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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)
NCT07361497 · Bristol-Myers Squibb
In plain English
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Official title
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.
About this study
A study to evaluate Pumitamig versus Durvalumab following concurrent chemoradiation therapy in participants with unresectable stage III Non-small Cell Lung Cancer (NSCLC)
Eligibility criteria
Inclusion Criteria
* 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.
Exclusion Criteria
* Participants with non-squamous histology must not have documented Epidermal Growth Factor Receptor (EGFR) and anaplastic lymphoma kinase (ALK) rearrangements.
* Participants must not have an active autoimmune disease.
* 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 protocol-defined Inclusion/Exclusion criteria apply.
Study design
Enrollment target: 850 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2026-03-16
Estimated completion: 2033-12-31
Last updated: 2026-04-06
Interventions
Drug: PumitamigDrug: Durvalumab
Primary outcomes
- • Progression-free survival (PFS) by blinded independent central review (BICR) (per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1) (Up to 3 years)
Sponsor
Bristol-Myers Squibb · industry
With: BioNTech SE
Contacts & investigators
ContactBMS Clinical Trials Contact Center www.BMSClinicalTrials.com · contact · Clinical.Trials@bms.com · 855-907-3286
ContactFirst line of the email MUST contain NCT # and Site #. · contact
InvestigatorBristol-Myers Squibb · study_director, Bristol-Myers Squibb
All locations (255)
Southern Cancer Center PcRecruiting
Daphne, Alabama, United States
Local Institution - 0780Not Yet Recruiting
Chandler, Arizona, United States
Local Institution - 0585Not Yet Recruiting
Golden, Colorado, United States
Medical Oncology Hematology Consultants, PARecruiting
Newark, Delaware, United States
Local Institution - 0711Not Yet Recruiting
Ocala, Florida, United States
Local Institution - 0756Not Yet Recruiting
Marietta, Georgia, United States
Local Institution - 0398Not Yet Recruiting
Chicago, Illinois, United States
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Evanston, Illinois, United States
Illinois Cancer CareRecruiting
Peoria, Illinois, United States
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Fort Wayne, Indiana, United States
Local Institution - 0656Not Yet Recruiting
Lexington, Kentucky, United States
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Boston, Massachusetts, United States
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Flint, Michigan, United States
Minnesota Oncology HematologyRecruiting
Maple Grove, Minnesota, United States
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Saint Paul, Minnesota, United States
Missouri Cancer AssociatesRecruiting
Columbia, Missouri, United States
Local Institution - 0606Not Yet Recruiting
New York, New York, United States
Local Institution - 0339Withdrawn
Westbury, New York, United States
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Westbury, New York, United States
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Winston-Salem, North Carolina, United States
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Akron, Ohio, United States
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Cincinnati, Ohio, United States
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Cleveland, Ohio, United States
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Cleveland, Ohio, United States
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Mayfield Heights, Ohio, United States
Oncology Associates Of Oregon, PcRecruiting
Eugene, Oregon, United States
Northwest Cancer Specialists, P.C.Recruiting
Happy Valley, Oregon, United States
Local Institution - 0480Not Yet Recruiting
Nashville, Tennessee, United States
SCRI Oncology PartnersRecruiting
Nashville, Tennessee, United States
Texas Oncology - Amarillo Cancer CenterRecruiting
Amarillo, Texas, United States
Texas Oncology-Austin CentralRecruiting
Austin, Texas, United States
Texas OncologyRecruiting
Denton, Texas, United States
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Fort Worth, Texas, United States
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Houston, Texas, United States
Texas Oncology - San Antonio Medical CenterRecruiting
San Antonio, Texas, United States
Texas Oncology - Northeast TexasRecruiting
Tyler, Texas, United States
Blue Ridge Cancer CareRecruiting
Christiansburg, Virginia, United States
Virginia Oncology AssociatesRecruiting
Norfolk, Virginia, United States
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Buenas Aires, Buenos Aires, Argentina
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Mar del Plata, Buenos Aires, Argentina
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Rosario, Santa Fe Province, Argentina
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Buenos Aires, Argentina
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Buenos Aires, Argentina
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Buenos Aires, Argentina
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Córdoba, Argentina
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Córdoba, Argentina
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Gosford, New South Wales, Australia
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Penrith, New South Wales, Australia
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Elizabeth Vale, South Australia, Australia
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Ballarat, Victoria, Australia
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Epping, Victoria, Australia
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Joondalup, Western Australia, Australia
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Wentworthville, Australia
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Innsbruck, Austria
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Linz, Austria
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Vienna, Austria
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Brasschaat, Antwerpen, Belgium
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Anderlecht, Bruxelles-Capitale, Région de, Belgium
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Charleroi, Hainaut, Belgium
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Genk, Limburg, Belgium
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Ghent, Oost-Vlaanderen, Belgium
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Sint-Niklaas, Oost-Vlaanderen, Belgium
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Leuven, Vlaams-Brabant, Belgium
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Teresina, Piauí, Brazil
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Natal/RN, Rio Grande do Norte, Brazil
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Porto Alegre, Rio Grande do Sul, Brazil
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Barretos, São Paulo, Brazil
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São José do Rio Preto, São Paulo, Brazil
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São Paulo, Brazil
