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)

December 11, 2023 updated by: Merck Sharp & Dohme LLC

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).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

436

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Argentina
      • Buenos Aires, Argentina, 1012
        • IDIM Instituto de Diagnostico e Investigaciones Metabolicas ( Site 0208)
      • Buenos Aires, Argentina, C1118AAT
        • Hospital Aleman ( Site 0200)
      • Buenos Aires, Argentina, C1426ANZ
        • Instituto Medico Especializado Alexander Fleming ( Site 0203)
      • Buenos Aires, Argentina, C1431
        • CEMIC ( Site 0201)
    • Caba
      • ABB, Caba, Argentina, C1199ABB
        • Hospital Italiano de Buenos Aires-Clinical Oncology ( Site 0206)
      • Buenos Aires, Caba, Argentina, C1280AEB
        • Hospital Britanico de Buenos Aires ( Site 0204)
    • Santa Fe
      • Rosario, Santa Fe, Argentina, S2000DSV
        • Sanatorio Parque ( Site 0207)
      • Rosario, Santa Fe, Argentina, S2002KDS
        • Hospital Provincial del Centenario ( Site 0205)
  • Australia
    • New South Wales
      • Port Macquarie, New South Wales, Australia, 2444
        • Port Macquarie Base Hospital ( Site 2500)
      • St Leonards, New South Wales, Australia, 2065
        • GenesisCare North Shore ( Site 2508)
    • Queensland
      • Herston, Queensland, Australia, 4029
        • Royal Brisbane and Women s Hospital ( Site 2502)
    • Tasmania
      • Hobart, Tasmania, Australia, 7000
        • Icon Cancer Centre Hobart ( Site 2507)
    • Victoria
      • Melbourne, Victoria, Australia, 3084
        • Austin Health ( Site 2501)
  • Austria
    • Oberosterreich
      • Linz, Oberosterreich, Austria, 4021
        • Keppler Universitatsklinikum ( Site 0806)
    • Steiermark
      • Graz, Steiermark, Austria, 8036
        • Landeskrankenhaus - Universitatsklinikum Graz ( Site 0804)
    • Tirol
      • Innsbruck, Tirol, Austria, 6020
        • Universitatsklinik LKH Innsbruck ( Site 0802)
    • Wien
      • Vienna, Wien, Austria, 1145
        • Social Medical Center - Otto Wagner Hospital ( Site 0801)
  • Brazil
      • Rio de Janeiro, Brazil, 20231-050
        • Instituto Nacional Do Cancer Jose Alencar Gomes Da Silva ( Site 0305)
      • Sao Paulo, Brazil, 01246-000
        • Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 0300)
      • Sao Paulo, Brazil, 01321-001
        • Hospital Paulistano - Amil Clinical Research ( Site 0316)
      • Sao Paulo, Brazil, 01509-900
        • A.C. Camargo Cancer Center ( Site 0312)
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90050-170
        • Irmandade da Santa Casa de Misericordia de Porto Alegre ( Site 0318)
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90610-000
        • Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs ( Site 0301)
    • Santa Catarina
      • Blumenau, Santa Catarina, Brazil, 89010-340
        • Clínica de Oncologia Reichow ( Site 0319)
    • Sao Paulo
      • Campinas, Sao Paulo, Brazil, 13060-904
        • Hospital e Maternidade Celso Pierro ( Site 0313)
  • Canada
    • New Brunswick
      • Moncton, New Brunswick, Canada, E1C 6Z8
        • Moncton Hospital - Horizon Health Network ( Site 0105)
    • Ontario
      • Kingston, Ontario, Canada, K7L 2V7
        • Kingston Health Sciences Centre ( Site 0100)
      • Mississauga, Ontario, Canada, L5M 2N1
        • Trillium Health Partners - Credit Valley Hospital ( Site 0102)
      • Ottawa, Ontario, Canada, K1H 8L6
        • The Ottawa Hospital ( Site 0104)
      • Sault Ste Marie, Ontario, Canada, P6B 0A8
        • Sault Area Hospital ( Site 0101)
      • Sudbury, Ontario, Canada, P3E 5J1
        • Health Sciences North Research Institute ( Site 0107)
    • Quebec
      • Montreal, Quebec, Canada, H1T 2M4
        • CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont ( Site 0110)
      • Montréal, Quebec, Canada, H4A 3J1
        • McGill University Health Centre ( Site 0113)
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • CHUS - Hopital Fleurimont ( Site 0111)
  • France
      • Paris, France, 75005
        • Institut Curie ( Site 1112)
      • Paris, France, 75014
        • Hopital Cochin ( Site 1107)
      • Paris, France, 75877
        • A.P.H. Paris. Hopital Bichat Claude Bernard ( Site 1114)
    • Ain
      • Poitiers, Ain, France, 86021
        • CHU Poitiers ( Site 1109)
    • Finistere
      • Brest, Finistere, France, 29200
        • CHU de Brest -Site Hopital Morvan ( Site 1100)
    • Gironde
      • Bordeaux, Gironde, France, 33076
        • Institut Bergonie ( Site 1102)
    • Herault
      • Montpellier, Herault, France, 34298
        • Institut Regional du Cancer de Montpellier - ICM ( Site 1108)
    • Seine-Maritime
      • Rouen, Seine-Maritime, France, 76000
        • CHU de Rouen ( Site 1113)
    • Somme
      • Amiens, Somme, France, 80054
        • Hopital Sud du Amiens ( Site 1115)
  • Germany
      • Berlin, Germany, 13353
        • Charite Universitaetsmedizin Berlin ( Site 1207)
    • Baden-Wurttemberg
      • Esslingen, Baden-Wurttemberg, Germany, 73730
        • Klinikum Esslingen-Klinik für Kardiologie und Pneumologie ( Site 1208)
      • Heidelberg, Baden-Wurttemberg, Germany, 69126
        • Universitaetsklinikum Heidelberg. ( Site 1204)
    • Bayern
      • Erlangen, Bayern, Germany, 91054
        • Universitaetsklinikum Erlangen ( Site 1209)
    • Hessen
      • Gießen, Hessen, Germany, 35392
        • UKGM Gießen/Marburg-Medical Clinic V ( Site 1210)
    • Niedersachsen
      • Oldenburg, Niedersachsen, Germany, 26121
        • Pius Hospital Oldenburg ( Site 1202)
    • Nordrhein-Westfalen
      • Essen, Nordrhein-Westfalen, Germany, 45147
        • Universitaetsklinikum Essen ( Site 1201)
      • Hamm, Nordrhein-Westfalen, Germany, 59063
        • Evangelisches Krankenhaus Hamm gGmbH ( Site 1205)
  • Hungary
      • Budapest, Hungary, 1085
        • Semmelweis University ( Site 2303)
      • Budapest, Hungary, 1121
        • Orszagos Koranyi Pulmonologiai Intezet ( Site 2304)
      • Budapest, Hungary, 1121
        • Orszagos Koranyi Pulmonologiai Intezet ( Site 2306)
      • Budapest, Hungary, 1122
        • Orszagos Onkologiai Intezet ( Site 2308)
    • Bacs-Kiskun
      • Kecskemét, Bacs-Kiskun, Hungary, 6000
        • Bacs-Kiskun Varmegyei Oktatokorhaz-Onkoradiologiai Kozpont ( Site 2311)
    • Baranya
      • Pécs, Baranya, Hungary, 7624
        • Pécsi Tudományegyetem Klinikai Központ-Onkoterápiás Intézet ( Site 2314)
    • Borsod-Abauj-Zemplen
      • Miskolc, Borsod-Abauj-Zemplen, Hungary, 3529
        • CRU Hungary KFT ( Site 2309)
    • Fejer
      • Szekesfehervar, Fejer, Hungary, 8000
        • Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz ( Site 2312)
    • Gyor-Moson-Sopron
      • Gyor, Gyor-Moson-Sopron, Hungary, 9024
        • Petz Aladar Megyei Oktato Korhaz ( Site 2305)
    • Hajdu-Bihar
      • Debrecen, Hajdu-Bihar, Hungary, 4032
        • Debreceni Egyetem Klinikai Kozpont ( Site 2301)
    • Jasz-Nagykun-Szolnok
      • Szolnok, Jasz-Nagykun-Szolnok, Hungary, 5004
        • Jász-Nagykun-Szolnok Vármegyei Hetényi Géza Kórház ( Site 2310)
    • Pest
      • Torokbalint, Pest, Hungary, 2045
        • Törökbálinti Tüdőgyógyintézet ( Site 2302)
    • Somogy
      • Kaposvar, Somogy, Hungary, 7400
        • Somogy Megyei Kaposi Mor Oktato Korhaz ( Site 2307)
    • Veszprem
      • Farkasgyepu, Veszprem, Hungary, 8582
        • Farkasgyepui Tudogyogyintezet ( Site 2313)
  • Italy
      • Chieti, Italy, 66100
        • Ospedale Santissima Annunziata ( Site 1303)
      • Firenze, Italy, 50134
        • A.O. Universitaria Careggi ( Site 1301)
      • Modena, Italy, 41124
