AzTrials
AzTrials

Non-Small Cell Lung CancerPhase 3NCT03924869

Efficacy and Safety Study of Stereotactic Body Radiotherapy (SBRT) With or Without Pembrolizumab (MK-3475) in Adults With Unresected Stage I or II Non-Small Cell Lung Cancer (NSCLC) (MK-3475-867/KEYNOTE-867)

A Phase 3 study testing Stereotactic Body Radiotherapy (SBRT) and Pembrolizumab in people with Non-Small Cell Lung Cancer, run by Merck Sharp & Dohme LLC at 194 sites in 24 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of this study is to assess the efficacy and safety of stereotactic body radiotherapy (SBRT) plus pembrolizumab (MK-3475) in the treatment of adult participants with unresected Stage I or II (Stage IIB N0, M0) non-small cell lung cancer (NSCLC). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-Small Cell Lung Cancer
What is being tested?
Stereotactic Body Radiotherapy (SBRT) and Pembrolizumab
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
448 participants
Where
194 sitesin 24 countries
Study dates
25 Jun 2019to 20 Jan 2025
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • 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

Who cannot join

  • 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.
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  • 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

Trial locations and contacts

194 sites in 24 countries.

194 sites in 24 countries

United States42 sites

  • Lehigh Valley Hospital- Cedar Crest ( Site 3005)

    Allentown, Pennsylvania, 18103

  • Alaska Oncology and Hematology ( Site 3063)

    Anchorage, Alaska, 99508

  • Sinai Hospital of Baltimore ( Site 3011)

    Baltimore, Maryland, 21215

  • Sanford Bemidji ( Site 0080)

    Bemidji, Minnesota, 56601

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

    Bethlehem, Pennsylvania, 18015

  • St. Vincent Healthcare Frontier Cancer Center ( Site 3012)

    Billings, Montana, 59102

  • University of Alabama ( Site 0099)

    Birmingham, Alabama, 35233

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

    Boston, Massachusetts, 02114

  • University of Missouri Hospital ( Site 3058)

    Columbia, Missouri, 65212

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

    Danvers, Massachusetts, 01923

  • National Jewish Health ( Site 0010)

    Denver, Colorado, 80206

  • Hematology-Oncology Associates of CNY ( Site 3055)

    East Syracuse, New York, 13057

  • Sanford Health Roger Maris Cancer Center ( Site 0079)

    Fargo, North Dakota, 58102

  • Banner MD Anderson Cancer Center ( Site 3029)

    Gilbert, Arizona, 85234

  • Goshen Center for Cancer Care ( Site 0022)

    Goshen, Indiana, 46526

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

    Hackensack, New Jersey, 07601

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

    Hershey, Pennsylvania, 17033

  • Franciscan Health Indianapolis ( Site 0024)

    Indianapolis, Indiana, 46237

  • Mountain States Health Alliance ( Site 3054)

    Johnson City, Tennessee, 37604

  • University of Tennessee Medical Center Knoxville ( Site 3010)

    Knoxville, Tennessee, 37920

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

    Lexington, Kentucky, 40536

  • CARTI Cancer Center ( Site 3045)

    Little Rock, Arkansas, 72205

  • USC Norris Comprehensive Cancer Center ( Site 0007)

    Los Angeles, California, 90033

  • University of Minnesota ( Site 0069)

    Minneapolis, Minnesota, 55455

  • Infirmary Cancer Care ( Site 3044)

    Mobile, Alabama, 36607

  • Vanderbilt University Medical Center ( Site 0075)

    Nashville, Tennessee, 37232

  • Rutgers Cancer Institute of New Jersey ( Site 0043)

    New Brunswick, New Jersey, 08903-2681

  • Yale University ( Site 0011)

    New Haven, Connecticut, 06510

  • Mount Sinai Hospital ( Site 0046)

    New York, New York, 10029

  • Mid Florida Hematology and Oncology Center ( Site 0067)

    Orange City, Florida, 32763

  • Veterans Affairs Palo Alto Health Care System ( Site 3039)

    Palo Alto, California, 94304

  • Fox Chase Cancer Center ( Site 0051)

    Philadelphia, Pennsylvania, 19111

  • Allegheny General Hospital ( Site 3028)

