Back to resultsEfficacy 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)
Primary Purpose
Non-Small Cell Lung Cancer
Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Stereotactic Body Radiotherapy (SBRT)
Pembrolizumab
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Non-Small Cell Lung Cancer focused on measuring Programmed Cell Death-1 (PD1, PD-1), Programmed Death-Ligand 1 (PDL1, PD-L1)
Eligibility Criteria
Inclusion Criteria:
- Has previously untreated non-small cell lung cancer (NSCLC) diagnosed by histology or cytology and confirmed as Stage I or II (T1 to limited T3, N0, M0) NSCLC (American Joint Committee on Cancer, AJCC) by chest computed tomography (CT) and positron emission tomography (PET) scan. Participants with pericardium invasion, >2 nodules or 2 nodules that cannot be treated in one field (>2 cm apart and/or total planned target volume [PTV] >163 cc) and diaphragm elevation suggestive of phrenic nerve invasion are excluded
- Cannot undergo thoracic surgery due to existing medical illness(es) as determined by the site's multi-disciplinary tumor board. Medically operable participants who decide to treat with stereotactic body radiotherapy (SBRT) as definitive therapy rather than surgery are also eligible, if patient's unwillingness to undergo surgical resection is clearly documented
- Has a Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
- Is able to receive SBRT and does not have an ultra-centrally located tumor
- Has adequate organ function within 7 days prior to the start of study treatment
- A female is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: a) not a women of childbearing potential (WOCBP) OR b) A WOCBP and uses contraceptive method that is highly effective (with a failure rate of <1% per year), or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis), during the intervention period and for at least 120 days after the last dose of pembrolizumab/placebo and 180 days after the last radiotherapy dose
- Male participants are eligible to participate if they agree to the following during the intervention period and for at least 90 days after the last dose of radiotherapy: refrain from donating sperm plus either be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agree to remain abstinent or must agree to use contraception per study protocol, unless confirmed to be azoospermic
- Has a radiation therapy plan approved by the central radiation therapy quality assurance vendor
Exclusion Criteria:
- Has received prior therapy with an anti-programmed cell death-1 (anti-PD-1), anti-programmed cell death-ligand 1 (anti-PD-L1), or anti PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g. cytotoxic T-lymphocyte-associated antigen 4 [CTLA-4], tumor necrosis factor receptor superfamily member 4 [OX-40], tumor necrosis factor receptor superfamily member 9 [CD137])
- Has received prior radiotherapy to the thorax, including radiotherapy to the esophagus, mediastinum, or breast
- Has received a live vaccine within 30 days prior to the first dose of study intervention
- Has received an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention administration
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study treatment
- Has a known additional malignancy that is progressing or has required active treatment within the past 3 years. A prior NSCLC that occurred and was treated curatively at least 2 years prior to the date of the current diagnosis would be considered a separate primary lung cancer, and therefore an additional malignancy. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g. breast c carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded.
- Has a known hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients
- Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis
- Has a known history of Hepatitis B or known active Hepatitis C virus infection
- Has an active autoimmune disease that has required systemic treatment in past 2 years, except replacement therapy
- Has an active infection requiring systemic therapy
- Has a known history of human immunodeficiency virus (HIV) infection
- Has a known history of active tuberculosis (TB; Bacillus tuberculosis)
- Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of pembrolizumab/placebo and 180 days after the last radiotherapy dose
- Have not adequately recovered from major surgery or have ongoing surgical complications
- Has had an allogenic tissue/solid organ transplant
Sites / Locations
- University of Alabama ( Site 0099)
- Infirmary Cancer Care ( Site 3044)Recruiting
- Alaska Oncology and Hematology ( Site 3063)Recruiting
- Banner MD Anderson Cancer Center ( Site 3029)
- CARTI Cancer Center ( Site 3045)Recruiting
- USC Norris Comprehensive Cancer Center ( Site 0007)
- Veterans Affairs Palo Alto Health Care System ( Site 3039)Recruiting
- National Jewish Health ( Site 0010)Recruiting
- Yale University ( Site 0011)
- Mid Florida Hematology and Oncology Center ( Site 0067)Recruiting
- H. Lee Moffitt Cancer Center and Research Institute ( Site 0016)
- Goshen Center for Cancer Care ( Site 0022)Recruiting
- Franciscan Health Indianapolis ( Site 0024)Recruiting
- University of Kentucky School of Medicine & Hospitals ( Site 0026)Recruiting
- Sinai Hospital of Baltimore ( Site 3011)
- William E. Kahlert Regional Cancer Center ( Site 3031)
- Massachusetts General Hospital-Cancer Center Protocol Office ( Site 3007)Recruiting
- Mass General / North Shore Center for Outpatient Care ( Site 3040)Recruiting
- University of Massachusetts ( Site 0029)
- Sanford Bemidji ( Site 0080)
- University of Minnesota ( Site 0069)
- University of Missouri Hospital ( Site 3058)Recruiting
- Cox Medical Center North-Cox Medical Center/Hulston Cancer Center/ Radiation Oncology ( Site 3060)Recruiting
- St. Vincent Healthcare Frontier Cancer Center ( Site 3012)Recruiting
- John Theurer Cancer Center at Hackensack University Medical Center ( Site 3036)
- Rutgers Cancer Institute of New Jersey ( Site 0043)
- Hematology-Oncology Associates of CNY ( Site 3055)Recruiting
- Mount Sinai Hospital ( Site 0046)
- Westchester Medical Center ( Site 3057)Recruiting
- White Plains Hospital ( Site 3014)Recruiting
- Sanford Health Roger Maris Cancer Center ( Site 0079)
- Lehigh Valley Hospital- Cedar Crest ( Site 3005)
- St. Luke's University Health Network ( Site 3006)Recruiting
- Penn State University Milton S. Hershey Medical Center ( Site 0064)
- Fox Chase Cancer Center ( Site 0051)
- Allegheny General Hospital ( Site 3028)Recruiting
- Lankenau Medical Center ( Site 3041)Recruiting
- Sanford Cancer Center Oncology Clinic ( Site 0053)Recruiting
- Mountain States Health Alliance ( Site 3054)Recruiting
- University of Tennessee Medical Center Knoxville ( Site 3010)Recruiting
- Vanderbilt University Medical Center ( Site 0075)Recruiting
- Cancer Care Northwest ( Site 0063)
- Hospital Italiano de Buenos Aires-Clinical Oncology ( Site 0206)Recruiting
