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NCT06472245RecruitingPhase 3

Trial of Therapeutic Cancer Vaccine OSE2101 in Patients With Non-Small Cell Lung Cancer and Secondary Resistance to Immune Checkpoint Inhibitor

A Randomised, Open-label, Phase 3 Trial Comparing the Efficacy and Safety of OSE2101 Versus Docetaxel in HLA-A2 Positive Patients With Metastatic Non-Small Cell Lung Cancer (NSCLC) With Secondary Resistance to Immune Checkpoint Inhibitor

Source: ClinicalTrials.gov · Last updated 2 Oct 2026

Brief summary (registry, in English)

Multicenter, randomized (2:1), open-label phase 3 study in HLA-A2 positive patients with squamous and non-squamous metastatic NSCLC with ICI secondary resistance. Patients will be randomized into 2 arms (randomization 2:1): experimental Arm A with OSE2101 monotherapy or control Arm B SoC with docetaxel monotherapy. Stratification factors will be histology (squamous versus non squamous) and ECOG Performance Status (0 versus 1).

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
363 (estimated)
First submitted
7 Jun 2024
Start date
3 Dec 2024
Primary completion date
15 Dec 2027
Lead sponsor
OSE Immunotherapeutics
Diseases
Lung cancer
NCT number
NCT06472245

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 363
  • From 3 Dec 2024 to the primary completion date, 15 Dec 2027
  • 207 sites in 14 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.

Who the study is looking for

  • Male or female, aged ≥ 18 years
  • Patients expressing HLA-A2 phenotype in blood by pre-screening central laboratory
  • Patients with histologically or cytologically squamous or non-squamous documented NSCLC, metastatic stage at study entry, not eligible for definite surgery or radiation, without EGFR, ALK and ROS1 gene alterations eligible for targeted therapy; for patients with squamous NSCLC, the molecular tests are not mandatory if age ≥ 50 years old and smoker ≥ 15 pack years; other sensitizing mutations known to be immunosensitive are eligible in case of lack of local access to targeted therapy (i.e.; KRAS G12C and BRAF mutations) after Sponsor' agreement.
  • Patients with secondary resistance to ICI;
    • Other inclusion and exclusion criteria will apply per protocol.

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

Full criteria on ClinicalTrials.gov

Sites (207)

