First Line Non-Small Cell Lung Cancer Clinical Trial
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
| Verified date | March 2024 |
| Source | EMD Serono |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 1214 |
| Est. completion date | January 29, 2024 |
| Est. primary completion date | December 6, 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Male or female subjects aged greater than or equal to (>=) 18 years - With Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 1 at trial entry - At least 1 measurable tumor lesion - With histologically confirmed metastatic or recurrent (Stage IV) non-small cell lung cancer (NSCLC) - With availability of a recently-obtained, formalin-fixed, paraffin-embedded (FFPE) tissue sample containing tumor (biopsy from a non-irradiated area preferably within 6 months) or a minimum number of 10 (preferably 25) unstained tumor slides cut within 1 week, and suitable for PD-L1 expression assessment - Subjects must not have received any treatment for systemic lung cancer, and have an estimated life expectancy of more than 12 weeks - Other protocol defined criteria could apply Exclusion Criteria: - Subjects whose disease harbors a EGFR mutation, or anaplastic lymphoma kinase (ALK) rearrangement are not eligible. - 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 |
| Country | Name | City | State |
|---|---|---|---|
| Australia | Albury Wodonga Regional Cancer Centre | Albury | New South Wales |
| Australia | Ballarat Base Hospital | Ballarat | Victoria |
| Australia | Bendigo Hospital | Bendigo | Victoria |
| Australia | Coffs Harbour Health Campus | Coffs Harbour | New South Wales |
| Australia | Gallipoli Medical Research Foundation Ltd | Greenslopes | Queensland |
| Australia | St George Private Hospital | Kogarah | New South Wales |
| Australia | Lismore Base Hospital | Lismore | New South Wales |
| Australia | Fiona Stanley Hospital | Murdoch | Western Australia |
| Australia | Orange Health Service | Orange | New South Wales |
| Australia | Gold Coast University Hospital | Southport | Queensland |
| Australia | Royal North Shore Hospital | St Leonards | New South Wales |
| Australia | Calvary Mater Newcastle | Waratah | New South Wales |
| Australia | South West Healthcare | Warrnambool | Victoria |
| Australia | The Queen Elizabeth Hospital | Woodville South | South Australia |
| Belgium | ZNA Middelheim | Antwerpen | |
| Belgium | A.Z. Klina | Brasschaat | |
| Belgium | CHU Ambroise Paré | Mons | |
| Brazil | Hospital de Câncer de Barretos - Fundação Pio XII | Barretos | Sao Paulo |
| Brazil | Hospital Erasto Gaertner - Liga Paranaense de Combate ao Câncer | Curitiba | Paraná |
| Brazil | CEPON - Centro de Pesquisas Oncológicas de Santa Catarina | Florianópolis | Santa Catarina |
| Brazil | CRIO - Centro Regional Integrado de Oncologia | Fortaleza | Ceará |
| Brazil | CEBROM - Centro Brasileiro de Radioterapia, Oncologia e Mastologia | Goiânia | Goiás |
| Brazil | Hospital de Caridade de Ijuí | Ijuí | Rio Grande Do Sul |
| Brazil | Clínica de Neoplasias Litoral Ltda. | Itajaí | Santa Catarina |
| Brazil | Fundação Doutor Amaral Carvalho | Jaú | Sao Paulo |
| Brazil | Hospital Bruno Born | Lajeado | Rio Grande Do Sul |
| Brazil | Hospital São Vicente de Paulo | Passo Fundo | Rio Grande Do Sul |
| Brazil | Hospital de Clínicas de Porto Alegre | Porto Alegre | Rio Grande Do Sul |
| Brazil | Hospital Nossa Senhora da Conceição | Porto Alegre | Rio Grande Do Sul |
| Brazil | Hospital São Lucas da PUCRS | Porto Alegre | Rio Grande Do Sul |
| Brazil | IMV-Pesquisa Cardiologica Sociedade Simples - HMD - COR | Porto Alegre | Rio Grande Do Sul |
| Brazil | INCA - Instituto Nacional de Câncer | Rio de Janeiro | |
| Brazil | NOB - Núcleo de Oncologia da Bahia | Salvador | Bahia |
| Brazil | CEPHO - Centro de Estudos e Pesquisas em Hematologia e Oncologia | Santo Andre | Sao Paulo |
