Trial of Therapeutic Cancer Vaccine OSE2101 in Patients With Non-Small Cell Lung Cancer and Secondary Resistance to Immune Checkpoint Inhibitor (ARTEMIA)
March 31, 2026 updated by: OSE Immunotherapeutics
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
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).
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
363
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Caroline Chevalier, MSc, MPH
- Phone Number: +33 630 842 002
- Email: caroline.chevalier@ose-immuno.com
Study Contact Backup
- Name: Bérangère Vasseur, MD
- Phone Number: +33 676 448 160
- Email: berangere.vasseur@ose-immuno.com
Study Locations
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Antwerpen
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Brasschaat, Antwerpen, Belgium, 2930
- Recruiting
- Algemeen Ziekenhuis klina
-
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Flemish Brabant
-
Leuven, Flemish Brabant, Belgium, 3000
- Recruiting
- Universitair Ziekenhuis Leuven - Campus Gasthuisberg
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Limburg
-
Hasselt, Limburg, Belgium, 3500
- Recruiting
- Jessa Ziekenhuis - Campus Virga Jesse
-
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Oost-Vlaaderen
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Ghent, Oost-Vlaaderen, Belgium, 9000
- Recruiting
- Algemeen Ziekenhuis Maria Middelares
-
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Wallonia
-
Namur, Wallonia, Belgium, B-5000
- Recruiting
- Centre Hospitalier Universitaire Université Catholique de Louvain Namur - Site Sainte-Elisabeth
-
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West-Vlaanderen
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Kortrijk, West-Vlaanderen, Belgium, 8500
- Active, not recruiting
- Algemeen Ziekenhuis Groeninge - Campus Kennedylaan
-
Roeselare, West-Vlaanderen, Belgium, 8800
- Recruiting
- Algemeen Ziekenhuis Delta - Campus Rumbeke
-
Roeselare, West-Vlaanderen, Belgium, 8800
- Active, not recruiting
- Algemeen Ziekenhuis Delta - Campus Rembert Torhout
-
Roeselare, West-Vlaanderen, Belgium
- Active, not recruiting
- Algemeen Ziekenhuis Delta - Campus Menen
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-
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Quebec
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Chicoutimi, Quebec, Canada, G7H 5H6
- Recruiting
- Centre Intégré Universitaire de Santé et de Services Sociaux du Saguenay - Lac-Saint-Jean
-
Montreal, Quebec, Canada, H4A 3J1
- Terminated
- McGill University Health Centre
-
Rimouski, Quebec, Canada, G5L 5T1
- Recruiting
- Centre Intégré de Santé et de Services Sociaux du Bas-Saint-Laurent
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-
-
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La Roche-sur-Yon, France, 85000
- Recruiting
- Centre Hospitalier Departemental Vendee
-
Le Mans, France, 72037
- Recruiting
- Centre Hospitalier Le Mans
-
Nantes, France, 44093
- Recruiting
- Centre Hospitalier Universitaire de Nantes - Hopital Nord Laennec
-
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Alpes-de-Haute-Provence
-
Toulon, Alpes-de-Haute-Provence, France, 83800
- Recruiting
- Hôpital d'instruction des armées Sainte-Anne
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Alsace
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Strasbourg, Alsace, France, 67091
- Recruiting
- Nouvel Hôpital Civil
-
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Auvergne-Rhône-Alpes
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Bron, Auvergne-Rhône-Alpes, France, 69500
- Active, not recruiting
- Hôpital Louis Pradel
-
Lyon, Auvergne-Rhône-Alpes, France, 69317
- Recruiting
- Centre Hospitalier Lyon-Sud
-
Lyon, Auvergne-Rhône-Alpes, France, 69317
- Active, not recruiting
- Hopital de la croix rousse
-
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Bouches-du-Rhône
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Marseille, Bouches-du-Rhône, France, 13273
- Recruiting
- Institut Paoli-Calmettes
-
