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NCT07361497RecruitingPhase 3

A Study to Evaluate Pumitamig Versus Durvalumab Following Concurrent Chemoradiation Therapy in Participants With Unresectable Stage III Non-small Cell Lung Cancer (NSCLC) (ROSETTA Lung-201)

ROSETTA Lung-201: A Randomized, Multicenter, Open-label Phase 3 Study of Pumitamig Monotherapy Compared to Durvalumab in Participants With Unresectable Stage III NSCLC Without Progression After Platinum-based Concurrent Chemoradiation Therapy.

Source: ClinicalTrials.gov · Last updated 5 Nov 2026

Brief summary (registry, in English)

A study to evaluate Pumitamig versus Durvalumab following concurrent chemoradiation therapy in participants with unresectable stage III Non-small Cell Lung Cancer (NSCLC)

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
850 (estimated)
First submitted
21 Jan 2026
Start date
16 Mar 2026
Primary completion date
18 Sept 2030
Lead sponsor
Bristol-Myers Squibb
Diseases
Lung cancer
NCT number
NCT07361497
EU CT number
2025-523576-23-00

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 850
  • From 16 Mar 2026 to the primary completion date, 18 Sept 2030
  • 256 sites in 32 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Participants must not have significant cardiovascular impairment such as uncontrolled hypertension (despite optimal medical treatment), congestive heart failure, active coronary disease (within 6 months prior to randomization), ventricular arrhythmias, major thrombotic or embolic events or major hemorrhagic events within 6 months prior to randomization, or significant risk of pulmonary hemorrhage.
  • Participants must not have advanced/clinically significant lung disease (within 6 months prior to randomization) or history of interstitial lung disease (ILD) or pneumonitis requiring treatment with systemic steroids (≥ Grade 2), or current or suspected ILD or pneumonitis.
  • Participants must not have any prior anticancer therapy (outside of CCRT) for locally advanced Stage III disease.

Other illness

  • Participants must not have an active autoimmune disease.

Lab values

  • Participants with non-squamous histology must not have documented Epidermal Growth Factor Receptor (EGFR) and anaplastic lymphoma kinase (ALK) rearrangements.

Other

  • Other protocol-defined Inclusion/Exclusion criteria apply.

