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)

Phase 3

Completed

Conditions: Non-Small Cell Lung Cancer

Interventions: Radiation: Stereotactic Body Radiotherapy (SBRT)
Biological: Pembrolizumab
Drug: Placebo

Registration Number: NCT03924869

Lead Sponsor: Merck Sharp & Dohme LLC

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).

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

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 448

Inclusion Criteria

Has previously untreated non-small cell lung cancer (NSCLC) diagnosed by histology or cytology and confirmed as Stage I or II (T1 to limited T3, N0, M0) NSCLC (American Joint Committee on Cancer, AJCC) by chest computed tomography (CT) and positron emission tomography (PET) scan. Participants with pericardium invasion, >2 nodules or 2 nodules that cannot be treated in one field (>2 cm apart and/or total planned target volume [PTV] >163 cc) and diaphragm elevation suggestive of phrenic nerve invasion are excluded
Cannot undergo thoracic surgery due to existing medical illness(es) as determined by the site's multi-disciplinary tumor board. Medically operable participants who decide to treat with stereotactic body radiotherapy (SBRT) as definitive therapy rather than surgery are also eligible, if patient's unwillingness to undergo surgical resection is clearly documented
Has a Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
Is able to receive SBRT and does not have an ultra-centrally located tumor
Has adequate organ function within 7 days prior to the start of study treatment
A female is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: a) not a women of childbearing potential (WOCBP) OR b) A WOCBP and uses contraceptive method that is highly effective (with a failure rate of <1% per year), or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis), during the intervention period and for at least 120 days after the last dose of pembrolizumab/placebo and 180 days after the last radiotherapy dose
Male participants are eligible to participate if they agree to the following during the intervention period and for at least 90 days after the last dose of radiotherapy: refrain from donating sperm plus either be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agree to remain abstinent or must agree to use contraception per study protocol, unless confirmed to be azoospermic
Has a radiation therapy plan approved by the central radiation therapy quality assurance vendor

Exclusion Criteria

Has received prior therapy with an anti-programmed cell death-1 (anti-PD-1), anti-programmed cell death-ligand 1 (anti-PD-L1), or anti PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g. cytotoxic T-lymphocyte-associated antigen 4 [CTLA-4], tumor necrosis factor receptor superfamily member 4 [OX-40], tumor necrosis factor receptor superfamily member 9 [CD137])
Has received prior radiotherapy to the thorax, including radiotherapy to the esophagus, mediastinum, or breast
Has received a live vaccine within 30 days prior to the first dose of study intervention
Has received an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention administration
Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study treatment
Has a known additional malignancy that is progressing or has required active treatment within the past 3 years. A prior NSCLC that occurred and was treated curatively at least 2 years prior to the date of the current diagnosis would be considered a separate primary lung cancer, and therefore an additional malignancy. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g. breast c carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded.
Has a known hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients
Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis
Has a known history of Hepatitis B or known active Hepatitis C virus infection
Has an active autoimmune disease that has required systemic treatment in past 2 years, except replacement therapy
Has an active infection requiring systemic therapy
Has a known history of human immunodeficiency virus (HIV) infection
Has a known history of active tuberculosis (TB; Bacillus tuberculosis)
Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of pembrolizumab/placebo and 180 days after the last radiotherapy dose
Have not adequately recovered from major surgery or have ongoing surgical complications
Has had an allogenic tissue/solid organ transplant

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SBRT + Pembolizumab	Stereotactic Body Radiotherapy (SBRT)	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.
SBRT + Pembolizumab	Pembrolizumab	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.
SBRT + Placebo	Stereotactic Body Radiotherapy (SBRT)	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.
SBRT + Placebo	Placebo	Participants receive SBRT once every 3 days for 3, 4, 5, or 8 fractions (dependent on tumor type/location; 45-70 Gy total) over approximately 2 weeks PLUS placebo (normal saline solution) via IV infusion once every 3 weeks for up to 17 cycles (up to approximately 1 year). Each cycle is 21 days.

Primary Outcome Measures

Name	Time	Method
Event-free Survival (EFS)	Up to approximately 56.8 months	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.