- Hospital Britanico de Buenos Aires ( Site 0204)Recruiting
- Sanatorio Parque ( Site 0207)Recruiting
- Hospital Provincial del Centenario ( Site 0205)
- IDIM Instituto de Diagnostico e Investigaciones Metabolicas ( Site 0208)Recruiting
- Hospital Aleman ( Site 0200)Recruiting
- Instituto Medico Especializado Alexander Fleming ( Site 0203)Recruiting
- CEMIC ( Site 0201)Recruiting
- Port Macquarie Base Hospital ( Site 2500)
- GenesisCare North Shore ( Site 2508)Recruiting
- Royal Brisbane and Women s Hospital ( Site 2502)Recruiting
- Icon Cancer Centre Hobart ( Site 2507)Recruiting
- Austin Health ( Site 2501)
- Keppler Universitatsklinikum ( Site 0806)Recruiting
- Landeskrankenhaus - Universitatsklinikum Graz ( Site 0804)
- Universitatsklinik LKH Innsbruck ( Site 0802)Recruiting
- Social Medical Center - Otto Wagner Hospital ( Site 0801)Recruiting
- Irmandade da Santa Casa de Misericordia de Porto Alegre ( Site 0318)Recruiting
- Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs ( Site 0301)Recruiting
- Clínica de Oncologia Reichow ( Site 0319)Recruiting
- Hospital e Maternidade Celso Pierro ( Site 0313)
- Instituto Nacional Do Cancer Jose Alencar Gomes Da Silva ( Site 0305)Recruiting
- Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 0300)Recruiting
- Hospital Paulistano - Amil Clinical Research ( Site 0316)Recruiting
- A.C. Camargo Cancer Center ( Site 0312)Recruiting
- Moncton Hospital - Horizon Health Network ( Site 0105)Recruiting
- Kingston Health Sciences Centre ( Site 0100)Recruiting
- Trillium Health Partners - Credit Valley Hospital ( Site 0102)Recruiting
- The Ottawa Hospital ( Site 0104)Recruiting
- Sault Area Hospital ( Site 0101)Recruiting
- Health Sciences North Research Institute ( Site 0107)
- CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont ( Site 0110)Recruiting
- McGill University Health Centre ( Site 0113)Recruiting
- CHUS - Hopital Fleurimont ( Site 0111)Recruiting
- CHU Poitiers ( Site 1109)Recruiting
- CHU de Brest -Site Hopital Morvan ( Site 1100)Recruiting
- Institut Bergonie ( Site 1102)Recruiting
- Institut Regional du Cancer de Montpellier - ICM ( Site 1108)Recruiting
- CHU de Rouen ( Site 1113)Recruiting
- Hopital Sud du Amiens ( Site 1115)Recruiting
- Institut Curie ( Site 1112)Recruiting
- Hopital Cochin ( Site 1107)Recruiting
- A.P.H. Paris. Hopital Bichat Claude Bernard ( Site 1114)
- Klinikum Esslingen-Klinik für Kardiologie und Pneumologie ( Site 1208)Recruiting
- Universitaetsklinikum Heidelberg. ( Site 1204)Recruiting
- Pius Hospital Oldenburg ( Site 1202)Recruiting
- Universitaetsklinikum Erlangen ( Site 1209)Recruiting
- UKGM Gießen/Marburg-Medical Clinic V ( Site 1210)Recruiting
- Universitaetsklinikum Essen ( Site 1201)
- Evangelisches Krankenhaus Hamm gGmbH ( Site 1205)
- Charite Universitaetsmedizin Berlin ( Site 1207)Recruiting
- Bacs-Kiskun Varmegyei Oktatokorhaz-Onkoradiologiai Kozpont ( Site 2311)Recruiting
- Pécsi Tudományegyetem Klinikai Központ-Onkoterápiás Intézet ( Site 2314)Recruiting
- CRU Hungary KFT ( Site 2309)
- Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz ( Site 2312)Recruiting
- Petz Aladar Megyei Oktato Korhaz ( Site 2305)Recruiting
- Debreceni Egyetem Klinikai Kozpont ( Site 2301)Recruiting
- Jász-Nagykun-Szolnok Vármegyei Hetényi Géza Kórház ( Site 2310)Recruiting
- Törökbálinti Tüdőgyógyintézet ( Site 2302)Recruiting
- Somogy Megyei Kaposi Mor Oktato Korhaz ( Site 2307)Recruiting
- Farkasgyepui Tudogyogyintezet ( Site 2313)Recruiting
- Semmelweis University ( Site 2303)Recruiting
- Orszagos Koranyi Pulmonologiai Intezet ( Site 2304)Recruiting
- Orszagos Koranyi Pulmonologiai Intezet ( Site 2306)Recruiting
- Orszagos Onkologiai Intezet ( Site 2308)Recruiting
- Ospedale Santissima Annunziata ( Site 1303)
- A.O. Universitaria Careggi ( Site 1301)Recruiting
- Policlinico di Modena ( Site 1306)Recruiting
- Policlinico Agostino Gemelli ( Site 1302)Recruiting
- Azienda Ospedaliera S. Giovanni Addolorata-Oncologia Medica ( Site 1309)Recruiting
- Aichi Cancer Center Hospital ( Site 2804)Recruiting
- National Cancer Center Hospital East ( Site 2800)Recruiting
- Kurume University Hospital ( Site 2815)Recruiting
- Kobe Minimally Invasive Cancer Center ( Site 2811)Recruiting
- University of Tsukuba Hospital ( Site 2809)Recruiting
- Sendai Kousei Hospital ( Site 2814)Recruiting
- Kansai Medical University Hospital ( Site 2808)Recruiting
- Osaka Medical and Pharmaceutical University Hospital ( Site 2813)Recruiting
- University of Yamanashi Hospital ( Site 2807)Recruiting
- Chiba University Hospital ( Site 2806)Recruiting
- National Hospital Organization Kyushu Cancer Center ( Site 2816)Recruiting
- Hiroshima University Hospital ( Site 2810)Recruiting
- Niigata Cancer Center Hospital ( Site 2801)Recruiting
- Osaka International Cancer Institute ( Site 2812)Recruiting
- Tokyo Metropolitan Komagome Hospital ( Site 2802)Recruiting
- The Cancer Institute Hospital of JFCR ( Site 2803)Recruiting
- Showa University Hospital ( Site 2805)Recruiting
- Chungbuk National University Hospital ( Site 2605)Recruiting
- National Cancer Center ( Site 2604)Recruiting
- The Catholic University of Korea St. Vincent s Hospital ( Site 2606)Recruiting
- Seoul National University Hospital ( Site 2600)
- Samsung Medical Center ( Site 2603)Recruiting
- Ziekenhuis Rijnstate ( Site 1405)Recruiting
- Tergooiziekenhuizen, locatie Hilversum-Oncology ( Site 1407)Recruiting
- Meander Medisch Centrum-Studie Team Oncologie ( Site 1403)Recruiting
- Auckland City Hospital ( Site 2900)
- St Olavs Hospital ( Site 1504)
- Helse Bergen HF Haukeland Universitetssykehus ( Site 1502)Recruiting
- Oslo Universitetssykehus HF Ulleval Sykehus ( Site 1500)Recruiting
- Centrum Onkologii im. prof. Franciszka ukaszczyka-Ambulatorium Chemioterapii ( Site 2407)Recruiting
- Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii ( Site 2402)Recruiting
- Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie ( Site 2400)
- Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie (Recruiting
- Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 2403)Recruiting
- SPZOZ MSWIA z Warminsko-Mazurskim Centrum Onkologii w Olsztynie ( Site 2404)Recruiting
- Amethyst Radiotherapy Center-Oncologie Medicala ( Site 3201)Recruiting
- Chelyabinsk Regional Clinical Oncology Dispensary ( Site 2014)
- GUZ Lipetsk Regional Oncology Dispensary ( Site 2010)
- N.N.Blokhin Russian Cancer Research center ( Site 2013)
- Russian Scientific Center of Roentgenoradiology ( Site 2011)
- Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 2000)
- Medical institute named after Berezin Sergey ( Site 2009)
- Sverdlovsk Regional Oncology Hospital ( Site 2012)
- Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 2001)
- Hospital Universitario Quiron Madrid ( Site 1601)
- Hospital Universitario La Fe ( Site 1603)
- Hospital General Universitari Vall d Hebron ( Site 1602)Recruiting