    Pittsburgh, Pennsylvania, 15212

  • Sanford Cancer Center Oncology Clinic ( Site 0053)

    Sioux Falls, South Dakota, 57104

  • Cancer Care Northwest ( Site 0063)

    Spokane Valley, Washington, 99216

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

    Springfield, Missouri, 65807

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

    Tampa, Florida, 33612

  • Westchester Medical Center ( Site 3057)

    Valhalla, New York, 10595

  • William E. Kahlert Regional Cancer Center ( Site 3031)

    Westminster, Maryland, 21157

  • White Plains Hospital ( Site 3014)

    White Plains, New York, 10601

  • University of Massachusetts ( Site 0029)

    Worcester, Massachusetts, 01655

  • Lankenau Medical Center ( Site 3041)

    Wynnewood, Pennsylvania, 19096

Other trials in United States

Japan17 sites

  • Chiba University Hospital ( Site 2806)

    Chiba, 260-8677

  • University of Yamanashi Hospital ( Site 2807)

    Chūō, Yamanashi, 409-3898

  • National Hospital Organization Kyushu Cancer Center ( Site 2816)

    Fukuoka, 811-1395

  • Kansai Medical University Hospital ( Site 2808)

    Hirakata, Osaka, 573-1191

  • Hiroshima University Hospital ( Site 2810)

    Hiroshima, 734-8551

  • National Cancer Center Hospital East ( Site 2800)

    Kashiwa, Chiba, 2778577

  • Kobe Minimally Invasive Cancer Center ( Site 2811)

    Kobe, Hyōgo, 650-0046

  • Kurume University Hospital ( Site 2815)

    Kurume, Fukuoka, 830-0011

  • Aichi Cancer Center Hospital ( Site 2804)

    Nagoya, Aichi-ken, 464-8681

  • Niigata Cancer Center Hospital ( Site 2801)

    Niigata, 951-8566

  • Osaka International Cancer Institute ( Site 2812)

    Osaka, 541-8567

  • Sendai Kousei Hospital ( Site 2814)

    Sendai, Miyagi, 980-0873

  • Osaka Medical and Pharmaceutical University Hospital ( Site 2813)

    Takatsuki, Osaka, 5698686

  • Tokyo Metropolitan Komagome Hospital ( Site 2802)

    Tokyo, 113-8677

  • The Cancer Institute Hospital of JFCR ( Site 2803)

    Tokyo, 135-8550

  • Showa University Hospital ( Site 2805)

    Tokyo, 142-8666

  • University of Tsukuba Hospital ( Site 2809)

    Tsukuba, Ibaraki, 305-8576

Other trials in Japan

Hungary14 sites

  • Semmelweis University ( Site 2303)

    Budapest, 1085

  • Orszagos Koranyi Pulmonologiai Intezet ( Site 2304)

    Budapest, 1121

  • Orszagos Koranyi Pulmonologiai Intezet ( Site 2306)

    Budapest, 1121

  • Orszagos Onkologiai Intezet ( Site 2308)

    Budapest, 1122

  • Debreceni Egyetem Klinikai Kozpont ( Site 2301)

    Debrecen, Hajdú-Bihar, 4032

  • Farkasgyepui Tudogyogyintezet ( Site 2313)

    Farkasgyepű, Veszprém megye, 8582

  • Petz Aladar Megyei Oktato Korhaz ( Site 2305)

    Győr, Győr-Moson-Sopron, 9024

  • Somogy Megyei Kaposi Mor Oktato Korhaz ( Site 2307)

    Kaposvár, Somogy County, 7400

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

    Kecskemét, Bács-Kiskun county, 6000

  • CRU Hungary KFT ( Site 2309)

    Miskolc, Borsod-Abauj Zemplen county, 3529

  • Pécsi Tudományegyetem Klinikai Központ-Onkoterápiás Intézet ( Site 2314)

    Pécs, Baranya, 7624

  • Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz ( Site 2312)

    Székesfehérvár, Fejér, 8000

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

    Szolnok, Jász-Nagykun-Szolnok, 5004

  • Törökbálinti Tüdőgyógyintézet ( Site 2302)

    Törökbálint, Pest County, 2045

Other trials in Hungary

United Kingdom12 sites

  • University Hospitals Bristol NHS Foundation Trust ( Site 1802)