Secondary Outcome Measures

Name	Time	Method
Overall Survival (OS)	Up to approximately 56.8 months	OS was defined as the time from date of randomization to date of death from any cause. OS was reported for each arm.
Time to Death or Distant Metastases (TDDM)	Up to approximately 56.8 months	TTDM was defined as the time from randomization to the first documented distant metastases or death from any cause, whichever occurred first. The TDDM was reported for each arm.
Number of Participants Who Experience an Adverse Event (AE)	Up to approximately 66 months	An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience an AE will be presented.
Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE)	Up to approximately 63 months	An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who 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	Baseline and up to 24 weeks	The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the questions "How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?" were scored on a 7-point scale (1=Very Poor to 7=Excellent). The combined score of Global Health Status (EORTC QLQ-C30 Item 29) and Quality of Life (EORTC QLQ-C30 Item 30) was computed by averaging the raw scores of the 2 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicates a better outcome. The change from baseline in GHS/QoL combined score was reported for each arm.
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	Baseline and up to 24 weeks	The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. The EORTC QLQ-LC13 is a lung cancer-specific supplemental questionnaire used in combination with the EORTC QLQ-C30. Participant responses to the EORTC QLQ-LC13 question "How much did you cough?" were scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores were standardized, so that scores ranged from 0 to 100. A lower score indicates a better outcome. The change from baseline in cough (EORTC QLQ LC13 Item 31) score was reported for each arm.
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer Module 13 (EORTC QLQ-LC13) Chest Pain (Item 40) Score	Baseline and up to 24 weeks	The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. The EORTC QLQ-LC13 is a lung cancer-specific supplemental questionnaire used in combination with the EORTC QLQ-C30. Participant responses to the question "Have you had pain in your chest?" were scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores were standardized, so that scores ranged from 0 to 100. A lower score indicates a better outcome. The change from baseline in chest pain (EORTC QLQ-LC13 Item 40) score was reported for each arm.
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	Baseline and up to 24 weeks	The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the question "Were you short of breath?" were scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores were standardized, so that scores ranged from 0 to 100. A lower score indicates a better outcome. The change from baseline in dyspnea (EORTC QLQ-C30 Item 8) score was reported for each arm.
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	Baseline and up to 24 weeks	The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to 5 questions about their physical functioning were scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores were standardized, so that scores ranged from 0 to 100. A higher score indicates a better quality of life. The change from baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) combined score was reported for each arm.

