Efficacy and Safety Study of Stereotactic Body Radiotherapy (SBRT) With or Without Pembrolizumab (MK-3475) in Adults With Unresected Stage I or II... | NCT03924869 | Trialant

Efficacy and Safety Study of Stereotactic Body Radiotherapy (SBRT) With or Without Pembrolizumab (MK-3475) in Adults With Unresected Stage I or II... | NCT03924869 | Trialant

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Eligibility Criteria: Inclusion Criteria:

Has previously untreated non-small cell lung cancer (NSCLC) diagnosed by histology or cytology and confirmed as Stage I or II (T1 to limited T3, N0, M0) NSCLC (American Joint Committee on Cancer, AJCC) by chest computed tomography (CT) and positron emission tomography (PET) scan. Participants with pericardium invasion, >2 nodules or 2 nodules that cannot be treated in one field (>2 cm apart and/or total planned target volume [PTV] >163 cc) and diaphragm elevation suggestive of phrenic nerve invasion are excluded

Cannot undergo thoracic surgery due to existing medical illness(es) as determined by the site's multi-disciplinary tumor board. Medically operable participants who decide to treat with stereotactic body radiotherapy (SBRT) as definitive therapy rather than surgery are also eligible, if patient's unwillingness to undergo surgical resection is clearly documented

Has a Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2

Is able to receive SBRT and does not have an ultra-centrally located tumor

Has adequate organ function within 7 days prior to the start of study treatment

A female is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: a) not a women of childbearing potential (WOCBP) OR b) A WOCBP and uses contraceptive method that is highly effective (with a failure rate of <1% per year), or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis), during the intervention period and for at least 120 days after the last dose of pembrolizumab/placebo and 180 days after the last radiotherapy dose

Male participants are eligible to participate if they agree to the following during the intervention period and for at least 90 days after the last dose of radiotherapy: refrain from donating sperm plus either be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agree to remain abstinent or must agree to use contraception per study protocol, unless confirmed to be azoospermic

Has a radiation therapy plan approved by the central radiation therapy quality assurance vendor

Exclusion Criteria:

Has received prior therapy with an anti-programmed cell death-1 (anti-PD-1), anti-programmed cell death-ligand 1 (anti-PD-L1), or anti PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g. cytotoxic T-lymphocyte-associated antigen 4 [CTLA-4], tumor necrosis factor receptor superfamily member 4 [OX-40], tumor necrosis factor receptor superfamily member 9 [CD137])

Has received prior radiotherapy to the thorax, including radiotherapy to the esophagus, mediastinum, or breast

Has received a live vaccine within 30 days prior to the first dose of study intervention

Has received an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention administration

Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study treatment

Has a known additional malignancy that is progressing or has required active treatment within the past 3 years. A prior NSCLC that occurred and was treated curatively at least 2 years prior to the date of the current diagnosis would be considered a separate primary lung cancer, and therefore an additional malignancy. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g. breast c carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded.

Has a known hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients

Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis

Has a known history of Hepatitis B or known active Hepatitis C virus infection

Has an active autoimmune disease that has required systemic treatment in past 2 years, except replacement therapy

Has an active infection requiring systemic therapy

Has a known history of human immunodeficiency virus (HIV) infection

Has a known history of active tuberculosis (TB; Bacillus tuberculosis)

Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of pembrolizumab/placebo and 180 days after the last radiotherapy dose

Have not adequately recovered from major surgery or have ongoing surgical complications

Has had an allogenic tissue/solid organ transplant

University of Alabama ( Site 0099)

Birmingham, Alabama 35233, United States

Infirmary Cancer Care ( Site 3044)

Mobile, Alabama 36607, United States

Alaska Oncology and Hematology ( Site 3063)

Anchorage, Alaska 99508, United States

Banner MD Anderson Cancer Center ( Site 3029)

Gilbert, Arizona 85234, United States

CARTI Cancer Center ( Site 3045)

Little Rock, Arkansas 72205, United States

USC Norris Comprehensive Cancer Center ( Site 0007)

Los Angeles, California 90033, United States

Veterans Affairs Palo Alto Health Care System ( Site 3039)

Palo Alto, California 94304, United States

National Jewish Health ( Site 0010)

