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)

NCT03924869 | Terminated Phase 3 Results DMC FDA Drug

• 7 other identifiers: 3475-867MK-3475-867KEYNOTE-8671949092022-500413-11-00U1111-1275-85152018-004320-11
• Study Type: interventional
• Target: 448
• Locations: 23 countries
• Sites: 190

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

Conditions

Non-Small Cell Lung Cancer

Keywords

Programmed Cell Death-1 (PD1, PD-1); Programmed Death-Ligand 1 (PDL1, PD-L1); Programmed Cell Death Receptor Ligand 2 (PDL2, PD-L2)

Outcome Measures

Primary Outcomes (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.

  Up to approximately 56.8 months

Secondary Outcomes (9)

• Overall Survival (OS)

  Up to approximately 56.8 months

• Time to Death or Distant Metastases (TDDM)

  Up to approximately 56.8 months

• Number of Participants Who Experienced an Adverse Event (AE)

  Up to approximately 64 months

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

  Up to approximately 16 months

• 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

  Baseline and up to 24 weeks

Study Arms (2)

SBRT + Pembrolizumab

EXPERIMENTAL

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.

Radiation: Stereotactic Body Radiotherapy (SBRT); Biological: Pembrolizumab

SBRT + Placebo

PLACEBO COMPARATOR

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.

Radiation: Stereotactic Body Radiotherapy (SBRT); Drug: Placebo

Interventions

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.

SBRT + Pembrolizumab; SBRT + Placebo

Pembrolizumab BIOLOGICAL

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

Also known as: MK-3475, KEYTRUDA®

SBRT + Pembrolizumab

Placebo DRUG

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).

SBRT + Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (194)

University of Alabama ( Site 0099)

Birmingham, Alabama, 35233, United States

Location

Infirmary Cancer Care ( Site 3044)

Mobile, Alabama, 36607, United States

Location

Alaska Oncology and Hematology ( Site 3063)

Anchorage, Alaska, 99508, United States

Location

Banner MD Anderson Cancer Center ( Site 3029)

Gilbert, Arizona, 85234, United States

Location

CARTI Cancer Center ( Site 3045)

Little Rock, Arkansas, 72205, United States

Location

USC Norris Comprehensive Cancer Center ( Site 0007)

Los Angeles, California, 90033, United States

Location

Veterans Affairs Palo Alto Health Care System ( Site 3039)

Palo Alto, California, 94304, United States

Location

National Jewish Health ( Site 0010)

Denver, Colorado, 80206, United States

Location

Yale University ( Site 0011)

New Haven, Connecticut, 06510, United States

Location

Mid Florida Hematology and Oncology Center ( Site 0067)

Orange City, Florida, 32763, United States

Location

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

Tampa, Florida, 33612, United States

Location

Goshen Center for Cancer Care ( Site 0022)

Goshen, Indiana, 46526, United States

Location

Franciscan Health Indianapolis ( Site 0024)

Indianapolis, Indiana, 46237, United States

Location

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

Lexington, Kentucky, 40536, United States

Location

Sinai Hospital of Baltimore ( Site 3011)

Baltimore, Maryland, 21215, United States

Location

William E. Kahlert Regional Cancer Center ( Site 3031)

Westminster, Maryland, 21157, United States

Location

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

Boston, Massachusetts, 02114, United States

Location

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

Danvers, Massachusetts, 01923, United States

Location

University of Massachusetts ( Site 0029)

Worcester, Massachusetts, 01655, United States

Location

Sanford Bemidji ( Site 0080)

Bemidji, Minnesota, 56601, United States

Location

University of Minnesota ( Site 0069)

Minneapolis, Minnesota, 55455, United States

Location

University of Missouri Hospital ( Site 3058)

Columbia, Missouri, 65212, United States

Location

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

Springfield, Missouri, 65807, United States

Location

St. Vincent Healthcare Frontier Cancer Center ( Site 3012)

Billings, Montana, 59102, United States

Location

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

Hackensack, New Jersey, 07601, United States

Location

Rutgers Cancer Institute of New Jersey ( Site 0043)

New Brunswick, New Jersey, 08903-2681, United States

Location

Hematology-Oncology Associates of CNY ( Site 3055)

East Syracuse, New York, 13057, United States

Location

Mount Sinai Hospital ( Site 0046)

New York, New York, 10029, United States

Location

Westchester Medical Center ( Site 3057)

Valhalla, New York, 10595, United States

Location

White Plains Hospital ( Site 3014)

White Plains, New York, 10601, United States

Location

Sanford Health Roger Maris Cancer Center ( Site 0079)