Trial Locations

Locations (194): Trillium Health Partners - Credit Valley Hospital ( Site 0102)
🇨🇦
Mississauga, Ontario, Canada
Moncton Hospital - Horizon Health Network ( Site 0105)
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Moncton, New Brunswick, Canada
Kingston Health Sciences Centre ( Site 0100)
🇨🇦
Kingston, Ontario, Canada
USC Norris Comprehensive Cancer Center ( Site 0007)
🇺🇸
Los Angeles, California, United States
Institut Curie ( Site 1112)
🇫🇷
Paris, France
Massachusetts General Hospital-Cancer Center Protocol Office ( Site 3007)
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Boston, Massachusetts, United States
Allegheny General Hospital ( Site 3028)
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Pittsburgh, Pennsylvania, United States
Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs ( Site 0301)
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Porto Alegre, Rio Grande Do Sul, Brazil
Irmandade da Santa Casa de Misericordia de Porto Alegre ( Site 0318)
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Porto Alegre, Rio Grande Do Sul, Brazil
University of Alabama ( Site 0099)
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Birmingham, Alabama, United States
National Jewish Health ( Site 0010)
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Denver, Colorado, United States
University of Minnesota ( Site 0069)
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Minneapolis, Minnesota, United States
Vanderbilt University Medical Center ( Site 0075)
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Nashville, Tennessee, United States
A.O. Universitaria Careggi ( Site 1301)
🇮🇹
Firenze, Italy
A.C. Camargo Cancer Center ( Site 0312)
🇧🇷
Sao Paulo, Brazil
Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi-oncology ( Site 2116)
🇹🇷
Istanbul, Turkey
I.E.U. Medical Point Hastanesi ( Site 2115)
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Izmir, Turkey
Seoul National University Hospital ( Site 2600)
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Seoul, Korea, Republic of
Universitaetsklinikum Heidelberg. ( Site 1204)
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Heidelberg, Baden-Wurttemberg, Germany
Universitaetsklinikum Erlangen ( Site 1209)
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Erlangen, Bayern, Germany
Orszagos Koranyi Pulmonologiai Intezet ( Site 2306)
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Budapest, Hungary
Universitaetsklinikum Essen ( Site 1201)
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Essen, Nordrhein-Westfalen, Germany
Infirmary Cancer Care ( Site 3044)
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Mobile, Alabama, United States
Alaska Oncology and Hematology ( Site 3063)
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Anchorage, Alaska, United States
CARTI Cancer Center ( Site 3045)
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Little Rock, Arkansas, United States
Banner MD Anderson Cancer Center ( Site 3029)
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Gilbert, Arizona, United States
Veterans Affairs Palo Alto Health Care System ( Site 3039)
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Palo Alto, California, United States
Yale University ( Site 0011)
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New Haven, Connecticut, United States
Mid Florida Hematology and Oncology Center ( Site 0067)
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Orange City, Florida, United States
Franciscan Health Indianapolis ( Site 0024)
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Indianapolis, Indiana, United States
H. Lee Moffitt Cancer Center and Research Institute ( Site 0016)
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Tampa, Florida, United States
Goshen Center for Cancer Care ( Site 0022)
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Goshen, Indiana, United States
William E. Kahlert Regional Cancer Center ( Site 3031)
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Westminster, Maryland, United States