Denver, Colorado 80206, United States

Yale University ( Site 0011)

New Haven, Connecticut 06510, United States

Mid Florida Hematology and Oncology Center ( Site 0067)

Orange City, Florida 32763, United States

H. Lee Moffitt Cancer Center and Research Institute ( Site 0016)

Tampa, Florida 33612, United States

Goshen Center for Cancer Care ( Site 0022)

Goshen, Indiana 46526, United States

Franciscan Health Indianapolis ( Site 0024)

Indianapolis, Indiana 46237, United States

University of Kentucky School of Medicine & Hospitals ( Site 0026)

Lexington, Kentucky 40536, United States

Sinai Hospital of Baltimore ( Site 3011)

Baltimore, Maryland 21215, United States

William E. Kahlert Regional Cancer Center ( Site 3031)

Westminster, Maryland 21157, United States

Massachusetts General Hospital-Cancer Center Protocol Office ( Site 3007)

Boston, Massachusetts 02114, United States

Mass General / North Shore Center for Outpatient Care ( Site 3040)

Danvers, Massachusetts 01923, United States

University of Massachusetts ( Site 0029)

Worcester, Massachusetts 01655, United States

Sanford Bemidji ( Site 0080)

Bemidji, Minnesota 56601, United States

University of Minnesota ( Site 0069)

Minneapolis, Minnesota 55455, United States

University of Missouri Hospital ( Site 3058)

Columbia, Missouri 65212, United States

Cox Medical Center North-Cox Medical Center/Hulston Cancer Center/ Radiation Oncology ( Site 3060)

Springfield, Missouri 65807, United States

St. Vincent Healthcare Frontier Cancer Center ( Site 3012)

Billings, Montana 59102, United States

John Theurer Cancer Center at Hackensack University Medical Center ( Site 3036)

Hackensack, New Jersey 07601, United States

Rutgers Cancer Institute of New Jersey ( Site 0043)

New Brunswick, New Jersey 08903-2681, United States

Hematology-Oncology Associates of CNY ( Site 3055)

East Syracuse, New York 13057, United States

Mount Sinai Hospital ( Site 0046)

New York, New York 10029, United States

Westchester Medical Center ( Site 3057)

Valhalla, New York 10595, United States

White Plains Hospital ( Site 3014)

White Plains, New York 10601, United States

Sanford Health Roger Maris Cancer Center ( Site 0079)

Fargo, North Dakota 58102, United States

Lehigh Valley Hospital- Cedar Crest ( Site 3005)

Allentown, Pennsylvania 18103, United States

St. Luke's University Health Network ( Site 3006)

Bethlehem, Pennsylvania 18015, United States

Penn State University Milton S. Hershey Medical Center ( Site 0064)

Hershey, Pennsylvania 17033, United States

Fox Chase Cancer Center ( Site 0051)

Philadelphia, Pennsylvania 19111, United States

Allegheny General Hospital ( Site 3028)

Pittsburgh, Pennsylvania 15212, United States

Lankenau Medical Center ( Site 3041)

Wynnewood, Pennsylvania 19096, United States

Sanford Cancer Center Oncology Clinic ( Site 0053)

Sioux Falls, South Dakota 57104, United States

Mountain States Health Alliance ( Site 3054)

Johnson City, Tennessee 37604, United States

University of Tennessee Medical Center Knoxville ( Site 3010)

Knoxville, Tennessee 37920, United States

Vanderbilt University Medical Center ( Site 0075)

Nashville, Tennessee 37232, United States

Cancer Care Northwest ( Site 0063)

Spokane Valley, Washington 99216, United States

Hospital Italiano de Buenos Aires-Clinical Oncology ( Site 0206)

ABB, Buenos Aires F.D. C1199ABB, Argentina

Hospital Britanico de Buenos Aires ( Site 0204)

Buenos Aires, Buenos Aires F.D. C1280AEB, Argentina

Sanatorio Parque ( Site 0207)

Rosario, Santa Fe Province S2000DSV, Argentina

Hospital Provincial del Centenario ( Site 0205)

Rosario, Santa Fe Province S2002KDS, Argentina

IDIM Instituto de Diagnostico e Investigaciones Metabolicas ( Site 0208)