Fargo, North Dakota, 58102, United States

Location

Lehigh Valley Hospital- Cedar Crest ( Site 3005)

Allentown, Pennsylvania, 18103, United States

Location

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

Bethlehem, Pennsylvania, 18015, United States

Location

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

Hershey, Pennsylvania, 17033, United States

Location

Fox Chase Cancer Center ( Site 0051)

Philadelphia, Pennsylvania, 19111, United States

Location

Allegheny General Hospital ( Site 3028)

Pittsburgh, Pennsylvania, 15212, United States

Location

Lankenau Medical Center ( Site 3041)

Wynnewood, Pennsylvania, 19096, United States

Location

Sanford Cancer Center Oncology Clinic ( Site 0053)

Sioux Falls, South Dakota, 57104, United States

Location

Mountain States Health Alliance ( Site 3054)

Johnson City, Tennessee, 37604, United States

Location

University of Tennessee Medical Center Knoxville ( Site 3010)

Knoxville, Tennessee, 37920, United States

Location

Vanderbilt University Medical Center ( Site 0075)

Nashville, Tennessee, 37232, United States

Location

Cancer Care Northwest ( Site 0063)

Spokane Valley, Washington, 99216, United States

Location

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

ABB, Buenos Aires F.D., C1199ABB, Argentina

Location

Hospital Britanico de Buenos Aires ( Site 0204)

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

Location

Sanatorio Parque ( Site 0207)

Rosario, Santa Fe Province, S2000DSV, Argentina

Location

Hospital Provincial del Centenario ( Site 0205)

Rosario, Santa Fe Province, S2002KDS, Argentina

Location

IDIM Instituto de Diagnostico e Investigaciones Metabolicas ( Site 0208)

Buenos Aires, 1012, Argentina

Location

Hospital Aleman ( Site 0200)

Buenos Aires, C1118AAT, Argentina

Location

Instituto Medico Especializado Alexander Fleming ( Site 0203)

Buenos Aires, C1426ANZ, Argentina

Location

CEMIC ( Site 0201)

Buenos Aires, C1431, Argentina

Location

Port Macquarie Base Hospital ( Site 2500)

Port Macquarie, New South Wales, 2444, Australia

Location

GenesisCare North Shore ( Site 2508)

St Leonards, New South Wales, 2065, Australia

Location

Royal Brisbane and Women s Hospital ( Site 2502)

Herston, Queensland, 4029, Australia

Location

Icon Cancer Centre Hobart ( Site 2507)

Hobart, Tasmania, 7000, Australia

Location

Austin Health ( Site 2501)

Melbourne, Victoria, 3084, Australia

Location

Landeskrankenhaus - Universitatsklinikum Graz ( Site 0804)

Graz, Styria, 8036, Austria

Location

Universitatsklinik LKH Innsbruck ( Site 0802)

Innsbruck, Tyrol, 6020, Austria

Location

Keppler Universitatsklinikum ( Site 0806)

Linz, Upper Austria, 4021, Austria

Location

Social Medical Center - Otto Wagner Hospital ( Site 0801)

Vienna, Vienna, 1145, Austria

Location

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

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

Location

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

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

Location

Clínica de Oncologia Reichow ( Site 0319)

Blumenau, Santa Catarina, 89010-340, Brazil

Location

Hospital e Maternidade Celso Pierro ( Site 0313)

Campinas, São Paulo, 13060-904, Brazil

Location

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

Rio de Janeiro, 20231-050, Brazil

Location

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

São Paulo, 01246-000, Brazil

Location

Hospital Paulistano - Amil Clinical Research ( Site 0316)

São Paulo, 01321-001, Brazil

Location

A.C. Camargo Cancer Center ( Site 0312)

São Paulo, 01509-900, Brazil

Location

Moncton Hospital - Horizon Health Network ( Site 0105)

Moncton, New Brunswick, E1C 6Z8, Canada

Location

Health Sciences North Research Institute ( Site 0107)

Greater Sudbury, Ontario, P3E 5J1, Canada

Location

Kingston Health Sciences Centre ( Site 0100)

Kingston, Ontario, K7L 2V7, Canada

Location

Trillium Health Partners - Credit Valley Hospital ( Site 0102)

Mississauga, Ontario, L5M 2N1, Canada

Location

The Ottawa Hospital ( Site 0104)

Ottawa, Ontario, K1H 8L6, Canada

Location

Sault Area Hospital ( Site 0101)

Sault Ste. Marie, Ontario, P6B 0A8, Canada

Location

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

Montreal, Quebec, H1T 2M4, Canada

Location

McGill University Health Centre ( Site 0113)