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Haskovo, Bulgaria
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Rousse, Bulgaria
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Sofia, Bulgaria
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Sofia, Bulgaria
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Sofia, Bulgaria
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Ottawa, Ontario, Canada
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Montreal, Quebec, Canada
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Québec, Canada
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Antofagasta, AN, Chile
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Las Condes, Arica y Parinacota Region, Chile
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Santiago, Santiago Metropolitan, Chile
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Santiago, Santiago Metropolitan, Chile
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Santiago, Santiago Metropolitan, Chile
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Viña del Mar, Valparaiso, Chile
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Beijing, Beijing Municipality, China
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Chongqing, Chongqing Municipality, China
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Fuzhou, Fujian, China
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Shantou, Guangdong, China
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Shenzhen, Guangdong, China
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Zhengzhou, Henan, China
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Jingzhou, Hubei, China
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Wuhan, Hubei, China
Local Institution - 0813Withdrawn
Wuhan, Hubei, China
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Changsha, Hunan, China
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Suzhou, Jiangsu, China
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Nanchang, Jiangxi, China
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Shenyang, Liaoning, China
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Xi'an, Shaanxi, China
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Jinan, Shandong, China
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Jinan, Shandong, China
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Shanghai, Shanghai Municipality, China
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Taiyuan, Shanxi, China
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Chengdu, Sichuan, China
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Chengdu, Sichuan, China
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Hangzhou, Zhejiang, China
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Linhai, Zhejiang, China
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Guangzhou, China
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Hangzhou, China
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Shanghai Shi, China
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Xi'an, China
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Bordeaux, Aquitaine, France
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Lyon Cedex08, Auvergne-Rhône-Alpes, France
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Dijon, Côte-d'Or, France
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Lille, Hauts-de-France, France
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Montpellier, Hérault, France
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Saint-Herblain, Loire-Atlantique, France
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Toulouse, Midi-Pyrénées, France
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Villejuif, Val-de-Marne, France
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Limoges, France
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Marseille, France
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Paris, France
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Paris, France
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Augsburg, Bavaria, Germany
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Koblenz, Rhineland-Palatinate, Germany
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Ludwigshafen am Rhein, Rhineland-Palatinate, Germany
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Kiel, Schleswig-Holstein, Germany
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Jena, Thuringia, Germany
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Berlin, Germany
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Berlin, Germany
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Göttingen, Germany
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Gröbenzell, Germany
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Haile, Germany
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Hamburg, Germany
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Immenhausen, Germany
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Regensburg, Germany
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Thessaloniki, Thessaloníki, Greece
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Larissa, Thessalía, Greece
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Athens, Greece
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Athens, Greece
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Athens, Greece
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Thessaloniki, Greece
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Tuenmen, NT, Hong Kong
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Hksar, Hong Kong
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Shatin, Hong Kong
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Kecskemét, Bács-Kiskun county, Hungary
Local Institution - 0787Not Yet Recruiting
Szolnok, Jász-Nagykun-Szolnok, Hungary
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Budapest, Hungary
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Farkasgyepű, Hungary
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Törökbálint, Hungary
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Eluru, Andhra Pradesh, India
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Pūlakkōd, Kerala, India
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Aurangabad, Maharashtra, India
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Mumbai, Maharashtra, India
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Mumbai, Maharashtra, India
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Nagpur, Maharashtra, India
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Dwarka, National Capital Territory of Delhi, India
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New Delhi, National Capital Territory of Delhi, India
Local Institution - 0657Not Yet Recruiting
Hyderabad, Telangana, India
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Delhi, India
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Pune, India
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Cork, Ireland
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Dublin, Ireland
