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NCT07218146RecruitingPhase 3

A Study of ZL-1310 Versus Investigator's Choice of Therapy in Participants With Relapsed Small Cell Lung Cancer (DLLEVATE)

A Randomized, Open-Label, Phase 3 Study of ZL-1310, a DLL3 Antibody-Drug Conjugate (ADC), Compared to Investigator's Choice Therapy in Participants With Relapsed Small Cell Lung Cancer

Source: ClinicalTrials.gov · Last updated 16 Oct 2026

Brief summary (registry, in English)

The purpose of this study is to evaluate the efficacy and safety of ZL-1310 compared to Investigator's Choice Therapy in participants with relapsed Small Cell Lung Cancer.

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
480 (estimated)
First submitted
8 Oct 2025
Start date
30 Nov 2025
Primary completion date
30 Jun 2028
Lead sponsor
Zai Lab (Shanghai) Co., Ltd.
Diseases
Lung cancer
NCT number
NCT07218146

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 480
  • From 30 Nov 2025 to the primary completion date, 30 Jun 2028
  • 165 sites in 15 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

  • Received more than one line of systemic therapy for Extensive-Stage SCLC.
  • Received any prior ADC with topoisomerase 1 inhibitor payload
  • Receipt of anti-cancer treatment known to treat cancers within 3 weeks before the first dose of study treatment.
  • Prior radiotherapy before study treatment based on criteria per protocol
  • Unresolved toxicity of Grade \>/= 2 from previous anti-cancer treatment, except for alopecia and skin pigmentation.
  • Clinically significant active cardiovascular disease or history of arterial thromboembolic event within 6 months prior to the first dose of study treatment based on criteria per protocol.

Other illness

  • Participants with another known malignancy with exceptions defined in the protocol.
  • History or suspected ILD/pneumonitis based on criteria per protocol
  • Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses.
  • Known infection or active infection defined in the protocol.

Who the study is looking for

  • Age \>/= 18 years, or considered an adult by local regulations, at the time of consent
  • Signed informed consent
  • Histologically or cytologically confirmed SCLC. Received 1L platinum-based systemic therapy and had documented disease progression during or after the most recent systemic therapy. Or received 2L tarlatamab is allowed.
  • Measurable disease according to RECIST v1.1 as assessed by the investigator.
  • Participants with a history of treated and stable or untreated and asymptomatic CNS metastases based on criteria per protocol.
  • Adequate organ and marrow function
  • Eastern Cooperative Group (ECOG) performance status of 0 or 1
  • Life expectancy of at least 3 months
  • Participants must be willing to undergo a tumor biopsy or provide archived tumor tissue sample at Screening
  • Participants must be willing and able to comply with protocol for the duration of the study

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

Full criteria on ClinicalTrials.gov

Sites (165)