Montreal, Quebec, H4A 3J1, Canada

Location

CHUS - Hopital Fleurimont ( Site 0111)

Sherbrooke, Quebec, J1H 5N4, Canada

Location

CHU Poitiers ( Site 1109)

Poitiers, Ain, 86021, France

Location

CHU de Brest -Site Hopital Morvan ( Site 1100)

Brest, Finistere, 29200, France

Location

Institut Bergonie ( Site 1102)

Bordeaux, Gironde, 33076, France

Location

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

Montpellier, Herault, 34298, France

Location

CHU de Rouen ( Site 1113)

Rouen, Seine-Maritime, 76000, France

Location

Hopital Sud du Amiens ( Site 1115)

Amiens, Somme, 80054, France

Location

Institut Curie ( Site 1112)

Paris, 75005, France

Location

Hopital Cochin ( Site 1107)

Paris, 75014, France

Location

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

Paris, 75877, France

Location

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

Esslingen am Neckar, Baden-Wurttemberg, 73730, Germany

Location

Universitaetsklinikum Heidelberg. ( Site 1204)

Heidelberg, Baden-Wurttemberg, 69126, Germany

Location

Universitaetsklinikum Erlangen ( Site 1209)

Erlangen, Bavaria, 91054, Germany

Location

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

Giessen, Hesse, 35392, Germany

Location

Pius Hospital Oldenburg ( Site 1202)

Oldenburg, Lower Saxony, 26121, Germany

Location

Universitaetsklinikum Essen ( Site 1201)

Essen, North Rhine-Westphalia, 45147, Germany

Location

Evangelisches Krankenhaus Hamm gGmbH ( Site 1205)

Hamm, North Rhine-Westphalia, 59063, Germany

Location

Charite Universitaetsmedizin Berlin ( Site 1207)

Berlin, 13353, Germany

Location

Pécsi Tudományegyetem Klinikai Központ-Onkoterápiás Intézet ( Site 2314)

Pécs, Baranya, 7624, Hungary

Location

CRU Hungary KFT ( Site 2309)

Miskolc, Borsod-Abauj Zemplen county, 3529, Hungary

Location

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

Kecskemét, Bács-Kiskun county, 6000, Hungary

Location

Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz ( Site 2312)

Székesfehérvár, Fejér, 8000, Hungary

Location

Petz Aladar Megyei Oktato Korhaz ( Site 2305)

Győr, Győr-Moson-Sopron, 9024, Hungary

Location

Debreceni Egyetem Klinikai Kozpont ( Site 2301)

Debrecen, Hajdú-Bihar, 4032, Hungary

Location

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

Szolnok, Jász-Nagykun-Szolnok, 5004, Hungary

Location

Törökbálinti Tüdőgyógyintézet ( Site 2302)

Törökbálint, Pest County, 2045, Hungary

Location

Somogy Megyei Kaposi Mor Oktato Korhaz ( Site 2307)

Kaposvár, Somogy County, 7400, Hungary

Location

Farkasgyepui Tudogyogyintezet ( Site 2313)

Farkasgyepű, Veszprém megye, 8582, Hungary

Location

Semmelweis University ( Site 2303)

Budapest, 1085, Hungary

Location

Orszagos Koranyi Pulmonologiai Intezet ( Site 2304)

Budapest, 1121, Hungary

Location

Orszagos Koranyi Pulmonologiai Intezet ( Site 2306)

Budapest, 1121, Hungary

Location

Orszagos Onkologiai Intezet ( Site 2308)

Budapest, 1122, Hungary

Location

Ospedale Santissima Annunziata ( Site 1303)

Chieti, 66100, Italy

Location

A.O. Universitaria Careggi ( Site 1301)

Florence, 50134, Italy

Location

Policlinico di Modena ( Site 1306)

Modena, 41124, Italy

Location

Policlinico Agostino Gemelli ( Site 1302)

Roma, 00168, Italy

Location

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

Roma, 00185, Italy

Location

Aichi Cancer Center Hospital ( Site 2804)

Nagoya, Aichi-ken, 464-8681, Japan

Location

National Cancer Center Hospital East ( Site 2800)

Kashiwa, Chiba, 2778577, Japan

Location

Kurume University Hospital ( Site 2815)

Kurume, Fukuoka, 830-0011, Japan

Location

Kobe Minimally Invasive Cancer Center ( Site 2811)

Kobe, Hyōgo, 650-0046, Japan

Location

University of Tsukuba Hospital ( Site 2809)

Tsukuba, Ibaraki, 305-8576, Japan

Location

Sendai Kousei Hospital ( Site 2814)

Sendai, Miyagi, 980-0873, Japan

Location

Kansai Medical University Hospital ( Site 2808)