    Bristol, Bristol, City of, BS2 8ED

  • Darlington Memorial Hospital NHS Trust ( Site 1810)

    Darlington, DLX 6HX

  • Leicester Royal Infirmary ( Site 1811)

    Leicester, Leicestershire, LE1 5WW

  • Clatterbridge Cancer Center NHS FT ( Site 1800)

    Liverpool, England, L7 8YA

  • Royal Free London NHS Foundation Trust ( Site 1813)

    London, Camden, NW3 2QG

  • University College London Hospital NHS Foundation Trust ( Site 1806)

    London, London, City of, NW1 2BU

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

    London, London, City of, SE1 9RT

  • Mount Vernon Hospital ( Site 1803)

    Northwood, HA6 2RN

  • Norfolk and Norwich University Foundation NHS Trust ( Site 1805)

    Norwich, Norfolk, NR47UY

  • Oxford University Hospitals NHS Foundation Trust ( Site 1812)

    Oxford, Oxfordshire, OX3 7LE

  • Lancashire Teaching Hospitals NHS Foundation Trust ( Site 1809)

    Preston, Lancashire, PR2 9HT

  • Weston Park Hospital ( Site 1801)

    Sheffield, Derbyshire, S10 2SJ

Other trials in United Kingdom

Canada9 sites

  • Health Sciences North Research Institute ( Site 0107)

    Greater Sudbury, Ontario, P3E 5J1

  • Kingston Health Sciences Centre ( Site 0100)

    Kingston, Ontario, K7L 2V7

  • Trillium Health Partners - Credit Valley Hospital ( Site 0102)

    Mississauga, Ontario, L5M 2N1

  • Moncton Hospital - Horizon Health Network ( Site 0105)

    Moncton, New Brunswick, E1C 6Z8

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

    Montreal, Quebec, H1T 2M4

  • McGill University Health Centre ( Site 0113)

    Montreal, Quebec, H4A 3J1

  • The Ottawa Hospital ( Site 0104)

    Ottawa, Ontario, K1H 8L6

  • Sault Area Hospital ( Site 0101)

    Sault Ste. Marie, Ontario, P6B 0A8

  • CHUS - Hopital Fleurimont ( Site 0111)

    Sherbrooke, Quebec, J1H 5N4

Other trials in Canada

France9 sites

  • Hopital Sud du Amiens ( Site 1115)

    Amiens, Somme, 80054

  • Institut Bergonie ( Site 1102)

    Bordeaux, Gironde, 33076

  • CHU de Brest -Site Hopital Morvan ( Site 1100)

    Brest, Finistere, 29200

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

    Montpellier, Herault, 34298

  • Institut Curie ( Site 1112)

    Paris, 75005

  • Hopital Cochin ( Site 1107)

    Paris, 75014

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

    Paris, 75877

  • CHU Poitiers ( Site 1109)

    Poitiers, Ain, 86021

  • CHU de Rouen ( Site 1113)

    Rouen, Seine-Maritime, 76000

Other trials in France

Argentina8 sites

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

    ABB, Buenos Aires F.D., C1199ABB

  • Hospital Britanico de Buenos Aires ( Site 0204)

    Buenos Aires, Buenos Aires F.D., C1280AEB

  • IDIM Instituto de Diagnostico e Investigaciones Metabolicas ( Site 0208)

    Buenos Aires, 1012

  • Hospital Aleman ( Site 0200)

    Buenos Aires, C1118AAT

  • Instituto Medico Especializado Alexander Fleming ( Site 0203)

    Buenos Aires, C1426ANZ

  • CEMIC ( Site 0201)

    Buenos Aires, C1431

  • Sanatorio Parque ( Site 0207)

    Rosario, Santa Fe Province, S2000DSV

  • Hospital Provincial del Centenario ( Site 0205)

    Rosario, Santa Fe Province, S2002KDS

Other trials in Argentina

Brazil8 sites

  • Clínica de Oncologia Reichow ( Site 0319)

    Blumenau, Santa Catarina, 89010-340

  • Hospital e Maternidade Celso Pierro ( Site 0313)

    Campinas, São Paulo, 13060-904

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

    Porto Alegre, Rio Grande do Sul, 90050-170

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

    Porto Alegre, Rio Grande do Sul, 90610-000

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

    Rio de Janeiro, 20231-050

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

    São Paulo, 01246-000

  • Hospital Paulistano - Amil Clinical Research ( Site 0316)