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

SiteCityCountrySite status
Uniklinikum Salzburg, Landeskrankenhaus, Universitatsklinik fur Innere Medizin III der PMU Department of Internal Medicine III
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SalzburgAustriaRecruiting
Medizinische Universitaet Wien - Allgemeines Krankenhaus der Stadt Wien (AKH)
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ViennaAustriaRecruiting
Universitair Ziekenhuis Antwerpen
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EdegemBelgiumRecruiting
Algemeen Ziekenhuis Sint-Lucas
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GhentBelgiumRecruiting
AZ Maria Middelares - Campus AZ Maria Middelares
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GhentBelgiumRecruiting
Jessa Ziekenhuis Salvador
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HasseltBelgiumRecruiting
Universitair Ziekenhuis Brussel
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JetteBelgiumRecruiting
AZ Groeninge
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KortrijkBelgiumRecruiting
Vivalia St Joseph
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LibramontBelgiumRecruiting
Universite Catholique de Louvain Namur, Centre Hospitalier Universitaire Dinant Godinne
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YvoirBelgiumRecruiting
Beijing Cancer Hospital
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BeijingChinaRecruiting
Cancer Hospital, Chinese Academy of Medical Sciences
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BeijingChinaRecruiting
Jilin Cancer Hospital
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ChangchunChinaRecruiting
Hunan Cancer Hospital
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ChangshaChinaRecruiting
Sichuan Cancer Hospital
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ChengduChinaRecruiting
Fujian Cancer Hospital
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FuzhouChinaRecruiting
Guangdong Provincial People's Hospital
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GuangzhouChinaRecruiting
Zhejiang Cancer Hospital
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HangzhouChinaRecruiting
Anhui Provincial Hospital
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HefeiChinaRecruiting
Harbin medical university cancer hospital
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HeilongjiangChinaRecruiting
Shandong Cancer Hospital
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JinanChinaRecruiting
LinYi Cancer Hospital
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LinyiChinaRecruiting
Jiangxi Cancer Hospital
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NanchangChinaRecruiting
Guangxi Medical University Affiliated Tumor Hospital
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NaningChinaRecruiting
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
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NanjingChinaRecruiting
Shanghai Pulmonary Hospital
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ShanghaiChinaRecruiting
Fourth Hospital of Hebei Medical University
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ShijiazhuangChinaRecruiting
Taizhou Hospital of Zhejiang Province
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TaizhouChinaRecruiting
Hubei Cancer Hospital
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WuhanChinaRecruiting
The First Affiliated hospital of Xiamen University
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XiamenChinaRecruiting
The First Affiliated Hospital of Xi'an Jiaotong University
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Xi’anChinaRecruiting
Henan Cancer Hospital
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ZhengzhouChinaRecruiting
The First Affiliated Hospital of Zhengzhou University
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ZhengzhouChinaRecruiting
Nemocnice Horovice
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HořoviceCzechiaRecruiting
Nemocnice AGEL Ostrava-Vitkovice a. s.
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VítkoviceCzechiaRecruiting
Evangelische Lungenklinik Berlin
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BerlinGermanyRecruiting
Krankenhaus Koeln-Merheim
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CologneGermanyRecruiting
University Hospital Carl Gustav Carus
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DresdenGermanyRecruiting
Klinikum der Johann Wolfgang Goethe-Universität
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Frankfurt am MainGermanyRecruiting
Krankenhaus Martha-Maria Halle-Doelau gGmbH
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HalleGermanyRecruiting
Studiengesellschaft Haemato-Onkologie Hamburg, Prof. Laack und Partner
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HamburgGermanyRecruiting
UOMI Cancer Center-Clinica Tres Torres
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BarcelonaSpainRecruiting
Hospital Clinic de Barcelona (Hospital Clinic i Provincial)
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BarcelonaSpainRecruiting
Hospital General Universitario de Elche
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ElcheSpainRecruiting
Institut Català D'Oncologia Girona
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GironaSpainRecruiting
Hospital Universitario De Jerez
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Jerez de la FronteraSpainRecruiting
Hospital Universitario La Paz
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MadridSpainRecruiting
Clinica Universidad de Navarra Madrid
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MadridSpainRecruiting
Hospital Universitario Ramón y Cajal
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MadridSpainRecruiting
Hospital Quironsalud Malaga
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MálagaSpainRecruiting
Universidad de Navarra - Clínica Universidad de Navarra (CUN)
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PamplonaSpainRecruiting
Hospital Universitari Sant Joan De Reus, S.A
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ReusSpainRecruiting
Hospital Universitario Virgen Macarena / Clinical Research Department
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SevilleSpainRecruiting
Hospital Universitario Virgen del Rocio
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SevilleSpainRecruiting
Fundación Instituto Valenciano de Oncología
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ValenciaSpainRecruiting
Institut Sainte-Catherine
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AvignonFranceRecruiting