        • Policlinico di Modena ( Site 1306)
      • Roma, Italy, 00168
        • Policlinico Agostino Gemelli ( Site 1302)
      • Roma, Italy, 00185
        • Azienda Ospedaliera S. Giovanni Addolorata-Oncologia Medica ( Site 1309)
  • Japan
      • Chiba, Japan, 260-8677
        • Chiba University Hospital ( Site 2806)
      • Fukuoka, Japan, 811-1395
        • National Hospital Organization Kyushu Cancer Center ( Site 2816)
      • Hiroshima, Japan, 734-8551
        • Hiroshima University Hospital ( Site 2810)
      • Niigata, Japan, 951-8566
        • Niigata Cancer Center Hospital ( Site 2801)
      • Osaka, Japan, 541-8567
        • Osaka International Cancer Institute ( Site 2812)
      • Tokyo, Japan, 113-8677
        • Tokyo Metropolitan Komagome Hospital ( Site 2802)
      • Tokyo, Japan, 135-8550
        • The Cancer Institute Hospital of JFCR ( Site 2803)
      • Tokyo, Japan, 142-8666
        • Showa University Hospital ( Site 2805)
    • Aichi
      • Nagoya, Aichi, Japan, 464-8681
        • Aichi Cancer Center Hospital ( Site 2804)
    • Chiba
      • Kashiwa, Chiba, Japan, 2778577
        • National Cancer Center Hospital East ( Site 2800)
    • Fukuoka
      • Kurume, Fukuoka, Japan, 830-0011
        • Kurume University Hospital ( Site 2815)
    • Hyogo
      • Kobe, Hyogo, Japan, 650-0046
        • Kobe Minimally Invasive Cancer Center ( Site 2811)
    • Ibaraki
      • Tsukuba, Ibaraki, Japan, 305-8576
        • University of Tsukuba Hospital ( Site 2809)
    • Miyagi
      • Sendai, Miyagi, Japan, 980-0873
        • Sendai Kousei Hospital ( Site 2814)
    • Osaka
      • Hirakata, Osaka, Japan, 573-1191
        • Kansai Medical University Hospital ( Site 2808)
      • Takatsuki, Osaka, Japan, 5698686
        • Osaka Medical and Pharmaceutical University Hospital ( Site 2813)
    • Yamanashi
      • Chuo, Yamanashi, Japan, 409-3898
        • University of Yamanashi Hospital ( Site 2807)
  • Korea, Republic of
      • Seoul, Korea, Republic of, 03080
        • Seoul National University Hospital ( Site 2600)
      • Seoul, Korea, Republic of, 06351
        • Samsung Medical Center ( Site 2603)
    • Chungbuk
      • Cheongju-si, Chungbuk, Korea, Republic of, 28644
        • Chungbuk National University Hospital ( Site 2605)
    • Kyonggi-do
      • Goyang-si, Kyonggi-do, Korea, Republic of, 10408
        • National Cancer Center ( Site 2604)
      • Gyeonggi-do, Kyonggi-do, Korea, Republic of, 16247
        • The Catholic University of Korea St. Vincent s Hospital ( Site 2606)
  • Netherlands
    • Gelderland
      • Arnhem, Gelderland, Netherlands, 6815 AD
        • Ziekenhuis Rijnstate ( Site 1405)
    • Noord-Holland
      • Hilversum, Noord-Holland, Netherlands, 1213 XZ
        • Tergooiziekenhuizen, locatie Hilversum-Oncology ( Site 1407)
    • Utrecht
      • Amersfoort, Utrecht, Netherlands, 3813 TZ
        • Meander Medisch Centrum-Studie Team Oncologie ( Site 1403)
  • New Zealand
    • Auckland
      • Grafton, Auckland, New Zealand, 1023
        • Auckland City Hospital ( Site 2900)
  • Norway
      • Oslo, Norway, 0450
        • Oslo Universitetssykehus HF Ulleval Sykehus ( Site 1500)
    • Sor-Trondelag
      • Trondheim, Sor-Trondelag, Norway, 7030
        • St Olavs Hospital ( Site 1504)
    • Vestfold
      • Bergen, Vestfold, Norway, 5021
        • Helse Bergen HF Haukeland Universitetssykehus ( Site 1502)
  • Poland
    • Kujawsko-pomorskie
      • Bydgoszcz, Kujawsko-pomorskie, Poland, 85-796
        • Centrum Onkologii im. prof. Franciszka ukaszczyka-Ambulatorium Chemioterapii ( Site 2407)
    • Lodzkie
      • Lodz, Lodzkie, Poland, 93-513
        • Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii ( Site 2402)
    • Malopolskie
      • Krakow, Malopolskie, Poland, 31-826
        • Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie ( Site 2400)