| Brazil | Fundação Faculdade Regional de Medicina de São José do Rio Preto | São José do Rio Preto | Sao Paulo |
| Brazil | IBCC - Instituto Brasileiro de Controle do Câncer | São Paulo | Sao Paulo |
| Brazil | ICESP - Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira | São Paulo | Sao Paulo |
| Bulgaria | Complex Oncological Center - Ruse, EODD | Ruse | |
| Bulgaria | MHAT for women's health - Nadezhda, OOD | Sofia | |
| Bulgaria | Shato, Ead | Sofia | |
| Bulgaria | UMHAT "Sv. Ivan Rilski", EAD | Sofia | |
| Canada | The Moncton Hospital | Moncton | New Brunswick |
| Canada | Mount Sinai Hospital | Toronto | Ontario |
| Chile | Clinica Santa Maria | Santiago | |
| Chile | FALP - Fundación Arturo López Pérez | Santiago | |
| Chile | Hospital Clínico San Borja Arriaran | Santiago | |
| Chile | Hospital Clínico Universidad de Chile | Santiago | |
| Chile | Hospital Militar de Santiago | Santiago | |
| Chile | IRAM - Instituto de Radio Medicina | Santiago | |
| Chile | Centro de Investigaciones Clinicas Viña del Mar | Viña del Mar | |
| Chile | Hospital Clinico Viña del Mar | Viña del Mar | |
| China | Beijing Cancer Hospital | Beijing | Beijing |
| China | Guangdong General Hospital | Guangzhou | Guangdong |
| China | Harbin Medical University Cancer Hospital | Harbin | Heilongjiang |
| China | Linyi Cancer Hospital | Linyi | Shandong |
| China | Liaoning Cancer Hospital & Institute | Shenyang | Liaoning |
| Colombia | Administradora Country S.A. | Bogotá | |
| Colombia | Fundación Oftalmológica de Santander - FOSCAL | Floridablanca | |
| Colombia | Hospital Pablo Tobón Uribe | Medellín | |
| Colombia | IPS IMAT- Instituto Medico de Alta Tecnologia - Oncomedica S.A. | Monteria | |
| Croatia | University Clinic for Pulmonary Diseases | Zagreb | |
| Croatia | University Hospital Centre "Sestre Milosrdnice" | Zagreb | |
| Cyprus | Bank of Cyprus Oncology Center | Nicosia | |
| Czechia | Krajska nemocnice Liberec, a.s. | Liberec | |
| Czechia | Nemocnice Na Plesi s.r.o. | Nova Ves pod Plesi | |
| Czechia | Fakultni nemocnice Olomouc | Olomouc | |
| Czechia | Vitkovicka nemocnice a.s | Ostrava - Vitkovice | |
| Czechia | Thomayerova nemocnice | Praha 4 - Krc | |
| Czechia | Krajska zdravotni, a.s. - Masarykova nemocnice v Usti nad Labem, o.z. | Usti nad Labem | |
| Denmark | Herning Sygehus | Herning | |
| Denmark | Roskilde Sygehus | Roskilde | |
| Estonia | North Estonia Medical Centre Foundation | Tallinn | |
| France | CHU Angers - Hôpital Hôtel Dieu# | Angers Cedex 9 | Maine Et Loire |
| France | Institut Sainte Catherine | Avignon Cedex 9 | Vaculuse |
| France | Centre Hospitalier de la Côte Basque | Bayonne | Pyrenees Atlantiques |
| France | CHU Besançon - Hôpital Jean Minjoz | Besancon Cedex | Doubs |
| France | CHU Brest - Hôpital Morvan | Brest Cedex | Finistere |
| France | Centre Hospitalier Intercommunal de Créteil | Creteil cedex | Val De Marne |
| France | Clinique Victor Hugo - Centre Jean Bernard | Le Mans Cedex 02 | Sarthe |
| France | Centre Hospitalier de la Croix Rousse | Lyon cedex 04 | Rhone |
| France | Hôpital privé Clairval | Marseille | Bouches-du-Rhône |
| France | Hôpital Nord - AP-HM Marseille# | Marseille cedex 20 | Bouches-du-Rhône |
| France | Centre Antoine Lacassagne | Nice cedex 02 | Alpes Maritimes |
| France | Hôpital Saint-Louis - Paris | Paris Cedex 10 | |
| France | Hôpital Cochin | Paris cedex 14 | Paris |
| France | Groupe Hospitalier Sud - Hôpital Haut-Lévêque | Pessac | Gironde |
| France | CHU de Strasbourg - Nouvel Hôpital Civil | Strasbourg | Bas Rhin |
| Germany | LungenClinic Grosshansdorf GmbH | Grosshansdorf | Schleswig Holstein |
| Germany | Universitaetsklinikum Heidelberg | Heidelberg | Baden Wuerttemberg |
| Greece | 251 General Air Force Hospital | Athens | |
