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NCT04026412CompletedPhase 3

A Study of Nivolumab and Ipilimumab in Untreated Participants With Stage 3 Non-small Cell Lung Cancer (NSCLC) That is Unable or Not Planned to be Removed by Surgery

A Phase 3, Randomized, Open Label Study to Compare Nivolumab Plus Concurrent Chemoradiotherapy (CCRT) Followed by Nivolumab Plus Ipilimumab or Nivolumab Plus CCRT Followed by Nivolumab vs CCRT Followed by Durvalumab in Previously Untreated, Locally Advanced Non-small Cell Lung Cancer (LA NSCLC)

Source: ClinicalTrials.gov · Last updated 24 Jul 2025

Brief summary (registry, in English)

The primary purpose of the study is to compare the effectiveness of nivolumab plus concurrent chemoradiotherapy (CCRT) followed by nivolumab plus ipilimumab vs CCRT followed by durvalumab in participants with untreated Locally Advanced Non-small Cell Lung Cancer (LA NSCLC).

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
925 (actual)
First submitted
18 Jul 2019
Start date
8 Oct 2019
Primary completion date
22 Mar 2024
Lead sponsor
Bristol-Myers Squibb
Diseases
Lung cancer
NCT number
NCT04026412
EU CT number
2022-502886-71-00
EudraCT number
2019-001222-98

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 925
  • From 8 Oct 2019 to the primary completion date, 22 Mar 2024
  • 168 sites in 27 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

  • Active infection requiring systemic therapy within 14 days prior to randomization
  • Prior thoracic radiotherapy
    • Other protocol-defined inclusion/exclusion criteria apply

Other illness

  • Any condition including medical, emotional, psychiatric, or logistical that, in the opinion of the Investigator would preclude the participant from adhering to the protocol or would increase the risk associated with study participation
  • History of organ or tissue transplant that requires systemic use of immune suppressive agents

Who the study is looking for

  • Eastern Cooperative Oncology Group (ECOG) performance status ≤1
  • Locally advanced stage IIIA, IIIB, or IIIC (T1-2 N2-3 M0, T3 N1-3 M0, or T4 N0-3 M0) pathologically-confirmed NSCLC, according to 8th TNM classification. Participants who are not planned for potential curative surgical resection are eligible.
  • Newly diagnosed and treatment-naïve, with no prior local or systemic anticancer therapy given as primary therapy for locally advanced disease

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

Full criteria on ClinicalTrials.gov

Sites (168)