Who the study is looking for

  • Participants must have a histologically- or cytologically-confirmed diagnoses of non-small cell lung cancer (NSCLC) with unresectable Stage III disease.
  • Participants must have received at least 2 cycles of platinum-based concurrent chemoradiotherapy (a total dose of radiation of at least 54 Gy).
  • Participants must have no progressive disease (PD) following treatment with concurrent chemoradiotherapy (CCRT).
  • Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (256)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Instituto Argentino De Diagnostico Y Tratamiento IADT
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Buenas AiresArgentinaRecruiting
Clinica Adventista Belgrano
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Buenos AiresArgentinaRecruiting
Hospital Italiano de Buenos Aires
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Buenos AiresArgentinaRecruiting
Instituto Medico Especializado Alexander Fleming
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Buenos AiresArgentinaRecruiting
Hospital Privado Universitario de Córdoba
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CórdobaArgentinaRecruiting
Instituto de Investigaciones Clinicas Cordoba S.A.
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CórdobaArgentinaRecruiting
Investigaciones Oncologicas C Colon SA
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Mar del PlataArgentinaRecruiting
Sanatorio Parque Rosario
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RosarioArgentinaRecruiting
Medizinische Universitaet Innsbruck
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InnsbruckAustriaRecruiting
Ordensklinikum Linz GmbH
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LinzAustriaRecruiting
Medical University of Vienna
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ViennaAustriaRecruiting
Grampians Health
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Ballarat CentralAustraliaRecruiting
Lyell McEwin Hospital
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Elizabeth ValeAustraliaRecruiting
Northern Hospital
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EppingAustraliaRecruiting
Gosford Hospital
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GosfordAustraliaRecruiting
Joondalup Health Campus
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JoondalupAustraliaRecruiting
Nepean Hospital
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PenrithAustraliaRecruiting
Westmead Hospital
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WestmeadAustraliaRecruiting
Institut Jules Bordet
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AnderlechtBelgiumRecruiting
Algemeen Ziekenhuis klina
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BrasschaatBelgiumRecruiting
Grand Hopital de Charleroi
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CharleroiBelgiumRecruiting
Ziekenhuis Oost-Limburg
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GenkBelgiumRecruiting
Universitair Ziekenhuis Gent
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GentBelgiumRecruiting
UZ Leuven
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LeuvenBelgiumRecruiting
Vitaz
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Sint-NiklaasBelgiumRecruiting
Specialized Hospital for Active Treatment of Oncology - Haskovo EOOD
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HaskovoBulgariaRecruiting
Complex Oncology Center Ruse EOOD
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RuseBulgariaRecruiting
Uniteversity Muliprofile Hospital For Active Treatment Tsaritsa Yoanna-Isul EAD
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SofiaBulgariaRecruiting
University Multidisciplinary Hospital For Active Treatment Sveta Ekaterina EAD
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SofiaBulgariaRecruiting
Diagnostics And Consultation Center Convex Ltd.
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SofiyaBulgariaRecruiting
Fundação Pio XII - Hospital de Câncer de Barretos
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BarretosBrazilRecruiting
Liga Norte Riograndense Contra o Cancer
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NatalBrazilRecruiting
Hospital de Clinicas de Porto Alegre
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Porto AlegreBrazilRecruiting
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto
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São José do Rio PretoBrazilRecruiting
Icesp - Instituto Do Câncer Do Estado de São Paulo
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São PauloBrazilRecruiting
Vencer Centro de Pesquisa LTDA
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TeresinaBrazilRecruiting
St. Marys Hospital Center
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MontrealCanadaRecruiting
The Ottawa Hospital - General Campus
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OttawaCanadaRecruiting
IUCPQ
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QuébecCanadaRecruiting
Universitaetsspital Basel
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BaselSwitzerlandRecruiting
Ospedale Regionale Bellinzona e Valli
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BellinzonaSwitzerlandRecruiting
Kantonsspital Münsterlingen - Spital Thurgau AG
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MünsterlingenSwitzerlandRecruiting
Kantonsspital St. Gallen
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Sankt GallenSwitzerlandRecruiting
Bradford Hill Norte
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AntofagastaChileRecruiting
Centro de Oncologia de Precision
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Las CondesChileRecruiting
Bradfordhill
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SantiagoChileRecruiting
FALP
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SantiagoChileRecruiting