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

SiteCityCountrySite status
Algemeen Ziekenhuis klina
Coordinator of this site? Confirm its status
BrasschaatBelgiumRecruiting
Algemeen Ziekenhuis Maria Middelares
Coordinator of this site? Confirm its status
GhentBelgiumRecruiting
Jessa Ziekenhuis - Campus Virga Jesse
Coordinator of this site? Confirm its status
HasseltBelgiumRecruiting
Algemeen Ziekenhuis Groeninge - Campus Kennedylaan
Coordinator of this site? Confirm its status
KortrijkBelgiumRecruiting
Universitair Ziekenhuis Leuven - Campus Gasthuisberg
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LeuvenBelgiumRecruiting
Centre Hospitalier Universitaire Université Catholique de Louvain Namur - Site Sainte-Elisabeth
Coordinator of this site? Confirm its status
NamurBelgiumRecruiting
Algemeen Ziekenhuis Delta - Campus Menen
Coordinator of this site? Confirm its status
RoeselareBelgiumActive, not recruiting
Algemeen Ziekenhuis Delta - Campus Rembert Torhout
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RoeselareBelgiumActive, not recruiting
Algemeen Ziekenhuis Delta - Campus Rumbeke
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RoeselareBelgiumRecruiting
Centre Integre universitaire de sante et de services sociaux du Saguenay-Lac-Saint -Jean
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ChicoutimiCanadaRecruiting
McGill University Health Centre
Coordinator of this site? Confirm its status
MontrealCanadaTerminated
Centre Intégré de Santé et de Services Sociaux du Bas-Saint-Laurent
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RimouskiCanadaRecruiting
Universitätsklinikum Aachen
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AachenGermanyTerminated
Charité Universitätsmedizin Berlin
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BerlinGermanyRecruiting
Universitätsklinikum Bonn
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BonnGermanyRecruiting
Universitätsklinikum Essen
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EssenGermanyRecruiting
Asklepios Fachkliniken München-Gauting
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GautingGermanyRecruiting
LungenClinic Grosshansdorf
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GroßhansdorfGermanyRecruiting
Krankenhaus Martha-Maria Halle-Dolau
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HalleGermanyRecruiting
Thoraxklinik Heidelberg
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HeidelbergGermanyRecruiting
Universitätsklinikum Gießen und Marburg - Gießen
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HomburgGermanyRecruiting
Klinikum Kassel
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KasselGermanyActive, not recruiting
Munchen Klinik Bogenhausen
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MünchenGermanyRecruiting
Robert Bosch Krankenhaus
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StuttgartGermanyRecruiting
Complejo Hospitalario Universitario A Coruña
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A CoruñaSpainRecruiting
Hospital Germans Trias i Pujol
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BadalonaSpainRecruiting
Biocruces Bizkaia Instituto de Investigación Sanitaria
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BarakaldoSpainRecruiting
Clínica Mi Tres Torres
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BarcelonaSpainRecruiting
Hospital Universitari Vall d'Hebron
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BarcelonaSpainRecruiting
Hospital Clinic de Barcelona
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BarcelonaSpainRecruiting
Hospital Universitari Dexeus
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BarcelonaSpainRecruiting
Hospital Universitario Reina Sofia
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CórdobaSpainRecruiting
Hospital Universitari de Girona Dr Josep Trueta
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GironaSpainRecruiting
Complejo Hospitalario Universitario Insular Materno Infantil
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Las Palmas de Gran CanariaSpainRecruiting
Institut Catala d'Oncologia - Hospital Duran i Reynals (ICO L'Hospitalet)
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L'Hospitalet de LlobregatSpainRecruiting
Hospital Universitario Lucus Augusti
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LugoSpainRecruiting
Hospital General Universitario Gregorio Marañón
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MadridSpainRecruiting
Hospital Universitario La Paz
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MadridSpainRecruiting
Hospital Universitario Ramón y Cajal
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MadridSpainRecruiting
Hospital Universitario Puerta de Hierro - Majadahonda
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MajadahondaSpainRecruiting
Hospital Regional Universitario de Malaga - Hospital General
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MálagaSpainRecruiting
HC Marbella
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MarbellaSpainRecruiting
Hospital Son Llàtzer
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Palma de MallorcaSpainRecruiting
Hospital Universitario Virgen Macarena
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SevilleSpainRecruiting