| Greece | General Hospital of Athens of Chest Diseases "SOTIRIA" | Athens | |
| Greece | General Oncology Hospital of Kifissia " Agioi Anargyroi" | Athens | |
| Greece | Metropolitan General Hospital | Athens | |
| Greece | University General Hospital "Attikon" | Athens | |
| Greece | University General Hospital of Heraklion | Heraklion | |
| Greece | University General Hospital of Patra | Patras | |
| Greece | Euromedica General Clinic Thessaloniki | Thessaloniki | |
| Hungary | Orszagos Koranyi Pulmonologiai Intezet | Budapest | |
| Hungary | Orszagos Koranyi Pulmonologiai Intezet | Budapest | |
| Hungary | Orszagos Onkologiai Intezet | Budapest | |
| Hungary | Semmelweis Egyetem | Budapest | |
| Hungary | Csongrad Megyei Mellkasi Betegsegek Szakkorhaza | Deszk | |
| Hungary | Petz Aladar Megyei Oktato Korhaz | Györ | |
| Hungary | Borsod-Abauj-Zemplen Megyei Kozponti Korhaz es Egyetemi Oktatokorhaz | Miskolc | |
| Hungary | SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz | Nyiregyhaza | |
| Hungary | Tolna Megyei Balassa Janos Korhaz | Szekszard | |
| Hungary | Tudogyogyintezet Torokbalint | Torokbalint | |
| Hungary | Zala Megyei Szent Rafael Korhaz | Zalaegerszeg | |
| Ireland | Cork University Hospital | Cork | |
| Israel | Soroka University Medical Center | Beer Sheva | |
| Israel | Rambam Health Care Center | Haifa | |
| Israel | Hadassah University Hospital - Ein Kerem | Jerusalem | |
| Israel | Sapir Medical Center, Meir Hospital | Kfar-Saba | |
| Israel | Rabin Medical Center-Beilinson Campus | Petach Tikva | |
| Israel | Chaim Sheba Medical Center | Ramat Gan | |
| Israel | Kaplan Medical Center | Rechovot | |
| Israel | Assaf Harofeh | Rishon Lezion | |
| Israel | Tel Aviv Sourasky Medical Center | Tel Aviv | |
| Italy | Fondazione Poliambulanza Istituto Ospedaliero | Brescia | |
| Italy | Presidio Ospedaliero Garibaldi Nesima | Catania | |
| Italy | Azienda Ospedaliero Universitaria San Martino | Genova | |
| Italy | Ospedale Mater Salutis | Legnago | Verona |
| Italy | Seconda Università degli Studi di Napoli | Napoli | |
| Italy | Azienda Ospedaliero Universitaria di Parma | Parma | |
| Italy | Azienda Ospedaliero Universitaria Pisana | Pisa | |
| Japan | National Cancer Center Hospital | Chuo-ku | Tokyo-To |
| Japan | Kansai Medical University Hospital | Hirakata-shi | Osaka-Fu |
| Japan | National Cancer Center Hospital East | Kashiwa-shi | Chiba-Ken |
| Japan | Institute of Biomedical Research and Innovation Hospital | Kobe-shi | Hyogo-Ken |
| Japan | Kobe City Hospital Organization Kobe City Medical Center General Hospital | Kobe-shi | Hyogo-Ken |
| Japan | Kobe City Hospital Organization Kobe City Medical Center General Hospital | Kobe-shi | |
| Japan | Kurume University Hospital | Kurume-shi | Fukuoka-Ken |
| Japan | NHO Hokkaido Cancer Center | Sapporo-shi | Hokkaido |
| Japan | Tokyo Medical University Hospital | Shinjuku-ku | Tokyo-To |
| Japan | Osaka Medical College Hospital | Takatsuki-shi | Osaka-Fu |
| Japan | Toyama University Hospital | Toyama-shi | Toyama-Ken |
| Japan | Kanagawa Cancer Center | Yokohama-shi | Kanagawa-Ken |
| Japan | Yokohama Municipal Citizen's Hospital | Yokohama-shi | Kanagawa-Ken |
| Korea, Republic of | Inje University Haeundae Paik Hospital | Busan | Gyeonggi-do |
| Korea, Republic of | Chungbuk National University Hospital | Cheongju-si | Chungcheongbuk-do |
| Korea, Republic of | Kyungpook National University Chilgok Hospital | Daegu | |
| Korea, Republic of | National Cancer Center | Goyang-si | Gyeonggi-do |
| Korea, Republic of | Gachon University Gil Medical Center | Incheon | |
| Korea, Republic of | CHA Bundang Medical Center, CHA University | Seongnam-si | Gyeonggi-do |
| Korea, Republic of | Seoul National University Bundang Hospital | Seongnam-si | Gyeonggi-do |
| Korea, Republic of | Asan Medical Center | Seoul | |