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Doubs
-
Besançon, Doubs, France, 25030
- Recruiting
- Centre Hospitalier Regional et Universitaire de Besancon - Hopital Jean-Minjoz
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Finistère
-
Brest, Finistère, France, 29200
- Recruiting
- Centre Hospitalier Regional Universitaire Brest - Hopital de la Cavale Blanche
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Grand Est
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Mulhouse, Grand Est, France, 68100
- Recruiting
- Hôpital Emile Muller
-
Nancy, Grand Est, France, 54035
- Recruiting
- Centre Hospitalier Régional Universitaire de Nancy
-
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Haute-Vienne
-
Limoges, Haute-Vienne, France, 87000
- Recruiting
- Centre Hospitalier Universitaire Dupuytren 1
-
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Hérault
-
Montpellier, Hérault, France, 34295
- Recruiting
- Hopital Arnaud de Villeneuve
-
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Ille-et-Vilaine
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Rennes, Ille-et-Vilaine, France, 35033
- Recruiting
- Hôpital Pontchaillou
-
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Loire-Atlantique
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Saint-Herblain, Loire-Atlantique, France, 44805
- Recruiting
- Institut de Cancérologie de l'Ouest - Saint-Herblain - Site René Gauducheau
-
-
Maine-et-Loire
-
Cholet, Maine-et-Loire, France, 49325
- Recruiting
- Centre Hospitalier (Ch) De Cholet
-
-
Midi-pyrenees
-
Toulouse, Midi-pyrenees, France, 31059
- Recruiting
- Hôpital Larrey
-
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Nouvelle-Aquitaine
-
Pessac, Nouvelle-Aquitaine, France, 33604
- Recruiting
- Hôpital Haut-Lévêque
-
-
Provence-Alpes-Côte d'Azur Region
-
Marseille, Provence-Alpes-Côte d'Azur Region, France, 13015
- Recruiting
- Hôpital Nord de Marseille
-
-
Pyrénées-Atlantiques
-
Bayonne, Pyrénées-Atlantiques, France, 64109
- Recruiting
- Centre Hospitalier de la Cote Basque
-
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Rhône
-
La Tronche, Rhône, France, 38700
- Recruiting
- Hôpital Michallon
-
-
Val-de-Marne
-
Villejuif, Val-de-Marne, France, 94805
- Recruiting
- Gustave Roussy
-
-
Vaucluse
-
Avignon, Vaucluse, France, 84000
- Recruiting
- Institut Sainte Catherine
-
-
Vienne
-
Poitiers, Vienne, France, 86021
- Recruiting
- Centre Hospitalier Universitaire De Poitiers
-
-
Île-de-France Region
-
Bobigny, Île-de-France Region, France, 93000
- Recruiting
- Hôpital Avicenne
-
Créteil, Île-de-France Region, France, 94000
- Recruiting
- Centre Hospitalier Intercommunal de Creteil
-
Paris, Île-de-France Region, France, 75014
- Recruiting
- Hopital Cochin
-
Paris, Île-de-France Region, France, 75014
- Recruiting
- Groupe Hospitalier Paris Saint-Joseph
-
Paris, Île-de-France Region, France, 75020
- Recruiting
- Hôpital Tenon
-
-
-
-
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Berlin, Germany, 13353
- Recruiting
- Charité - Universitätsmedizin Berlin
-
-
Baden-Wurttemberg
-
Heidelberg, Baden-Wurttemberg, Germany, 69126
- Recruiting
- Thoraxklinik-Heidelberg
-
Stuttgart, Baden-Wurttemberg, Germany, 70376
- Recruiting
- Robert-Bosch-Krankenhaus
-
-
Bavaria
-
Gauting, Bavaria, Germany, 82131
- Recruiting
- Asklepios Fachkliniken München-Gauting
-
München, Bavaria, Germany, 81925
- Active, not recruiting
- Munchen Klinik Bogenhausen
-
-
Hesse
-
Kassel, Hesse, Germany, 34125
- Active, not recruiting
- Klinikum Kassel
-
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North Rhine-Westphalia
-
Aachen, North Rhine-Westphalia, Germany, 52074
- Recruiting
- Universitätsklinikum Aachen
-
Bonn, North Rhine-Westphalia, Germany, 53127
- Recruiting
- Universitätsklinikum Bonn
-
Essen, North Rhine-Westphalia, Germany, 45147
- Recruiting
- Universitätsklinikum Essen
-
-
Saarland
-
Homburg, Saarland, Germany, 66421
- Recruiting
- Universitätsklinikum Gießen und Marburg - Gießen
-
-
Saxony-Anhalt
-
Halle, Saxony-Anhalt, Germany, 06120
- Recruiting
- Krankenhaus Martha-Maria Halle-Dölau
