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NCT04619797CompletedPhase 2/3

A Study of Tiragolumab in Combination With Atezolizumab Plus Pemetrexed and Carboplatin/Cisplatin Versus Pembrolizumab Plus Pemetrexed and Carboplatin/Cisplatin in Participants With Previously Untreated Advanced Non-Squamous Non-Small Cell Lung Cancer

A Phase II/III, Randomized, Double-Blind, Placebo-Controlled Study of Tiragolumab in Combination With Atezolizumab Plus Pemetrexed and Carboplatin/Cisplatin Versus Pembrolizumab Plus Pemetrexed and Carboplatin/Cisplatin in Patients With Previously Untreated Advanced Non-Squamous Non-Small-Cell Lung Cancer

Source: ClinicalTrials.gov · Last updated 3 Jun 2026

Brief summary (registry, in English)

The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of tiragolumab in combination with atezolizumab plus pemetrexed and carboplatin/cisplatin (Arm A) compared with placebo in combination with pembrolizumab plus pemetrexed and carboplatin/cisplatin (Arm B) in participants with previously untreated, locally advanced unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC). Eligible participants will be randomized in a 1:1 ratio to receive one of the following treatment regimens during the induction phase: * Arm A: Tiragolumab plus atezolizumab plus pemetrexed and carboplatin or cisplatin * Arm B: Placebo plus pembrolizumab plus pemetrexed and carboplatin or cisplatin Following the induction phase, participants will continue maintenance therapy with either tiragolumab in combination with atezolizumab and pemetrexed (Arm A) or placebo in combination with pembrolizumab and pemetrexed (Arm B).

Status (registry)
Completed
Phase (registry)
Phase 2/3
Study type
Interventional
Enrollment
542 (actual)
First submitted
30 Oct 2020
Start date
15 Dec 2020
Primary completion date
19 Apr 2024
Lead sponsor
Hoffmann-La Roche
Diseases
Lung cancer
NCT number
NCT04619797
EU CT number
2022-502031-20-00
EudraCT number
2020-002851-39

What you commit to

  • Study type: Interventional · Phase 2/3
  • Participants enrolled: 542
  • From 15 Dec 2020 to the primary completion date, 19 Apr 2024
  • 127 sites in 21 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

  • Severe infection within 4 weeks prior to initiation of study treatment or any active infection that, in the opinion of the investigator, could impact patient safety
  • Treatment with investigational therapy within 28 days prior to initiation of study treatment
  • Treatment with systemic immunostimulatory agents within 4 weeks or 5 drug-elimination half-lives (whichever is longer) prior to initiation of study treatment
  • Treatment with systemic immunosuppressive medication within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during study treatment

Other illness

  • Active or history of autoimmune disease or immune deficiency
  • History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis
  • History of malignancy other than NSCLC within 5 years prior to randomization, with the exception of malignancies with a negligible risk of metastasis or death
  • Known allergy or hypersensitivity or other contraindication to any component of the chemotherapy regimen the participant may receive during the study

Lab values

  • Mutations in epidermal growth factor receptor (EGFR) gene or anaplastic lymphoma kinase (ALK) fusion oncogene
  • Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-cytotoxic T lymphocyte-associated protein 4, anti-TIGIT, anti-PD-1, and anti-PD-L1 therapeutic antibodies

Other

  • Pulmonary lymphoepithelioma-like carcinoma subtype of NSCLC
  • Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
  • Women who are pregnant, or breastfeeding
  • Known targetable c-ROS oncogene 1 (ROS1) or BRAFV600E genomic aberration.

Who the study is looking for

  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  • Histologically or cytologically documented locally advanced unresectable or metastatic non-squamous NSCLC that is not eligible for curative surgery and/or definitive chemoradiotherapy
  • No prior systemic treatment for metastatic non-squamous NSCLC
  • Known tumor programmed death-ligand 1 (PD-L1) status
  • Measurable disease, as defined by Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1)
  • Life expectancy \>= 12 weeks
  • Adequate hematologic and end-organ function
  • Negative human immunodeficiency virus (HIV) test at screening
  • Serology test negative for active hepatitis B virus or active hepatitis C virus at screening.