- Hospital General Universitario Gregorio Maranon ( Site 1604)Recruiting
- Hopitaux Universitaires de Geneve HUG ( Site 1706)Recruiting
- Universitaetsspital Zuerich ( Site 1700)Recruiting
- Tri-Service General Hospital ( Site 3300)Recruiting
- Kaohsiung Medical University Chung-Ho Memorial Hospital ( Site 3304)Recruiting
- Taipei Medical University Hospital ( Site 3303)Recruiting
- Taipei Veterans General Hospital ( Site 3301)Recruiting
- Baskent Adana Dr Turgut Noyan Uygulama ve Arastirma Merkezi ( Site 2105)Recruiting
- Hacettepe University Medical Faculty ( Site 2100)Recruiting
- Dr Abdurrahman Yurtaslan Oncology Training and Research Hospital ( Site 2101)Recruiting
- Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi-oncology ( Site 2116)Recruiting
- Kartal Training and Research Hospital ( Site 2102)
- I.E.U. Medical Point Hastanesi ( Site 2115)Recruiting
- Erciyes University Medical Faculty ( Site 2109)Recruiting
- Sakarya Universitesi Tip Fakultesi Hastanesi ( Site 2114)Recruiting
- Medical center Medikal Plaza of Ecodnipro LLC ( Site 2207)
- Regional Centre of Oncology-Thoracic organs ( Site 2202)Recruiting
- Ukrainian Center of Tomotherapy ( Site 2206)
- Medical Center of Yuriy Spizhenko LLC.-Clinical Trial ( Site 2205)
- Medical Center Asklepion LLC ( Site 2208)
- Medical and Diagnostic Centre LLC Dobryi Prognoz ( Site 2203)
- Kyiv City Clinical Oncology Centre ( Site 2200)
- University Hospitals Bristol NHS Foundation Trust ( Site 1802)Recruiting
- Royal Free London NHS Foundation Trust ( Site 1813)Recruiting
- Weston Park Hospital ( Site 1801)Recruiting
- Clatterbridge Cancer Center NHS FT ( Site 1800)Recruiting
- Lancashire Teaching Hospitals NHS Foundation Trust ( Site 1809)
- Leicester Royal Infirmary ( Site 1811)
- University College London Hospital NHS Foundation Trust ( Site 1806)Recruiting
- Guy s and St Thomas Hospital NHS Foundation Trust ( Site 1808)Recruiting
- Norfolk and Norwich University Foundation NHS Trust ( Site 1805)
- Oxford University Hospitals NHS Foundation Trust ( Site 1812)Recruiting
- Darlington Memorial Hospital NHS Trust ( Site 1810)
- Mount Vernon Hospital ( Site 1803)Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
SBRT+Pembolizumab
SBRT+Placebo
Arm Description
Participants receive SBRT once every 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.
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.
Outcomes
Primary Outcome Measures
Event-free Survival (EFS)
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.
Overall Survival (OS)
OS is defined as the time from date of randomization to date of death from any cause. OS will be presented.
Secondary Outcome Measures
Time to Death or Distant Metastases (TDDM)
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.
Number of Participants Who Experience an Adverse Event (AE)
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.
Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE)
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.
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?" 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.
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-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.
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
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.
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?" 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.
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 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.
Full Information
NCT ID
NCT03924869
First Posted
April 22, 2019
Last Updated
October 18, 2023
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT03924869
Brief Title
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)
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)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 25, 2019 (Actual)
Primary Completion Date
April 11, 2025 (Anticipated)
Study Completion Date
July 1, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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 hypotheses are:
SBRT plus pembrolizumab prolongs Event-free Survival (EFS) compared to SBRT plus placebo (normal saline solution), and
SBRT plus pembrolizumab prolongs Overall Survival (OS) compared to SBRT plus placebo.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Small Cell Lung Cancer
Keywords
Programmed Cell Death-1 (PD1, PD-1), Programmed Death-Ligand 1 (PDL1, PD-L1)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
530 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SBRT+Pembolizumab
Arm Type
Experimental
Arm Description
Participants receive SBRT once every 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.
Arm Title
SBRT+Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Radiation
Intervention Name(s)
Stereotactic Body Radiotherapy (SBRT)
Intervention Description
SBRT
Intervention Type
Biological
Intervention Name(s)
Pembrolizumab
Other Intervention Name(s)
MK-3475, KEYTRUDA®
Intervention Description
IV infusion
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Normal saline solution
Intervention Description
IV infusion
Primary Outcome Measure Information:
Title
Event-free Survival (EFS)
Description
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.
Time Frame
Up to approximately 58 months
Title
Overall Survival (OS)
Description
OS is defined as the time from date of randomization to date of death from any cause. OS will be presented.
Time Frame
Up to approximately 68 months
Secondary Outcome Measure Information:
Title
Time to Death or Distant Metastases (TDDM)
Description
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.
Time Frame
Up to approximately 68 months
Title
Number of Participants Who Experience an Adverse Event (AE)
Description
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.
Time Frame
Up to approximately 16 months
Title
Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE)
Description
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.
Time Frame
Up to approximately 1 year
Title
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
Description
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.
Time Frame
Baseline and up to approximately 52 weeks
Title
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
Description
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.
Time Frame
Baseline and up to approximately 52 weeks
Title
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
Description
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.
Time Frame
Baseline and up to approximately 52 weeks
Title
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
Description
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.
Time Frame
Baseline and up to approximately 52 weeks
Title
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
Description
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.