    • Mazowieckie
      • Warszawa, Mazowieckie, Poland, 02-781
        • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie (
    • Slaskie
      • Gliwice, Slaskie, Poland, 44-101
        • Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 2403)
    • Warminsko-mazurskie
      • Olsztyn, Warminsko-mazurskie, Poland, 10-228
        • SPZOZ MSWIA z Warminsko-Mazurskim Centrum Onkologii w Olsztynie ( Site 2404)
  • Romania
      • Cluj, Romania, 400015
        • Institutul Oncologic-Oncologie Medicala ( Site 3202)
    • Cluj
      • Florești, Cluj, Romania, 407280
        • Amethyst Radiotherapy Center-Oncologie Medicala ( Site 3201)
  • Russian Federation
    • Chelyabinskaya Oblast
      • Chelyabinsk, Chelyabinskaya Oblast, Russian Federation, 454087
        • Chelyabinsk Regional Clinical Oncology Dispensary ( Site 2014)
    • Lipetskaya Oblast
      • Lipetsk, Lipetskaya Oblast, Russian Federation, 398005
        • GUZ Lipetsk Regional Oncology Dispensary ( Site 2010)
    • Moskva
      • Moscow, Moskva, Russian Federation, 115478
        • N.N.Blokhin Russian Cancer Research center ( Site 2013)
      • Moscow, Moskva, Russian Federation, 117997
        • Russian Scientific Center of Roentgenoradiology ( Site 2011)
    • Sankt-Peterburg
      • Saint-Petersburg, Sankt-Peterburg, Russian Federation, 197758
        • Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 2000)
      • St. Petersburg, Sankt-Peterburg, Russian Federation, 197758
        • Medical institute named after Berezin Sergey ( Site 2009)
    • Sverdlovskaya Oblast
      • Ekaterinburg, Sverdlovskaya Oblast, Russian Federation, 620036
        • Sverdlovsk Regional Oncology Hospital ( Site 2012)
    • Tatarstan, Respublika
      • Kazan, Tatarstan, Respublika, Russian Federation, 420029
        • Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 2001)
  • Spain
      • Barcelona, Spain, 08035
        • Hospital General Universitari Vall d Hebron ( Site 1602)
      • Madrid, Spain, 28009
        • Hospital General Universitario Gregorio Maranon ( Site 1604)
    • Madrid
      • Pozuelo de Alarcon, Madrid, Spain, 28223
        • Hospital Universitario Quiron Madrid ( Site 1601)
    • Valenciana, Comunitat
      • Valencia, Valenciana, Comunitat, Spain, 46206
        • Hospital Universitario La Fe ( Site 1603)
  • Switzerland
    • Geneve
      • Geneva, Geneve, Switzerland, 1211
        • Hopitaux Universitaires de Geneve HUG ( Site 1706)
    • Zurich
      • Zuerich, Zurich, Switzerland, 8091
        • Universitaetsspital Zuerich ( Site 1700)
  • Taiwan
      • Kaohsiung, Taiwan, 807
        • Kaohsiung Medical University Chung-Ho Memorial Hospital ( Site 3304)
      • Taipei, Taiwan, 110301
        • Taipei Medical University Hospital ( Site 3303)
      • Taipei, Taiwan, 11217
        • Taipei Veterans General Hospital ( Site 3301)
    • Taipei
      • Taipei City, Taipei, Taiwan, 114
        • Tri-Service General Hospital ( Site 3300)
  • Turkey
      • Adana, Turkey, 01250
        • Baskent Adana Dr Turgut Noyan Uygulama ve Arastirma Merkezi ( Site 2105)
      • Ankara, Turkey, 06100
        • Hacettepe University Medical Faculty ( Site 2100)
      • Ankara, Turkey, 06200
        • Dr Abdurrahman Yurtaslan Oncology Training and Research Hospital ( Site 2101)
      • Istanbul, Turkey, 34722
        • Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi-oncology ( Site 2116)
      • Istanbul, Turkey, 34890
        • Kartal Training and Research Hospital ( Site 2102)
      • Izmir, Turkey, 35520
        • I.E.U. Medical Point Hastanesi ( Site 2115)
      • Kayseri, Turkey, 38030
        • Erciyes University Medical Faculty ( Site 2109)
      • Sakarya, Turkey, 54290
        • Sakarya Universitesi Tip Fakultesi Hastanesi ( Site 2114)
  • Ukraine
      • Kyiv, Ukraine, 03115
        • Kyiv City Clinical Oncology Centre ( Site 2200)