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Dublin, Ireland
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Orbassano, Piedmont, Italy
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Rome, Roma, Italy
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Aviano (PN), Italy
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Milan, Italy
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Milan, Italy
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Naples, Italy
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Parma, Italy
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Ravenna, Italy
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Nagoya, Aichi-ken, Japan
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Kobe, Hyōgo, Japan
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Nishinomiya-shi, Hyōgo, Japan
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Sendai, Miyagi, Japan
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Okayama, Okayama-ken, Japan
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Osakasayama-shi, Osaka, Japan
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Hidaka, Saitama-Pref, Japan
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Bunkyo Ku, Tokyo, Japan
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Hamamatsu, Japan
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Hirakata-shi, Japan
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Minami-Ku, Fukuoka, Japan
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Sagamihara, Japan
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Sendai, Japan
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Yokohama, Japan
Local Institution - 0772Not Yet Recruiting
Saltillo, Coahuila, Mexico
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Tijuana, Estado de Baja California, Mexico
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Zapopan, Jalisco, Mexico
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Monterrey, Nuevo León, Mexico
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Puebla City, Mexico
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Querétaro, Mexico
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Nijmegen, Gelderland, Netherlands
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Breda, North Brabant, Netherlands
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Amsterdam, North Holland, Netherlands
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Zwolle, Overijssel, Netherlands
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Groningen, Netherlands
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Tilburg, Netherlands
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Lublin, Lublin Voivodeship, Poland
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Przemyśl, Podkarpackie Voivodeship, Poland
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Katowice, Silesian Voivodeship, Poland
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Opole, Poland
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Bucharest, Bucharest, Romania
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Bucharest, Romania
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Cluj-Napoca, Romania
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Craiova, Romania
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Floresti/ Cluj, Romania
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Iași, Romania
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Iași, Romania
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Singapore, Central Singapore, Singapore
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Singapore, Singapore
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Seongnam, Kyǒnggi-do, South Korea
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Seoul, Seoul Teugbyeolsi, South Korea
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Seoul, Seoul Teugbyeolsi, South Korea
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Seoul, Seoul-teukbyeolsi, South Korea
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Cheongju-si, South Korea
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Seoul, South Korea
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L'Hospitalet Del Llobregat, Barcelona [Barcelona], Spain
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Barakaldo, Spain
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Barcelona, Spain
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Barcelona, Spain
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Madrid, Spain
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Málaga, Spain
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Seville, Spain
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Valencia, Spain
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Zaragoza, Spain
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Gävle, Gävleborgs Län [se-21], Sweden
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Solna, Stockholms Län [se-01], Sweden
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Uppsala, Sweden
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Basel, Switzerland
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Bellinzona, Switzerland
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Münsterlingen, Switzerland
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Sankt Gallen, Switzerland
Local Institution - 0734Not Yet Recruiting
Zhubei, Hsinchu, Taiwan
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Chiayi City, Taiwan
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Taipei, Taiwan
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Taipei, Taiwan
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Bangkok, Thailand
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Chiang Mai, Thailand
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Khon Kaen, Thailand
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Songkhla, Thailand
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Adana, Turkey (Türkiye)
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Adana, Turkey (Türkiye)
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Antalya, Turkey (Türkiye)
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Çankaya, Turkey (Türkiye)
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Istanbul, Turkey (Türkiye)
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Istanbul, Turkey (Türkiye)
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Manchester, Lancashire, United Kingdom
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Cambridge, United Kingdom
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Cardiff, United Kingdom
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Guildford, United Kingdom
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Leeds, United Kingdom
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Liverpool, United Kingdom
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London, United Kingdom
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London, United Kingdom
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Middlesex, United Kingdom
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Sutton, United Kingdom