instituto Medico de Alta Tecnologia - Oncomedica S.A.
Montería, 230002
South Africa4 sites
Emery Clinical Services
Alberton, Gauteng, 1449
Cape Town Oncology Trials Pty Ltd
Cape Town, Western Cape, 7570
University of Pretoria Oncology Department
Pretoria, Gauteng, 0002
Johese Clinical Research
Pretoria, Gauteng, 1692
Belgium3 sites
ZNA Middelheim
Antwerp, 2020
A.Z. Klina
Brasschaat, 2930
CHU Ambroise Paré
Mons, 7000
Netherlands3 sites
Martini Ziekenhuis
Groningen, 9728 NT
Westfriesgasthuis - PARENT
Hoorn, 1624 NP
ETZ Elisabeth
Tilburg, 5022 GC
Peru3 sites
Instituto Nacional de Enfermedades Neoplásicas
Lima, LIMA 34
Clinica Internacional Sede San Borja
Lima, LIMA 41
Oncosalud
Lima, Lima 41
Singapore3 sites
National University Cancer Institute
Singapore, 119074
National Cancer Centre
Singapore, 169610
Tan Tock Seng Hospital
Singapore, 308433
Canada2 sites
The Moncton Hospital
Moncton, New Brunswick, E1C 6Z8
Mount Sinai Hospital
Toronto, Ontario, M5G 1X5
Croatia2 sites
University Clinic for Pulmonary Diseases
Zagreb, 10 000
University Hospital Centre "Sestre Milosrdnice"
Zagreb, 10000
Germany2 sites
LungenClinic Grosshansdorf GmbH
Großhansdorf, Schleswig-Holstein, 22927
Universitaetsklinikum Heidelberg
Heidelberg, Baden-Wurttemberg, 69126
Slovakia2 sites
Nemocnica s poliklinikou Sv. Jakuba, n.o. Bardejov
Bardejov, 08501
Univerzitna nemocnica Bratislava, Nemocnica Ruzinov
Bratislava, 82606
Lithuania1 site
Hospital of Lithuanian University of Health Sciences Kaunas Clinics
Kaunas, 50009
About this study
Official title: A Phase III, Open-label, Multicenter Trial of Avelumab (MSB0010718C) Versus Platinum-based Doublet as a First-line Treatment of Recurrent or Stage IV PD-L1+NSCLC
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
- Being tested
- Avelumab, Pemetrexed, Paclitaxel, Gemcitabine, Carboplatin
- Keywords
- Avelumab, MSB0010718C, Non-Small Cell Lung Cancer
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AvelumabDrug
Also called Anti-PD-L1, MSB0010718C
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.
PemetrexedDrug
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.
PaclitaxelDrug
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.
GemcitabineDrug
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.
GemcitabineDrug
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.
CarboplatinDrug
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.
CisplatinDrug
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.
CarboplatinDrug
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.
Avelumab WeeklyDrug
Also called Anti-PD-L1, MSB0010718C
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.
| Study group | Role | What they receive |
|---|---|---|
| Avelumab Biweekly | Experimental | Not described Receives: Drug: Avelumab |
| Avelumab Weekly | Experimental | Not described Receives: Drug: Cisplatin; Drug: Avelumab Weekly |
| Chemotherapy | Active comparator | Not described Receives: Drug: Pemetrexed; Drug: Paclitaxel; Drug: Gemcitabine; Drug: Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)
Overall Survival (OS) in 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.
Measured: Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)
Overall Survival (OS) in 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.
Measured: Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)
Percentage of Participants With Confirmed Objective Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Independent Review Committee (IRC) in High PD-L1+ Full Analysis Set
Confirmed objective response was defined as the percentage of participants with a confirmed objective response of complete response (CR) or partial response (PR). CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions.
Measured: Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)
Percentage of Participants With Confirmed Objective Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Independent Review Committee (IRC) in High PD-L1+ Modified Full Analysis Set
Confirmed objective response was defined as the percentage of participants with a confirmed objective response of complete response (CR) or partial response (PR). CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions.