-
-
Schleswig-Holstein
-
Großhansdorf, Schleswig-Holstein, Germany, 22927
- Recruiting
- LungenClinic Grosshansdorf
-
-
-
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Athens
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Piraeus, Athens, Greece, 185 47
- Recruiting
- Metropolitan Hospital
-
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Attica
-
Athens, Attica, Greece, 11527
- Recruiting
- General Hospital for Thoracic Diseases Sotiria
-
Athens, Attica, Greece, 11522
- Recruiting
- Saint Savvas Anticancer - Oncological Hospital of Athens
-
Athens, Attica, Greece, 11526
- Recruiting
- Henry Dunant Hospital Center
-
Nea Kifissia, Attica, Greece, 14564
- Recruiting
- Agii Anargiri Cancer Hospital
-
-
Central Macedonia
-
Thessaloniki, Central Macedonia, Greece, 55236
- Recruiting
- Clinic Agios Loukas
-
-
Crete
-
Heraklion, Crete, Greece, 711 10
- Recruiting
- University General Hospital of Heraklion (PAGNI)
-
-
Macedoni
-
Thessaloniki, Macedoni, Greece, TK 56403
- Active, not recruiting
- General Hospital Of Thessaloniki Papageorgiou
-
-
Peloponnese
-
Patra, Peloponnese, Greece, 26504
- Recruiting
- University General Hospital of Patras
-
-
Thessaloniki
-
Thessaloniki, Thessaloniki, Greece, 546 39
- Recruiting
- Theagenio Anti-Cancer Hospital of Thessaloniki
-
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Thessaly
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Larissa, Thessaly, Greece, 411 10
- Recruiting
- University General Hospital of Larissa
-
-
-
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Budapest, Hungary, 1121
- Recruiting
- Országos Korányi Pulmonológiai Intézet
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Gyöngyös, Hungary, 3200
- Recruiting
- Clinexpert Kft. telephelye, Bugát Pál Kórház - Phase I. Clinical Trial Site
-
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Heves County
-
Gyöngyös, Heves County, Hungary, 3200
- Active, not recruiting
- Matrai Gyogyintezet
-
-
-
-
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Genova, Italy, 16132
- Recruiting
- Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale Policlinico San Martino
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Lecce, Italy, 73100
- Active, not recruiting
- Ospedale Vito Fazzi Lecce
-
Milan, Italy, 20132
- Recruiting
- Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San Raffaele
-
Milan, Italy, 20133
- Recruiting
- Fondazione IRCCS - Istituto Nazionale dei Tumori
-
Novara, Italy, 28100
- Recruiting
- Azienda Ospedaliero-Universitaria Maggiore della Carità di Novara
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Padua, Italy, 35128
- Recruiting
- Ospedale Busonera - Istituto Oncologico Veneto (IOV) - Padua
-
Pisa, Italy, 56126
- Recruiting
- Azienda Ospedaliero-Universitaria Pisana
-
Rimini, Italy, 47923
- Active, not recruiting
- Azienda Unità Sanitaria Locale della Romagna - Ospedale Infermi di Rimini
-
Roma, Italy, 00144
- Recruiting
- IRCCS Istituto Nazionale Tumori Regina Elena
-
Rome, Italy, 00152
- Recruiting
- Azienda Ospedaliera San Camillo Forlanini
-
Siena, Italy, 53100
- Recruiting
- Azienda Ospedaliera Universitaria Senese - L'ospedale Santa Maria alle Scotte
-
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Forlì-Cesena
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Meldola, Forlì-Cesena, Italy, 47014
- Recruiting
- Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST
-
-
Lucca
-
San Filippo, Lucca, Italy, 55100
- Recruiting
- Presidio Ospedaliero di Lucca
-
-
Milan
-
Rozzano, Milan, Italy, 20089
- Active, not recruiting
- Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Istituto Clinico Humanitas
-
-
Naples
-
Naples, Naples, Italy, 80131
- Recruiting
- Azienda Ospedaliera Universitaria - Università degli Studi della Campania Luigi Vanvitelli
-
-
Torino
-
Orbassano, Torino, Italy, 10043
- Recruiting
- Azienda Ospedaliero - Universitaria San Luigi Gonzaga
-
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Verona
-
Legnago, Verona, Italy, 37045
- Recruiting
- Ospedale P. Pederzoli - Casa di Cura Privata S.p.A.