Buenos Aires, 1012, Argentina

Hospital Aleman ( Site 0200)

Buenos Aires, C1118AAT, Argentina

Instituto Medico Especializado Alexander Fleming ( Site 0203)

Buenos Aires, C1426ANZ, Argentina

CEMIC ( Site 0201)

Buenos Aires, C1431, Argentina

Port Macquarie Base Hospital ( Site 2500)

Port Macquarie, New South Wales 2444, Australia

GenesisCare North Shore ( Site 2508)

St Leonards, New South Wales 2065, Australia

Royal Brisbane and Women s Hospital ( Site 2502)

Herston, Queensland 4029, Australia

Icon Cancer Centre Hobart ( Site 2507)

Hobart, Tasmania 7000, Australia

Austin Health ( Site 2501)

Melbourne, Victoria 3084, Australia

Social Medical Center - Otto Wagner Hospital ( Site 0801)

Vienna, State of Vienna 1145, Austria

Landeskrankenhaus - Universitatsklinikum Graz ( Site 0804)

Graz, Styria 8036, Austria

Universitatsklinik LKH Innsbruck ( Site 0802)

Innsbruck, Tyrol 6020, Austria

Keppler Universitatsklinikum ( Site 0806)

Linz, Upper Austria 4021, Austria

Irmandade da Santa Casa de Misericordia de Porto Alegre ( Site 0318)

Porto Alegre, Rio Grande do Sul 90050-170, Brazil

Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs ( Site 0301)

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

Clínica de Oncologia Reichow ( Site 0319)

Blumenau, Santa Catarina 89010-340, Brazil

Hospital e Maternidade Celso Pierro ( Site 0313)

Campinas, São Paulo 13060-904, Brazil

Instituto Nacional Do Cancer Jose Alencar Gomes Da Silva ( Site 0305)

Rio de Janeiro, 20231-050, Brazil

Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 0300)

São Paulo, 01246-000, Brazil

Hospital Paulistano - Amil Clinical Research ( Site 0316)

São Paulo, 01321-001, Brazil

A.C. Camargo Cancer Center ( Site 0312)

São Paulo, 01509-900, Brazil

Moncton Hospital - Horizon Health Network ( Site 0105)

Moncton, New Brunswick E1C 6Z8, Canada

Health Sciences North Research Institute ( Site 0107)

Greater Sudbury, Ontario P3E 5J1, Canada

Kingston Health Sciences Centre ( Site 0100)

Kingston, Ontario K7L 2V7, Canada

Trillium Health Partners - Credit Valley Hospital ( Site 0102)

Mississauga, Ontario L5M 2N1, Canada

The Ottawa Hospital ( Site 0104)

Ottawa, Ontario K1H 8L6, Canada

Sault Area Hospital ( Site 0101)

Sault Ste. Marie, Ontario P6B 0A8, Canada

CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont ( Site 0110)

Montreal, Quebec H1T 2M4, Canada

McGill University Health Centre ( Site 0113)

Montreal, Quebec H4A 3J1, Canada

CHUS - Hopital Fleurimont ( Site 0111)

Sherbrooke, Quebec J1H 5N4, Canada

CHU Poitiers ( Site 1109)

Poitiers, Ain 86021, France

CHU de Brest -Site Hopital Morvan ( Site 1100)

Brest, Finistere 29200, France

Institut Bergonie ( Site 1102)

Bordeaux, Gironde 33076, France

Institut Regional du Cancer de Montpellier - ICM ( Site 1108)

Montpellier, Herault 34298, France

CHU de Rouen ( Site 1113)

Rouen, Seine-Maritime 76000, France

Hopital Sud du Amiens ( Site 1115)

Amiens, Somme 80054, France

Institut Curie ( Site 1112)

Paris, 75005, France

Hopital Cochin ( Site 1107)

Paris, 75014, France

A.P.H. Paris. Hopital Bichat Claude Bernard ( Site 1114)

Paris, 75877, France

Klinikum Esslingen-Klinik für Kardiologie und Pneumologie ( Site 1208)

Esslingen am Neckar, Baden-Wurttemberg 73730, Germany

Universitaetsklinikum Heidelberg. ( Site 1204)