Institut Sainte-Catherine
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AvignonFranceRecruiting
Centre Hospitalier de la Cote Basque
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BayonneFranceRecruiting
Centre Hospitalier Régional et Universitaire de Besançon - Hôpital Jean-Minjoz
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BesançonFranceRecruiting
Hopital Avicenne
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BobignyFranceRecruiting
Centre Hospitalier Regional Universitaire Brest - Hopital de la Cavale Blanche
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BrestFranceRecruiting
Hôpital Louis Pradel
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BronFranceActive, not recruiting
Centre Hospitalier (Ch) De Cholet
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CholetFranceRecruiting
Centre Hospitalier Intercommunal de Créteil
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CréteilFranceRecruiting
Centre Hospitalier Départemental Vendée
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La Roche-sur-YonFranceRecruiting
Hopital Michallon
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La TroncheFranceRecruiting
Centre Hospitalier Le Mans
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Le MansFranceRecruiting
Centre Hospitalier Universitaire Dupuytren 1
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LimogesFranceRecruiting
Centre Hospitalier Lyon Sud
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LyonFranceRecruiting
Hôpital de la Croix Rousse
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LyonFranceRecruiting
Institut Paoli-Calmettes
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MarseilleFranceRecruiting
Hopital Nord de Marseille
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MarseilleFranceRecruiting
Hôpital Arnaud de Villeneuve
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MontpellierFranceRecruiting
Hôpital Emile Muller
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MulhouseFranceRecruiting
Centre Hospitalier Régional Universitaire de Nancy
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NancyFranceRecruiting
Centre Hospitalier Universitaire De Nantes - Hôpital Nord Laennec
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NantesFranceRecruiting
Groupe hospitalier Paris saint Joseph
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ParisFranceRecruiting
Hôpital Tenon
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ParisFranceRecruiting
Hôpital Cochin
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ParisFranceRecruiting
Hopital Haut-Leveque
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PessacFranceRecruiting
Centre Hospitalier Universitaire de Poitiers
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PoitiersFranceRecruiting
Hôpital Pontchaillou
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RennesFranceRecruiting
Institut de Cancérologie de l'Ouest - Saint-Herblain - Site René Gauducheau
Coordinator of this site? Confirm its status
Saint-HerblainFranceRecruiting
Nouvel Hôpital Civil
Coordinator of this site? Confirm its status
StrasbourgFranceRecruiting
Hopital d instruction des armees sainte anne
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ToulonFranceRecruiting
Hopital Larrey
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ToulouseFranceRecruiting
Gustave Roussy
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VillejuifFranceRecruiting
NHS Grampian
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AberdeenUnited KingdomRecruiting
University Hospitals of Leicester NHS Trust
Coordinator of this site? Confirm its status
LeicesterUnited KingdomRecruiting
The Christie NHS Foundation Trust
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ManchesterUnited KingdomRecruiting
The Clatterbridge Cancer Centre NHS Foundation Trust
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Metropolitan Borough of WirralUnited KingdomRecruiting
The Royal Marsden NHS Foundation Trust
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SuttonUnited KingdomRecruiting
Saint Savvas Anticancer - Oncological Hospital of Athens
Coordinator of this site? Confirm its status
AthensGreeceRecruiting
Henry Dunant Hospital Center
Coordinator of this site? Confirm its status
AthensGreeceRecruiting
General Hospital for Thoracic Diseases Sotiria
Coordinator of this site? Confirm its status
AthensGreeceRecruiting
University General Hospital of Heraklion (PAGNI)
Coordinator of this site? Confirm its status
HeraklionGreeceRecruiting
University General Hospital of Larissa
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LarissaGreeceRecruiting
Agii Anargiri Cancer Hospital
Coordinator of this site? Confirm its status
Nea KifissiaGreeceRecruiting
University General Hospital of Patras
Coordinator of this site? Confirm its status
PatraGreeceRecruiting
Metropolitan Hospital
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PiraeusGreeceRecruiting
Theagenio Anti-Cancer Hospital of Thessaloniki
Coordinator of this site? Confirm its status
ThessalonikiGreeceRecruiting
General Hospital of Thessaloniki Papageorgiou
Coordinator of this site? Confirm its status
ThessalonikiGreeceActive, not recruiting
Clinic Agios Loukas
Coordinator of this site? Confirm its status