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

Full criteria on ClinicalTrials.gov

Sites (127)

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

SiteCityCountrySite status
Onze-Lieve-Vrouwziekenhuis
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AalstBelgiumCompleted
Cliniques Universitaires Saint-Luc
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Sint-Lambrechts-WoluweBelgiumCompleted
Vitaz
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Sint-NiklaasBelgiumCompleted
UCL Mont-Godinne
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YvoirBelgiumCompleted
Hospital de Cancer de Barretos
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BarretosBrazilUnknown status
Oncocentro Belo Horizonte
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Belo HorizonteBrazilUnknown status
Crio - Centro Regional Integrado de Oncologia
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FortalezaBrazilUnknown status
Oncosite - Centro de Pesquisa Clínica em Oncologia Ltda
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IjuíBrazilUnknown status
Hospital Nossa Senhora da Conceição
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Porto AlegreBrazilUnknown status
Hospital das Clinicas - UFRGS
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Porto AlegreBrazilUnknown status
Instituto do Cancer do Estado de Sao Paulo - ICESP
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São PauloBrazilUnknown status
Royal Victoria Regional Health Centre
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BarrieCanadaUnknown status
Cross Cancer Institute
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EdmontonCanadaUnknown status
Lakeridge Health Oshawa
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OshawaCanadaUnknown status
Sault Area Hospital
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Sault Ste. MarieCanadaUnknown status
Kantonsspital Aarau
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AarauSwitzerlandUnknown status
Kantonsspital Graubünden Medizin Onkologie
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ChurSwitzerlandUnknown status
Universitätsspital Zürich
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ZurichSwitzerlandUnknown status
Beijing Cancer Hospital
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BeijingChinaUnknown status
Jilin Cancer Hospital
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ChangchunChinaUnknown status
Xiangya Hospital Central South University
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ChangshaChinaUnknown status
Affiliated Hospital of Chengde Medical University
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ChengdeChinaUnknown status
West China Hospital,Sichuan University
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ChengduChinaUnknown status
Sichuan Cancer Hospital
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ChengduChinaUnknown status
Anhui Provincial Hospital
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HefeiChinaUnknown status
Jinan Central Hospital
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JinanChinaUnknown status
Pingxiang People's Hospital
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PingxiangChinaUnknown status
Qingdao Central Hospital
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QingdaoChinaUnknown status
Weifang People's Hospital
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WeifangChinaUnknown status
Hubei Cancer Hospital
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WuhanChinaUnknown status
The First Affiliated Hospital of Xian Jiao Tong University
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Xi'anChinaUnknown status
The First Affiliated Hospital of Xinxiang Medical University
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XinxiangChinaUnknown status
The First Affiliated Hospital of Zhengzhou University
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ZhengzhouChinaUnknown status
Helios Klinikum Emil von Behring GmbH
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BerlinGermanyCompleted
Klinikum Chemnitz gGmbH
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ChemnitzGermanyCompleted
Vincentius-Diakonissen-Kliniken gAG
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KarlsruheGermanyCompleted
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
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MainzGermanyCompleted
Universitaetsklinikum Giessen und Marburg GmbH
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MarburgGermanyCompleted
Rigshospitalet
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Copenhagen OeDenmarkCompleted
Odense University Hospital
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Odense CDenmarkCompleted
Region Sjaelland
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RoskildeDenmarkCompleted
Complexo Hospitalario Universitario A Coruña
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A CoruñaSpainCompleted
Hospital Clinic de Barcelona
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BarcelonaSpainCompleted
Hospital del Mar
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BarcelonaSpainCompleted
Complejo Hospitalario Universitario Insular Materno Infantil
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Las Palmas de Gran CanariaSpainCompleted
Institut Catala D'oncologia
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L'Hospitalet de LlobregatSpainCompleted
Hospital Universitario Lucus Augusti
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LugoSpainCompleted
Hospital Universitario La Paz
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MadridSpainCompleted
Hospital General Universitario Gregorio Marañón
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MadridSpainCompleted
Hospital Son Llatzer
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PalmaSpainCompleted
Hospital Universitario Virgen De Valme
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SevillaSpainCompleted
Hospital Clinico Universitario de Valencia
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ValenciaSpainCompleted
Institut Bergonie
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BordeauxFranceCompleted
Assistance Publique Hôpitaux de Marseille
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MarseilleFranceCompleted
Centre Hospitalier Universitaire de Rennes
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RennesFranceCompleted
Les Hopitaux Universitaires De Strasbourg
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Strasbourg CedexFranceCompleted
Centre Hospitalier Universitaire de Toulouse
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ToulouseFranceCompleted
Castle Hill Hospital
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HullUnited KingdomUnknown status
Guy's Hospital
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LondonUnited KingdomUnknown status
Barts & London School of Med
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LondonUnited KingdomUnknown status
Christie Hospital NHS Trust
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ManchesterUnited KingdomUnknown status
Nottingham City Hospital
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NottinghamUnited KingdomUnknown status
New Cross Hospital
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WolverhamptonUnited KingdomUnknown status
Hong Kong United Oncology Centre
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Hong KongHong Kong SAR ChinaUnknown status
Tuen Mun Hospital