    • Dnipropetrovska Oblast
      • Dnipro, Dnipropetrovska Oblast, Ukraine, 49055
        • Medical center Medikal Plaza of Ecodnipro LLC ( Site 2207)
    • Kharkivska Oblast
      • Kharkiv, Kharkivska Oblast, Ukraine, 61070
        • Regional Centre of Oncology-Thoracic organs ( Site 2202)
    • Kirovohradska Oblast
      • Kropyvnitskiy, Kirovohradska Oblast, Ukraine, 25011
        • Ukrainian Center of Tomotherapy ( Site 2206)
    • Kyivska Oblast
      • Kapitanivka Village, Kyivska Oblast, Ukraine, 08111
        • Medical Center of Yuriy Spizhenko LLC.-Clinical Trial ( Site 2205)
      • Khodosivka, Kyivska Oblast, Ukraine, 08173
        • Medical Center Asklepion LLC ( Site 2208)
      • Kyiv, Kyivska Oblast, Ukraine, 03126
        • Medical and Diagnostic Centre LLC Dobryi Prognoz ( Site 2203)
  • United Kingdom
      • Darlington, United Kingdom, DLX 6HX
        • Darlington Memorial Hospital NHS Trust ( Site 1810)
      • Northwood, United Kingdom, HA6 2RN
        • Mount Vernon Hospital ( Site 1803)
    • Bristol, City Of
      • Bristol, Bristol, City Of, United Kingdom, BS2 8ED
        • University Hospitals Bristol NHS Foundation Trust ( Site 1802)
    • Camden
      • London, Camden, United Kingdom, NW3 2QG
        • Royal Free London NHS Foundation Trust ( Site 1813)
    • Derbyshire
      • Sheffield, Derbyshire, United Kingdom, S10 2SJ
        • Weston Park Hospital ( Site 1801)
    • England
      • Liverpool, England, United Kingdom, L7 8YA
        • Clatterbridge Cancer Center NHS FT ( Site 1800)
    • Lancashire
      • Preston, Lancashire, United Kingdom, PR2 9HT
        • Lancashire Teaching Hospitals NHS Foundation Trust ( Site 1809)
    • Leicestershire
      • Leicester, Leicestershire, United Kingdom, LE1 5WW
        • Leicester Royal Infirmary ( Site 1811)
    • London, City Of
      • London, London, City Of, United Kingdom, NW1 2BU
        • University College London Hospital NHS Foundation Trust ( Site 1806)
      • London, London, City Of, United Kingdom, SE1 9RT
        • Guy s and St Thomas Hospital NHS Foundation Trust ( Site 1808)
    • Norfolk
      • Norwich, Norfolk, United Kingdom, NR47UY
        • Norfolk and Norwich University Foundation NHS Trust ( Site 1805)
    • Oxfordshire
      • Oxford, Oxfordshire, United Kingdom, OX3 7LE
        • Oxford University Hospitals NHS Foundation Trust ( Site 1812)
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • University of Alabama ( Site 0099)
      • Mobile, Alabama, United States, 36607
        • Infirmary Cancer Care ( Site 3044)
    • Alaska
      • Anchorage, Alaska, United States, 99508
        • Alaska Oncology and Hematology ( Site 3063)
    • Arizona
      • Gilbert, Arizona, United States, 85234
        • Banner MD Anderson Cancer Center ( Site 3029)
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • CARTI Cancer Center ( Site 3045)
    • California
      • Los Angeles, California, United States, 90033
        • USC Norris Comprehensive Cancer Center ( Site 0007)
      • Palo Alto, California, United States, 94304
        • Veterans Affairs Palo Alto Health Care System ( Site 3039)
    • Colorado
      • Denver, Colorado, United States, 80206
        • National Jewish Health ( Site 0010)
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Yale University ( Site 0011)
    • Florida
      • Orange City, Florida, United States, 32763
        • Mid Florida Hematology and Oncology Center ( Site 0067)
      • Tampa, Florida, United States, 33612
        • H. Lee Moffitt Cancer Center and Research Institute ( Site 0016)
    • Indiana
      • Goshen, Indiana, United States, 46526
        • Goshen Center for Cancer Care ( Site 0022)
      • Indianapolis, Indiana, United States, 46237
        • Franciscan Health Indianapolis ( Site 0024)