Hirakata, Osaka, 573-1191, Japan

Location

Osaka Medical and Pharmaceutical University Hospital ( Site 2813)

Takatsuki, Osaka, 5698686, Japan

Location

University of Yamanashi Hospital ( Site 2807)

Chūō, Yamanashi, 409-3898, Japan

Location

Chiba University Hospital ( Site 2806)

Chiba, 260-8677, Japan

Location

National Hospital Organization Kyushu Cancer Center ( Site 2816)

Fukuoka, 811-1395, Japan

Location

Hiroshima University Hospital ( Site 2810)

Hiroshima, 734-8551, Japan

Location

Niigata Cancer Center Hospital ( Site 2801)

Niigata, 951-8566, Japan

Location

Osaka International Cancer Institute ( Site 2812)

Osaka, 541-8567, Japan

Location

Tokyo Metropolitan Komagome Hospital ( Site 2802)

Tokyo, 113-8677, Japan

Location

The Cancer Institute Hospital of JFCR ( Site 2803)

Tokyo, 135-8550, Japan

Location

Showa University Hospital ( Site 2805)

Tokyo, 142-8666, Japan

Location

Ziekenhuis Rijnstate ( Site 1405)

Arnhem, Gelderland, 6815 AD, Netherlands

Location

Tergooiziekenhuizen, locatie Hilversum-Oncology ( Site 1407)

Hilversum, North Holland, 1213 XZ, Netherlands

Location

Meander Medisch Centrum-Studie Team Oncologie ( Site 1403)

Amersfoort, Utrecht, 3813 TZ, Netherlands

Location

Auckland City Hospital ( Site 2900)

Grafton, Auckland, 1023, New Zealand

Location

St Olavs Hospital ( Site 1504)

Trondheim, Sor-Trondelag, 7030, Norway

Location

Helse Bergen HF Haukeland Universitetssykehus ( Site 1502)

Bergen, Vestfold, 5021, Norway

Location

Oslo Universitetssykehus HF Ulleval Sykehus ( Site 1500)

Oslo, 0450, Norway

Location

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

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-796, Poland

Location

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

Krakow, Lesser Poland Voivodeship, 31-826, Poland

Location

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

Warsaw, Masovian Voivodeship, 02-781, Poland

Location

Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 2403)

Gliwice, Silesian Voivodeship, 44-101, Poland

Location

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

Olsztyn, Warmian-Masurian Voivodeship, 10-228, Poland

Location

Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii ( Site 2402)

Lodz, Łódź Voivodeship, 93-513, Poland

Location

Amethyst Radiotherapy Center-Oncologie Medicala ( Site 3201)

Florești, Cluj, 407280, Romania

Location

Institutul Oncologic-Oncologie Medicala ( Site 3202)

Cluj-Napoca, 400015, Romania

Location

Chelyabinsk Regional Clinical Oncology Dispensary ( Site 2014)

Chelyabinsk, Chelyabinsk Oblast, 454087, Russia

Location

GUZ Lipetsk Regional Oncology Dispensary ( Site 2010)

Lipetsk, Lipetsk Oblast, 398005, Russia

Location

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

Moscow, Moscow, 115478, Russia

Location

Russian Scientific Center of Roentgenoradiology ( Site 2011)

Moscow, Moscow, 117997, Russia

Location

Medical institute named after Berezin Sergey ( Site 2009)

Saint Petersburg, Sankt-Peterburg, 197758, Russia

Location

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

Saint Petersburg, Sankt-Peterburg, 197758, Russia

Location

Sverdlovsk Regional Oncology Hospital ( Site 2012)

Yekaterinburg, Sverdlovsk Oblast, 620036, Russia

Location

Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 2001)

Kazan', Tatarstan, Respublika, 420029, Russia

Location

National Cancer Center ( Site 2604)

Goyang-si, Kyonggi-do, 10408, South Korea

Location

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

Gyeonggi-do, Kyonggi-do, 16247, South Korea

Location

Chungbuk National University Hospital ( Site 2605)

Cheongju-si, North Chungcheong, 28644, South Korea

Location

Seoul National University Hospital ( Site 2600)

Seoul, 03080, South Korea

Location

Samsung Medical Center ( Site 2603)

Seoul, 06351, South Korea

Location

Hospital Universitario Quiron Madrid ( Site 1601)

Pozuelo de Alarcón, Madrid, 28223, Spain

Location

Hospital Universitario La Fe ( Site 1603)

Valencia, Valenciana, Comunitat, 46206, Spain

Location

Hospital General Universitari Vall d Hebron ( Site 1602)

