A Randomised, Open-label, Phase 3 Trial Comparing OSE2101 Cancer Vaccine Versus Docetaxel Chemotherapy in HLA-A2 Positive Patients With Metastatic Non-Small Cell Lung Cancer and Secondary Resistance to Immune Checkpoint Inhibitors Led by OSE Immunotherapeutics · Updated on 2026-04-01
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Common Questions
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Frequently Asked Questions
Sponsors O
OSE Immunotherapeutics
Lead Sponsor
E
Exystat
Collaborating Sponsor
What this Trial Is About Researchers are conducting a multicenter, randomized, open-label phase 3 trial to evaluate treatments for patients with metastatic non-small cell lung cancer (NSCLC) who have developed secondary resistance to immune checkpoint inhibitors (ICI). The study focuses on patients positive for the HLA-A2 phenotype with either squamous or non-squamous histology. The trial compares the cancer vaccine OSE2101 to the standard chemotherapy drug docetaxel. Stratification factors include cancer histology and the patients' performance status.
Participants will be randomly assigned in a 2:1 ratio to receive either OSE2101 or docetaxel. OSE2101 is a peptidic cancer vaccine given by subcutaneous injection every three weeks for six cycles, then every eight weeks through the first year, and every twelve weeks during the second year. Docetaxel is given as an intravenous infusion every three weeks. Additionally, a companion diagnostic device system is used to detect HLA-A2 status and analyze genetic markers.
During the study, patient survival will be monitored from the time of randomization for an average of three years. Researchers will track overall survival as the primary outcome. Patients will undergo regular treatment visits, assessments, and monitoring according to the schedule. Safety, efficacy, and disease progression will be evaluated throughout the trial period, which starts in December 2024 and continues until December 2028.
Patients With Non-Small Cell Lung Cancer
Trial of Therapeutic Cancer Vaccine OSE2101 in Patients With Non-Small Cell Lung Cancer and Secondary Resistance to Immune Checkpoint Inhibitor
Age: 18Years +
All Genders
Eligibility Criteria You may qualify if you...
Male or female aged 18 years or older
Patients expressing HLA-A2 phenotype confirmed by blood test
Diagnosed with metastatic squamous or non-squamous non-small cell lung cancer (NSCLC) not eligible for surgery or radiation
No EGFR, ALK, or ROS1 gene alterations eligible for targeted therapy; molecular tests not mandatory for squamous NSCLC if age 50 or older and history of smoking 15 pack years or more
Patients with secondary resistance to immune checkpoint inhibitor treatment
You will not qualify if you...
History of severe allergic reactions to study medication
Currently pregnant or breastfeeding
Recent participation in another clinical trial within the last 30 days
Presence of uncontrolled medical conditions that could affect safety
Complete this quick 3-step screening to check your eligibility
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for HLA-A2 phenotype blood test and eligibility confirmation
Treatment
Duration - Up to 2 years with dosing schedules specific to each treatment
Participants receive either the OSE2101 cancer vaccine or Docetaxel chemotherapy as active cancer treatments.
For OSE2101: One subcutaneous injection every three weeks for six cycles, then every eight weeks until the end of year one, and every twelve weeks until the end of the second year; For Docetaxel: One intravenous infusion every three weeks
Follow-up
Duration - Up to 1 year after treatment completion
Participants are monitored for overall survival and long-term outcomes following treatment completion.