| Korea, Republic of | Korea University Anam Hospital | Seoul | |
| Korea, Republic of | Korea University Guro Hospital | Seoul | |
| Korea, Republic of | Samsung Medical Center | Seoul | |
| Korea, Republic of | Seoul National University Hospital | Seoul | |
| Korea, Republic of | Severance Hospital, Yonsei University | Seoul | |
| Korea, Republic of | The Catholic University of Korea, Seoul St. Mary's Hospital | Seoul | |
| Korea, Republic of | The Catholic University of Korea, Yeouido St. Mary's Hospital | Seoul | |
| Korea, Republic of | Ajou University Hospital | Suwon-si | Gyeonggi-do |
| Korea, Republic of | The Catholic University of Korea, St. Vincent's Hospital | Suwon-si | Gyeonggi-do |
| Korea, Republic of | Ulsan University Hospital | Ulsan | |
| Korea, Republic of | Yonsei University Wonju Severance Christian Hospital | Wonju-si | Gangwon-do |
| Lebanon | American University of Beirut Medical Center | Beirut | |
| Lebanon | Hotel Dieu de France Hospital | Beirut | |
| Lebanon | Mount Lebanon Hospital | Beirut | |
| Lebanon | Rafik Hariri University Hospital | Beirut | |
| Lebanon | Hammoud Hospital University Medical Center | Saida | |
| Lithuania | Hospital of Lithuanian University of Health Sciences Kaunas Clinics | Kaunas | |
| Netherlands | Martini Ziekenhuis | Groningen | |
| Netherlands | Westfriesgasthuis - PARENT | Hoorn | |
| Netherlands | ETZ Elisabeth | Tilburg | |
| New Zealand | Auckland City Hospital | Auckland | |
| New Zealand | Dunedin Public Hospital | Dunedin | |
| New Zealand | Waikato Hospital | Hamilton | |
| New Zealand | Palmerston North Hospital | Palmerston North | |
| New Zealand | Tauranga Hospital | Tauranga | |
| New Zealand | Wellington Hospital | Wellington | |
| Peru | Clinica Internacional Sede San Borja | Lima | |
| Peru | Instituto Nacional de Enfermedades Neoplásicas | Lima | |
| Peru | Oncosalud | Lima | |
| Poland | Centrum Terapii Wspolczesnej J.M. Jasnorzewska sp. komandytowo-akcyjna | Lodz | |
| Poland | Instytut MSF Sp. o.o | Lodz | |
| Poland | Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi | Lodz | |
| Poland | KO-MED Centra Kliniczne Lublin II | Lublin | |
| Poland | SSZZOZ im. Dr Teodora Dunina w Rudce | Mrozy | |
| Poland | SP Zespol Gruzlicy i Chorob Pluc w Olsztynie | Olsztyn | |
| Poland | Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy | Otwock | |
| Poland | Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego | Poznan | |
| Poland | Izerskie Centrum Pulmonologii i Chemioterapii "IZER-MED" Spolka z o.o. | Szklarska Poreba | |
| Poland | Centrum Onkologii-Instytut im. M. Sklodowskiej Curie | Warszawa | |
| Poland | Mazowiecki Szpital Onkologiczny | Wieliszew | |
| Portugal | Hospital Garcia de Orta, EPE | Almada | |
| Portugal | Hospital Professor Doutor Fernando Fonseca, E.P.E. | Amadora-Lisbon | |
| Portugal | Centro Hospitalar De Coimbra-CHUC | Coimbra | |
| Portugal | Centro Hospitalar e Universitário de Coimbra, E.P.E (CHC) | Coimbra | |
| Portugal | Centro Hospitalar de Lisboa Central, E.P.E. - Hospital de Santo António dos Capuchos | Lisboa | |
| Portugal | Centro Hospitalar de Lisboa Norte, E.P.E. - Hospital Pulido Valente | Lisboa | |
| Portugal | Centro Hospitalar de São João, E.P.E. | Porto | |
| Portugal | Centro Hospitalar do Porto, E.P.E. - Hospital de Santo António | Porto | |
| Portugal | Hospital CUF Porto | Porto | |
| Portugal | Instituto Português de Oncologia do Porto Francisco Gentil, EPE | Porto | |
| Portugal | Centro Hospitalar de Entre o Douro e Vouga, E.P.E - Hospital de São Sebastião | Santa Maria da Feira | |
| Portugal | Centro Hospitalar Vila Nova de Gaia/Espinho, E.P.E | Vila Nova de Gaia | |
| Romania | Spitalul Judetean de Urgenta "Dr. Constantin Opris" Baia Mare | Baia Mare | |
| Romania | S.C Policlinica de Diagnostic Rapid S.A | Brasov | |