Barcelona, 08035, Spain

Location

Hospital General Universitario Gregorio Maranon ( Site 1604)

Madrid, 28009, Spain

Location

Hopitaux Universitaires de Geneve HUG ( Site 1706)

Geneva, Canton of Geneva, 1211, Switzerland

Location

Universitaetsspital Zuerich ( Site 1700)

Zurich, Canton of Zurich, 8091, Switzerland

Location

Tri-Service General Hospital ( Site 3300)

Taipei City, Taipei, 114, Taiwan

Location

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

Kaohsiung City, 807, Taiwan

Location

Taipei Medical University Hospital ( Site 3303)

Taipei, 110301, Taiwan

Location

Taipei Veterans General Hospital ( Site 3301)

Taipei, 11217, Taiwan

Location

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

Adana, 01250, Turkey (Türkiye)

Location

Hacettepe University Medical Faculty ( Site 2100)

Ankara, 06100, Turkey (Türkiye)

Location

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

Ankara, 06200, Turkey (Türkiye)

Location

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

Istanbul, 34722, Turkey (Türkiye)

Location

Kartal Training and Research Hospital ( Site 2102)

Istanbul, 34890, Turkey (Türkiye)

Location

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

Izmir, 35520, Turkey (Türkiye)

Location

Erciyes University Medical Faculty ( Site 2109)

Kayseri, 38030, Turkey (Türkiye)

Location

Sakarya Universitesi Tip Fakultesi Hastanesi ( Site 2114)

Sakarya, 54290, Turkey (Türkiye)

Location

Medical center Medikal Plaza of Ecodnipro LLC ( Site 2207)

Dnipro, Dnipropetrovsk Oblast, 49055, Ukraine

Location

Regional Centre of Oncology-Thoracic organs ( Site 2202)

Kharkiv, Kharkivs’ka Oblast’, 61070, Ukraine

Location

Ukrainian Center of Tomotherapy ( Site 2206)

Kropyvnitskiy, Kirovohrad Oblast, 25011, Ukraine

Location

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

Kapitanivka Village, Kyivska Oblast, 08111, Ukraine

Location

Medical Center Asklepion LLC ( Site 2208)

Khodosovka, Kyivska Oblast, 08173, Ukraine

Location

Medical and Diagnostic Centre LLC Dobryi Prognoz ( Site 2203)

Kyiv, Kyivska Oblast, 03126, Ukraine

Location

Kyiv City Clinical Oncology Centre ( Site 2200)

Kyiv, 03115, Ukraine

Location

University Hospitals Bristol NHS Foundation Trust ( Site 1802)

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

Location

Royal Free London NHS Foundation Trust ( Site 1813)

London, Camden, NW3 2QG, United Kingdom

Location

Weston Park Hospital ( Site 1801)

Sheffield, Derbyshire, S10 2SJ, United Kingdom

Location

Clatterbridge Cancer Center NHS FT ( Site 1800)

Liverpool, England, L7 8YA, United Kingdom

Location

Lancashire Teaching Hospitals NHS Foundation Trust ( Site 1809)

Preston, Lancashire, PR2 9HT, United Kingdom

Location

Leicester Royal Infirmary ( Site 1811)

Leicester, Leicestershire, LE1 5WW, United Kingdom

Location

University College London Hospital NHS Foundation Trust ( Site 1806)

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

Location

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

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

Location

Norfolk and Norwich University Foundation NHS Trust ( Site 1805)

Norwich, Norfolk, NR47UY, United Kingdom

Location

Oxford University Hospitals NHS Foundation Trust ( Site 1812)

Oxford, Oxfordshire, OX3 7LE, United Kingdom

Location

Darlington Memorial Hospital NHS Trust ( Site 1810)

Darlington, DLX 6HX, United Kingdom

Location

Mount Vernon Hospital ( Site 1803)

Northwood, HA6 2RN, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 39298144 DERIVED

Related Links

• Merck Clinical Trials Information
• Plain Language Summary

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Parkinson Disease 4, Autosomal Dominant Lewy Body

Interventions

Radiosurgery; pembrolizumab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme LLC

ClinicalTrialsDisclosure@msd.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2019
• First Posted: April 23, 2019
• Study Start: June 25, 2019
• Primary Completion: June 11, 2024
• Study Completion: January 20, 2025
• Last Updated: December 11, 2025
• Results First Posted: May 11, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share

Locations

DE (8); PL (6); NL (3); KR (5); RO (2); HU (14); AR (8); CA (9); NZ (1); UA (7); IT (5); US (42); AU (5); BR (8); FR (9); NO (3); RU (8); ES (4); CH (2); GB (12); TU (8); JP (17); TW (4)