Sinai Hospital of Baltimore ( Site 3011)
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Baltimore, Maryland, United States
Mass General / North Shore Center for Outpatient Care ( Site 3040)
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Danvers, Massachusetts, United States
University of Kentucky School of Medicine & Hospitals ( Site 0026)
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Lexington, Kentucky, United States
University of Massachusetts ( Site 0029)
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Worcester, Massachusetts, United States
University of Missouri Hospital ( Site 3058)
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Columbia, Missouri, United States
Cox Medical Center North-Cox Medical Center/Hulston Cancer Center/ Radiation Oncology ( Site 3060)
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Springfield, Missouri, United States
Sanford Bemidji ( Site 0080)
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Bemidji, Minnesota, United States
John Theurer Cancer Center at Hackensack University Medical Center ( Site 3036)
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Hackensack, New Jersey, United States
St. Vincent Healthcare Frontier Cancer Center ( Site 3012)
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Billings, Montana, United States
Hematology-Oncology Associates of CNY ( Site 3055)
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East Syracuse, New York, United States
Rutgers Cancer Institute of New Jersey ( Site 0043)
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New Brunswick, New Jersey, United States
White Plains Hospital ( Site 3014)
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White Plains, New York, United States
Westchester Medical Center ( Site 3057)
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Valhalla, New York, United States
Mount Sinai Hospital ( Site 0046)
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New York, New York, United States
Sanford Health Roger Maris Cancer Center ( Site 0079)
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Fargo, North Dakota, United States
St. Luke's University Health Network ( Site 3006)
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Bethlehem, Pennsylvania, United States
Lehigh Valley Hospital- Cedar Crest ( Site 3005)
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Allentown, Pennsylvania, United States
Fox Chase Cancer Center ( Site 0051)
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Philadelphia, Pennsylvania, United States
Sanford Cancer Center Oncology Clinic ( Site 0053)
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Sioux Falls, South Dakota, United States
Penn State University Milton S. Hershey Medical Center ( Site 0064)
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Hershey, Pennsylvania, United States
Lankenau Medical Center ( Site 3041)
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Wynnewood, Pennsylvania, United States
Mountain States Health Alliance ( Site 3054)
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Johnson City, Tennessee, United States
University of Tennessee Medical Center Knoxville ( Site 3010)
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Knoxville, Tennessee, United States
Hospital Italiano de Buenos Aires-Clinical Oncology ( Site 0206)
🇦🇷
ABB, Caba, Argentina
Cancer Care Northwest ( Site 0063)
🇺🇸
Spokane Valley, Washington, United States
Hospital Britanico de Buenos Aires ( Site 0204)
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Buenos Aires, Caba, Argentina
Hospital Aleman ( Site 0200)
🇦🇷
Buenos Aires, Argentina
Instituto Medico Especializado Alexander Fleming ( Site 0203)
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Buenos Aires, Argentina
Hospital Provincial del Centenario ( Site 0205)
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Rosario, Santa Fe, Argentina
IDIM Instituto de Diagnostico e Investigaciones Metabolicas ( Site 0208)
🇦🇷
Buenos Aires, Argentina
CEMIC ( Site 0201)