Time Frame
Baseline and up to approximately 52 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Has previously untreated non-small cell lung cancer (NSCLC) diagnosed by histology or cytology and confirmed as Stage I or II (T1 to limited T3, N0, M0) NSCLC (American Joint Committee on Cancer, AJCC) by chest computed tomography (CT) and positron emission tomography (PET) scan. Participants with pericardium invasion, >2 nodules or 2 nodules that cannot be treated in one field (>2 cm apart and/or total planned target volume [PTV] >163 cc) and diaphragm elevation suggestive of phrenic nerve invasion are excluded
Cannot undergo thoracic surgery due to existing medical illness(es) as determined by the site's multi-disciplinary tumor board. Medically operable participants who decide to treat with stereotactic body radiotherapy (SBRT) as definitive therapy rather than surgery are also eligible, if patient's unwillingness to undergo surgical resection is clearly documented
Has a Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
Is able to receive SBRT and does not have an ultra-centrally located tumor
Has adequate organ function within 7 days prior to the start of study treatment
A female is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: a) not a women of childbearing potential (WOCBP) OR b) A WOCBP and uses contraceptive method that is highly effective (with a failure rate of <1% per year), or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis), during the intervention period and for at least 120 days after the last dose of pembrolizumab/placebo and 180 days after the last radiotherapy dose
Male participants are eligible to participate if they agree to the following during the intervention period and for at least 90 days after the last dose of radiotherapy: refrain from donating sperm plus either be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agree to remain abstinent or must agree to use contraception per study protocol, unless confirmed to be azoospermic
Has a radiation therapy plan approved by the central radiation therapy quality assurance vendor
Exclusion Criteria:
Has received prior therapy with an anti-programmed cell death-1 (anti-PD-1), anti-programmed cell death-ligand 1 (anti-PD-L1), or anti PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g. cytotoxic T-lymphocyte-associated antigen 4 [CTLA-4], tumor necrosis factor receptor superfamily member 4 [OX-40], tumor necrosis factor receptor superfamily member 9 [CD137])
Has received prior radiotherapy to the thorax, including radiotherapy to the esophagus, mediastinum, or breast
Has received a live vaccine within 30 days prior to the first dose of study intervention
Has received an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention administration
Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study treatment
Has a known additional malignancy that is progressing or has required active treatment within the past 3 years. A prior NSCLC that occurred and was treated curatively at least 2 years prior to the date of the current diagnosis would be considered a separate primary lung cancer, and therefore an additional malignancy. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g. breast c carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded.
Has a known hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients
Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis
Has a known history of Hepatitis B or known active Hepatitis C virus infection
Has an active autoimmune disease that has required systemic treatment in past 2 years, except replacement therapy
Has an active infection requiring systemic therapy
Has a known history of human immunodeficiency virus (HIV) infection
Has a known history of active tuberculosis (TB; Bacillus tuberculosis)
Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of pembrolizumab/placebo and 180 days after the last radiotherapy dose
Have not adequately recovered from major surgery or have ongoing surgical complications
Has had an allogenic tissue/solid organ transplant
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Toll Free Number
Phone
1-888-577-8839
Email
Trialsites@merck.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama ( Site 0099)
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Individual Site Status
Completed
Facility Name
Infirmary Cancer Care ( Site 3044)
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36607
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
251-435-6582
Facility Name
Alaska Oncology and Hematology ( Site 3063)
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99508
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
907-257-9851
Facility Name
Banner MD Anderson Cancer Center ( Site 3029)
City
Gilbert
State/Province
Arizona
ZIP/Postal Code
85234
Country
United States
Individual Site Status
Completed
Facility Name
CARTI Cancer Center ( Site 3045)
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
501-366-1163
Facility Name
USC Norris Comprehensive Cancer Center ( Site 0007)
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Individual Site Status
Completed
Facility Name
Veterans Affairs Palo Alto Health Care System ( Site 3039)
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
650-239-2820
Facility Name
National Jewish Health ( Site 0010)
City
Denver
State/Province
Colorado
ZIP/Postal Code
80206
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
303-398-1233
Facility Name
Yale University ( Site 0011)
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Mid Florida Hematology and Oncology Center ( Site 0067)
City
Orange City
State/Province
Florida
ZIP/Postal Code
32763
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
386-774-1223
Facility Name
H. Lee Moffitt Cancer Center and Research Institute ( Site 0016)
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Individual Site Status
Completed
Facility Name
Goshen Center for Cancer Care ( Site 0022)
City
Goshen
State/Province
Indiana
ZIP/Postal Code
46526
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
574-364-2649
Facility Name
Franciscan Health Indianapolis ( Site 0024)
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46237
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
317-528-7685
Facility Name
University of Kentucky School of Medicine & Hospitals ( Site 0026)
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
859-323-0250
Facility Name
Sinai Hospital of Baltimore ( Site 3011)
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21215
Country
United States
Individual Site Status
Completed
Facility Name
William E. Kahlert Regional Cancer Center ( Site 3031)
City
Westminster
State/Province
Maryland
ZIP/Postal Code
21157
Country
United States
Individual Site Status
Completed
Facility Name
Massachusetts General Hospital-Cancer Center Protocol Office ( Site 3007)
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
617-724-3661
Facility Name
Mass General / North Shore Center for Outpatient Care ( Site 3040)
City
Danvers
State/Province
Massachusetts
ZIP/Postal Code
01923
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
617-724-3661
Facility Name
University of Massachusetts ( Site 0029)
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Individual Site Status
Completed
Facility Name
Sanford Bemidji ( Site 0080)
City
Bemidji
State/Province
Minnesota
ZIP/Postal Code
56601
Country
United States
Individual Site Status
Completed
Facility Name
University of Minnesota ( Site 0069)
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Individual Site Status
Completed
Facility Name
University of Missouri Hospital ( Site 3058)
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