ThessalonikiGreeceRecruiting
Orszagos Koranyi Pulmonologiai Intezet
Coordinator of this site? Confirm its status
BudapestHungaryRecruiting
Clinexpert Kft. telephelye, Bugát Pál Kórház - Phase I. Clinical Trial Site
Coordinator of this site? Confirm its status
GyöngyösHungaryRecruiting
Matrai Gyogyintezet
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GyöngyösHungaryTerminated
Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale Policlinico San Martino
Coordinator of this site? Confirm its status
GenovaItalyRecruiting
Ospedale Vito Fazzi Lecce
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LecceItalyRecruiting
Ospedale P. Pederzoli - Casa di Cura Privata S.p.A.
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LegnagoItalyRecruiting
Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST
Coordinator of this site? Confirm its status
MeldolaItalyRecruiting
Fondazione IRCCS - Istituto Nazionale dei Tumori
Coordinator of this site? Confirm its status
MilanItalyRecruiting
Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San Raffaele
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MilanItalyRecruiting
Azienda Ospedaliera Universitaria - Universita degli Studi della Campania Luigi Vanvitelli
Coordinator of this site? Confirm its status
NaplesItalyRecruiting
Azienda Ospedaliero Universitaria Maggiore della Carita di Novara
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NovaraItalyRecruiting
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
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OrbassanoItalyRecruiting
Ospedale Busonera - Istituto Oncologico Veneto (IOV) - Padua
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PadovaItalyRecruiting
Azienda Ospedaliero Universitaria Pisana
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PisaItalyRecruiting
Azienda Unità Sanitaria Locale della Romagna - Ospedale Infermi di Rimini
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RiminiItalyActive, not recruiting
IRCCS Istituto Nazionale Tumori Regina Elena
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RomaItalyRecruiting
Azienda Ospedaliera San Camillo Forlanini
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RomeItalyRecruiting
Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Istituto Clinico Humanitas
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RozzanoItalyActive, not recruiting
Presidio Ospedaliero di Lucca
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San FilippoItalyRecruiting
Azienda Ospedaliera Universitaria Senese - L'ospedale Santa Maria alle Scotte
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SienaItalyRecruiting
Universitair Medisch Centrum Groningen
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GroningenNetherlandsRecruiting
Radboud Universitair Medisch Centrum
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NijmegenNetherlandsRecruiting
Erasmus Medisch Centrum
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RotterdamNetherlandsRecruiting
Centrum Onkologii Im. Prof. F. Łukaszczyka w Bydgoszczy
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BydgoszczPolandRecruiting
Uniwersyteckie Centrum Kliniczne w Gdańsku
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GdanskPolandRecruiting
Przychodnia Lekarska Komed Roman Karaszewski
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KoninPolandRecruiting
Instytut Centrum Zdrowia Matki Polki
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LodzPolandRecruiting
Uniwersytecki Szpital Kliniczny nr 4 w Lublinie
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LublinPolandRecruiting
Wielkopolskie Centrum Pulmonologii i Torakochirurgii im. Eugenii i Janusza Zeylandow
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PoznanPolandRecruiting
Unidade Local de Saude de Coimbra
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CoimbraPortugalRecruiting
Hospital CUF Descobertas
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LisbonPortugalRecruiting
Unidade Local de Saude de Santa Maria, E.P.E. - Hospital Pulido Valente
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LisbonPortugalRecruiting
Hospital CUF Porto
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PortoPortugalRecruiting
Unidade Local de Saúde de Gaia/Espinho, E. P. E
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Vila Nova de GaiaPortugalRecruiting
Institutul Oncologic Prof. Dr. Ion Chiricuta
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Cluj-NapocaRomaniaRecruiting
Centrul de Oncologie Sf Nectarie
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CraiovaRomaniaRecruiting
SC Oncomed SRL
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TimișoaraRomaniaRecruiting
New York Cancer & Blood Specialists - Babylon Medical Oncology
Coordinator of this site? Confirm its status
BabylonUnited StatesActive, not recruiting
Ascension Saint Agnes Hospital
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BaltimoreUnited StatesRecruiting
Mary Bird Perkins Cancer Center - Baton Rouge
Coordinator of this site? Confirm its status
Baton RougeUnited StatesActive, not recruiting
Clinical Research Advisors, LLC
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Beverly HillsUnited StatesRecruiting
Northwest Medical Specialties - Bonney Lake