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Buenos Aires, Argentina
Austin Health ( Site 2501)
🇦🇺
Melbourne, Victoria, Australia
GenesisCare North Shore ( Site 2508)
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St Leonards, New South Wales, Australia
Port Macquarie Base Hospital ( Site 2500)
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Port Macquarie, New South Wales, Australia
Royal Brisbane and Women s Hospital ( Site 2502)
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Herston, Queensland, Australia
Universitatsklinik LKH Innsbruck ( Site 0802)
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Innsbruck, Tirol, Austria
Icon Cancer Centre Hobart ( Site 2507)
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Hobart, Tasmania, Australia
Keppler Universitatsklinikum ( Site 0806)
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Linz, Oberosterreich, Austria
Landeskrankenhaus - Universitatsklinikum Graz ( Site 0804)
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Graz, Steiermark, Austria
Clínica de Oncologia Reichow ( Site 0319)
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Blumenau, Santa Catarina, Brazil
Social Medical Center - Otto Wagner Hospital ( Site 0801)
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Vienna, Wien, Austria
Hospital e Maternidade Celso Pierro ( Site 0313)
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Campinas, Sao Paulo, Brazil
Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 0300)
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Sao Paulo, Brazil
Instituto Nacional Do Cancer Jose Alencar Gomes Da Silva ( Site 0305)
🇧🇷
Rio de Janeiro, Brazil
Hospital Paulistano - Amil Clinical Research ( Site 0316)
🇧🇷
Sao Paulo, Brazil
Sault Area Hospital ( Site 0101)
🇨🇦
Sault Ste Marie, Ontario, Canada
Health Sciences North Research Institute ( Site 0107)
🇨🇦
Sudbury, Ontario, Canada
The Ottawa Hospital ( Site 0104)
🇨🇦
Ottawa, Ontario, Canada
McGill University Health Centre ( Site 0113)
🇨🇦
Montréal, Quebec, Canada
CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont ( Site 0110)
🇨🇦
Montreal, Quebec, Canada
CHUS - Hopital Fleurimont ( Site 0111)
🇨🇦
Sherbrooke, Quebec, Canada
Institut Bergonie ( Site 1102)
🇫🇷
Bordeaux, Gironde, France
CHU Poitiers ( Site 1109)
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Poitiers, Ain, France
CHU de Brest -Site Hopital Morvan ( Site 1100)
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Brest, Finistere, France
CHU de Rouen ( Site 1113)
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Rouen, Seine-Maritime, France
Hopital Sud du Amiens ( Site 1115)
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Amiens, Somme, France
Institut Regional du Cancer de Montpellier - ICM ( Site 1108)
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Montpellier, Herault, France
Hopital Cochin ( Site 1107)
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Paris, France
A.P.H. Paris. Hopital Bichat Claude Bernard ( Site 1114)
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Paris, France
Klinikum Esslingen-Klinik für Kardiologie und Pneumologie ( Site 1208)
🇩🇪
Esslingen, Baden-Wurttemberg, Germany
UKGM Gießen/Marburg-Medical Clinic V ( Site 1210)
🇩🇪
Gießen, Hessen, Germany
Bacs-Kiskun Varmegyei Oktatokorhaz-Onkoradiologiai Kozpont ( Site 2311)
🇭🇺
Kecskemét, Bacs-Kiskun, Hungary
Pius Hospital Oldenburg ( Site 1202)
🇩🇪
Oldenburg, Niedersachsen, Germany
Charite Universitaetsmedizin Berlin ( Site 1207)
🇩🇪
Berlin, Germany
Pécsi Tudományegyetem Klinikai Központ-Onkoterápiás Intézet ( Site 2314)
🇭🇺
Pécs, Baranya, Hungary
CRU Hungary KFT ( Site 2309)
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Miskolc, Borsod-Abauj-Zemplen, Hungary
Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz ( Site 2312)
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Szekesfehervar, Fejer, Hungary
Petz Aladar Megyei Oktato Korhaz ( Site 2305)
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Gyor, Gyor-Moson-Sopron, Hungary
Debreceni Egyetem Klinikai Kozpont ( Site 2301)
