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NCT05353257Active, not recruitingPhase 3

A Study to Evaluate the Efficacy and Safety of Serplulimab in Combination With Chemotherapy and Concurrent Radiotherapy in Patients With Limited-Stage Small Cell Lung Cancer

A Randomized, Double-Blind, International Multicenter, Phase III Study to Evaluate the Anti-Tumor Efficacy and Safety of Serplulimab or Placebo in Combination With Chemotherapy and Concurrent Radiotherapy in Patients With Limited-Stage Small Cell Lung Cancer

Source: ClinicalTrials.gov · Last updated 13 Jan 2026

Brief summary (registry, in English)

This study is a randomized, double-blind, multicenter, phase III clinical study to compare the clinical efficacy and safety of Serplulimab + chemotherapy+ concurrent radiotherapy vs chemotherapy+ concurrent radiotherapy in subjects with Limited-Stage Small Cell Lung Cancer.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
511 (actual)
First submitted
25 Apr 2022
Start date
17 May 2022
Primary completion date
30 Jun 2026
Lead sponsor
Shanghai Henlius Biotech
Diseases
Lung cancer
NCT number
NCT05353257
EU CT number
2024-515047-31-00
EudraCT number
2022-002226-27

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 511
  • From 17 May 2022 to the primary completion date, 30 Jun 2026
  • 152 sites in 11 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

  • Subjects suitable for surgery. Subjects who are suitable for surgery but refuse surgical treatment can be included.
  • Patients who have previously received systematic anti-tumor treatments for small cell lung cancer, including but not limited to radiotherapy, chemotherapy, and immunotherapy.

Other illness

  • Patients with other active malignancies within 5 years or at the same time.
  • Subjects with known history of severe allergy to any monoclonal antibody.

Other

  • Histologically or cytologically confirmed mixed SCLC.
  • Subjects with known anaphylaxis to carboplatin/cisplatin or etoposide.
  • In the judgment of the investigator, subjects who have any other factors that may lead to a premature discontinuation.

Who the study is looking for

  • Male or female, aged ≥18 years when signing the ICF.
  • Histologically diagnosed with SCLC.
  • Diagnosed with LS-SCLC (stage Ⅰ-Ⅲ of the AJCC 8th edition of the cancer staging), which can be safely treated with curative radiation doses.
  • Major organs are functioning well.

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

Full criteria on ClinicalTrials.gov

Sites (152)