| Romania | Institutul Oncologic "Prof. Dr. Al. Trestioreanu" | Bucuresti | |
| Romania | S.C Gral Medical S.R.L | Bucuresti | |
| Romania | Spitalul Clinic Coltea | Bucuresti | |
| Romania | Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj Napoca | Cluj Napoca | |
| Romania | S.C Medisprof S.R.L | Cluj-Napoca | |
| Romania | Spitalul Militar de Urgenta "Dr.Constantin Papilian"Cluj -Napoca | Cluj-Napoca | |
| Romania | S.C Radiotherapy Center Cluj S.R.L | Comuna Floresti | |
| Romania | Spitalul Clinic Judetean de Urgenta "Sf. Apostol Andrei" Constanta | Constanta | |
| Romania | S.C Centrul de Oncologie Sf. Nectarie S.R.L | Craiova | |
| Romania | Institutul Regional de Oncologie Iasi | Iasi | |
| Romania | S.C Pelican Impex S.R.L | Oradea | |
| Romania | Spitalul Clinic Municipal "Dr. Gavril Curteanu" Oradea | Oradea | |
| Romania | Spitalul Judetean de Urgenta "Sf. Ioan cel Nou" Suceava | Suceava | |
| Romania | S.C Oncocenter Oncologie Clinica S.R.L | Timisoara | |
| Romania | S.C Oncomed S.R.L | Timisoara | |
| Russian Federation | SBIH of Arkhangelsk region "Arkhangelsk Clinical Oncological Dispensary" | Arkhangelsk | |
| Russian Federation | Chelyabinsk Regional Oncology Dispensary | Chelyabinsk | |
| Russian Federation | LLC Evimed | Chelyabinsk | |
| Russian Federation | Irkutsk Regional Oncology Dispensary | Irkutsk | |
| Russian Federation | RBIH "Ivanovo Regional Oncological Dispensary" | Ivanovo | |
| Russian Federation | SBHI of Kaluga Region "Kaluga regional clinical oncology dispensary" | Kaluga | |
| Russian Federation | SAIH "Republican Clinical Oncological Dispensary of the Ministry of Healthcare of Republic Tatarstan | Kazan | |
| Russian Federation | Kemerovo SPI Regional Clinical Oncology Dispensary | Kemerovo | |
| Russian Federation | SBHI "Krasnoyarsk Regional Oncology Dispensary n.a. A.I. Kryzhanovsky" | Krasnoyarsk | |
| Russian Federation | RBIH "Kursk regional clinical oncology dispensary" of Kursk Region Healthcare Committee | Kursk | |
| Russian Federation | FSBSI "Russian Oncological Scientific Center n.a. N.N. Blokhin" | Moscow | |
| Russian Federation | Murmansk Regional Clinical Hospital named after Bayandin | Murmansk | |
| Russian Federation | SBHI of Novosibirsk region "Novosibirsk Regional Oncological Dispensary" | Novosibirsk | |
| Russian Federation | SBIH of Stavropol territory "Pyatigorsk Oncological Dispensary" | Pyatigorsk | |
| Russian Federation | "Bio Eq" LLC | Saint-Petersburg | |
| Russian Federation | FBI "Scientific Research Institute of Oncology n. a. N. N. Petrov" | Saint-Petersburg | |
| Russian Federation | SBIH "Leningrad Regional Oncological Dispensary" | Saint-Petersburg | |
| Russian Federation | SBIH "Samara Regional Clinical Oncological Dispensary" | Samara | |
| Russian Federation | SBIH "Oncological Dispensary # 2" of the MoH of Krasnodar territory | Sochi | |
| Russian Federation | FSBHI Clinical research institute of phthisiopulmonology | St. Petersburg | |
| Russian Federation | BHI of Omsk region "Clinical Oncology Dispensary" | Tomsk | |
| Russian Federation | Tomsk Research Instutite of Oncology | Tomsk | |
| Russian Federation | Medicinskiy gorod | Tyumen | |
| Russian Federation | SBIH of Yaroslavl region "Regional Clinical Oncological Hospital" | Yaroslavl | |
| Serbia | Clinical Center Bezanijska Kosa | Belgrade | |
| Serbia | Clinical Center of Serbia | Belgrade | |
| Serbia | Institute of Oncology and Radiology of Serbia | Belgrade | |
| Serbia | Military Medical Academy | Belgrade | |
| Serbia | Clinical Center Nis, Pulmonary Diseases Clinic | Gornji Matejevac | |
| Serbia | Clinical Center Kragujevac | Kragujevac | |
| Serbia | Institute for Pulmonary Diseases of Vojvodina | Sremska Kamenica | |
| Singapore | National Cancer Centre | Singapore | |
| Singapore | National University Cancer Institute | Singapore | |