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Debrecen, Hajdu-Bihar, Hungary
Jász-Nagykun-Szolnok Vármegyei Hetényi Géza Kórház ( Site 2310)
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Szolnok, Jasz-Nagykun-Szolnok, Hungary
Törökbálinti Tüdőgyógyintézet ( Site 2302)
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Torokbalint, Pest, Hungary
Evangelisches Krankenhaus Hamm gGmbH ( Site 1205)
🇩🇪
Hamm, Nordrhein-Westfalen, Germany
Orszagos Onkologiai Intezet ( Site 2308)
🇭🇺
Budapest, Hungary
Semmelweis University ( Site 2303)
🇭🇺
Budapest, Hungary
Ospedale Santissima Annunziata ( Site 1303)
🇮🇹
Chieti, Italy
Somogy Megyei Kaposi Mor Oktato Korhaz ( Site 2307)
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Kaposvar, Somogy, Hungary
Farkasgyepui Tudogyogyintezet ( Site 2313)
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Farkasgyepu, Veszprem, Hungary
Orszagos Koranyi Pulmonologiai Intezet ( Site 2304)
🇭🇺
Budapest, Hungary
Policlinico di Modena ( Site 1306)
🇮🇹
Modena, Italy
Aichi Cancer Center Hospital ( Site 2804)
🇯🇵
Nagoya, Aichi, Japan
Policlinico Agostino Gemelli ( Site 1302)
🇮🇹
Roma, Italy
Azienda Ospedaliera S. Giovanni Addolorata-Oncologia Medica ( Site 1309)
🇮🇹
Roma, Italy
National Cancer Center Hospital East ( Site 2800)
🇯🇵
Kashiwa, Chiba, Japan
Kurume University Hospital ( Site 2815)
🇯🇵
Kurume, Fukuoka, Japan
Kobe Minimally Invasive Cancer Center ( Site 2811)
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Kobe, Hyogo, Japan
University of Tsukuba Hospital ( Site 2809)
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Tsukuba, Ibaraki, Japan
Sendai Kousei Hospital ( Site 2814)
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Sendai, Miyagi, Japan
Kansai Medical University Hospital ( Site 2808)
🇯🇵
Hirakata, Osaka, Japan
University of Yamanashi Hospital ( Site 2807)
🇯🇵
Chuo, Yamanashi, Japan
Osaka Medical and Pharmaceutical University Hospital ( Site 2813)
🇯🇵
Takatsuki, Osaka, Japan
Chiba University Hospital ( Site 2806)
🇯🇵
Chiba, Japan
National Hospital Organization Kyushu Cancer Center ( Site 2816)
🇯🇵
Fukuoka, Japan
Hiroshima University Hospital ( Site 2810)
🇯🇵
Hiroshima, Japan
Niigata Cancer Center Hospital ( Site 2801)
🇯🇵
Niigata, Japan
Osaka International Cancer Institute ( Site 2812)
🇯🇵
Osaka, Japan
Tokyo Metropolitan Komagome Hospital ( Site 2802)
🇯🇵
Tokyo, Japan
The Cancer Institute Hospital of JFCR ( Site 2803)
🇯🇵
Tokyo, Japan
National Cancer Center ( Site 2604)
🇰🇷
Goyang-si, Kyonggi-do, Korea, Republic of
Showa University Hospital ( Site 2805)
🇯🇵
Tokyo, Japan
The Catholic University of Korea St. Vincent s Hospital ( Site 2606)
🇰🇷
Gyeonggi-do, Kyonggi-do, Korea, Republic of
Chungbuk National University Hospital ( Site 2605)
🇰🇷
Cheongju-si, Chungbuk, Korea, Republic of
Ziekenhuis Rijnstate ( Site 1405)
🇳🇱
Arnhem, Gelderland, Netherlands
Tergooiziekenhuizen, locatie Hilversum-Oncology ( Site 1407)
🇳🇱
Hilversum, Noord-Holland, Netherlands
Samsung Medical Center ( Site 2603)
🇰🇷
Seoul, Korea, Republic of
St Olavs Hospital ( Site 1504)
🇳🇴
Trondheim, Sor-Trondelag, Norway
Auckland City Hospital ( Site 2900)
🇳🇿
Grafton, Auckland, New Zealand
Helse Bergen HF Haukeland Universitetssykehus ( Site 1502)
🇳🇴
Bergen, Vestfold, Norway
Oslo Universitetssykehus HF Ulleval Sykehus ( Site 1500)
🇳🇴
Oslo, Norway
Centrum Onkologii im. prof. Franciszka ukaszczyka-Ambulatorium Chemioterapii ( Site 2407)
🇵🇱
Bydgoszcz, Kujawsko-pomorskie, Poland
Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie ( Site 2400)
🇵🇱
Krakow, Malopolskie, Poland
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii ( Site 2402)
🇵🇱
Lodz, Lodzkie, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie (
🇵🇱
Warszawa, Mazowieckie, Poland
Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 2403)
🇵🇱
Gliwice, Slaskie, Poland
SPZOZ MSWIA z Warminsko-Mazurskim Centrum Onkologii w Olsztynie ( Site 2404)
🇵🇱
Olsztyn, Warminsko-mazurskie, Poland
Amethyst Radiotherapy Center-Oncologie Medicala ( Site 3201)
🇷🇴
Florești, Cluj, Romania
Institutul Oncologic-Oncologie Medicala ( Site 3202)