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

SiteCityCountrySite status
Stadt Wien Wiener Gesundheitsverbund
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ViennaAustriaActive, not recruiting
Affiliated Hospital of Hebei University
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BaodingChinaUnknown status
Baoji Central Hospital
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BaojiChinaUnknown status
Beijing Cancer Hospital
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BeijingChinaUnknown status
Cancer Hospital, Chinese Academy of Medical Sciences
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BeijingChinaUnknown status
The First Affiliated Hospital of Bengbu Medical College
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BengbuChinaUnknown status
Cangzhou People's Hospital
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CangzhouChinaUnknown status
Jilin Cancer Hospital
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ChangchunChinaUnknown status
The First People's Hospital of Changde City
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ChangdeChinaUnknown status
Hunan Cancer Hospital
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ChangshaChinaUnknown status
The Second Xiangya Hospita
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ChangshaChinaUnknown status
Xiangya Hospital Central South University
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ChangshaChinaUnknown status
West China Hospital of Sichuan University
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ChengduChinaUnknown status
The First Affiliated Hospital of Chongqing Medical
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ChongqingChinaUnknown status
Chongqing University Cancer Hospital
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ChongqingChinaUnknown status
Fujian Cancer Hospital
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FuzhouChinaUnknown status
First Affiliated Hospital Of Gannan Medical University
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GanzhouChinaUnknown status
Ganzhou Cancer Hospital
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GanzhouChinaUnknown status
The First Affiliated Hospital of Guangdong Pharmaceutical University
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GuangzhouChinaUnknown status
Gungzhouyikedaxuefushuzhongliuyiyuan
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GuangzhouChinaUnknown status
Sun Yat-sen University Cancer Center
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GuangzhouChinaUnknown status
The Second Affiliated Hospital of Guilin Medical University
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GuilinChinaUnknown status
Zhejiang Cancer Hospital
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HangzhouChinaUnknown status
The Second Affiliated Hospital Zhejiang University School of Medicine
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HangzhouChinaUnknown status
Yuhang Branch of the First Affiliated Hospital of Zhejiang University
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HangzhouChinaUnknown status
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
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HangzhouChinaUnknown status
Harbin Medical University Cancer Hospital
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HarbinChinaUnknown status
Anhui Chest Hospital
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HefeiChinaUnknown status
Queen Elizabeth Hospital
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Hong KongChinaUnknown status
Hong Kong United Oncology Centre
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Hong KongChinaUnknown status
Queen Mary Hospital
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Hong KongChinaUnknown status
Jiamusi Cancer Hospital
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JiamusiChinaUnknown status
Qilu Hospital of Shandong University
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JinanChinaUnknown status
Shandong Cancer Hospital
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JinanChinaUnknown status
Yunnan Cancer Hospital
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KunmingChinaUnknown status
Linyi Tumor Hospital
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LinyiChinaUnknown status
The First Affiliated Hospital of Henan University of Science and Technology
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LuoyangChinaUnknown status
The First Affiliated Hospital of NanChang University
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NanchangChinaUnknown status
Guangxi Medical University Cancer Hospital
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NanningChinaUnknown status
Affiliated Hospital of Qingdao University
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QingdaoChinaUnknown status
Zhongshan Hospital of Fudan University
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ShanghaiChinaUnknown status
Fudan University Shanghai Cancer Center
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ShanghaiChinaUnknown status
Shanghai Chest Hospital
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ShanghaiChinaUnknown status
Liaoning Cancer Hospital & Institute
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ShenyangChinaUnknown status
Shenyang The Tenth People's Hospital
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ShenyangChinaUnknown status
Peking University Shenzhen Hospital
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ShenzhenChinaUnknown status
TaiHe Hospital Affiliated Hospital of Hubei University of Medicine
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ShiyanChinaUnknown status
The Second People's Hospital Of Yibin
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SichuanChinaUnknown status
Shanxi Provincial Cancer Hospital
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TaiyuanChinaUnknown status
Taizhou Hospital of Zhejiang Province
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TaizhouChinaUnknown status
Tangshan People's Hospital
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TangshanChinaUnknown status
Tianjin Medical University General Hospital
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TianjinChinaUnknown status
Tianjin Medical University Cancer Institute & Hospital
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TianjinChinaUnknown status
The 1st Affiliated Hospital of WMU
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WenzhouChinaUnknown status
Wenzhou University Hospital
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WenzhouChinaUnknown status
Zhongnan Hospital of Wuhan University
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WuhanChinaUnknown status
Hubei Cancer Hospital
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WuhanChinaUnknown status
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology
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WuhanChinaUnknown status
First Affiliated Hospital of Xi'an Jiaotong University
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Xi'anChinaUnknown status
The First Affiliated Hospital of Xinxiang Medical University
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XinxiangChinaUnknown status
Xuzhou Central Hospital
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XuzhouChinaUnknown status
Northern Jiangsu People's Hospital
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YangzhouChinaUnknown status
Henan Cancer Hospital
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ZhengzhouChinaUnknown status
The First Affiliated Hospital of Zhengzhou University
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ZhengzhouChinaUnknown status
Fakultni nemocnice Brno
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BrnoCzechiaActive, not recruiting
University Hospital Olomouc
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OlomoucCzechiaActive, not recruiting
Fakultni nemocnice Ostrava
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OstravaCzechiaActive, not recruiting
Nemocnice AGEL Ostrava - Vitkovice a.s.
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OstravaCzechiaActive, not recruiting
Fakultni nemocnice v Motole
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PragueCzechiaActive, not recruiting
Vseobecna Fakultni Nemocnice V Praze
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Prague 2CzechiaActive, not recruiting
Klinikum Chemnitz gGmbH
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ChemnitzGermanyActive, not recruiting
Kliniken der Stadt Koeln gGmbH
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CologneGermanyActive, not recruiting
Kaiserswerther Diakonie
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DuesseldorfGermanyActive, not recruiting
Medical Center- University of Freiburg
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Freiburg im BreisgauGermanyActive, not recruiting
MVZ fuer Haematologie und Onkologie Rhein-Kreis GmbH
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NeussGermanyActive, not recruiting
Klinikum Nuernberg
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NurembergGermanyActive, not recruiting
Onkologie Zentrum Sued MVZ GmbH
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RemscheidGermanyActive, not recruiting
Onkologie Remscheid GmbH
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RemscheidGermanyActive, not recruiting