| Singapore | Tan Tock Seng Hospital | Singapore | |
| Slovakia | Nemocnica s poliklinikou Sv. Jakuba, n.o. Bardejov | Bardejov | |
| Slovakia | Univerzitna nemocnica Bratislava, Nemocnica Ruzinov | Bratislava | |
| South Africa | Emery Clinical Services | Alberton | Gauteng |
| South Africa | Cape Town Oncology Trials Pty Ltd | Cape Town | Western Cape |
| South Africa | Johese Clinical Research | Pretoria | Gauteng |
| South Africa | University of Pretoria Oncology Department | Pretoria | Gauteng |
| Spain | Hospital de la Santa Creu i Sant Pau | Barcelona | |
| Spain | Hospital Universitari Quiron Dexeus | Barcelona | |
| Spain | Hospital Universitari Vall d'Hebron | Barcelona | |
| Spain | Specialist | Barcelona | |
| Spain | ICO Girona - Hospital Universitari de Girona Dr. Josep Trueta | Girona | |
| Spain | Fundacion Jimenez Diaz | Madrid | |
| Spain | Hospital General Universitario Gregorio Marañon | Madrid | |
| Spain | Hospital Universitario La Paz | Madrid | |
| Spain | MD Anderson Cancer Centre | Madrid | |
| Spain | Hospital Regional Universitario de Malaga | Málaga | |
| Spain | Hospital de Mataro | Mataro | Barcelona |
| Spain | Hospital Universitario Donostia | San Sebastian | Guipuzcoa |
| Spain | Complejo Hospitalario Universitario de Santiago | Santiago de Compostela | La Coruña |
| Spain | Hospital Quiron Sagrado Corazon | Sevilla | |
| Spain | Hospital Universitario Virgen del Rocio | Sevilla | |
| Spain | Hospital Universitario Mutua de Terrassa | Terrassa | Barcelona |
| Spain | Complejo Hospitalario Universitario de Vigo | Vigo | Pontevedra |
| Spain | Hospital Txagorritxu | Vitoria | |
| Taiwan | Kaohsiung Chang Gung Memorial Hospital | Kaohsiung | |
| Taiwan | China Medical University Hospital | Taichung | |
| Taiwan | Taichung Veterans General Hospital | Taichung | |
| Taiwan | National Taiwan University Hospital | Taipei | |
| Taiwan | Taipei Veterans General Hospital | Taipei | |
| Taiwan | Tri-Service General Hospital | Taipei | |
| Taiwan | Chang Gung Memorial Hospital, Linkou | Taoyuan County | |
| Thailand | Siriraj Hospital | Bangkok | |
| Thailand | Songklanagarind Hospital | Hat Yai | Songkhla |
| Thailand | Maharaj Nakorn Chiang Mai Hospital | Muang | Chiang Mai |
| Thailand | Naresuan University Hospital | Muang | Phitsanulok |
| Thailand | Srinagarind Hospital | Muang | Khon Kaen |
| Thailand | King Chulalongkorn Memorial Hospital | Patumwan | Bangkok |
| Thailand | Rajavithi Hospital | Rajathevee | Bangkok |
| Turkey | Acibadem Adana Hospital | Adana | |
| Turkey | Adana City Hospital | Adana | |
| Turkey | Adana Numune Training and Research Hospital | Adana | |
| Turkey | Baskent University Adana Application and Research Center | Adana | |
| Turkey | Cukurova University Medical Faculty | Adana | |
| Turkey | Ankara University Medical Faculty | Ankara | |
| Turkey | Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital | Ankara | |
| Turkey | Hacettepe University Medical Faculty | Ankara | |
| Turkey | Memorial Antalya Hastanesi | Antalya | |
| Turkey | Bakirkoy Dr. Sadi Konuk Teaching and Research Hospital | Istanbul | |
| Turkey | Istanbul University Cerrahpasa Medical Faculty | Istanbul | |
| Turkey | Kartal Lutfi Kirdar Research and Training Hospital | Istanbul | |
| Turkey | Medipol University Medical Faculty | Istanbul | |
| Turkey | Okmeydani Research and Training Hospital | Istanbul | |
| Turkey | Ege University Medical Faculty | Izmir | |
| Turkey | Inonu Uni. Med. Fac. | Malatya | |
| Turkey | Mersin University Medical Faculty | Mersin | |
| Turkey | Sakarya Traning and Research Hospital | Sakarya | |
| Turkey | Namik Kemal University | Tekirdag | |
| Ukraine | CI Chernivtsi RC Oncological Dispensary Bukovinian SMU Ch of Oncology and Radiology | Chernivtsi | |
| Ukraine | CI Dnipropetrovsk CMCH #4 of Dnipropetrovsk RC Dept of Chemotherapy SI Dnipropetrovsk MA of MOHU | Dnipro | |