Heidelberg, Baden-Wurttemberg 69126, Germany

Universitaetsklinikum Erlangen ( Site 1209)

Erlangen, Bavaria 91054, Germany

UKGM Gießen/Marburg-Medical Clinic V ( Site 1210)

Giessen, Hesse 35392, Germany

Pius Hospital Oldenburg ( Site 1202)

Oldenburg, Lower Saxony 26121, Germany

Universitaetsklinikum Essen ( Site 1201)

Essen, North Rhine-Westphalia 45147, Germany

Evangelisches Krankenhaus Hamm gGmbH ( Site 1205)

Hamm, North Rhine-Westphalia 59063, Germany

Charite Universitaetsmedizin Berlin ( Site 1207)

Berlin, 13353, Germany

Pécsi Tudományegyetem Klinikai Központ-Onkoterápiás Intézet ( Site 2314)

Pécs, Baranya 7624, Hungary

CRU Hungary KFT ( Site 2309)

Miskolc, Borsod-Abauj Zemplen county 3529, Hungary

Bacs-Kiskun Varmegyei Oktatokorhaz-Onkoradiologiai Kozpont ( Site 2311)

Kecskemét, Bács-Kiskun county 6000, Hungary

Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz ( Site 2312)

Székesfehérvár, Fejér 8000, Hungary

Petz Aladar Megyei Oktato Korhaz ( Site 2305)

Győr, Győr-Moson-Sopron 9024, Hungary

Debreceni Egyetem Klinikai Kozpont ( Site 2301)

Debrecen, Hajdú-Bihar 4032, Hungary

Jász-Nagykun-Szolnok Vármegyei Hetényi Géza Kórház ( Site 2310)

Szolnok, Jász-Nagykun-Szolnok 5004, Hungary

Törökbálinti Tüdőgyógyintézet ( Site 2302)

Törökbálint, Pest County 2045, Hungary

Somogy Megyei Kaposi Mor Oktato Korhaz ( Site 2307)

Kaposvár, Somogy County 7400, Hungary

Farkasgyepui Tudogyogyintezet ( Site 2313)

Farkasgyepű, Veszprém megye 8582, Hungary

Semmelweis University ( Site 2303)

Budapest, 1085, Hungary

Orszagos Koranyi Pulmonologiai Intezet ( Site 2304)

Budapest, 1121, Hungary

Orszagos Koranyi Pulmonologiai Intezet ( Site 2306)

Budapest, 1121, Hungary

Orszagos Onkologiai Intezet ( Site 2308)

Budapest, 1122, Hungary

Ospedale Santissima Annunziata ( Site 1303)

Chieti, 66100, Italy

A.O. Universitaria Careggi ( Site 1301)

Florence, 50134, Italy

Policlinico di Modena ( Site 1306)

Modena, 41124, Italy

Policlinico Agostino Gemelli ( Site 1302)

Roma, 00168, Italy

Azienda Ospedaliera S. Giovanni Addolorata-Oncologia Medica ( Site 1309)

Roma, 00185, Italy

Aichi Cancer Center Hospital ( Site 2804)

Nagoya, Aichi-ken 464-8681, Japan

National Cancer Center Hospital East ( Site 2800)

Kashiwa, Chiba 2778577, Japan

Kurume University Hospital ( Site 2815)

Kurume, Fukuoka 830-0011, Japan

Kobe Minimally Invasive Cancer Center ( Site 2811)

Kobe, Hyōgo 650-0046, Japan

University of Tsukuba Hospital ( Site 2809)

Tsukuba, Ibaraki 305-8576, Japan

Sendai Kousei Hospital ( Site 2814)

Sendai, Miyagi 980-0873, Japan

Kansai Medical University Hospital ( Site 2808)

Hirakata, Osaka 573-1191, Japan

Osaka Medical and Pharmaceutical University Hospital ( Site 2813)

Takatsuki, Osaka 5698686, Japan

University of Yamanashi Hospital ( Site 2807)

Chūō, Yamanashi 409-3898, Japan

Chiba University Hospital ( Site 2806)

Chiba, 260-8677, Japan

National Hospital Organization Kyushu Cancer Center ( Site 2816)

Fukuoka, 811-1395, Japan

Hiroshima University Hospital ( Site 2810)