Measured: Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)
Percentage of Participants With Confirmed Objective Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Independent Review Committee (IRC) in Moderate and High PD-L1+ Full Analysis Set
Confirmed objective response was defined as the percentage of participants with a confirmed objective response of complete response (CR) or partial response (PR). CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions.
Measured: Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)
Percentage of Participants With Confirmed Objective Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Independent Review Committee (IRC) in Moderate and High PD-L1+ Modified Full Analysis Set
Confirmed objective response was defined as the percentage of participants with a confirmed objective response of complete response (CR) or partial response (PR). CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions.
Measured: Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)
Duration of Response (DOR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Independent Review Committee (IRC) in High Programmed Death Ligand 1 (PD-L1)+ Full Analysis Set (FAS)
DOR was defined for participants with confirmed response, as the time from first documentation of objective response (Complete Response [CR] or Partial Response [PR]) to the date of first documentation of progression disease (PD) or death due to any cause, whichever occurred first. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the SLD of all lesions. PD: 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.
Measured: Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)
Duration of Response (DOR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Independent Review Committee (IRC) in High Programmed Death Ligand 1 (PD-L1)+ Modified Full Analysis Set (mFAS)
DOR was defined for participants with confirmed response, as the time from first documentation of objective response (Complete Response [CR] or Partial Response [PR]) to the date of first documentation of progression disease (PD) or death due to any cause, whichever occurred first. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the SLD of all lesions. PD: 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.
Measured: Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)
Change From Baseline in European Quality Of Life 5-dimensions (EQ-5D-5L) Visual Analog Scale (VAS) in High PD-L1+ Health-related Quality of Life (HRQoL) Analysis Set at End of Treatment
EQ-5D-5L is comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive overall score using a visual analog scale (VAS) that ranged from 0 to 100 millimeter (mm), where 0 is the worst health you can imagine and 100 is the best health you can imagine.
Measured: Baseline, End of treatment (up to Week 283.9)
Change From Baseline in European Quality Of Life 5-dimensions (EQ-5D-5L) Visual Analog Scale (VAS) in High Programmed Death Ligand 1 (PD-L1)+ Modified HRQoL Analysis Set
EQ-5D-5L is comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive overall score using a visual analog scale (VAS) that ranged from 0 to 100 millimeter (mm), where 0 is the worst health you can imagine and 100 is the best health you can imagine.
Measured: Baseline, End of treatment (Week 283.9)
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) Global Health Status at End of Treatment (EOT) in High Programmed Death Ligand 1 (PD-L1)+ HRQoL Analysis Set
EORTC QLQ-C30 was a 30-question tool used to assess the overall quality of life (QoL) in cancer participants. It consisted of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, role, cognitive, emotional, social), and 9 symptom scales/items (Fatigue, nausea and vomiting, pain, dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, financial impact). The EORTC QLQ-C30 GHS/QoL score ranged from 0 to 100; High score indicated better GHS/QoL. Score 0 represents: very poor physical condition and QoL. Score 100 represents: excellent overall physical condition and QoL.
Measured: Baseline, End of treatment (up to Week 283.9)
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) Global Health Status at End of Treatment (EOT) in High Programmed Death Ligand 1 (PD-L1)+ Modified HRQoL Analysis Set
EORTC QLQ-C30 was a 30-question tool used to assess the overall quality of life (QoL) in cancer participants. It consisted of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, role, cognitive, emotional, social), and 9 symptom scales/items (Fatigue, nausea and vomiting, pain, dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, financial impact). The EORTC QLQ-C30 GHS/QoL score ranged from 0 to 100; High score indicated better GHS/QoL. Score 0 represents: very poor physical condition and QoL. Score 100 represents: excellent overall physical condition and QoL.
Measured: Baseline, End of treatment (Week 283.9)
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) at End of Treatment (EOT) in High Programmed Death Ligand 1 (PD-L1)+ HRQoL Analysis Set
EORTC QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy. The EORTC QLQ-LC13 module generated one multiple-item score assessing dyspnea and a series of single item scores assessing coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arms or shoulder and pain in other parts. Score range: 0 (no burden of symptom domain or single symptom item) to 100 (highest burden of symptoms for symptom domains and single items).