573-882-7440
Facility Name
Cox Medical Center North-Cox Medical Center/Hulston Cancer Center/ Radiation Oncology ( Site 3060)
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65807
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
417-269-6115
Facility Name
St. Vincent Healthcare Frontier Cancer Center ( Site 3012)
City
Billings
State/Province
Montana
ZIP/Postal Code
59102
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
406-238-6685
Facility Name
John Theurer Cancer Center at Hackensack University Medical Center ( Site 3036)
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Individual Site Status
Completed
Facility Name
Rutgers Cancer Institute of New Jersey ( Site 0043)
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Hematology-Oncology Associates of CNY ( Site 3055)
City
East Syracuse
State/Province
New York
ZIP/Postal Code
13057
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
315-472-7504
Facility Name
Mount Sinai Hospital ( Site 0046)
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Completed
Facility Name
Westchester Medical Center ( Site 3057)
City
Valhalla
State/Province
New York
ZIP/Postal Code
10595
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
914-493-8881
Facility Name
White Plains Hospital ( Site 3014)
City
White Plains
State/Province
New York
ZIP/Postal Code
10601
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
914-849-7500
Facility Name
Sanford Health Roger Maris Cancer Center ( Site 0079)
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58122
Country
United States
Individual Site Status
Completed
Facility Name
Lehigh Valley Hospital- Cedar Crest ( Site 3005)
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103
Country
United States
Individual Site Status
Completed
Facility Name
St. Luke's University Health Network ( Site 3006)
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18015
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
484-526-7000
Facility Name
Penn State University Milton S. Hershey Medical Center ( Site 0064)
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Individual Site Status
Completed
Facility Name
Fox Chase Cancer Center ( Site 0051)
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Individual Site Status
Completed
Facility Name
Allegheny General Hospital ( Site 3028)
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
412-359-6137
Facility Name
Lankenau Medical Center ( Site 3041)
City
Wynnewood
State/Province
Pennsylvania
ZIP/Postal Code
19096
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
484-476-8426
Facility Name
Sanford Cancer Center Oncology Clinic ( Site 0053)
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
605-312-3320
Facility Name
Mountain States Health Alliance ( Site 3054)
City
Johnson City
State/Province
Tennessee
ZIP/Postal Code
37604
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
423-534-3627
Facility Name
University of Tennessee Medical Center Knoxville ( Site 3010)
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
865-305-4893
Facility Name
Vanderbilt University Medical Center ( Site 0075)
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
615-875-0060
Facility Name
Cancer Care Northwest ( Site 0063)
City
Spokane Valley
State/Province
Washington
ZIP/Postal Code
99216
Country
United States
Individual Site Status
Completed
Facility Name
Hospital Italiano de Buenos Aires-Clinical Oncology ( Site 0206)
City
ABB
State/Province
Caba
ZIP/Postal Code
C1199ABB
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
54 114959 0200 ext 8159
Facility Name
Hospital Britanico de Buenos Aires ( Site 0204)
City
Buenos Aires
State/Province
Caba
ZIP/Postal Code
C1280AEB
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+5491121571056
Facility Name
Sanatorio Parque ( Site 0207)
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
S2000DSV
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+5493416955611
Facility Name
Hospital Provincial del Centenario ( Site 0205)
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
S2002KDS
Country
Argentina
Individual Site Status
Completed
Facility Name
IDIM Instituto de Diagnostico e Investigaciones Metabolicas ( Site 0208)
City
Buenos Aires
ZIP/Postal Code
1012
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+549-1141625353
Facility Name
Hospital Aleman ( Site 0200)
City
Buenos Aires
ZIP/Postal Code
C1118AAT
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+541148277000
Facility Name
Instituto Medico Especializado Alexander Fleming ( Site 0203)
City
Buenos Aires
ZIP/Postal Code
C1426ANZ
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+5491166936669
Facility Name
CEMIC ( Site 0201)
City
Buenos Aires
ZIP/Postal Code
C1431FWO
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+5411529901002543
Facility Name
Port Macquarie Base Hospital ( Site 2500)
City
Port Macquarie
State/Province
New South Wales
ZIP/Postal Code
2444
Country
Australia
Individual Site Status
Completed
Facility Name
GenesisCare North Shore ( Site 2508)
City
St Leonards
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
61294631172
Facility Name
Royal Brisbane and Women s Hospital ( Site 2502)
City
Herston
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+61736467983
Facility Name
Icon Cancer Centre Hobart ( Site 2507)
City
Hobart
State/Province
Tasmania
ZIP/Postal Code
7000
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+61 407 110 474
Facility Name
Austin Health ( Site 2501)
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Individual Site Status
Completed
Facility Name
Keppler Universitatsklinikum ( Site 0806)
City
Linz
State/Province
Oberosterreich
ZIP/Postal Code
4021
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+4373278066910
Facility Name
Landeskrankenhaus - Universitatsklinikum Graz ( Site 0804)
City
Graz
State/Province
Steiermark
ZIP/Postal Code
8036
Country
Austria
Individual Site Status
Completed
Facility Name
Universitatsklinik LKH Innsbruck ( Site 0802)
City
Innsbruck
State/Province
Tirol
ZIP/Postal Code
6020
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+4351250481058
Facility Name
Social Medical Center - Otto Wagner Hospital ( Site 0801)
City
Vienna
State/Province
Wien
ZIP/Postal Code
1145
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+4319106042003
Facility Name
Irmandade da Santa Casa de Misericordia de Porto Alegre ( Site 0318)
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90050-170
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+5551999818669
Facility Name
Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs ( Site 0301)
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90610-000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+555133203039
Facility Name
Clínica de Oncologia Reichow ( Site 0319)
City
Blumenau
State/Province
Santa Catarina
ZIP/Postal Code
89010-340
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
55 47 3380-5890
Facility Name
Hospital e Maternidade Celso Pierro ( Site 0313)
City
Campinas
State/Province
Sao Paulo
ZIP/Postal Code
13060-904
Country
Brazil
Individual Site Status
Completed
Facility Name
Instituto Nacional Do Cancer Jose Alencar Gomes Da Silva ( Site 0305)
City
Rio de Janeiro
ZIP/Postal Code
20231-050
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+552132076564
Facility Name
Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 0300)
City
Sao Paulo
ZIP/Postal Code
01246-000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+551138932615
Facility Name
Hospital Paulistano - Amil Clinical Research ( Site 0316)
City
Sao Paulo
ZIP/Postal Code
01321-001
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+552132071657
Facility Name