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

SiteCityCountrySite status
Local Institution - 0043
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Buenos AiresArgentinaUnknown status
Local Institution - 0042
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CabaArgentinaUnknown status
Local Institution - 0044
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CABAArgentinaUnknown status
Local Institution - 0045
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Río CuartoArgentinaUnknown status
Local Institution - 0028
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AdelaideAustraliaUnknown status
Local Institution - 0224
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Ballarat CentralAustraliaUnknown status
Local Institution - 0031
Coordinator of this site? Confirm its status
DarlinghurstAustraliaUnknown status
Local Institution - 0134
Coordinator of this site? Confirm its status
GosfordAustraliaUnknown status
Local Institution - 0029
Coordinator of this site? Confirm its status
GreenslopesAustraliaUnknown status
Local Institution - 0033
Coordinator of this site? Confirm its status
KingswoodAustraliaUnknown status
Local Institution
Coordinator of this site? Confirm its status
MelbourneAustraliaUnknown status
Local Institution - 0052
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MelbourneAustraliaUnknown status
Local Institution - 0030
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MurdochAustraliaUnknown status
Universitair Ziekenhuis Gent
Coordinator of this site? Confirm its status
GentBelgiumCompleted
CHC MontLégia
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LiègeBelgiumCompleted
Cliniques Universitaires Saint-Luc
Coordinator of this site? Confirm its status
Sint-Lambrechts-WoluweBelgiumCompleted
UCL Mont-Godinne
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YvoirBelgiumCompleted
Local Institution - 0036
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BarretosBrazilUnknown status
Local Institution - 0037
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BlumenauBrazilUnknown status
Local Institution - 0234
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IjuíBrazilUnknown status
Local Institution - 0038
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IpatingaBrazilUnknown status
Local Institution - 0034
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Porto AlegreBrazilUnknown status
Local Institution - 0035
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Rio de JaneiroBrazilUnknown status
Local Institution - 0237
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ChicoutimiCanadaUnknown status
Local Institution - 0127
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KingstonCanadaUnknown status
Local Institution - 0078
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OshawaCanadaUnknown status
Local Institution - 0126
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QuébecCanadaUnknown status
Local Institution - 0070
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RimouskiCanadaUnknown status
Local Institution - 0092
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Trois-RivièresCanadaUnknown status
Local Institution - 0057
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BaselSwitzerlandUnknown status
Local Institution - 0058
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LausanneSwitzerlandUnknown status
Local Institution - 0059
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Sankt GallenSwitzerlandUnknown status
Local Institution - 0056
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ZurichSwitzerlandUnknown status
Local Institution - 0041
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SantiagoChileUnknown status
Local Institution - 0040
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Viña del MarChileUnknown status
Local Institution - 0146
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BeijingChinaUnknown status
Local Institution - 0170
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ChangchunChinaUnknown status
Local Institution - 0183
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ChangchunChinaUnknown status
Local Institution - 0154
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ChangshaChinaUnknown status
Local Institution - 0186
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ChengduChinaUnknown status
Local Institution - 0189
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ChengduChinaUnknown status
Local Institution - 0149
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ChongqingChinaUnknown status
Local Institution - 0179
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FuzhouChinaUnknown status
Local Institution - 0180
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GongzhulingChinaUnknown status
Local Institution - 0192
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GuiyangChinaUnknown status
Local Institution - 0140
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HangzhouChinaUnknown status
Local Institution - 0147
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HankouChinaUnknown status
Local Institution - 0138
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JinanChinaUnknown status
Local Institution - 0184
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LinhaiChinaUnknown status
Local Institution - 0178
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NanchangChinaUnknown status
Local Institution - 0139
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NanjingChinaUnknown status
Local Institution - 0145
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ShanghaiChinaUnknown status
Local Institution - 0150
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WuhanChinaUnknown status
Local Institution - 0148
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WuhanChinaUnknown status
Local Institution - 0164
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XiamenChinaUnknown status
Helios Klinikum Emil von Behring GmbH
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BerlinGermanyCompleted
KEM I Evang. Kliniken Essen-Mitte gGmbH
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EssenGermanyCompleted
LungenClinic Grosshansdorf GmbH
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GroßhansdorfGermanyCompleted
Evangelisches Krankenhaus Hamm gGmbH
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HammGermanyCompleted
Thoraxklinik At University Of Heidelberg
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HeidelbergGermanyCompleted
Lungenfachklinik Immenhausen
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ImmenhausenGermanyCompleted
Klinikverbund Allgau gGmbH
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Kempten (Allgau)GermanyCompleted
SLK-Kliniken GmbH - Standort Fachklinik Löwenstein
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LöwensteinGermanyCompleted
Universitatsmedizin der Johannes Gutenberg-Universitat Mainz KöR
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MainzGermanyCompleted
Robert Bosch Krankenhaus GmbH
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StuttgartGermanyCompleted
Hospital de la Santa Creu i Sant Pau
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BarcelonaSpainCompleted
Bellvitge University Hospital
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L'hospitalet De LlobregatSpainCompleted
Hospital General Universitario Gregorio Marañón
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MadridSpainCompleted
Hospital Universitario La Paz
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MadridSpainCompleted
Complexo Hospitalario Universitario De Santiago
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Santiago de CompostelaSpainCompleted
University Hospital Virgen Del Rocio S.L.
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SevillaSpainCompleted
Hospital Clinico Universitario Lozano Blesa
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ZaragozaSpainCompleted
Institut Bergonie
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BordeauxFranceCompleted
Centr Georges Francois Leclerc
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DijonFranceCompleted
Centre Leon Berard
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LyonFranceCompleted
Centre de Cancérologie du Grand Montpellier
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MontpellierFranceCompleted
Assistance Publique Hopitaux de Paris
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ParisFranceCompleted
Institut Curie
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ParisFranceCompleted
Assistance Publique Hopitaux De Paris
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Paris Cedex 18FranceCompleted
Centre Hospitalier Universitaire de Nantes
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Saint-HerblainFranceCompleted
Centre Hospitalier Régional Universitaire de Tours
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ToursFranceCompleted
Local Institution - 0054
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AberdeenUnited KingdomUnknown status
Local Institution - 0007
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BebingtonUnited KingdomUnknown status
Local Institution - 0009
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HullUnited KingdomUnknown status
Local Institution - 0010
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PooleUnited KingdomUnknown status