Oncocentro APYS - Centro de Atencion Medica Oncologica Integral
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Viña del MarChileRecruiting
Beijing Cancer Hospital
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BeijingChinaRecruiting
-
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ChangshaChinaNot yet recruiting
West China Hospital,Sichuan University
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ChengduChinaRecruiting
Sichuan Cancer Hospital
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ChengduChinaRecruiting
Chongqing University Cancer Hospital
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ChongqingChinaRecruiting
Fujian Cancer Hospital
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FuzhouChinaRecruiting
Sun Yat-sen University Cancer Center
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GuangzhouChinaRecruiting
The second Affiliated Hospital of College of Medicine, Zhejiang University
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HangzhouChinaRecruiting
Zhejiang Cancer Hospital
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HangzhouChinaRecruiting
Qilu Hospital of Shandong University
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JinanChinaRecruiting
Shandong Cancer Hospital
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JinanChinaRecruiting
Jingzhou First People's Hospital
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JingzhouChinaRecruiting
Taizhou Hospital of Zhejiang Province
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LinhaiChinaRecruiting
The Second Affiliated Hospital of Nanchang University
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NanchangChinaRecruiting
-
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ShanghaiChinaNot yet recruiting
-
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Shanghai ShiChinaNot yet recruiting
Cancer Hospital of Shantou University Medical College
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ShantouChinaRecruiting
-
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ShenyangChinaNot yet recruiting
Peking University Shenzhen Hospital
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ShenzhenChinaRecruiting
The First Affiliated Hospital of Soochow University
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SuzhouChinaRecruiting
Shanxi Cancer hospital
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TaiyuanChinaRecruiting
-
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WuhanChinaWithdrawn
The Central Hospital of Wuhan
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WuhanChinaRecruiting
The Second Affiliated Hospital of Xi'an Jiaotong University
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Xi'anChinaRecruiting
The First Affiliated Hospital of Xi'an Jiaotong University
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Xi’anChinaRecruiting
Henan Cancer Hospital
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ZhengzhouChinaRecruiting
Universitaetsklinikum Augsburg
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AugsburgGermanyRecruiting
Charite Universitaetsmedizin Berlin KöR
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BerlinGermanyRecruiting
Helios Klinikum Emil von Behring GmbH
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BerlinGermanyRecruiting
Asklepios Klinik Gauting GmbH
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GautingGermanyRecruiting
Universitaetsmedizin Goettingen
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GoettingenGermanyRecruiting
LungenClinic Grosshansdorf GmbH
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GrosshansdorfGermanyRecruiting
Martha-Maria Krankenhaus Halle-Doelau gGmbH
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Halle (saale)GermanyRecruiting
Lungenfachklinik Immenhausen
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ImmenhausenGermanyRecruiting
Universitaetsklinikum Jena KöR
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JenaGermanyRecruiting
Katholisches Klinikum Koblenz Montabaur gGmbH
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KoblenzGermanyRecruiting
Klinikum der Stadt Ludwigshafen am Rhein gGmbH
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Ludwigshafen Am RheinGermanyRecruiting
Universitaetsklinikum Schleswig-Holstein AöR
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LuebeckGermanyRecruiting
Universitaetsklinikum Regensburg AöR
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RegensburgGermanyRecruiting
Hospital Universitario de Cruces
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BarakaldoSpainRecruiting
Hospital de la Santa Creu i Sant Pau
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BarcelonaSpainRecruiting
Hospital del Mar
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BarcelonaSpainRecruiting
Institut Català d'Oncologia
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GironaSpainRecruiting
Hospital Universitario 12 de Octubre
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MadridSpainRecruiting
Hospital Universitario Virgen de la Victoria
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MálagaSpainRecruiting
Hospital Universitario Virgen De La Macarena
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SevillaSpainRecruiting
Hospital Clinico Universitario de Valencia
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ValenciaSpainRecruiting
Hospital Clinico Universitario Lozano Blesa
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ZaragozaSpainRecruiting
Institut Bergonie
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BordeauxFranceRecruiting
Centr Georges Francois Leclerc
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DijonFranceRecruiting
Centre Hospitalier Universitaire de Lille
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LilleFranceRecruiting