| Ukraine | CI Transcarpathian Cl Onc Center Dep of Surgery#1 SHEI Ivano-Frankivsk NMU | Ivano-Frankivsk | |
| Ukraine | Communal Non-profit Enterprise Regional Center of Oncology | Kharkiv | |
| Ukraine | SI S.P.Grygoriev Institute of Medical Radiology of NAMSU | Kharkiv | |
| Ukraine | Kherson Regional Oncologic Dispensary | Kherson | |
| Ukraine | Treatment-Diagnostic Center of Private Enterprise of PPC Atsynus | Kropyvnytskyi | |
| Ukraine | CI Kryvyi Rih Oncological Dispensary of DRC | Kryvyi Rih, Dnipropetrovsk Region | |
| Ukraine | Kyiv City Clinical Oncological Center | Kyiv | |
| Ukraine | Treatment-Prevention Institution Volyn Regional Oncological Dispensary | Lutsk | |
| Ukraine | Lviv State Oncological Regional Treatment and Diagnostic Center | Lviv | |
| Ukraine | Odesa Regional Oncologic Dispensary | Odesa | |
| Ukraine | RCI Sumy Regional Clinical Oncological Dispensary | Sumy | |
| Ukraine | CCCH City Oncological Center SHEI Uzhgorod NU | Uzhgorod | |
| Ukraine | Podilskyi Regional Oncological Center | Vinnytsia | |
| Ukraine | Vinnytsia Regional Clinical Oncological Dispensary | Vinnytsia | |
| United Kingdom | Cheltenham General Hospital | Cheltenham | Gloucestershire |
| United Kingdom | Chelsea and Westminster Hospital | London | Greater London |
| United Kingdom | Mount Vernon Hospital | Stevenage | Hertfordshire |
| United Kingdom | Royal Stoke University Hospital | Stoke on Trent | Staffordshire |
| United Kingdom | Southend University Hospital | Westcliff on Sea | Essex |
| United Kingdom | The Clatterbridge Cancer Centre | Wirral | Merseyside |
| United States | St. Vincent Frontier Cancer Center | Billings | Montana |
| United States | University Cancer Institute | Boynton Beach | Florida |
| United States | University of Vermont Medical Center | Burlington | Vermont |
| United States | Cheyenne Regional Medical Center | Cheyenne | Wyoming |
| United States | Cookeville Regional Medical Center | Cookeville | Tennessee |
| United States | Coastal Bend Cancer Center | Corpus Christi | Texas |
| United States | Henry Ford Hospital | Detroit | Michigan |
| United States | San Juan Oncology Associates | Farmington | New Mexico |
| United States | Oncology Consultants, P.A. | Houston | Texas |
| United States | Clearview Cancer Institute | Huntsville | Alabama |
| United States | Novant Health Oncology Specialists | Kernersville | North Carolina |
| United States | Thompson Cancer Survival Center | Knoxville | Tennessee |
| United States | Lancaster Cancer Center | Lancaster | Pennsylvania |
| United States | Nevada Cancer Research Foundation | Las Vegas | Nevada |
| United States | Mercy Research | Oklahoma City | Oklahoma |
| United States | Kaiser Permanente Northwest | Portland | Oregon |
| United States | Sharp Memorial Hospital | San Diego | California |
| United States | Christus Cancer Treatment Center | Shreveport | Louisiana |
| United States | Arizona Center for Cancer Care | Surprise | Arizona |
| United States | Northwest Medical Specialties, PLLC | Tacoma | Washington |
| United States | South Georgia Medical Center | Valdosta | Georgia |
| Lead Sponsor | Collaborator |
|---|---|
| EMD Serono Research & Development Institute, Inc. | Merck KGaA, Darmstadt, Germany |
United States, Australia, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Cyprus, Czechia, Denmark, Estonia, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Korea, Republic of, Lebanon, Lithuania, Netherlands, New Zealand, Peru, Poland, Portugal, Romania, Russian Federation, Serbia, Singapore, Slovakia, South Africa, Spain, Taiwan, Thailand, Turkey, Ukraine, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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) | |
| Primary | 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) | |