Hospices Civils de Lyon - Hopital Louis Pradel
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BronFranceRecruiting
Centre Hospitalier Intercommunal de Creteil (CHIC) - Centre de ressources et de competences pour la mucoviscidose (C.R.C.M.)
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CréteilFranceRecruiting
Centre Hospitalier Le Mans
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Le MansFranceRecruiting
Centre Hospitalier Universitaire (CHU) De Limoges Hopital Dupuytren
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LimogesFranceRecruiting
Centre Leon-Berard (CLB) - Centre de Recherche en Cancerologie Lyon-Est
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LyonFranceRecruiting
Centre de Recherche Clinique Hôpital de la Croix-Rousse
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LyonFranceRecruiting
Centre Hospitalier Regional Universitaire (CHRU) Montpellier Arnaud de Villeneuve
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MontpellierFranceRecruiting
Centre Hospitalier Lyon-Sud, CHLS
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Pierre-BéniteFranceRecruiting
Centre Hospitalier de Cornouaille - Hopital Laennec
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QuimperFranceRecruiting
Hôpital Nord Guillaume-et-René-Laennec / CHU de Nantes
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Saint-HerblainFranceRecruiting
Hopital Foch
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SuresnesFranceRecruiting
Centre Hospitalier Intercommunal Toulon La Seyne Sur Mer (C.H.I.T.S) - Hospital Font-Pre
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ToulonFranceRecruiting
Clinique Teissier
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ValenciennesFranceRecruiting
Addenbrooke's Hospital, Cambridge University Hospitals NHS Foundation Trust
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CambridgeUnited KingdomRecruiting
Royal Marsden Hospital (RMH) - Royal Marsden NHS Foundation Trust
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ChelseaUnited KingdomRecruiting
Sarah Cannon Research Institute
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LondonUnited KingdomRecruiting
Nottingham University Hospitals NHS Trust - Nottingham City Hospital
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NottinghamUnited KingdomRecruiting
Royal Stoke University Hospital - University Hospitals of North Midlands NHS Trust
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Stoke-on-TrentUnited KingdomRecruiting
Royal Marsden Hospital (Sutton) - Royal Marsden NHS Foundation Trus
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SuttonUnited KingdomRecruiting
New Cross Hospital
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WolverhamptonUnited KingdomRecruiting
Sotiria General Hospital of Athens
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AthensGreeceRecruiting
University General Hospital of Patras
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RioGreeceRecruiting
Iatriko Diavalkaniko Thessalonikis
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ThessalonikiGreeceRecruiting
NOSILEFTIKI A.E. - Saint Luke's Clinic
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ThessalonikiGreeceRecruiting
European Interbalkan Medical Center
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ThessalonikiGreeceRecruiting
Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I
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AnconaItalyRecruiting
FPO IRCCS Candiolo
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CandioloItalyRecruiting
IRCCS Istituto Romagnolo per lo studio dei Tumori Dino Amadori (IRST)
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MeldolaItalyRecruiting
AUSL Della Romagna - Ospedale S.Maria delle Croci
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RavennaItalyRecruiting
Istituti Fisioterapici Ospitalieri (IFO) - Istituto Nazionale Tumori Regina Elena (IRE) UO Oncologia Ospedali Civili di Livorno
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RomaItalyRecruiting
Centro Ricerche Cliniche di Verona s.r.l.
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VeronaItalyRecruiting
Asahikawa Medical University Hospital
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AsahikawaJapanRecruiting
Nippon Medical School Hospital
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Bunkyo-kuJapanRecruiting
Komagome Hospital
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Bunkyō-KuJapanRecruiting
Kyushu University Hospital
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FukuokaJapanRecruiting
Kyushu Medical Center
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FukuokaJapanRecruiting
Kansai Medical University Hospital
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HirakataJapanRecruiting
Hiroshima University Hospital
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HiroshimaJapanRecruiting
Izumi City General Hospital
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IzumiJapanRecruiting
Nara Medical University Hospital
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KashiharaJapanRecruiting
National Cancer Center Hospital East
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KashiwaJapanRecruiting
Dokkyo Medical University Saitama Medical Center
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KoshigayaJapanRecruiting
The Cancer Institute Hospital of JFCR
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Koto-kuJapanRecruiting
Kurume University Hospital
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KurumeJapanRecruiting
Shinshu University Hospital
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MatsumotoJapanRecruiting
National Hospital Organization Nagasaki Medical Center
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ŌmuraJapanRecruiting
Osaka International Cancer Institute
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OsakaJapanRecruiting
Kinki Chuo Chest Medical Center
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SakaiJapanRecruiting
KKR Sapporo Medical Center
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SapporoJapanRecruiting
Sendai Kousei Hospital
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SendaiJapanRecruiting
Dokkyo Medical University Hospital
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ShimosugaJapanRecruiting
National Center for Global Health and Medicine
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Shinjuku-KuJapanRecruiting
Shizuoka Cancer Center
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ShizuokaJapanRecruiting
Kanagawa Cancer Center
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YokohamaJapanRecruiting