Visits scheduled according to study protocol for survival monitoring
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Los Angeles, California, United States, 90211
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Littleton, Colorado, United States, 80218
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Wheat Ridge, Colorado, United States, 80033-6013
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Norwich, Connecticut, United States, 06360
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Bradenton, Florida, United States, 34210
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Brandon, Florida, United States, 33511
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Fleming Island, Florida, United States, 32003
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Jacksonville, Florida, United States, 32204
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Jacksonville, Florida, United States, 32218
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Jacksonville, Florida, United States, 32256-6932
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Jacksonville Beach, Florida, United States, 32250
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Largo, Florida, United States, 33770
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Palm Harbor, Florida, United States, 34685
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St. Petersburg, Florida, United States, 33709
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Merriam, Kansas, United States, 66204
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Baton Rouge, Louisiana, United States, 70809
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Covington, Louisiana, United States, 70433
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Hammond, Louisiana, United States, 70403-1452
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Baltimore, Maryland, United States, 21229
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Lincoln, Nebraska, United States, 68506
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Babylon, New York, United States, 11702
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Brewster, New York, United States, 10509
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Brooklyn, New York, United States, 11201
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Fishkill, New York, United States, 12524
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Lake Success, New York, United States, 11042
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Mount Kisco, New York, United States, 10549
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New Hyde Park, New York, United States, 11042
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New Hyde Park, New York, United States, 11042
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New York, New York, United States, 10028
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Port Jefferson Station, New York, United States, 11776
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Port Jefferson Station, New York, United States, 11776
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Poughkeepsie, New York, United States, 12601
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The Bronx, New York, United States, 10469
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The Bronx, New York, United States, 10469
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Perrysburg, Ohio, United States, 43551
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Toledo, Ohio, United States, 43623
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Greenville, South Carolina, United States, 29607
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Cleveland, Tennessee, United States, 37311
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Cookeville, Tennessee, United States, 38501
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Dickson, Tennessee, United States, 37055
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Franklin, Tennessee, United States, 37067
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Gallatin, Tennessee, United States, 37066
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Hendersonville, Tennessee, United States, 37075
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Hermitage, Tennessee, United States, 37076
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Lebanon, Tennessee, United States, 37090
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Murfreesboro, Tennessee, United States, 37129
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Nashville, Tennessee, United States, 37203
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Nashville, Tennessee, United States, 37207
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Nashville, Tennessee, United States, 37232
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Shelbyville, Tennessee, United States, 37160
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Smyrna, Tennessee, United States, 37167
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Bonney Lake, Washington, United States, 98391
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Federal Way, Washington, United States, 98003
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Gig Harbor, Washington, United States, 98332
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Puyallup, Washington, United States, 98373
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Algemeen Ziekenhuis Klina
Brasschaat, Antwerpen, Belgium, 2930
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Leuven, Flemish Brabant, Belgium, 3000
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Kortrijk, West-Vlaanderen, Belgium, 8500
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Toulon, Alpes-de-Haute-Provence, France, 83800
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Strasbourg, Alsace, France, 67091
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Marseille, Bouches-du-Rhône, France, 13273
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Besançon, Doubs, France, 25030
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Brest, Finistère, France, 29200
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Rennes, Ille-et-Vilaine, France, 35033
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Saint-Herblain, Loire-Atlantique, France, 44805
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Cholet, Maine-et-Loire, France, 49325
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Toulouse, Midi-pyrenees, France, 31059
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Pessac, New Aquitaine, France, 33604
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Marseille, Provence-Alpes-Côte d'Azur Region, France, 13015
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Bayonne, Pyrénées-Atlantiques, France, 64109
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La Tronche, Rhône, France, 38700
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Villejuif, Val-de-Marne, France, 94805
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Avignon, Vaucluse, France, 84000
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Poitiers, Vienne, France, 86021
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Bobigny, Île-de-France Region, France, 93000
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Créteil, Île-de-France Region, France, 94000
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Paris, Île-de-France Region, France, 75014
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Paris, Île-de-France Region, France, 75014
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Gauting, Bavaria, Germany, 82131
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München, Bavaria, Germany, 81925
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Kassel, Hesse, Germany, 34125
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Aachen, North Rhine-Westphalia, Germany, 52074
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Bonn, North Rhine-Westphalia, Germany, 53127
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Essen, North Rhine-Westphalia, Germany, 45147
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Halle, Saxony-Anhalt, Germany, 06120
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Großhansdorf, Schleswig-Holstein, Germany, 22927
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Piraeus, Athens, Greece, 185 47
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Athens, Attica, Greece, 11522
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Athens, Attica, Greece, 11526
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General Hospital for Thoracic Diseases Sotiria
Athens, Attica, Greece, 11527
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Nea Kifissia, Attica, Greece, 14564
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Thessaloniki, Central Macedonia, Greece, 55236
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University General Hospital of Heraklion (PAGNI)
Heraklion, Crete, Greece, 711 10
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General Hospital of Thessaloniki Papageorgiou
Thessaloniki, Macedoni, Greece, TK 56403
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Patra, Peloponnese, Greece, 26504
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Theagenio Anti-Cancer Hospital of Thessaloniki
Thessaloniki, Thessaloniki, Greece, 546 39
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Larissa, Thessaly, Greece, 411 10
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Mátrai Gyógyintézet
Gyöngyös, Heves County, Hungary, 3200
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Országos Korányi Pulmonológiai Intézet
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Clinexpert Kft. telephelye, Bugát Pál Kórház - Phase I. Clinical Trial Site
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Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST
Meldola, Forlì-Cesena, Italy, 47014
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Presidio Ospedaliero di Lucca
San Filippo, Lucca, Italy, 55100
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Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Istituto Clinico Humanitas
Rozzano, Milan, Italy, 20089
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Naples, Naples, Italy, 80131
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Orbassano, Torino, Italy, 10043
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Ospedale P. Pederzoli - Casa di Cura Privata S.p.A.