Coordinator of this site? Confirm its status
Bonney LakeUnited StatesActive, not recruiting
Comprehensive Hematology Oncology - Bradenton Clinic
Coordinator of this site? Confirm its status
BradentonUnited StatesActive, not recruiting
Comprehensive Hematology Oncology - Brandon Clinic
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BrandonUnited StatesActive, not recruiting
Optum Medical Care - Carmel/Brewster Campus
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BrewsterUnited StatesTerminated
Brooklyn Radiation Oncology
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BrooklynUnited StatesTerminated
Tennessee Oncology Chattanooga Memorial Plaza
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ChattanoogaUnited StatesRecruiting
Tennessee Oncology - Chattanooga - Medical Park II
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ChattanoogaUnited StatesActive, not recruiting
Tennessee Oncology - Chattanooga - GHCR Site I
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ChattanoogaUnited StatesRecruiting
Tennessee Oncology - Chattanooga - Downtown
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ChattanoogaUnited StatesRecruiting
University of Illinois Cancer Center
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ChicagoUnited StatesRecruiting
Tennessee Oncology - Cleveland Clinic
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ClevelandUnited StatesRecruiting
Tennessee Oncology - Cookeville Clinic
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CookevilleUnited StatesActive, not recruiting
Pontchartrain Cancer Center - Covington Office
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CovingtonUnited StatesRecruiting
Tennessee Oncology - Dickson Clinic
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DicksonUnited StatesActive, not recruiting
Clinical Research Advisors - Encino
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EncinoUnited StatesActive, not recruiting
Northwest Medical Specialties - Federal Way
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Federal WayUnited StatesActive, not recruiting
Optum Medical Care - Fishkill Westage Campus
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FishkillUnited StatesTerminated
Cancer Specialists of North Florida - Fleming Island
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Fleming IslandUnited StatesRecruiting
Tennessee Oncology - Franklin Clinic
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FranklinUnited StatesRecruiting
Tennessee Oncology - Gallatin Clinic
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GallatinUnited StatesActive, not recruiting
Northwest Medical Specialties - Gig Harbor
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Gig HarborUnited StatesRecruiting
Bon Secours Hematology and Oncology
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GreenvilleUnited StatesRecruiting
Pontchartrain Cancer Center - Hammond Office
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HammondUnited StatesRecruiting
Tennessee Oncology - Hendersonville Clinic
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HendersonvilleUnited StatesActive, not recruiting
Tennessee Oncology - Hermitage - Summit Clinic
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HermitageUnited StatesActive, not recruiting
Cancer Specialists of North Florida - Riverside
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JacksonvilleUnited StatesRecruiting
Cancer Specialists of North Florida - Northside
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JacksonvilleUnited StatesRecruiting
Cancer Specialists of North Florida - Southpoint
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JacksonvilleUnited StatesRecruiting
Cancer Specialists of North Florida - Baptist South
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JacksonvilleUnited StatesActive, not recruiting
Cancer Specialists of North Florida Southside
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JacksonvilleUnited StatesRecruiting
Cancer Specialists of North Florida
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Jacksonville BeachUnited StatesRecruiting
Clinical Research Alliance
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Lake SuccessUnited StatesTerminated
Comprehensive Hematology Oncology - Largo Clinic
Coordinator of this site? Confirm its status
LargoUnited StatesActive, not recruiting
Tennessee Oncology - Lebanon Clinic
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LebanonUnited StatesActive, not recruiting
Nebraska Hematology-Oncology - Revive Research Institute LLC
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LincolnUnited StatesRecruiting
SCL Health - Saint Joseph Hospital Cancer Center
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LittletonUnited StatesWithdrawn
Clinical Research Advisors - West Hollywood
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Los AngelesUnited StatesActive, not recruiting
Clinical Research Advisors - Korea Town
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Los AngelesUnited StatesActive, not recruiting
Alliance for Multispecialty Research (AMR) - Kansas City Oncology
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MerriamUnited StatesWithdrawn
Optum Medical Care - Mount Kisco Campus 90