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • University of Kentucky School of Medicine & Hospitals ( Site 0026)
    • Maryland
      • Baltimore, Maryland, United States, 21215
        • Sinai Hospital of Baltimore ( Site 3011)
      • Westminster, Maryland, United States, 21157
        • William E. Kahlert Regional Cancer Center ( Site 3031)
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital-Cancer Center Protocol Office ( Site 3007)
      • Danvers, Massachusetts, United States, 01923
        • Mass General / North Shore Center for Outpatient Care ( Site 3040)
      • Worcester, Massachusetts, United States, 01655
        • University of Massachusetts ( Site 0029)
    • Minnesota
      • Bemidji, Minnesota, United States, 56601
        • Sanford Bemidji ( Site 0080)
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota ( Site 0069)
    • Missouri
      • Columbia, Missouri, United States, 65212
        • University of Missouri Hospital ( Site 3058)
      • Springfield, Missouri, United States, 65807
        • Cox Medical Center North-Cox Medical Center/Hulston Cancer Center/ Radiation Oncology ( Site 3060)
    • Montana
      • Billings, Montana, United States, 59102
        • St. Vincent Healthcare Frontier Cancer Center ( Site 3012)
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • John Theurer Cancer Center at Hackensack University Medical Center ( Site 3036)
      • New Brunswick, New Jersey, United States, 08903-2681
        • Rutgers Cancer Institute of New Jersey ( Site 0043)
    • New York
      • East Syracuse, New York, United States, 13057
        • Hematology-Oncology Associates of CNY ( Site 3055)
      • New York, New York, United States, 10029
        • Mount Sinai Hospital ( Site 0046)
      • Valhalla, New York, United States, 10595
        • Westchester Medical Center ( Site 3057)
      • White Plains, New York, United States, 10601
        • White Plains Hospital ( Site 3014)
    • North Dakota
      • Fargo, North Dakota, United States, 58102
        • Sanford Health Roger Maris Cancer Center ( Site 0079)
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • Lehigh Valley Hospital- Cedar Crest ( Site 3005)
      • Bethlehem, Pennsylvania, United States, 18015
        • St. Luke's University Health Network ( Site 3006)
      • Hershey, Pennsylvania, United States, 17033
        • Penn State University Milton S. Hershey Medical Center ( Site 0064)
      • Philadelphia, Pennsylvania, United States, 19111
        • Fox Chase Cancer Center ( Site 0051)
      • Pittsburgh, Pennsylvania, United States, 15212
        • Allegheny General Hospital ( Site 3028)
      • Wynnewood, Pennsylvania, United States, 19096
        • Lankenau Medical Center ( Site 3041)
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57104
        • Sanford Cancer Center Oncology Clinic ( Site 0053)
    • Tennessee
      • Johnson City, Tennessee, United States, 37604
        • Mountain States Health Alliance ( Site 3054)
      • Knoxville, Tennessee, United States, 37920
        • University of Tennessee Medical Center Knoxville ( Site 3010)
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center ( Site 0075)
    • Washington
      • Spokane Valley, Washington, United States, 99216
        • Cancer Care Northwest ( Site 0063)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: SBRT+Placebo
Participants 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.
Drug: Placebo
IV infusion
Other Names:
  • Normal saline solution
Radiation: Stereotactic Body Radiotherapy (SBRT)
SBRT
Experimental: SBRT+Pembolizumab
Participants 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.
Biological: Pembrolizumab
IV infusion
Other Names:
  • MK-3475
  • KEYTRUDA®
Radiation: Stereotactic Body Radiotherapy (SBRT)
SBRT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Event-free Survival (EFS)
Time Frame: Up to approximately 68 months