Centre Hospitalier Et Universitaire de Limoges
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LimogesFranceRecruiting
Centre Leon Berard
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LyonFranceRecruiting
Centre Hospitalier Regional De Marseille
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MarseilleFranceRecruiting
Institut Regional Du Cancer De Montpellier
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Montpellier Cedex 5FranceRecruiting
Institut Curie
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ParisFranceRecruiting
Assistance Publique Hopitaux de Paris
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ParisFranceRecruiting
Centre Hospitalier Universitaire de Nantes
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Saint-HerblainFranceRecruiting
Centre Hospitalier Universitaire de Toulouse
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ToulouseFranceRecruiting
Institut Gustave Roussy
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VillejuifFranceRecruiting
-
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BirminghamUnited KingdomNot yet recruiting
Addenbrooke's Hospital
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CambridgeUnited KingdomRecruiting
Velindre Cancer Centre
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CardiffUnited KingdomRecruiting
The Royal Surrey County Hospital NHS Foundation Trust
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GuildfordUnited KingdomRecruiting
-
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LeedsUnited KingdomWithdrawn
Clatterbridge Cancer Centre - Liverpool
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LiverpoolUnited KingdomRecruiting
University College London Hospital
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LondonUnited KingdomRecruiting
Royal Marsden Hospital (Chelsea)
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LondonUnited KingdomRecruiting
The Christie NHS Foundation Trust
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ManchesterUnited KingdomRecruiting
Mount Vernon Hospital
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MiddlesexUnited KingdomRecruiting
-
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Newcastle upon TyneUnited KingdomNot yet recruiting
The Royal Marsden NHS Foundation Trust
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SuttonUnited KingdomRecruiting
Henry Dunant Hospital Center
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AthensGreeceRecruiting
Thoracic General Hospital of Athens "I Sotiria"
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AthensGreeceRecruiting
Laiko General Hospital of Athens
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AthensGreeceRecruiting
General Hospital Of Thessaloniki Papageorgiou
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EfkarpiaGreeceRecruiting
General University Hospital of Larissa
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LarissaGreeceRecruiting
Geniko Nosokomeio Thessalonikis George Papanikolaou
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ThessalonikiGreeceRecruiting
Queen Mary Hospital
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HksarHong Kong SAR ChinaRecruiting
-
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ShatinHong Kong SAR ChinaNot yet recruiting
-
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TuenmenHong Kong SAR ChinaNot yet recruiting
Orszagos Koranyi Pulmonologiai Intezet
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Budapest XIIHungaryRecruiting
Farkasgyepui Tudogyogyintezet
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FarkasgyepűHungaryRecruiting
Bacs-Kiskun Varmegyei Oktatokorhaz
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KecskemétHungaryRecruiting
Jasz-Nagykun-Szolnok Varmegyei Hetenyi Geza Korhaz-Rendelointézet
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SzolnokHungaryRecruiting
Református Pulmonológiai Centrum
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TörökbálintHungaryRecruiting
Mater Private Hospital
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Dublin 7IrelandRecruiting
St James's Hospital
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Dublin 8IrelandRecruiting
Beaumont Hospital
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Dublin 9IrelandRecruiting
-
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Chhatrapati SambhajinagarIndiaNot yet recruiting
-
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DelhiIndiaNot yet recruiting
-
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DwarkaIndiaNot yet recruiting
-
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EluruIndiaNot yet recruiting
-
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GorajIndiaNot yet recruiting
-
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HyderabadIndiaNot yet recruiting
-
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MumbaiIndiaNot yet recruiting
-
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NagpurIndiaNot yet recruiting
-
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New DelhiIndiaNot yet recruiting
-
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PūlakkōdIndiaNot yet recruiting
-
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PuneIndiaNot yet recruiting
Centro di Riferimento Oncologico di Aviano
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AvianoItalyRecruiting
Ospedale San Raffaele S.r.l.
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MilanItalyRecruiting
Istituto Europeo di Oncologia s.r.l
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MilanItalyRecruiting
IRCCS Istituto Nazionale Tumori Fondazione Pascale
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NaplesItalyRecruiting
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
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OrbassanoItalyRecruiting
Azienda Ospedaliero Universitaria Parma
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ParmaItalyRecruiting
Azienda Unità Sanitaria Locale della Romagna
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RavennaItalyRecruiting
Università Campus Bio-Medico di Roma
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RomeItalyRecruiting
Tokyo Metropolitan Komagome Hospital
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Bunkyo KuJapanRecruiting
National Hospital Organization Kyushu Cancer Center
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FukuokaJapanRecruiting
Hamamatsu University Hospital
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HamamatsuJapanRecruiting
Saitama Medical University International Medical Center
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HidakaJapanRecruiting
Kansai Medical University Hospital
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HirakataJapanRecruiting
Kobe University Hospital
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KobeJapanRecruiting
Aichi Cancer Center Hospital
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NagoyaJapanRecruiting
Hyogo Medical University Hospital
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NishinomiyaJapanRecruiting
Okayama University Hospital
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OkayamaJapanRecruiting
Kitasato University Hospital
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SagamiharaJapanRecruiting
Kindai University Hospital
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SakaiJapanRecruiting
Sendai Kousei Hospital
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SendaiJapanRecruiting
Tohoku University Hospital
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SendaiJapanRecruiting
Kanagawa Cancer Center
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YokohamaJapanRecruiting
Chungbuk National University Hospital
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Cheongju-siSouth KoreaRecruiting
Seoul National University Bundang Hospital
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SeongnamSouth KoreaRecruiting
Severance Hospital, Yonsei University Health System
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SeoulSouth KoreaRecruiting
Seoul National University Hospital
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SeoulSouth KoreaRecruiting
Asan Medical Center
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SeoulSouth KoreaRecruiting
Samsung Medical Center
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SeoulSouth KoreaRecruiting
-
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MonterreyMexicoNot yet recruiting
-
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Puebla CityMexicoNot yet recruiting
-
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QuerétaroMexicoNot yet recruiting
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SaltilloMexicoNot yet recruiting
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TijuanaMexicoNot yet recruiting
-
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ZapopanMexicoNot yet recruiting
Amsterdam UMC Stichting
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AmsterdamNetherlandsRecruiting
Amphia Hospital
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BredaNetherlandsRecruiting
Universitair Medisch Centrum Groningen
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GroningenNetherlandsRecruiting
Radboud universitair medisch centrum Stichting
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NijmegenNetherlandsRecruiting
Isala Klinieken Stichting
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ZwolleNetherlandsRecruiting
Uniwersyteckie Centrum Kliniczne im. Prof K. Gibinskiego Slaskiego Uniwersytetu Medycznego w Katowicach
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KatowicePolandRecruiting
Uniwersytecki Szpital Kliniczny nr 4 w Lublinie
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LublinPolandRecruiting
Opolskie Centrum Onkologii Im. Prof. Tadeusza Koszarowskiego W Opolu Samodzielny Publiczny Zaklad Opieki Zdrowotnej
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OpolePolandRecruiting
Wojewodzki Szpital im Sw Ojca Pio w Przemyslu
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PrzemyślPolandRecruiting
Centrul De Diagnostic Si Tratament Provita S.A.
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BucharestRomaniaRecruiting
Spitalul Universitar de Urgență București
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BucharestRomaniaRecruiting
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
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Cluj-NapocaRomaniaRecruiting
Centrul De Oncologie SF Nectarie S.R.L.
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CraiovaRomaniaRecruiting
Radiotherapy Center Cluj S.R.L.
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FlorestiRomaniaRecruiting
Centrul De Oncologie-Euroclinic S.R.L.
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IasiRomaniaRecruiting
Institutul Regional de Oncologie Iasi
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IașiRomaniaRecruiting
Asociatia Oncohelp
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TimișoaraRomaniaRecruiting
Region Gaevleborg
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GavleSwedenRecruiting
Karolinska University Hospital
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SolnaSwedenRecruiting
Uppsala University Hospital
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UppsalaSwedenRecruiting
National Cancer Centre Singapore
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SingaporeSingaporeRecruiting
Tan Tock Seng Hospital
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SingaporeSingaporeRecruiting
-
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BangkokThailandNot yet recruiting