| Primary | 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) | |
| Primary | 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 | 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. | Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months) | |
| Secondary | 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. | Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months) | |
| Secondary | 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. | Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months) | |
| Secondary | 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. | Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months) | |
| Secondary | 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. | Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months) | |
| Secondary | 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. | Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months) | |
| Secondary | 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. | Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months) | |
| Secondary | 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. | Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months) | |
| Secondary | 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. | Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months) | |
| Secondary | 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. | Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months) | |
| Secondary | 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. | Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months) | |
| Secondary | 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. | Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months) | |
| Secondary | 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. | Baseline, End of treatment (up to Week 283.9) | |
| Secondary | 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. | Baseline, End of treatment (Week 283.9) | |
| Secondary | 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. | Baseline, End of treatment (up to Week 283.9) | |
| Secondary | 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. | Baseline, End of treatment (Week 283.9) | |
| Secondary | 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). | Baseline, End of treatment (up to Week 283.9) | |
| Secondary | 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). | Baseline, End of treatment (up to Week 283.9) | |
| Secondary | 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. | Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months) | |
| Secondary | 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. | Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months) | |
| Secondary | 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. | Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months) | |
| Secondary | 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. | Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months) | |
| Secondary | 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. | Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months) | |
| Secondary | 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. | Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months) | |
| Secondary | 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. | Time from date of randomization up to data cutoff (assessed up to 71.5 months) | |
| Secondary | 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. | Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months) | |
| Secondary | 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). | Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months) | |
| Secondary | 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. | Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months) |