EFS is defined as the time from randomization to the first occurrence of any of the following events:

  • 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
  • Death due to any cause. EFS will be presented.
Up to approximately 68 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Who Experience an Adverse Event (AE)
Time Frame: Up to approximately 16 months
An AE is 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 experience an AE will be presented.
Up to approximately 16 months
Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE)
Time Frame: Up to approximately 1 year
An AE is 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 discontinue study treatment due to an AE will be presented.
Up to approximately 1 year
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
Time Frame: Baseline and up to approximately 52 weeks
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?" are scored on a 7-point scale (1=Very Poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better overall outcome. The change from baseline in Global Health Status/Quality of Life (EORTC QLQ-C30 Items 29 and 30) combined score will be presented.
Baseline and up to approximately 52 weeks
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
Time Frame: Baseline and up to approximately 52 weeks
The EORTC QLQ-LC13 is a lung cancer-specific supplemental questionnaire used in combination with the EORTC QLQ-C30. Participant responses to the question "How much did you cough?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower score indicates a better outcome. The change from baseline in cough (EORTC QLQ LC13 Item 31) score will be presented.
Baseline and up to approximately 52 weeks
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 10) Score
Time Frame: Baseline and up to approximately 52 weeks
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?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower score indicates a better outcome. The change from baseline in chest pain (EORTC QLQ-LC13 Item 40) score will be presented.
Baseline and up to approximately 52 weeks
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
Time Frame: Baseline and up to approximately 52 weeks
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?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower score indicates a better outcome. The change from baseline in dyspnea (EORTC QLQ-C30 Item 8) score will be presented.
Baseline and up to approximately 52 weeks
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
Time Frame: Baseline and up to approximately 52 weeks
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 are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range 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 will be presented.
Baseline and up to approximately 52 weeks
Overall Survival (OS)
Time Frame: Up to approximately 81 months
OS is defined as the time from date of randomization to date of death from any cause. OS will be presented.
Up to approximately 81 months
Time to Death or Distant Metastases (TDDM)
Time Frame: Up to approximately 81 months
TTDM is defined as the time from randomization to the first documented distant metastases or death from any cause, whichever occurs first. The TDDM will be presented.
Up to approximately 81 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Investigators

  • Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 25, 2019

Primary Completion (Estimated)

April 11, 2025

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

April 22, 2019

First Submitted That Met QC Criteria

April 22, 2019

First Posted (Actual)

April 23, 2019

Study Record Updates

Last Update Posted (Actual)

December 15, 2023

Last Update Submitted That Met QC Criteria

December 11, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3475-867
  • MK-3475-867 (Other Identifier: Merck)
  • KEYNOTE-867 (Other Identifier: Merck)
  • 194909 (Registry Identifier: JAPAC-CTI)
  • 2022-500413-11-00 (Registry Identifier: EU CT)
  • 2018-004320-11 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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