    São Paulo, 01321-001

  • A.C. Camargo Cancer Center ( Site 0312)

    São Paulo, 01509-900

Other trials in Brazil

Germany8 sites

  • Charite Universitaetsmedizin Berlin ( Site 1207)

    Berlin, 13353

  • Universitaetsklinikum Erlangen ( Site 1209)

    Erlangen, Bavaria, 91054

  • Universitaetsklinikum Essen ( Site 1201)

    Essen, North Rhine-Westphalia, 45147

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

    Esslingen am Neckar, Baden-Wurttemberg, 73730

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

    Giessen, Hesse, 35392

  • Evangelisches Krankenhaus Hamm gGmbH ( Site 1205)

    Hamm, North Rhine-Westphalia, 59063

  • Universitaetsklinikum Heidelberg. ( Site 1204)

    Heidelberg, Baden-Wurttemberg, 69126

  • Pius Hospital Oldenburg ( Site 1202)

    Oldenburg, Lower Saxony, 26121

Other trials in Germany

Russia8 sites

  • Chelyabinsk Regional Clinical Oncology Dispensary ( Site 2014)

    Chelyabinsk, Chelyabinsk Oblast, 454087

  • Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 2001)

    Kazan', Tatarstan, Respublika, 420029

  • GUZ Lipetsk Regional Oncology Dispensary ( Site 2010)

    Lipetsk, Lipetsk Oblast, 398005

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

    Moscow, Moscow, 115478

  • Russian Scientific Center of Roentgenoradiology ( Site 2011)

    Moscow, Moscow, 117997

  • Medical institute named after Berezin Sergey ( Site 2009)

    Saint Petersburg, Sankt-Peterburg, 197758

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

    Saint Petersburg, Sankt-Peterburg, 197758

  • Sverdlovsk Regional Oncology Hospital ( Site 2012)

    Yekaterinburg, Sverdlovsk Oblast, 620036

Other trials in Russia

Turkey (Türkiye)8 sites

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

    Adana, 01250

  • Hacettepe University Medical Faculty ( Site 2100)

    Ankara, 06100

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

    Ankara, 06200

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

    Istanbul, 34722

  • Kartal Training and Research Hospital ( Site 2102)

    Istanbul, 34890

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

    Izmir, 35520

  • Erciyes University Medical Faculty ( Site 2109)

    Kayseri, 38030

  • Sakarya Universitesi Tip Fakultesi Hastanesi ( Site 2114)

    Sakarya, 54290

Other trials in Turkey (Türkiye)

Ukraine7 sites

  • Medical center Medikal Plaza of Ecodnipro LLC ( Site 2207)

    Dnipro, Dnipropetrovsk Oblast, 49055

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

    Kapitanivka Village, Kyivska Oblast, 08111

  • Regional Centre of Oncology-Thoracic organs ( Site 2202)

    Kharkiv, Kharkiv Oblast, 61070

  • Medical Center Asklepion LLC ( Site 2208)

    Khodosovka, Kyivska Oblast, 08173

  • Ukrainian Center of Tomotherapy ( Site 2206)

    Kropyvnitskiy, Kirovohrad Oblast, 25011

  • Medical and Diagnostic Centre LLC Dobryi Prognoz ( Site 2203)

    Kyiv, Kyivska Oblast, 03126

  • Kyiv City Clinical Oncology Centre ( Site 2200)

    Kyiv, 03115

Other trials in Ukraine

Poland6 sites

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

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-796

  • Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 2403)

    Gliwice, Silesian Voivodeship, 44-101

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

    Krakow, Lesser Poland Voivodeship, 31-826

  • Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii ( Site 2402)

    Lodz, Łódź Voivodeship, 93-513

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

    Olsztyn, Warmian-Masurian Voivodeship, 10-228

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

    Warsaw, Masovian Voivodeship, 02-781

Other trials in Poland

Australia5 sites

  • Royal Brisbane and Women s Hospital ( Site 2502)

    Herston, Queensland, 4029

  • Icon Cancer Centre Hobart ( Site 2507)

    Hobart, Tasmania, 7000

  • Austin Health ( Site 2501)