Amphia Ziekenhuis
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BredaNetherlandsRecruiting
Tergooi Ziekenhuizen
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HilversumNetherlandsRecruiting
Instytut MSF Sp. z o.o.
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LodzPolandRecruiting
Pratia S.A. , Pratia Poznan
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PoznanPolandRecruiting
Med Polonia Sp z o.o.
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PoznanPolandRecruiting
Wojewodzki Szpital im Sw Ojca Pio w Przemyslu
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PrzemyślPolandRecruiting
Wojskowy Instytut Medyczny,Centralny Szpital Kliniczny Ministerstwa Obronty Narodowej
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SiedlcePolandRecruiting
Wojskowy Instytut Medyczny
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WarsawPolandRecruiting
Cleveland Clinic - Akron General Medical Center
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AkronUnited StatesRecruiting
University of Colorado
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AuroraUnited StatesRecruiting
Texas Oncology - Central South
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AustinUnited StatesRecruiting
American Oncology Partners, PA - The Center for Cancer and Blood Disorders
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BethesdaUnited StatesRecruiting
Consultants in Medical Oncology and Hematology
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BroomallUnited StatesRecruiting
Clermont Oncology Center
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ClermontUnited StatesRecruiting
University Hospitals Cleveland Medical Center*
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ClevelandUnited StatesRecruiting
Cleveland Clinic
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ClevelandUnited StatesRecruiting
Cleveland Clinic - Fairview Hospital Molly Pavilion
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ClevelandUnited StatesRecruiting
Missouri Cancer Associates
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ColumbiaUnited StatesRecruiting
University of Texas Southwestern Medical Center/Clinical Research Department
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DallasUnited StatesRecruiting
Henry Ford Health Cancer
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DetroitUnited StatesRecruiting
Virginia Cancer Specialists
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FairfaxUnited StatesRecruiting
University of Iowa
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Iowa CityUnited StatesRecruiting
University of California San Diego
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La JollaUnited StatesRecruiting
Norton Cancer Institute
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LouisvilleUnited StatesRecruiting
Cleveland Clinic - Hillcrest Hospital Cancer Center
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Mayfield HeightsUnited StatesRecruiting
Alliance Cancer Specialists
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MediaUnited StatesRecruiting
SCRI OP (Oncology Partners)
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NashvilleUnited StatesRecruiting
Yale Cancer Center/Clinical Trials Office
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New HavenUnited StatesRecruiting
Texas Oncology - West Texas
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OdessaUnited StatesRecruiting
Mid Florida Hematology and oncology Center
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Orange CityUnited StatesRecruiting
Illinois Cancer Care
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PeoriaUnited StatesRecruiting
OSF St Francis Medical Center
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PeoriaUnited StatesRecruiting
University of Pittsburgh (UPMC) Hillman Cancer Center
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PittsburghUnited StatesRecruiting
Allegheny General Hospital
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PittsburghUnited StatesRecruiting
Cancer Centers of Bevard
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RockledgeUnited StatesRecruiting
UC Davis Comprehensive Cancer Center
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SacramentoUnited StatesRecruiting
Sarah Cannon Research Institute
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SarasotaUnited StatesRecruiting
Maryland Oncology Hematology
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Silver SpringUnited StatesRecruiting
Mercy South
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St LouisUnited StatesRecruiting
Stony Brook Cancer Center
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Stony BrookUnited StatesRecruiting
Florida Cancer Specialists - North
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St. PetersburgUnited StatesRecruiting
Moffitt Cancer Center
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TampaUnited StatesRecruiting
Montefiore Medical Center
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The BronxUnited StatesRecruiting
University of Iowa Mission Health Cancer + Blood
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WaukeeUnited StatesRecruiting
Florida Cancer Specialists - East
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West Palm BeachUnited StatesRecruiting
Medical Park Seyhan Hospital
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AdanaTurkey (Türkiye)Recruiting
Baskent University Adana Turgut Noyan Application and Research Center Kisla Health Campus
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AdanaTurkey (Türkiye)Recruiting
Ankara Bilkent City Hospital
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AnkaraTurkey (Türkiye)Recruiting
Liv Hospital Ankara
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AnkaraTurkey (Türkiye)Recruiting
Memorial Ankara Hospital
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ÇankayaTurkey (Türkiye)Recruiting
Istanbul University Cerrahpasa Faculty of Medicine Hospital
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FatihTurkey (Türkiye)Recruiting
Medical Park Florya Hospital
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IstanbulTurkey (Türkiye)Recruiting
Yeditepe University Hospital
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IstanbulTurkey (Türkiye)Recruiting
Istanbul Medeniyet University Medical Faculty
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KadıköyTurkey (Türkiye)Recruiting
Sakarya University - Faculty of Medicine
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SakaryaTurkey (Türkiye)Recruiting

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