Measured: Baseline, End of treatment (up to Week 283.9)
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) at End of Treatment (EOT) in High Programmed Death Ligand 1 (PD-L1)+ Modified HRQoL Analysis Set
EORTC QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy. The EORTC QLQ-LC13 module generated one multiple-item score assessing dyspnea and a series of single item scores assessing coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arms or shoulder and pain in other parts. Score range: 0 (no burden of symptom domain or single symptom item) to 100 (highest burden of symptoms for symptom domains and single items).
Measured: Baseline, End of treatment (up to Week 283.9)
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and AEs of Special Interest (AESIs)
Adverse event (AE) was defined as any untoward medical occurrence in a participant, which does not necessarily have causal relationship with treatment. A serious AE was defined as an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged in participant hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. The term TEAEs were those events with onset dates occurring during the on-treatment period or if the worsening of an event is during the on-treatment period TEAEs included both serious TEAEs and non-serious TEAEs. Any AE that was suspicious to be a potential Immune-related adverse event (irAE) including infusion related reactions were considered AESIs. Number of participants with TEAEs and AESIs were reported.
Measured: Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)
Number of Participants With Shift From Baseline to Greater Than or Equal to (>=) Grade 3 in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03
Number of participants with shifts from Baseline values (Grade 0/1/2/3) to abnormal post-baseline values (shift to >= Grade 4) were reported as per NCI-CTCAE, v4.03 graded from Grade 1 to 5. Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life-threatening; Grade 5: Death. Shifts in laboratory parameter (anemia, lymphocyte count decreased, neutrophil count decreased, platelet count decreased, white blood cell count decreased, alanine aminotransferase increased, alkaline phosphatase increased, aspartate aminotransferase increased, blood bilirubin increased, creatine phosphokinase increased, creatinine increased and Hyperglycemia) were reported.
Measured: Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)
Number of Participants With Maximal On-Treatment Changes From Baseline in Vital Signs - Maximal Body Temperature Increase
The number of participants with changes from baseline in increased Body Temperature (degree Celsius [°C]) were reported by using criteria: Baseline temperature (temp.) less than (<) 37°C, on treatment change <1°C, 1 - <2°C, 2 - <3°C, greater than or equal to (>=)3°C and missing; Baseline temp. 37 - <38°C, on treatment change <1°C, 1 - <2°C, 2 - <3°C, >=3°C and missing; Baseline temp. 38 - <39°C, on treatment change <1°C, 1 - <2°C, 2 - <3°C, >=3°C and missing; Baseline temp. 39-<40°C, on treatment change <1°C, 1 - <2°C, 2 - <3°C, >=3°C and missing; Baseline temp. >=40°C, on treatment change <1°C, 1 - <2°C, 2 - <3°C, >=3°C and missing; Baseline temp. missing, on treatment change missing.
Measured: Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)
Number of Participants With Maximal On-Treatment Changes From Baseline in Vital Signs - Maximal Weight Increase/Decrease
The number of participants with maximal on-treatment changes from baseline in Increase (Ic.)/Decrease (Dc.) in maximal weight were reported by using criteria: Ic./Dc. From baseline, on treatment (TR) change <10 percentage (%), >=10% and missing.
Measured: Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)
Number of Participants With Maximal On-Treatment Changes From Baseline in Vital Signs - Maximal Heart Rate Increase/Decrease
The number of participants with maximal on-treatment (TR) changes from baseline (BS) in Increase (Ic.)/Decrease (Dc.) heart rate (HR) (beats per minute [bpm]) were reported by using criteria: Ic./Dc. BS HR <100/>=100 bpm, on treatment change =<20 bpm, >20 - =<40 bpm, >40 bpm and missing; Ic./Dc. BS HR missing, on treatment change missing.