    Melbourne, Victoria, 3084

  • Port Macquarie Base Hospital ( Site 2500)

    Port Macquarie, New South Wales, 2444

  • GenesisCare North Shore ( Site 2508)

    St Leonards, New South Wales, 2065

Other trials in Australia

Italy5 sites

  • Ospedale Santissima Annunziata ( Site 1303)

    Chieti, 66100

  • A.O. Universitaria Careggi ( Site 1301)

    Florence, 50134

  • Policlinico di Modena ( Site 1306)

    Modena, 41124

  • Policlinico Agostino Gemelli ( Site 1302)

    Roma, 00168

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

    Roma, 00185

Other trials in Italy

South Korea5 sites

  • Chungbuk National University Hospital ( Site 2605)

    Cheongju-si, North Chungcheong, 28644

  • National Cancer Center ( Site 2604)

    Goyang-si, Kyonggi-do, 10408

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

    Gyeonggi-do, Kyonggi-do, 16247

  • Seoul National University Hospital ( Site 2600)

    Seoul, 03080

  • Samsung Medical Center ( Site 2603)

    Seoul, 06351

Other trials in South Korea

Austria4 sites

  • Landeskrankenhaus - Universitatsklinikum Graz ( Site 0804)

    Graz, Styria, 8036

  • Universitatsklinik LKH Innsbruck ( Site 0802)

    Innsbruck, Tyrol, 6020

  • Keppler Universitatsklinikum ( Site 0806)

    Linz, Upper Austria, 4021

  • Social Medical Center - Otto Wagner Hospital ( Site 0801)

    Vienna, State of Vienna, 1145

Other trials in Austria

Spain4 sites

  • Hospital General Universitari Vall d Hebron ( Site 1602)

    Barcelona, 08035

  • Hospital General Universitario Gregorio Maranon ( Site 1604)

    Madrid, 28009

  • Hospital Universitario Quiron Madrid ( Site 1601)

    Pozuelo de Alarcón, Madrid, 28223

  • Hospital Universitario La Fe ( Site 1603)

    Valencia, Valenciana, Comunitat, 46206

Other trials in Spain

Taiwan4 sites

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

    Kaohsiung City, 807

  • Taipei Medical University Hospital ( Site 3303)

    Taipei, 110301

  • Taipei Veterans General Hospital ( Site 3301)

    Taipei, 11217

  • Tri-Service General Hospital ( Site 3300)

    Taipei City, Taipei, 114

Other trials in Taiwan

Netherlands3 sites

  • Meander Medisch Centrum-Studie Team Oncologie ( Site 1403)

    Amersfoort, Utrecht, 3813 TZ

  • Ziekenhuis Rijnstate ( Site 1405)

    Arnhem, Gelderland, 6815 AD

  • Tergooiziekenhuizen, locatie Hilversum-Oncology ( Site 1407)

    Hilversum, North Holland, 1213 XZ

Other trials in Netherlands

Norway3 sites

  • Helse Bergen HF Haukeland Universitetssykehus ( Site 1502)

    Bergen, Vestfold, 5021

  • Oslo Universitetssykehus HF Ulleval Sykehus ( Site 1500)

    Oslo, 0450

  • St Olavs Hospital ( Site 1504)

    Trondheim, Sor-Trondelag, 7030

Other trials in Norway

Romania2 sites

  • Institutul Oncologic-Oncologie Medicala ( Site 3202)

    Cluj-Napoca, 400015

  • Amethyst Radiotherapy Center-Oncologie Medicala ( Site 3201)

    Florești, Cluj, 407280

Other trials in Romania

Switzerland2 sites

  • Hopitaux Universitaires de Geneve HUG ( Site 1706)

    Geneva, Canton of Geneva, 1211

  • Universitaetsspital Zuerich ( Site 1700)

    Zurich, Canton of Zurich, 8091

Other trials in Switzerland

New Zealand1 site

  • Auckland City Hospital ( Site 2900)

    Grafton, Auckland, 1023

Other trials in New Zealand

About this study

Official title: A Phase 3, Randomized, Placebo-Controlled Clinical Study to Evaluate the Safety and Efficacy of Stereotactic Body Radiotherapy (SBRT) With or Without Pembrolizumab (MK-3475) in Participants With Unresected Stages I or II Non Small Cell Lung Cancer (NSCLC) (KEYNOTE-867)

The purpose of this study is to assess the efficacy and safety of stereotactic body radiotherapy (SBRT) plus pembrolizumab (MK-3475) in the treatment of adult participants with unresected Stage I or II (Stage IIB N0, M0) non-small cell lung cancer (NSCLC).