Coordinator of this site? Confirm its status
Mount KiscoUnited StatesTerminated
Tennessee Oncology - Murfreesboro Clinic
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MurfreesboroUnited StatesActive, not recruiting
Tennessee Oncology - Nashville - Southern Hills Clinic
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NashvilleUnited StatesActive, not recruiting
Tennessee Oncology - Nashville - Centennial Clinic - Medical Oncology
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NashvilleUnited StatesActive, not recruiting
Tennessee Oncology - Nashville St. Thomas Midtown Clinic
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NashvilleUnited StatesActive, not recruiting
Tennessee Oncology - Nashville - Midtown Center for Blood Cancers
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NashvilleUnited StatesActive, not recruiting
Tennessee Oncology - Nashville - Skyline Clinic
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NashvilleUnited StatesActive, not recruiting
Tennessee Oncology - Nashville - St. Thomas West Clinic
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NashvilleUnited StatesRecruiting
Tennessee Oncology - Nashville - Centennial Center for Blood Cancers Clinic
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NashvilleUnited StatesActive, not recruiting
Greco-Hainsworth Tennessee Oncology Centers for Research (GHCR) - Corporate
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NashvilleUnited StatesRecruiting
Cancer Specialists of North Florida - Beaches
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Neptune BeachUnited StatesActive, not recruiting
New York Cancer & Blood Specialists - New Hyde Park
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New Hyde ParkUnited StatesRecruiting
Optum Hematology Oncology - Lake Success
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New Hyde ParkUnited StatesTerminated
New York Cancer & Blood Specialists - Cancer Center - Research Headquarters
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New YorkUnited StatesRecruiting
New York Cancer & Blood Specialists - Central Park Medical Oncology
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New YorkUnited StatesActive, not recruiting
Eastern Connecticut Hematology and Oncology Associates
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NorwichUnited StatesRecruiting
Comprehensive Hematology Oncology - Palm Harbor Clinic
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Palm HarborUnited StatesActive, not recruiting
New York Cancer & Blood Specialists - Patchogue Medical Oncology
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PatchogueUnited StatesRecruiting
Mercy Health Perrysburg Cancer Center
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PerrysburgUnited StatesActive, not recruiting
New York Cancer & Blood Specialists - Port Jefferson Medical Oncology
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Port Jefferson StationUnited StatesActive, not recruiting
New York Cancer & Blood Specialists - Port Jefferson Station Medical Oncology
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Port Jefferson StationUnited StatesActive, not recruiting
Optum Medical Care - Poughkeepsie
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PoughkeepsieUnited StatesTerminated
Northwest Medical Specialties - Puyallup Medical Oncology
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PuyallupUnited StatesRecruiting
Cancer Specialists Of North Florida - St. Augustine
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Saint AugustineUnited StatesRecruiting
Tennessee Oncology - Shelbyville Clinic
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ShelbyvilleUnited StatesRecruiting
Tennessee Oncology - Smyrna Clinic
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SmyrnaUnited StatesRecruiting
Comprehensive Hematology Oncology - Bayfront Clinic
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St. PetersburgUnited StatesActive, not recruiting
Comprehensive Hematology Oncology
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St. PetersburgUnited StatesRecruiting
Northwest Medical Specialties - Tacoma
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TacomaUnited StatesRecruiting
New York Cancer & Blood Specialists - Eastchester Cancer Care Center
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The BronxUnited StatesActive, not recruiting
New York Cancer & Blood Specialists - Riverhead Medical Oncology
Coordinator of this site? Confirm its status
The BronxUnited StatesActive, not recruiting
Mercy Health - St. Anne Cancer Center
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ToledoUnited StatesActive, not recruiting
Comprehensive Hematology Oncology - Trinity Clinic
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TrinityUnited StatesRecruiting
Georgetown Lombardi Comprehensive Cancer Center
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Washington D.C.United StatesRecruiting
Lutheran Medical Center - Cancer Centers of Colorado
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Wheat RidgeUnited StatesRecruiting
University of Massachusetts Memorial Medical Center
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WorcesterUnited StatesRecruiting

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