Measured: Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)
Number of Participants With Maximal On-Treatment Changes From Baseline in Vital Signs - Maximal Systolic Blood Pressure Increase/Decrease and Maximal Diastolic Blood Pressure Increase/Decrease
The number of participants with maximal on-treatment changes from baseline (BS) in Increase (Ic.)/Decrease (Dc.) Systolic Blood Pressure (SBP) and diastolic blood pressure (DBP) (millimeter of mercury [mmHg]) were reported by using criteria: Ic./Dc. BS SBP <140 mmHg and >=140 mmHg, on maximal treatment (TR) change =<20 mmHg, >20 - =<40 mmHg, >40 mmHg and missing; Ic./Dc. BS SBP missing, on maximal treatment (TR) change missing; Ic./Dc. BS DBP <90 mmHg and >= 90 mmHg, on maximal TR change =<20 mmHg, >20 - =<40 mmHg, >40 mmHg and missing; Ic./Dc. BS DBP missing on maximal TR change missing.
Measured: Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)
Number of Participants With Maximal On-Treatment Changes From Baseline in Vital Signs - Maximal Respiration Rate Increase/Decrease
The number of participants with maximal on-treatment (TR) changes from baseline (BS) in Increase (Ic.)/Decrease (Dc.) maximal Respiration Rate (RR) were reported by using criteria: Ic./Dc. BS RR <20 breaths per minute (breaths/min), on TR change =<5 breaths/min, >5 - =<10 breaths/min, >10 breaths/min and missing. Ic./Dc. BS RR missing, on TR change missing. Ic./Dc. BS RR >=20 breaths/min, on TR change =<5 breaths/min, >5 - =<10 breaths/min, >10 breaths/min and missing.
Measured: Time from date of randomization up to data cutoff (assessed up to 71.5 months)
Number of Participants With Potentially Clinically Significant Abnormalities (PCSA) in Electrocardiogram (ECG) Parameters
ECG parameters included heart rate, PR interval, QRS interval, corrected QT interval using Bazett's formula (QTcB) and corrected QT interval using Fridericia's formula (QTcF). PCSA criteria for abnormal value of ECG parameters: any heart rate <= 50 bpm and decrease from baseline >=20 bpm , any hear rate >= 120 bpm and increase from baseline >= 20 bpm; PR interval: >= 220 milliseconds (ms) and increase from baseline >= 20 ms; QRS interval >= 120 ms; QTcF > 450 ms, > 480 ms, > 500 ms, QTcF increase from baseline > 30 ms and QTcF increase from baseline > 60 ms; QTcB > 450 ms, > 480 ms, > 500 ms, QTcB increase from baseline > 30 ms and QTcB increase from baseline > 60 ms.
Measured: Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance: Baseline Score Versus (Vs) Worst Post-baseline Score
ECOG performance status measured to assess participant's performance status on a scale of 0 to 5, where 0 = Fully active, able to carry on all pre-disease activities without restriction; 1 = Restricted in physically strenuous activity, ambulatory and able to carry out light or sedentary work; 2 = Ambulatory and capable of all selfcare but unable to carry out any work activities; 3 = Capable of only limited self-care, confined to bed/chair for more than 50 percent of waking hours; 4 = Completely disabled, cannot carry on any self-care, totally confined to bed/chair; 5 = dead. ECOG performance status was reported in terms of number of participants with baseline value vs worst post-baseline value (that is [i.e.] highest score).
Measured: Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)
Number of Participants With At Least One Positive Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs) for Avelumab
Serum samples were analyzed by a validated electrochemiluminesce immunoassay to detect the presence of antidrug antibodies (ADA). Samples that screened positive were subsequently tested in a confirmatory assay were tested for neutralizing antibodies (nAb). Number of participants with ADA or nAb positive results for Avelumab were reported.
Measured: Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2015 (estimated)
- Study start29 Oct 2015
- Primary completion6 Dec 2021
- Study completion29 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for First Line Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by EMD Serono Research & Development Institute, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,214 participants (actual)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck KGaA, Darmstadt, Germany
- Responsible party
- Sponsor
- Investigators
- Medical Responsible, Study director, EMD Serono Inc., an affiliate of Merck KGaA, Darmstadt, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02576574
- Sponsor's protocol ID
- EMR 100070-005
- Other IDs
- 2015-001537-24, 2015
- Status last verified
- Jan 2025
- First submitted
- 13 Oct 2015
- Last updated
- 31 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 37748693