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Chiang MaiThailandNot yet recruiting
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Khon KaenThailandNot yet recruiting
-
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SongkhlaThailandNot yet recruiting
Far Eastern Memorial Hospital
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New Taipei CityTaiwanRecruiting
Taichung Veterans General Hospital
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TaichungTaiwanRecruiting
National Taiwan University Hospital
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TaipeiTaiwanRecruiting
National Taiwan University Hospital - Hsinchu branch
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ZhubeiTaiwanRecruiting
Akron General Medical Center
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AkronUnited StatesRecruiting
Texas Oncology - Amarillo Cancer Center
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AmarilloUnited StatesRecruiting
Texas Oncology - Austin Central
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AustinUnited StatesRecruiting
-
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BostonUnited StatesNot yet recruiting
University of Chicago Medical Center
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ChicagoUnited StatesRecruiting
Blue Ridge Cancer Care
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ChristiansburgUnited StatesRecruiting
The Christ Hospital
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CincinnatiUnited StatesRecruiting
University Hospitals Cleveland Medical Center*
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ClevelandUnited StatesRecruiting
Cleveland Clinic
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ClevelandUnited StatesRecruiting
Missouri Cancer Associates
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ColumbiaUnited StatesRecruiting
Southern Cancer Center Pc
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DaphneUnited StatesRecruiting
Texas Oncology
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DentonUnited StatesRecruiting
Karmanos Cancer Institute
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DetroitUnited StatesRecruiting
Oncology Associates Of Oregon, Pc
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EugeneUnited StatesRecruiting
Endeavor Health
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EvanstonUnited StatesRecruiting
Fort Wayne Medical Oncology and Hematology
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Fort WayneUnited StatesRecruiting
The Center for Cancer and Blood Disorders
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Fort WorthUnited StatesRecruiting
Intermountain Health Cancer Center Lutheran Hospital
Coordinator of this site? Confirm its status
GoldenUnited StatesRecruiting
Northwest Cancer Specialists, P.C.
Coordinator of this site? Confirm its status
Happy ValleyUnited StatesRecruiting
The University of Texas MD Anderson Cancer Center
Coordinator of this site? Confirm its status
HoustonUnited StatesRecruiting
University of Kentucky Chandler Medical Center
Coordinator of this site? Confirm its status
LexingtonUnited StatesRecruiting
Minnesota Oncology Hematology
Coordinator of this site? Confirm its status
Maple GroveUnited StatesRecruiting
Northwest Georgia Oncology Centers, a Service of WellStar Cobb Hospital
Coordinator of this site? Confirm its status
MariettaUnited StatesRecruiting
Cleveland Clinic - Hillcrest Hospital
Coordinator of this site? Confirm its status
Mayfield HeightsUnited StatesRecruiting
Allina Health Cancer Institute - Abbott Northwestern Hospital
Coordinator of this site? Confirm its status
MinneapolisUnited StatesRecruiting
SCRI Oncology Partners
Coordinator of this site? Confirm its status
NashvilleUnited StatesRecruiting
Tennessee Oncology
Coordinator of this site? Confirm its status
NashvilleUnited StatesRecruiting
Medical Oncology Hematology Consultants PA
Coordinator of this site? Confirm its status
NewarkUnited StatesRecruiting
Memorial Sloan-Kettering Cancer Center
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New YorkUnited StatesRecruiting
Virginia Oncology Associates
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NorfolkUnited StatesRecruiting
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Coordinator of this site? Confirm its status
OcalaUnited StatesNot yet recruiting
Illinois Cancer Care
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PeoriaUnited StatesRecruiting
Texas Oncology - San Antonio Medical Center
Coordinator of this site? Confirm its status
San AntonioUnited StatesRecruiting
Florida Clinical Trials Group
Coordinator of this site? Confirm its status
TamaracUnited StatesRecruiting
Texas Oncology - Northeast Texas
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TylerUnited StatesRecruiting
-
Coordinator of this site? Confirm its status
WestburyUnited StatesWithdrawn
Optum Medical Care, PC
Coordinator of this site? Confirm its status
WestburyUnited StatesRecruiting
Novant Health Pharmacy Oncology Specialists
Coordinator of this site? Confirm its status
Winston-SalemUnited StatesRecruiting
-
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AdanaTurkey (Türkiye)Not yet recruiting
-
Coordinator of this site? Confirm its status
AdanaTurkey (Türkiye)Not yet recruiting
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Coordinator of this site? Confirm its status
AntalyaTurkey (Türkiye)Not yet recruiting
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ÇankayaTurkey (Türkiye)Not yet recruiting
-
Coordinator of this site? Confirm its status
IstanbulTurkey (Türkiye)Not yet recruiting
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Coordinator of this site? Confirm its status
IstanbulTurkey (Türkiye)Not yet recruiting

This page is information, not medical advice. Discuss any trial with your doctor.