Hiroshima, 734-8551, Japan

Niigata Cancer Center Hospital ( Site 2801)

Niigata, 951-8566, Japan

Osaka International Cancer Institute ( Site 2812)

Osaka, 541-8567, Japan

Tokyo Metropolitan Komagome Hospital ( Site 2802)

Tokyo, 113-8677, Japan

The Cancer Institute Hospital of JFCR ( Site 2803)

Tokyo, 135-8550, Japan

Showa University Hospital ( Site 2805)

Tokyo, 142-8666, Japan

Ziekenhuis Rijnstate ( Site 1405)

Arnhem, Gelderland 6815 AD, Netherlands

Tergooiziekenhuizen, locatie Hilversum-Oncology ( Site 1407)

Hilversum, North Holland 1213 XZ, Netherlands

Meander Medisch Centrum-Studie Team Oncologie ( Site 1403)

Amersfoort, Utrecht 3813 TZ, Netherlands

Auckland City Hospital ( Site 2900)

Grafton, Auckland 1023, New Zealand

St Olavs Hospital ( Site 1504)

Trondheim, Sor-Trondelag 7030, Norway

Helse Bergen HF Haukeland Universitetssykehus ( Site 1502)

Bergen, Vestfold 5021, Norway

Oslo Universitetssykehus HF Ulleval Sykehus ( Site 1500)

Oslo, 0450, Norway

Centrum Onkologii im. prof. Franciszka ukaszczyka-Ambulatorium Chemioterapii ( Site 2407)

Bydgoszcz, Kuyavian-Pomeranian Voivodeship 85-796, Poland

Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie ( Site 2400)

Krakow, Lesser Poland Voivodeship 31-826, Poland

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie (

Warsaw, Masovian Voivodeship 02-781, Poland

Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 2403)

Gliwice, Silesian Voivodeship 44-101, Poland

SPZOZ MSWIA z Warminsko-Mazurskim Centrum Onkologii w Olsztynie ( Site 2404)

Olsztyn, Warmian-Masurian Voivodeship 10-228, Poland

Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii ( Site 2402)

Lodz, Łódź Voivodeship 93-513, Poland

Amethyst Radiotherapy Center-Oncologie Medicala ( Site 3201)

Florești, Cluj 407280, Romania

Institutul Oncologic-Oncologie Medicala ( Site 3202)

Cluj-Napoca, 400015, Romania

Chelyabinsk Regional Clinical Oncology Dispensary ( Site 2014)

Chelyabinsk, Chelyabinsk Oblast 454087, Russia

GUZ Lipetsk Regional Oncology Dispensary ( Site 2010)

Lipetsk, Lipetsk Oblast 398005, Russia

N.N.Blokhin Russian Cancer Research center ( Site 2013)

Moscow, Moscow 115478, Russia

Russian Scientific Center of Roentgenoradiology ( Site 2011)

Moscow, Moscow 117997, Russia

Medical institute named after Berezin Sergey ( Site 2009)

Saint Petersburg, Sankt-Peterburg 197758, Russia

Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 2000)

Saint Petersburg, Sankt-Peterburg 197758, Russia

Sverdlovsk Regional Oncology Hospital ( Site 2012)

Yekaterinburg, Sverdlovsk Oblast 620036, Russia

Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 2001)

Kazan', Tatarstan, Respublika 420029, Russia

National Cancer Center ( Site 2604)

Goyang-si, Kyonggi-do 10408, South Korea

The Catholic University of Korea St. Vincent s Hospital ( Site 2606)

Gyeonggi-do, Kyonggi-do 16247, South Korea

Chungbuk National University Hospital ( Site 2605)

Cheongju-si, North Chungcheong 28644, South Korea

Seoul National University Hospital ( Site 2600)

Seoul, 03080, South Korea

Samsung Medical Center ( Site 2603)

Seoul, 06351, South Korea

Hospital Universitario Quiron Madrid ( Site 1601)

Pozuelo de Alarcón, Madrid 28223, Spain

Hospital Universitario La Fe ( Site 1603)

Valencia, Valenciana, Comunitat 46206, Spain

Hospital General Universitari Vall d Hebron ( Site 1602)

Barcelona, 08035, Spain

Hospital General Universitario Gregorio Maranon ( Site 1604)