A.C. Camargo Cancer Center ( Site 0312)
City
Sao Paulo
ZIP/Postal Code
01509-900
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+551121895021
Facility Name
Moncton Hospital - Horizon Health Network ( Site 0105)
City
Moncton
State/Province
New Brunswick
ZIP/Postal Code
E1C 6Z8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
5068575669
Facility Name
Kingston Health Sciences Centre ( Site 0100)
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 2V7
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
6135496666
Facility Name
Trillium Health Partners - Credit Valley Hospital ( Site 0102)
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L5M 2N1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
905-813-4299
Facility Name
The Ottawa Hospital ( Site 0104)
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
613737770070175
Facility Name
Sault Area Hospital ( Site 0101)
City
Sault Ste Marie
State/Province
Ontario
ZIP/Postal Code
P6B 0A8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
7057593434
Facility Name
Health Sciences North Research Institute ( Site 0107)
City
Sudbury
State/Province
Ontario
ZIP/Postal Code
P3E 5J1
Country
Canada
Individual Site Status
Completed
Facility Name
CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont ( Site 0110)
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
15142523400
Facility Name
McGill University Health Centre ( Site 0113)
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
514-934-1934
Facility Name
CHUS - Hopital Fleurimont ( Site 0111)
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
819-346-1110
Facility Name
CHU Poitiers ( Site 1109)
City
Poitiers
State/Province
Ain
ZIP/Postal Code
86021
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+33549444538
Facility Name
CHU de Brest -Site Hopital Morvan ( Site 1100)
City
Brest
State/Province
Finistere
ZIP/Postal Code
29200
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+33298223578
Facility Name
Institut Bergonie ( Site 1102)
City
Bordeaux
State/Province
Gironde
ZIP/Postal Code
33076
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+33556333229
Facility Name
Institut Regional du Cancer de Montpellier - ICM ( Site 1108)
City
Montpellier
State/Province
Herault
ZIP/Postal Code
34298
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+33467612581
Facility Name
CHU de Rouen ( Site 1113)
City
Rouen
State/Province
Seine-Maritime
ZIP/Postal Code
76000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+33232888990
Facility Name
Hopital Sud du Amiens ( Site 1115)
City
Amiens
State/Province
Somme
ZIP/Postal Code
80054
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+33322455902
Facility Name
Institut Curie ( Site 1112)
City
Paris
ZIP/Postal Code
75005
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+33144324606
Facility Name
Hopital Cochin ( Site 1107)
City
Paris
ZIP/Postal Code
75014
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+33158413091
Facility Name
A.P.H. Paris. Hopital Bichat Claude Bernard ( Site 1114)
City
Paris
ZIP/Postal Code
75877
Country
France
Individual Site Status
Completed
Facility Name
Klinikum Esslingen-Klinik für Kardiologie und Pneumologie ( Site 1208)
City
Esslingen
State/Province
Baden-Wurttemberg
ZIP/Postal Code
73730
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
0049 711 3103 865109
Facility Name
Universitaetsklinikum Heidelberg. ( Site 1204)
City
Heidelberg
State/Province
Baden-Wurttemberg
ZIP/Postal Code
69126
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+4962213968359
Facility Name
Pius Hospital Oldenburg ( Site 1202)
City
Oldenburg
State/Province
Baden-Wurttemberg
ZIP/Postal Code
26121
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+494412291610
Facility Name
Universitaetsklinikum Erlangen ( Site 1209)
City
Erlangen
State/Province
Bayern
ZIP/Postal Code
91054
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
0049 9131 8533968
Facility Name
UKGM Gießen/Marburg-Medical Clinic V ( Site 1210)
City
Gießen
State/Province
Hessen
ZIP/Postal Code
35392
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+49 (0)641 985 59253
Facility Name
Universitaetsklinikum Essen ( Site 1201)
City
Essen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
45147
Country
Germany
Individual Site Status
Completed
Facility Name
Evangelisches Krankenhaus Hamm gGmbH ( Site 1205)
City
Hamm
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
59063
Country
Germany
Individual Site Status
Completed
Facility Name
Charite Universitaetsmedizin Berlin ( Site 1207)
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+4930450553044
Facility Name
Bacs-Kiskun Varmegyei Oktatokorhaz-Onkoradiologiai Kozpont ( Site 2311)
City
Kecskemét
State/Province
Bacs-Kiskun
ZIP/Postal Code
6000
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+3676516719
Facility Name
Pécsi Tudományegyetem Klinikai Központ-Onkoterápiás Intézet ( Site 2314)
City
Pécs
State/Province
Baranya
ZIP/Postal Code
7624
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+36205264756
Facility Name
CRU Hungary KFT ( Site 2309)
City
Miskolc
State/Province
Borsod-Abauj-Zemplen
ZIP/Postal Code
3529
Country
Hungary
Individual Site Status
Completed
Facility Name
Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz ( Site 2312)
City
Szekesfehervar
State/Province
Fejer
ZIP/Postal Code
8000
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+3622535722
Facility Name
Petz Aladar Megyei Oktato Korhaz ( Site 2305)
City
Gyor
State/Province
Gyor-Moson-Sopron
ZIP/Postal Code
9024
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+36309758356
Facility Name
Debreceni Egyetem Klinikai Kozpont ( Site 2301)
City
Debrecen
State/Province
Hajdu-Bihar
ZIP/Postal Code
4032
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+3652255222
Facility Name
Jász-Nagykun-Szolnok Vármegyei Hetényi Géza Kórház ( Site 2310)
City
Szolnok
State/Province
Jasz-Nagykun-Szolnok
ZIP/Postal Code
5004
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+36209323256
Facility Name
Törökbálinti Tüdőgyógyintézet ( Site 2302)
City
Torokbalint
State/Province
Pest
ZIP/Postal Code
2045
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+36307005601
Facility Name
Somogy Megyei Kaposi Mor Oktato Korhaz ( Site 2307)
City
Kaposvar
State/Province
Somogy
ZIP/Postal Code
7400
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+36703685838
Facility Name
Farkasgyepui Tudogyogyintezet ( Site 2313)
City
Farkasgyepu
State/Province
Veszprem
ZIP/Postal Code
8582
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+3689358013
Facility Name
Semmelweis University ( Site 2303)
City
Budapest
ZIP/Postal Code
1085
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+3613558682
Facility Name
Orszagos Koranyi Pulmonologiai Intezet ( Site 2304)
City
Budapest
ZIP/Postal Code
1121
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+36703288101
Facility Name
Orszagos Koranyi Pulmonologiai Intezet ( Site 2306)
City
Budapest
ZIP/Postal Code
1121
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+36302005233
Facility Name
Orszagos Onkologiai Intezet ( Site 2308)
City
Budapest
ZIP/Postal Code
1122
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+3612248600
Facility Name
Ospedale Santissima Annunziata ( Site 1303)
City
Chieti
ZIP/Postal Code
66100
Country
Italy
Individual Site Status
Completed
Facility Name
A.O. Universitaria Careggi ( Site 1301)
City
Firenze
ZIP/Postal Code
50134
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+39055794111
Facility Name
Policlinico di Modena ( Site 1306)
City
Modena
ZIP/Postal Code
41124
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+39594224385
Facility Name
Policlinico Agostino Gemelli ( Site 1302)
City
Roma
ZIP/Postal Code
00168