Local Institution - 0012
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SwanseaUnited KingdomUnknown status
Thoracic General Hospital of Athens "I Sotiria"
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AthensGreeceCompleted
General University Hospital of Larissa
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LarissaGreeceCompleted
St Vincent's University Hospital
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Dublin 4IrelandCompleted
St James's Hospital
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Dublin 8IrelandCompleted
Fondazione IRCCS San Gerardo dei Tintori
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MonzaItalyCompleted
University Hospital Of Perugia
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PerugiaItalyCompleted
Local Institution - 0199
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Bunkyo-kuJapanUnknown status
Local Institution - 0200
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Chuo-kuJapanUnknown status
Local Institution - 0212
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FukuokaJapanUnknown status
Local Institution - 0198
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Hidaka-shiJapanUnknown status
Local Institution - 0203
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KanazawaJapanUnknown status
Local Institution - 0174
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Kitaadachi-gunJapanUnknown status
Local Institution - 0206
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KobeJapanUnknown status
Local Institution - 0211
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Kurume-shiJapanUnknown status
Local Institution - 0204
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NagoyaJapanUnknown status
Local Institution - 0202
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NiigataJapanUnknown status
Local Institution - 0205
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OsakaJapanUnknown status
Local Institution - 0197
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ŌtaJapanUnknown status
Local Institution - 0195
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SapporoJapanUnknown status
Local Institution - 0210
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SayamaJapanUnknown status
Local Institution - 0196
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SendaiJapanUnknown status
Local Institution - 0232
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UbeJapanUnknown status
Local Institution - 0175
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WakayamaJapanUnknown status
Local Institution - 0217
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YokohamaJapanUnknown status
Local Institution - 0201
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YokohamaJapanUnknown status
Local Institution - 0216
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YokohamaJapanUnknown status
Local Institution - 0167
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Cheongju-si, Chungcheonbuk-do,South KoreaUnknown status
Local Institution - 0152
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SeoulSouth KoreaUnknown status
Local Institution - 0168
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SeoulSouth KoreaUnknown status
Local Institution - 0015
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CuliacánMexicoUnknown status
Local Institution - 0067
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DfMexicoUnknown status
Local Institution - 0080
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GuadalajaraMexicoUnknown status
Local Institution - 0027
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La PazMexicoUnknown status
Local Institution - 0014
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MonterreyMexicoUnknown status
Stichting VUmc
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AmsterdamNetherlandsCompleted
Stichting Rijnstate Ziekenhuis
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ArnhemNetherlandsCompleted
University Hospital Maastricht
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MaastrichtNetherlandsCompleted
Maxima Medisch Centrum
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VeldhovenNetherlandsCompleted
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy
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BydgoszczPolandCompleted
Uniwersyteckie Centrum Kliniczne
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GdanskPolandCompleted
Provita Centrum Medyczne Sp. z o.o.
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Tomaszow MazowieckiPolandCompleted
Local Institution - 0120
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Hato ReyPuerto RicoUnknown status
GCM Medical Group, PSC - Hato Rey Site
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San JuanPuerto RicoUnknown status
Focus Lab Plus S.R.L.
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BucharestRomaniaCompleted
Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti
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BucharestRomaniaCompleted
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
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Cluj-NapocaRomaniaCompleted
Centrul De Oncologie SF Nectarie S.R.L.
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CraiovaRomaniaCompleted
Radiotherapy Center Cluj S.R.L.
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FlorestiRomaniaCompleted
Local Institution
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MoscowRussiaUnknown status
Local Institution
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Saint PetersburgRussiaUnknown status
Sahlgrenska University Hospital-Vastra Gotalandsregionen
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GoteborgSwedenCompleted
Local Institution - 0171
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SingaporeSingaporeUnknown status
Local Institution - 0208
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KaohsiungCityTaiwanUnknown status
Local Institution - 0214
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New Taipei CityTaiwanUnknown status
Local Institution - 0209
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TainanTaiwanUnknown status
Local Institution - 0143
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TaipeiTaiwanUnknown status
Local Institution - 0133
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TaipeiTaiwanUnknown status
Local Institution - 0213
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TaipeiTaiwanUnknown status
Local Institution - 0125
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AtlantaUnited StatesUnknown status
Local Institution - 0165
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AugustaUnited StatesUnknown status
Local Institution - 0191
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AustinUnited StatesUnknown status
Local Institution - 0108
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BethesdaUnited StatesUnknown status
Local Institution - 0079
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BryanUnited StatesUnknown status
Local Institution - 0071
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BurlingtonUnited StatesUnknown status
Local Institution - 0077
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CharlestonUnited StatesUnknown status
Local Institution - 0131
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CincinnatiUnited StatesUnknown status
Local Institution - 0188
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CincinnatiUnited StatesUnknown status
Local Institution - 0053
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CincinnatiUnited StatesUnknown status
Local Institution - 0047
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ClevelandUnited StatesUnknown status
Local Institution - 0124
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ClevelandUnited StatesUnknown status
Local Institution - 0112
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ClevelandUnited StatesUnknown status
Local Institution - 0130
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DallasUnited StatesUnknown status
Local Institution - 0218
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EdgewoodUnited StatesUnknown status
Local Institution - 0233
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JacksonvilleUnited StatesUnknown status
Local Institution - 0119
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La JollaUnited StatesUnknown status
Local Institution - 0129
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Lone TreeUnited StatesUnknown status
Local Institution - 0219
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OrlandoUnited StatesUnknown status
Local Institution - 0039
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PensacolaUnited StatesUnknown status
Local Institution - 0166
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San FranciscoUnited StatesUnknown status
Local Institution - 0207
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San FranciscoUnited StatesUnknown status
Local Institution - 0116
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Traverse CityUnited StatesUnknown status
Local Institution - 0123
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YoungstownUnited StatesUnknown status

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