The primary study hypothesis is SBRT plus pembrolizumab prolongs Event-free Survival (EFS) compared to SBRT plus placebo (normal saline solution).

Read the detailed description

As of protocol amendment 8, the study was stopped due to an interim analysis that did not support the study primary and key secondary endpoints. All study participants stopped ongoing treatment with pembrolizumab/placebo, and must complete end of trial and safety follow-up visits.

Being tested
Stereotactic Body Radiotherapy (SBRT), Pembrolizumab, Placebo
Keywords
Programmed Cell Death-1 (PD1, PD-1), Programmed Death-Ligand 1 (PDL1, PD-L1), Programmed Cell Death Receptor Ligand 2 (PDL2, PD-L2)
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Parkinson Disease 4, Autosomal Dominant Lewy Body

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Stereotactic Body Radiotherapy (SBRT)Radiation

    SBRT will be administered once every 3 days for 3, 4, 5, or 8 fractions (dependent on tumor type/location; 45-70 Gray [Gy] total) over approximately 2 weeks.

  • PembrolizumabBiological

    Also called MK-3475, KEYTRUDA®

    Pembrolizumab will be administered at 200 mg via IV infusion once every 3 weeks for up to 17 cycles (up to approximately 1 year).

  • PlaceboDrug

    Placebo (normal saline solution) will be administered at 200 mg via IV infusion once every 3 weeks for up to 17 cycles (up to approximately 1 year).

Study groups in NCT03924869
Study groupRoleWhat they receive
SBRT + PembrolizumabExperimentalParticipants receive SBRT once every 3 days for 3, 4, 5, or 8 fractions (dependent on tumor type/location; 45-70 Gray [Gy] total) over approximately 2 weeks PLUS pembrolizumab 200 mg via intravenous (IV) infusion once every 3 weeks for up to 17 cycles (up to approximately 1 year). Each cycle is 21 days.
Receives: Radiation: Stereotactic Body Radiotherapy (SBRT); Biological: Pembrolizumab
SBRT + PlaceboPlacebo comparatorParticipants receive SBRT once every 3 days for 3, 4, 5, or 8 fractions (dependent on tumor type/location; 45-70 Gy total) over approximately 2 weeks PLUS placebo (normal saline solution) via IV infusion once every 3 weeks for up to 17 cycles (up to approximately 1 year). Each cycle is 21 days.
Receives: Radiation: Stereotactic Body Radiotherapy (SBRT); Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Event-free Survival (EFS)

    EFS was defined as the time from randomization to the first occurrence of any of the following events: 1) local, regional, or distant recurrence of disease as assessed by radiographic recurrence by blinded independent central review (BICR), positive pathology by local assessment, physical examination by local assessment confirmed by positive pathology and/or radiographic recurrence by BICR, OR 2) death due to any cause. EFS was reported for each arm.

    Measured: Up to approximately 56.8 months

Secondary outcomes (9)

  1. Overall Survival (OS)

    OS was defined as the time from date of randomization to date of death from any cause. OS was reported for each arm.

    Measured: Up to approximately 56.8 months

  2. Time to Death or Distant Metastases (TDDM)

    TTDM was defined as the time from randomization to the first documented distant metastases or death from any cause, whichever occurred first. The TDDM was reported for each arm.

    Measured: Up to approximately 56.8 months

  3. Number of Participants Who Experienced an Adverse Event (AE)

    An AE was defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experienced an AE were reported.

    Measured: Up to approximately 64 months

  4. Number of Participants Who Discontinued Study Treatment Due to an Adverse Event (AE)

    An AE was defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinued study treatment due to an AE were reported.

    Measured: Up to approximately 16 months

  5. Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status/Quality of Life (Items 29 and 30) Score

    The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the questions "How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?" were scored on a 7-point scale (1=Very Poor to 7=Excellent). The combined score of Global Health Status (EORTC QLQ-C30 Item 29) and Quality of Life (EORTC QLQ-C30 Item 30) was computed by averaging the raw scores of the 2 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicates a better outcome. The change from baseline in GHS/QoL combined score was reported for each arm.