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+390630155440
Facility Name
Azienda Ospedaliera S. Giovanni Addolorata-Oncologia Medica ( Site 1309)
City
Roma
ZIP/Postal Code
00185
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+393476063165
Facility Name
Aichi Cancer Center Hospital ( Site 2804)
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
464-8681
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81527626111
Facility Name
National Cancer Center Hospital East ( Site 2800)
City
Kashiwa
State/Province
Chiba
ZIP/Postal Code
2778577
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81471331111
Facility Name
Kurume University Hospital ( Site 2815)
City
Kurume
State/Province
Fukuoka
ZIP/Postal Code
830-0011
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
81942317200
Facility Name
Kobe Minimally Invasive Cancer Center ( Site 2811)
City
Kobe
State/Province
Hyogo
ZIP/Postal Code
650-0046
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81-78-304-4100
Facility Name
University of Tsukuba Hospital ( Site 2809)
City
Tsukuba
State/Province
Ibaraki
ZIP/Postal Code
305-8576
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81298533900
Facility Name
Sendai Kousei Hospital ( Site 2814)
City
Sendai
State/Province
Miyagi
ZIP/Postal Code
980-0873
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81-22-222-6181
Facility Name
Kansai Medical University Hospital ( Site 2808)
City
Hirakata
State/Province
Osaka
ZIP/Postal Code
573-1191
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81728040101
Facility Name
Osaka Medical and Pharmaceutical University Hospital ( Site 2813)
City
Takatsuki
State/Province
Osaka
ZIP/Postal Code
5698686
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81-72-683-1221
Facility Name
University of Yamanashi Hospital ( Site 2807)
City
Chuo
State/Province
Yamanashi
ZIP/Postal Code
409-3898
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81552731111
Facility Name
Chiba University Hospital ( Site 2806)
City
Chiba
ZIP/Postal Code
260-8677
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81432227171
Facility Name
National Hospital Organization Kyushu Cancer Center ( Site 2816)
City
Fukuoka
ZIP/Postal Code
811-1395
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81925413231
Facility Name
Hiroshima University Hospital ( Site 2810)
City
Hiroshima
ZIP/Postal Code
734-8551
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81822575555
Facility Name
Niigata Cancer Center Hospital ( Site 2801)
City
Niigata
ZIP/Postal Code
951-8566
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81252665111
Facility Name
Osaka International Cancer Institute ( Site 2812)
City
Osaka
ZIP/Postal Code
541-8567
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81-6-6945-1181
Facility Name
Tokyo Metropolitan Komagome Hospital ( Site 2802)
City
Tokyo
ZIP/Postal Code
113-8677
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81338232101
Facility Name
The Cancer Institute Hospital of JFCR ( Site 2803)
City
Tokyo
ZIP/Postal Code
135-8550
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81335200111
Facility Name
Showa University Hospital ( Site 2805)
City
Tokyo
ZIP/Postal Code
142-8666
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81337848000
Facility Name
Chungbuk National University Hospital ( Site 2605)
City
Cheongju-si
State/Province
Chungbuk
ZIP/Postal Code
28644
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+82432696015
Facility Name
National Cancer Center ( Site 2604)
City
Goyang-si
State/Province
Kyonggi-do
ZIP/Postal Code
10408
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+82319201694
Facility Name
The Catholic University of Korea St. Vincent s Hospital ( Site 2606)
City
Gyeonggi-do
State/Province
Kyonggi-do
ZIP/Postal Code
16247
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+82312498153
Facility Name
Seoul National University Hospital ( Site 2600)
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Completed
Facility Name
Samsung Medical Center ( Site 2603)
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+82234103609
Facility Name
Ziekenhuis Rijnstate ( Site 1405)
City
Arnhem
State/Province
Gelderland
ZIP/Postal Code
6815 AD
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+31880056730
Facility Name
Tergooiziekenhuizen, locatie Hilversum-Oncology ( Site 1407)
City
Hilversum
State/Province
Noord-Holland
ZIP/Postal Code
1213 XZ
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+31887531753
Facility Name
Meander Medisch Centrum-Studie Team Oncologie ( Site 1403)
City
Amersfoort
State/Province
Utrecht
ZIP/Postal Code
3813 TZ
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+31338507843
Facility Name
Auckland City Hospital ( Site 2900)
City
Grafton
State/Province
Auckland
ZIP/Postal Code
1023
Country
New Zealand
Individual Site Status
Completed
Facility Name
St Olavs Hospital ( Site 1504)
City
Trondheim
State/Province
Sor-Trondelag
ZIP/Postal Code
7030
Country
Norway
Individual Site Status
Completed
Facility Name
Helse Bergen HF Haukeland Universitetssykehus ( Site 1502)
City
Bergen
State/Province
Vestfold
ZIP/Postal Code
5021
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+4755973245
Facility Name
Oslo Universitetssykehus HF Ulleval Sykehus ( Site 1500)
City
Oslo
ZIP/Postal Code
0450
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+4722934809
Facility Name
Centrum Onkologii im. prof. Franciszka ukaszczyka-Ambulatorium Chemioterapii ( Site 2407)
City
Bydgoszcz
State/Province
Kujawsko-pomorskie
ZIP/Postal Code
85-796
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
523743525
Facility Name
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii ( Site 2402)
City
Lodz
State/Province
Lodzkie
ZIP/Postal Code
93-513
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+48426895551
Facility Name
Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie ( Site 2400)
City
Krakow
State/Province
Malopolskie
ZIP/Postal Code
31-826
Country
Poland
Individual Site Status
Completed
Facility Name
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie (
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
02-781
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+48225463066
Facility Name
Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 2403)
City
Gliwice
State/Province
Slaskie
ZIP/Postal Code
44101
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+48322788805
Facility Name
SPZOZ MSWIA z Warminsko-Mazurskim Centrum Onkologii w Olsztynie ( Site 2404)
City
Olsztyn
State/Province
Warminsko-mazurskie
ZIP/Postal Code
10-228
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+48895398527
Facility Name
Amethyst Radiotherapy Center-Oncologie Medicala ( Site 3201)
City
Florești
State/Province
Cluj
ZIP/Postal Code
407280
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
40742206212
Facility Name
Chelyabinsk Regional Clinical Oncology Dispensary ( Site 2014)
City
Chelyabinsk
State/Province
Chelyabinskaya Oblast
ZIP/Postal Code
454087
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
GUZ Lipetsk Regional Oncology Dispensary ( Site 2010)
City
Lipetsk
State/Province
Lipetskaya Oblast
ZIP/Postal Code
398005
Country
Russian Federation
Individual Site Status
Completed
Facility Name
N.N.Blokhin Russian Cancer Research center ( Site 2013)
City
Moscow
State/Province
Moskva
ZIP/Postal Code
115478
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Russian Scientific Center of Roentgenoradiology ( Site 2011)
City
Moscow
State/Province
Moskva
ZIP/Postal Code
117997
Country
Russian Federation
Individual Site Status
Completed
Facility Name
Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 2000)
City
Saint-Petersburg
State/Province