Legnago, Verona, Italy, 37045
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Radboud Universitair Medisch Centrum
Nijmegen, Gelderland, Netherlands, 6525 GA
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Rotterdam, South Holland, Netherlands, 3015 GD
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Groningen, Netherlands, 9713 GZ
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Przychodnia Lekarska KOMED Roman Karaszewski
Konin, Greater Poland Voivodeship, Poland, 62-500
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Wielkopolskie Centrum Pulmonologii i Torakochirurgii im. Eugenii i Janusza Zeylandów
Poznan, Greater Poland Voivodeship, Poland, 60-569
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Centrum Onkologii Im. Prof. F. Łukaszczyka w Bydgoszczy
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland, 85-796
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Uniwersytecki Szpital Kliniczny Nr 4 w Lublinie
Lublin, Lublin Voivodeship, Poland, 20-090
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Instytut Centrum Zdrowia Matki Polki
Lodz, Lódzkie, Poland, 93-338
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Uniwersyteckie Centrum Kliniczne w Gdańsku
Gdansk, Pomeranian Voivodeship, Poland, 80-210
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Unidade Local de Saúde de Coimbra
Coimbra, Portugal, 3000-075
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Hospital CUF Descobertas
Lisbon, Portugal, 1769-001
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Unidade Local de Saúde de Santa Maria, E. P. E. - Hospital Pulido Valente
Lisbon, Portugal, 1769-001
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Unidade Local de Saúde de Gaia/Espinho, E. P. E
Vila Nova de Gaia, Portugal, 4434-502
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Institutul Oncologic Prof. Dr. Ion Chiricuta
Cluj-Napoca, Cluj, Romania, 400015
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Centrul de Oncologie Sf Nectarie
Craiova, Dolj, Romania, 200746
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SC OncoMed SRL
Timișoara, Timiș County, Romania, 300239
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Hospital Son Llàtzer
Palma de Mallorca, Balearic Islands, Spain, 07198
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Hospital Germans Trias i Pujol
Badalona, Barcelona, Spain, 08916
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Institut Català d'Oncologia - Hospital Duran i Reynals (ICO L'Hospitalet)
L'Hospitalet de Llobregat, Barcelona, Spain, 08907
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186
Biocruces Bizkaia Instituto de Investigación Sanitaria
Barakaldo, Biscay, Spain, 48903
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187
Complejo Hospitalario Universitario A Coruña
A Coruña, La Coruña, Spain, 15006
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Complejo Hospitalario Universitario Insular Materno Infantil
Las Palmas de Gran Canaria, Las Palmas, Spain, 35016
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Hospital Universitario Puerta de Hierro - Majadahonda
Majadahonda, Madrid, Spain, 28222
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Marbella, Malaga, Spain, 29660
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Clínica Mi Tres Torres
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Hospital Universitari Dexeus
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Hospital Clinic de Barcelona
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Leicester, England, United Kingdom, LE2 9LX
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Manchester, England, United Kingdom, M20 4BX
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205
The Clatterbridge Cancer Centre NHS Foundation Trust
Metropolitan Borough of Wirral, England, United Kingdom, CH63 4JY
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206
The Royal Marsden NHS Foundation Trust
Sutton, England, United Kingdom, SM2 5PT
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207
NHS Grampian
Aberdeen, Scotland, United Kingdom, AB25 2ZN
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Caroline Chevalier, MSc, MPH
What is OSE2101 studying for non-small cell lung cancer? Who may be eligible for this non-small cell lung cancer clinical trial? Is there any cost to participate in this non-small cell lung cancer clinical trial? Will I receive OSE2101 or a placebo? What is the main outcome being measured in this trial? What happens after this non-small cell lung cancer clinical trial ends? Can I leave this non-small cell lung cancer clinical trial if I change my mind? Have more questions? Get in touch with our team for quick support
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