    Measured: Baseline and up to 24 weeks

  6. Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer Module 13 (EORTC QLQ-LC13) Cough (Item 31) Score

    The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. The EORTC QLQ-LC13 is a lung cancer-specific supplemental questionnaire used in combination with the EORTC QLQ-C30. Participant responses to the EORTC QLQ-LC13 question "How much did you cough?" were scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores were standardized, so that scores ranged from 0 to 100. A lower score indicates a better outcome. The change from baseline in cough (EORTC QLQ LC13 Item 31) score was reported for each arm.

    Measured: Baseline and up to 24 weeks

  7. Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer Module 13 (EORTC QLQ-LC13) Chest Pain (Item 40) Score

    The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. The EORTC QLQ-LC13 is a lung cancer-specific supplemental questionnaire used in combination with the EORTC QLQ-C30. Participant responses to the question "Have you had pain in your chest?" were scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores were standardized, so that scores ranged from 0 to 100. A lower score indicates a better outcome. The change from baseline in chest pain (EORTC QLQ-LC13 Item 40) score was reported for each arm.

    Measured: Baseline and up to 24 weeks

  8. Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Dyspnea (Item 8) Score

    The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the question "Were you short of breath?" were scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores were standardized, so that scores ranged from 0 to 100. A lower score indicates a better outcome. The change from baseline in dyspnea (EORTC QLQ-C30 Item 8) score was reported for each arm.

    Measured: Baseline and up to 24 weeks

  9. Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Physical Functioning (Items 1-5) Score

    The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to 5 questions about their physical functioning were scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores were standardized, so that scores ranged from 0 to 100. A higher score indicates a better quality of life. The change from baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) combined score was reported for each arm.

    Measured: Baseline and up to 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Apr 2019
  2. Study start25 Jun 2019
  3. Primary completion11 Jun 2024
  4. Study completion20 Jan 2025

Why it stopped: Terminated for business reasons

Resources

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
Double blind
Who is masked
Participant, Investigator
Enrolment
448 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03924869
Sponsor's protocol ID
3475-867
Other IDs
MK-3475-867, KEYNOTE-867, 194909, 2022-500413-11-00, U1111-1275-8515, 2018-004320-11, 2018
Status last verified
Nov 2025
First submitted
22 Apr 2019
Last updated
11 Dec 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Publications

  • Jabbour SK, Soter S, Eaton M, Galffy G, Kowalski D, Hata A, Valdivia A, Frost N, Levchenko E, Monteiro M, Haridass A, Bouchard M, Lee KH, Ahn MJ, Hughes BGM, Durham A, Xu Y, Samkari A, Song A, Pircher A. KEYNOTE-867: A Phase III, Randomized, Double-Blind Study of Stereotactic Body Radiotherapy With Pembrolizumab for Unresected Stage I or II Non-Small Cell Lung Cancer. J Clin Oncol. 2026 Oct 28:JCO2600404. doi: 10.1200/JCO-26-00404. Online ahead of print.

    PubMed 42950173

  • Swaminath A, Parpia S, Wierzbicki M, Kundapur V, Faria S, Okawara GS, Tsakiridis TK, Ahmed N, Bujold A, Hirmiz K, Owen T, Leong N, Ramchandar K, Filion E, Lau H, Gabos Z, Thompson R, Yaremko B, Mehiri S, Louie AV, Quan K, Levine MN, Wright JR, Whelan TJ. Stereotactic vs Hypofractionated Radiotherapy for Inoperable Stage I Non-Small Cell Lung Cancer: The LUSTRE Phase 3 Randomized Clinical Trial. JAMA Oncol. 2024 Nov;10(11):1571-1575. doi: 10.1001/jamaoncol.2024.3089. Epub 2024 Sep 19.

    PubMed 39298144

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Stereotactic Body Radiotherapy (SBRT) and Pembrolizumab in people with Non-Small Cell Lung Cancer, run by Merck Sharp & Dohme LLC at 194 sites in 24 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 11 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 194 sites in United States, Japan, Hungary, United Kingdom, Canada and 19 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Event-free Survival (EFS) (time frame: Up to approximately 56.8 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03924869, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2025.

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