Sankt-Peterburg
ZIP/Postal Code
197758
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Medical institute named after Berezin Sergey ( Site 2009)
City
St. Petersburg
State/Province
Sankt-Peterburg
ZIP/Postal Code
197758
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Sverdlovsk Regional Oncology Hospital ( Site 2012)
City
Ekaterinburg
State/Province
Sverdlovskaya Oblast
ZIP/Postal Code
620036
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 2001)
City
Kazan
State/Province
Tatarstan, Respublika
ZIP/Postal Code
420029
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Hospital Universitario Quiron Madrid ( Site 1601)
City
Pozuelo de Alarcon
State/Province
Madrid
ZIP/Postal Code
28223
Country
Spain
Individual Site Status
Completed
Facility Name
Hospital Universitario La Fe ( Site 1603)
City
Valencia
State/Province
Valenciana, Comunitat
ZIP/Postal Code
46206
Country
Spain
Individual Site Status
Completed
Facility Name
Hospital General Universitari Vall d Hebron ( Site 1602)
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+34934894158
Facility Name
Hospital General Universitario Gregorio Maranon ( Site 1604)
City
Madrid
ZIP/Postal Code
28009
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+34914265134
Facility Name
Hopitaux Universitaires de Geneve HUG ( Site 1706)
City
Geneva
State/Province
Geneve
ZIP/Postal Code
1211
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+41223729881
Facility Name
Universitaetsspital Zuerich ( Site 1700)
City
Zuerich
State/Province
Zurich
ZIP/Postal Code
8091
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+41442558902
Facility Name
Tri-Service General Hospital ( Site 3300)
City
Taipei City
State/Province
Taipei
ZIP/Postal Code
114
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+886-2-8792-3311ext13899
Facility Name
Kaohsiung Medical University Chung-Ho Memorial Hospital ( Site 3304)
City
Kaohsiung
ZIP/Postal Code
807
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
886-7-3121101 ext5651
Facility Name
Taipei Medical University Hospital ( Site 3303)
City
Taipei
ZIP/Postal Code
110
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
886227372181-3599
Facility Name
Taipei Veterans General Hospital ( Site 3301)
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+886-2-2875-7865
Facility Name
Baskent Adana Dr Turgut Noyan Uygulama ve Arastirma Merkezi ( Site 2105)
City
Adana
ZIP/Postal Code
01250
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+903223444444
Facility Name
Hacettepe University Medical Faculty ( Site 2100)
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+9031230543304336
Facility Name
Dr Abdurrahman Yurtaslan Oncology Training and Research Hospital ( Site 2101)
City
Ankara
ZIP/Postal Code
06200
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+90 312 336 09 09
Facility Name
Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi-oncology ( Site 2116)
City
Istanbul
ZIP/Postal Code
34722
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
905063509061
Facility Name
Kartal Training and Research Hospital ( Site 2102)
City
Istanbul
ZIP/Postal Code
34890
Country
Turkey
Individual Site Status
Completed
Facility Name
I.E.U. Medical Point Hastanesi ( Site 2115)
City
Izmir
ZIP/Postal Code
35520
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+902323995050
Facility Name
Erciyes University Medical Faculty ( Site 2109)
City
Kayseri
ZIP/Postal Code
38030
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+903522076666
Facility Name
Sakarya Universitesi Tip Fakultesi Hastanesi ( Site 2114)
City
Sakarya
ZIP/Postal Code
54290
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+905052014666
Facility Name
Medical center Medikal Plaza of Ecodnipro LLC ( Site 2207)
City
Dnipro
State/Province
Dnipropetrovska Oblast
ZIP/Postal Code
49055
Country
Ukraine
Individual Site Status
Completed
Facility Name
Regional Centre of Oncology-Thoracic organs ( Site 2202)
City
Kharkiv
State/Province
Kharkivska Oblast
ZIP/Postal Code
61070
Country
Ukraine
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+380503802915
Facility Name
Ukrainian Center of Tomotherapy ( Site 2206)
City
Kropyvnitskiy
State/Province
Kirovohradska Oblast
ZIP/Postal Code
25011
Country
Ukraine
Individual Site Status
Suspended
Facility Name
Medical Center of Yuriy Spizhenko LLC.-Clinical Trial ( Site 2205)
City
Kapitanivka Village
State/Province
Kyivska Oblast
ZIP/Postal Code
08111
Country
Ukraine
Individual Site Status
Completed
Facility Name
Medical Center Asklepion LLC ( Site 2208)
City
Khodosivka
State/Province
Kyivska Oblast
ZIP/Postal Code
08173
Country
Ukraine
Individual Site Status
Completed
Facility Name
Medical and Diagnostic Centre LLC Dobryi Prognoz ( Site 2203)
City
Kyiv
State/Province
Kyivska Oblast
ZIP/Postal Code
03126
Country
Ukraine
Individual Site Status
Completed
Facility Name
Kyiv City Clinical Oncology Centre ( Site 2200)
City
Kyiv
ZIP/Postal Code
03115
Country
Ukraine
Individual Site Status
Completed
Facility Name
University Hospitals Bristol NHS Foundation Trust ( Site 1802)
City
Bristol
State/Province
Bristol, City Of
ZIP/Postal Code
BS2 8ED
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+447884216871
Facility Name
Royal Free London NHS Foundation Trust ( Site 1813)
City
London
State/Province
Camden
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
02077940500
Facility Name
Weston Park Hospital ( Site 1801)
City
Sheffield
State/Province
Derbyshire
ZIP/Postal Code
S10 2SJ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+441142265913
Facility Name
Clatterbridge Cancer Center NHS FT ( Site 1800)
City
Liverpool
State/Province
England
ZIP/Postal Code
L7 8YA
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+441515565723
Facility Name
Lancashire Teaching Hospitals NHS Foundation Trust ( Site 1809)
City
Preston
State/Province
Lancashire
ZIP/Postal Code
PR2 9HT
Country
United Kingdom
Individual Site Status
Completed
Facility Name
Leicester Royal Infirmary ( Site 1811)
City
Leicester
State/Province
Leicestershire
ZIP/Postal Code
LE1 5WW
Country
United Kingdom
Individual Site Status
Completed
Facility Name
University College London Hospital NHS Foundation Trust ( Site 1806)
City
London
State/Province
London, City Of
ZIP/Postal Code
NW1 2BU
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+447929450961
Facility Name
Guy s and St Thomas Hospital NHS Foundation Trust ( Site 1808)
City
London
State/Province
London, City Of
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+02071882006
Facility Name
Norfolk and Norwich University Foundation NHS Trust ( Site 1805)
City
Norwich
State/Province
Norfolk
ZIP/Postal Code
NR47UY
Country
United Kingdom
Individual Site Status
Completed
Facility Name
Oxford University Hospitals NHS Foundation Trust ( Site 1812)
City
Oxford
State/Province
Oxfordshire
ZIP/Postal Code
OX3 7LE
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+441865235206
Facility Name
Darlington Memorial Hospital NHS Trust ( Site 1810)
City
Darlington
ZIP/Postal Code
DLX 6HX
Country
United Kingdom
Individual Site Status
Completed
Facility Name
Mount Vernon Hospital ( Site 1803)
City
Northwood
ZIP/Postal Code
HA6 2RN
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+441438284298
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
IPD Sharing URL
http://engagezone.msd.com/ds_documentation.php
Links:
URL
https://www.merckclinicaltrials.com/
Description
Merck Clinical Trials Information
URL
https://trialstransparency.merckclinicaltrials.com/Study.aspx?id=3475-867&&kw=3475-867
Description
Plain Language Summary
Learn more about this trial
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)
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