Madrid, 28009, Spain

Hopitaux Universitaires de Geneve HUG ( Site 1706)

Geneva, Canton of Geneva 1211, Switzerland

Universitaetsspital Zuerich ( Site 1700)

Zurich, Canton of Zurich 8091, Switzerland

Tri-Service General Hospital ( Site 3300)

Taipei City, Taipei 114, Taiwan

Kaohsiung Medical University Chung-Ho Memorial Hospital ( Site 3304)

Kaohsiung City, 807, Taiwan

Taipei Medical University Hospital ( Site 3303)

Taipei, 110301, Taiwan

Taipei Veterans General Hospital ( Site 3301)

Taipei, 11217, Taiwan

Baskent Adana Dr Turgut Noyan Uygulama ve Arastirma Merkezi ( Site 2105)

Adana, 01250, Turkey (Türkiye)

Hacettepe University Medical Faculty ( Site 2100)

Ankara, 06100, Turkey (Türkiye)

Dr Abdurrahman Yurtaslan Oncology Training and Research Hospital ( Site 2101)

Ankara, 06200, Turkey (Türkiye)

Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi-oncology ( Site 2116)

Istanbul, 34722, Turkey (Türkiye)

Kartal Training and Research Hospital ( Site 2102)

Istanbul, 34890, Turkey (Türkiye)

I.E.U. Medical Point Hastanesi ( Site 2115)

Izmir, 35520, Turkey (Türkiye)

Erciyes University Medical Faculty ( Site 2109)

Kayseri, 38030, Turkey (Türkiye)

Sakarya Universitesi Tip Fakultesi Hastanesi ( Site 2114)

Sakarya, 54290, Turkey (Türkiye)

Medical center Medikal Plaza of Ecodnipro LLC ( Site 2207)

Dnipro, Dnipropetrovsk Oblast 49055, Ukraine

Regional Centre of Oncology-Thoracic organs ( Site 2202)

Kharkiv, Kharkiv Oblast 61070, Ukraine

Ukrainian Center of Tomotherapy ( Site 2206)

Kropyvnitskiy, Kirovohrad Oblast 25011, Ukraine

Medical Center of Yuriy Spizhenko LLC.-Clinical Trial ( Site 2205)

Kapitanivka Village, Kyivska Oblast 08111, Ukraine

Medical Center Asklepion LLC ( Site 2208)

Khodosovka, Kyivska Oblast 08173, Ukraine

Medical and Diagnostic Centre LLC Dobryi Prognoz ( Site 2203)

Kyiv, Kyivska Oblast 03126, Ukraine

Kyiv City Clinical Oncology Centre ( Site 2200)

Kyiv, 03115, Ukraine

University Hospitals Bristol NHS Foundation Trust ( Site 1802)

Bristol, Bristol, City of BS2 8ED, United Kingdom

Royal Free London NHS Foundation Trust ( Site 1813)

London, Camden NW3 2QG, United Kingdom

Weston Park Hospital ( Site 1801)

Sheffield, Derbyshire S10 2SJ, United Kingdom

Clatterbridge Cancer Center NHS FT ( Site 1800)

Liverpool, England L7 8YA, United Kingdom

Lancashire Teaching Hospitals NHS Foundation Trust ( Site 1809)

Preston, Lancashire PR2 9HT, United Kingdom

Leicester Royal Infirmary ( Site 1811)

Leicester, Leicestershire LE1 5WW, United Kingdom

University College London Hospital NHS Foundation Trust ( Site 1806)

London, London, City of NW1 2BU, United Kingdom

Guy s and St Thomas Hospital NHS Foundation Trust ( Site 1808)

London, London, City of SE1 9RT, United Kingdom

Norfolk and Norwich University Foundation NHS Trust ( Site 1805)

Norwich, Norfolk NR47UY, United Kingdom

Oxford University Hospitals NHS Foundation Trust ( Site 1812)

Oxford, Oxfordshire OX3 7LE, United Kingdom

Darlington Memorial Hospital NHS Trust ( Site 1810)

Darlington, DLX 6HX, United Kingdom

Mount Vernon Hospital ( Site 1803)

Northwood, HA6 2RN, United Kingdom