Hospital General Universitario Dr. Balmis
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AlicanteSpainActive, not recruiting
Hospital Universitario de Badajoz
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BadajozSpainActive, not recruiting
Institut Catala d'Oncologia
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BadalonaSpainActive, not recruiting
Hospital de la Santa Creu i Sant Pau
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BarcelonaSpainActive, not recruiting
Hospital Universitari Vall d'Hebron
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BarcelonaSpainActive, not recruiting
Hospital del Mar
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BarcelonaSpainActive, not recruiting
Hospital Universitario Puerta del Mar
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CadizSpainActive, not recruiting
Hospital Universitario Reina Sofia
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CórdobaSpainActive, not recruiting
Hospital de Jerez de la Frontera
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Jerez de la FronteraSpainActive, not recruiting
Hospital Universitario La Paz
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MadridSpainActive, not recruiting
Hospital Universitario HM Sanchinarro
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MadridSpainActive, not recruiting
Hospital General Universitario Gregorio Marañón
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MadridSpainActive, not recruiting
Hospital Clínico San Carlos
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MadridSpainActive, not recruiting
Hospital Universitario Fundación Jiménez Díaz
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MadridSpainActive, not recruiting
Hospital Universitario Puerta de Hierro de Majadahonda
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MajadahondaSpainActive, not recruiting
Hospital Vithas Parque San Antonio
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MalagaSpainActive, not recruiting
Hospital Universitario de Navarra
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PamplonaSpainActive, not recruiting
Hospital Universitario Marqués de Valdecilla
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SantanderSpainActive, not recruiting
Complexo Hospitalario Universitario De Santiago
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Santiago de CompostelaSpainActive, not recruiting
Hospital Quironsalud Sagrado Corazon
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SevillaSpainActive, not recruiting
University Hospital Virgen Del Rocio S.L.
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SevillaSpainActive, not recruiting
Hospital Universitario Y Politecnico La Fe
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ValenciaSpainActive, not recruiting
Fundación Instituto Valenciano de Oncología
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ValenciaSpainActive, not recruiting
Alexandra Hospital
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AthensGreeceActive, not recruiting
Thoracic General Hospital of Athens "I Sotiria"
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AthensGreeceActive, not recruiting
University General Hospital "ATTIKON" - General Hospital of West Attica "H AGIA VARVARA"
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ChaïdáriGreeceActive, not recruiting
General Oncological Hospital Of Kifissia Agioi Anargyroi
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KifissiaGreeceActive, not recruiting
General University Hospital Of Patras
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PatrasGreeceActive, not recruiting
Theageneio Cancer Hospital
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ThessalonikiGreeceActive, not recruiting
St. Luke's Hospital S.A.
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ThessalonikiGreeceActive, not recruiting
Orszagos Koranyi Pulmonologiai Intezet
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Budapest XIIHungaryActive, not recruiting
Fejer Varmegyei Szent Gyoergy Egyetemi Oktato Korhaz
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SzekesfehervarHungaryActive, not recruiting
Református Pulmonológiai Centrum
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TörökbálintHungaryActive, not recruiting
Rigas Austrumu kliniska universitates slimnica SIA
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RigaLatviaActive, not recruiting
Pauls Stradins Clinical University Hospital
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RigaLatviaActive, not recruiting
Ziekenhuis St Jansdal
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HarderwijkNetherlandsActive, not recruiting
Isala Klinieken Stichting
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ZwolleNetherlandsActive, not recruiting
Uniwersyteckie Centrum Kliniczne im. Prof K. Gibinskiego Slaskiego Uniwersytetu Medycznego w Katowicach
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KatowicePolandActive, not recruiting
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi
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LodzPolandActive, not recruiting
Med Polonia Sp z o.o.
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PoznanPolandActive, not recruiting
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
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WarsawPolandActive, not recruiting
Mazowiecki Szpital Onkologiczny Sp. z o.o.
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WieliszewPolandActive, not recruiting
Dolnośląskie Centrum Onkologii, Pulmonologii i Hematologii
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WroclawPolandActive, not recruiting
OPN-Glendale
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ArcadiaUnited StatesUnknown status
Health Partners
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BloomingtonUnited StatesUnknown status
Gabrail Cancer Center
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CantonUnited StatesUnknown status
Cleveland Clinic Mercy Hospital
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CantonUnited StatesUnknown status
Pontchartrain Cancer Center
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CovingtonUnited StatesUnknown status
New York City Health+HospitalsCorporation Elmhurst Hospital Center
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ElmhurstUnited StatesUnknown status
Innova Schar Cancer Insitute
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FairfaxUnited StatesUnknown status
Kansas University Mediacal Center
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FairwayUnited StatesUnknown status
The Center for Cancer and Blood Disorders
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Fort WorthUnited StatesUnknown status
Lutheran Medical Center - Cancer Centers of Colorado
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GoldenUnited StatesUnknown status
Millennium Research & Clinical Development
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HoustonUnited StatesUnknown status
The University of Texas MD Anderson Cancer Center
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HoustonUnited StatesUnknown status
Cancer Specialists of North Florida
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JacksonvilleUnited StatesUnknown status
Pro Research Tools, INC DBA Lumi Research
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KingwoodUnited StatesUnknown status
Dartmouth Hitchcock Medical Center
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LebanonUnited StatesUnknown status
OPN-Los Alamitos
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Los AlamitosUnited StatesUnknown status
Southern California Permanente Group
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Los AngelesUnited StatesUnknown status
Tricounty Hematology and Oncology Associates
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MassillonUnited StatesUnknown status
Tulane University
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New OrleansUnited StatesUnknown status
Eastern Connecticut Hematology & Oncology Associates
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NorwichUnited StatesUnknown status
Mid Florida Hematology and oncology Center
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Orange CityUnited StatesUnknown status
Advent Health Orlando
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OrlandoUnited StatesUnknown status
Napa Research
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Pompano BeachUnited StatesUnknown status
Kaiser Permanente Northwest
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PortlandUnited StatesUnknown status
Northwell Health
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QueensUnited StatesUnknown status
Emad Ibrahim, MD, Inc.
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RedlandsUnited StatesUnknown status
Renown Health
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RenoUnited StatesUnknown status
Providence Medical Foundation
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Santa RosaUnited StatesUnknown status
Northwest Medical Specialties
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TacomaUnited StatesUnknown status
Montefiore Medical Center
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The BronxUnited StatesUnknown status
The University of Texas - Hope Cancer Center
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TylerUnited StatesUnknown status

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