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Hong KongHong Kong SAR ChinaUnknown status
Queen Mary Hospital
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Hong KongHong Kong SAR ChinaUnknown status
Prince of Wales Hospital
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ShatinHong Kong SAR ChinaUnknown status
Centro di Riferimento Oncologico
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AvianoItalyUnknown status
Azienda Ospedaliero-Universitaria Careggi
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FlorenceItalyUnknown status
A.O. Villa Scassi
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GenoaItalyUnknown status
Kyushu University Hospital
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FukuokaJapanUnknown status
Kurume University Hospital
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FukuokaJapanUnknown status
Hiroshima University Hospital
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HiroshimaJapanUnknown status
Takarazuka City Hospital
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HyōgoJapanUnknown status
University Hospital Kyoto Prefectural University of Medicine
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KyotoJapanUnknown status
Sendai Kousei Hospital
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MiyagiJapanUnknown status
NHO Kinki-Chuo Chest Medical Center
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OsakaJapanUnknown status
Kansai Medical University Hospital
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OsakaJapanUnknown status
Osaka International Cancer Institute
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OsakaJapanUnknown status
Kindai University Hospital
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OsakaJapanUnknown status
Saitama Cancer Center
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SaitamaJapanUnknown status
The Cancer Institute Hospital of JFCR
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TokyoJapanUnknown status
Wakayama Medical University Hospital
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WakayamaJapanUnknown status
Kosin University Gospel Hospital
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BusanSouth KoreaUnknown status
Kyungpook National University Chilgok Hospital
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DaeguSouth KoreaUnknown status
Chungnam National University Hospital
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DaejeonSouth KoreaUnknown status
St. Vincent's Hospital
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Gyeonggi-doSouth KoreaUnknown status
Samsung Changwon Hospital
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Gyeongsangnam-doSouth KoreaUnknown status
Seoul National University Hospital
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SeoulSouth KoreaUnknown status
Severance Hospital, Yonsei University Health System
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SeoulSouth KoreaUnknown status
Kangbuk Samsung Hospital
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SeoulSouth KoreaUnknown status
Seoul St. Mary's Hospital
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SeoulSouth KoreaUnknown status
Asan Medical Center
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SeoulSouth KoreaUnknown status
ARKE Estudios Clínicos S.A. de C.V.
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Mexico CityMexicoUnknown status
Cuidados oncologicos
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Querétaro CityMexicoUnknown status
Oncologico Potosino
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San Luis Potosí CityMexicoUnknown status
Auckland City Hospital, Cancer and Blood Research
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AucklandNew ZealandUnknown status
Waikato Hospital - Cancer and Blood Research Trials Unit
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HamiltonNew ZealandUnknown status
Palmerston North Hospital
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Palmerston NorthNew ZealandUnknown status
Centrum Terapii Wspolczesnej J.M. Jasnorzewska S.K.A.
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LodzPolandCompleted
Warminsko-Mazurskie Centrum Chorob Pluc w Olsztynie
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OlsztynPolandCompleted
Faculty of Med. Siriraj Hosp.
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BangkokThailandUnknown status
Vajira Hospital
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BangkokThailandUnknown status
Chulalongkorn Hospital
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BangkokThailandUnknown status
Maharaj Nakorn Chiang Mai Hospital
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Chiang MaiThailandUnknown status
Songklanagarind Hospital
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SongkhlaThailandUnknown status
Changhua Christian Hospital
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Chang-huaTaiwanUnknown status
China Medical University Hospital
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TaichungTaiwanUnknown status
Taipei Veterans General Hospital
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TaipeiTaiwanUnknown status
Tennessee Oncology - Chattanooga
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ChattanoogaUnited StatesUnknown status
Inova Schar Cancer Institute
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FairfaxUnited StatesUnknown status
SCRI Florida Cancer Specialists South
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Fort MyersUnited StatesUnknown status
Fort Wayne Medical Oncology and Hematology, Inc
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Fort WayneUnited StatesUnknown status
Baptist Health Lexington
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LexingtonUnited StatesUnknown status
UCLA
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Los AngelesUnited StatesUnknown status
Northwest Georgia Oncology Centers PC - Marietta
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MariettaUnited StatesUnknown status
Sarah Cannon Research Institute (Tennessee Oncology)
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NashvilleUnited StatesUnknown status
SCRI Florida Cancer Specialists North
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St. PetersburgUnited StatesUnknown status
PIH Health Whittier Hospital
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WhittierUnited StatesUnknown status
Advent Health Orlando
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Winter ParkUnited StatesUnknown status
Adana Baskent University Medical Faculty
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AdanaTurkey (Türkiye)Unknown status
Ankara Bilkent City Hospital
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AnkaraTurkey (Türkiye)Unknown status
Liv Hospital Ankara
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AnkaraTurkey (Türkiye)Unknown status
Dicle University Faculty of Medicine
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DiyarbakırTurkey (Türkiye)Unknown status
Trakya University Medical Faculty
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EdirneTurkey (Türkiye)Unknown status
Istanbul University Cerrahpasa Medical Faculty
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IstanbulTurkey (Türkiye)Unknown status
Medeniyet University Goztepe Training and Research Hospital.
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KadiköyTurkey (Türkiye)Unknown status

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