🇷🇴
Cluj, Romania
N.N.Blokhin Russian Cancer Research center ( Site 2013)
🇷🇺
Moscow, Moskva, Russian Federation
GUZ Lipetsk Regional Oncology Dispensary ( Site 2010)
🇷🇺
Lipetsk, Lipetskaya Oblast, Russian Federation
Chelyabinsk Regional Clinical Oncology Dispensary ( Site 2014)
🇷🇺
Chelyabinsk, Chelyabinskaya Oblast, Russian Federation
Russian Scientific Center of Roentgenoradiology ( Site 2011)
🇷🇺
Moscow, Moskva, Russian Federation
Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 2000)
🇷🇺
Saint-Petersburg, Sankt-Peterburg, Russian Federation
Medical institute named after Berezin Sergey ( Site 2009)
🇷🇺
St. Petersburg, Sankt-Peterburg, Russian Federation
Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 2001)
🇷🇺
Kazan, Tatarstan, Respublika, Russian Federation
Hospital Universitario Quiron Madrid ( Site 1601)
🇪🇸
Pozuelo de Alarcon, Madrid, Spain
Sverdlovsk Regional Oncology Hospital ( Site 2012)
🇷🇺
Ekaterinburg, Sverdlovskaya Oblast, Russian Federation
Hospital Universitario La Fe ( Site 1603)
🇪🇸
Valencia, Valenciana, Comunitat, Spain
Hospital General Universitari Vall d Hebron ( Site 1602)
🇪🇸
Barcelona, Spain
Hopitaux Universitaires de Geneve HUG ( Site 1706)
🇨🇭
Geneva, Geneve, Switzerland
Hospital General Universitario Gregorio Maranon ( Site 1604)
🇪🇸
Madrid, Spain
Kaohsiung Medical University Chung-Ho Memorial Hospital ( Site 3304)
🇨🇳
Kaohsiung, Taiwan
Taipei Medical University Hospital ( Site 3303)
🇨🇳
Taipei, Taiwan
Baskent Adana Dr Turgut Noyan Uygulama ve Arastirma Merkezi ( Site 2105)
🇹🇷
Adana, Turkey
Dr Abdurrahman Yurtaslan Oncology Training and Research Hospital ( Site 2101)
🇹🇷
Ankara, Turkey
Taipei Veterans General Hospital ( Site 3301)
🇨🇳
Taipei, Taiwan
Hacettepe University Medical Faculty ( Site 2100)
🇹🇷
Ankara, Turkey
Kartal Training and Research Hospital ( Site 2102)
🇹🇷
Istanbul, Turkey
Erciyes University Medical Faculty ( Site 2109)
🇹🇷
Kayseri, Turkey
Sakarya Universitesi Tip Fakultesi Hastanesi ( Site 2114)
🇹🇷
Sakarya, Turkey
Medical center Medikal Plaza of Ecodnipro LLC ( Site 2207)
🇺🇦
Dnipro, Dnipropetrovska Oblast, Ukraine
Ukrainian Center of Tomotherapy ( Site 2206)
🇺🇦
Kropyvnitskiy, Kirovohradska Oblast, Ukraine
Medical Center of Yuriy Spizhenko LLC.-Clinical Trial ( Site 2205)
🇺🇦
Kapitanivka Village, Kyivska Oblast, Ukraine
Kyiv City Clinical Oncology Centre ( Site 2200)
🇺🇦
Kyiv, Ukraine
University Hospitals Bristol NHS Foundation Trust ( Site 1802)
🇬🇧
Bristol, Bristol, City Of, United Kingdom
Royal Free London NHS Foundation Trust ( Site 1813)
🇬🇧
London, Camden, United Kingdom
Clatterbridge Cancer Center NHS FT ( Site 1800)
🇬🇧
Liverpool, England, United Kingdom
Leicester Royal Infirmary ( Site 1811)
🇬🇧
Leicester, Leicestershire, United Kingdom
Lancashire Teaching Hospitals NHS Foundation Trust ( Site 1809)
🇬🇧
Preston, Lancashire, United Kingdom
University College London Hospital NHS Foundation Trust ( Site 1806)
🇬🇧
London, London, City Of, United Kingdom
Guy s and St Thomas Hospital NHS Foundation Trust ( Site 1808)
🇬🇧
London, London, City Of, United Kingdom
Norfolk and Norwich University Foundation NHS Trust ( Site 1805)
🇬🇧
Norwich, Norfolk, United Kingdom
Darlington Memorial Hospital NHS Trust ( Site 1810)
🇬🇧
Darlington, United Kingdom
Mount Vernon Hospital ( Site 1803)
🇬🇧
Northwood, United Kingdom
Medical Center Asklepion LLC ( Site 2208)
🇺🇦
Khodosivka, Kyivska Oblast, Ukraine
Oxford University Hospitals NHS Foundation Trust ( Site 1812)
🇬🇧
Oxford, Oxfordshire, United Kingdom
Sanatorio Parque ( Site 0207)
🇦🇷
Rosario, Santa Fe, Argentina
Meander Medisch Centrum-Studie Team Oncologie ( Site 1403)
🇳🇱
Amersfoort, Utrecht, Netherlands
Weston Park Hospital ( Site 1801)
🇬🇧
Sheffield, Derbyshire, United Kingdom
Universitaetsspital Zuerich ( Site 1700)
🇨🇭
Zuerich, Zurich, Switzerland
Medical and Diagnostic Centre LLC Dobryi Prognoz ( Site 2203)
🇺🇦
Kyiv, Kyivska Oblast, Ukraine
Regional Centre of Oncology-Thoracic organs ( Site 2202)
🇺🇦
Kharkiv, Kharkivska Oblast, Ukraine
Tri-Service General Hospital ( Site 3300)
🇨🇳
Taipei City, Taipei, Taiwan