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-
-
-
-
Groningen, Netherlands, 9713 GZ
- Recruiting
- Universitair Medisch Centrum Groningen
-
-
Gelderland
-
Nijmegen, Gelderland, Netherlands, 6525 GA
- Recruiting
- Radboud Universitair Medisch Centrum
-
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South Holland
-
Rotterdam, South Holland, Netherlands, 3015 GD
- Recruiting
- Erasmus Medisch Centrum
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-
-
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Greater Poland Voivodeship
-
Konin, Greater Poland Voivodeship, Poland, 62-500
- Recruiting
- Przychodnia Lekarska KOMED Roman Karaszewski
-
Poznan, Greater Poland Voivodeship, Poland, 60-569
- Recruiting
- Wielkopolskie Centrum Pulmonologii i Torakochirurgii im. Eugenii i Janusza Zeylandów
-
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Kuyavian-Pomeranian Voivodeship
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Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland, 85-796
- Recruiting
- Centrum Onkologii Im. Prof. F. Łukaszczyka w Bydgoszczy
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Lublin Voivodeship
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Lublin, Lublin Voivodeship, Poland, 20-090
- Recruiting
- Uniwersytecki Szpital Kliniczny Nr 4 W Lublinie
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Lódzkie
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Lodz, Lódzkie, Poland, 93-338
- Recruiting
- Instytut Centrum Zdrowia Matki Polki
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Pomeranian Voivodeship
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Gdansk, Pomeranian Voivodeship, Poland, 80-210
- Recruiting
- Uniwersyteckie Centrum Kliniczne w Gdansku
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-
-
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Coimbra, Portugal, 3000-075
- Recruiting
- Unidade Local de Saude de Coimbra
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Lisbon, Portugal, 1769-001
- Active, not recruiting
- Hospital CUF Descobertas
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Lisbon, Portugal, 1769-001
- Recruiting
- Unidade Local de Saúde de Santa Maria, E. P. E. - Hospital Pulido Valente
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Porto, Portugal, 14341
- Active, not recruiting
- Hospital CUF Porto
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Vila Nova de Gaia, Portugal, 4434-502
- Recruiting
- Unidade Local de Saúde de Gaia/Espinho, E. P. E
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-
-
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Cluj
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Cluj-Napoca, Cluj, Romania, 400015
- Recruiting
- Institutul Oncologic Prof. Dr. Ion Chiricuta
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Dolj
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Craiova, Dolj, Romania, 200746
- Recruiting
- Centrul de Oncologie Sf Nectarie
-
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Timiș County
-
Timișoara, Timiș County, Romania, 300239
- Recruiting
- SC Oncomed SRL
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-
-
-
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Barcelona, Spain, 08035
- Recruiting
- Hospital Universitari Vall d'Hebron
-
Barcelona, Spain, 08036
- Recruiting
- Hospital Clinic De Barcelona
-
Barcelona, Spain, 08028
- Recruiting
- Hospital Universitari Dexeus
-
Barcelona, Spain, 08017
- Recruiting
- Clínica Mi Tres Torres
-
Córdoba, Spain, 14004
- Recruiting
- Hospital Universitario Reina Sofia
-
Girona, Spain, 17007
- Recruiting
- Hospital Universitari de Girona Dr. Josep Trueta
-
Lugo, Spain, 27004
- Recruiting
- Hospital Universitario Lucus Augusti
-
Madrid, Spain, 28034
- Recruiting
- Hospital Universitario Ramon y Cajal
-
Madrid, Spain, 28046
- Recruiting
- Hospital Universitario La Paz
-
Madrid, Spain, 28007
- Recruiting
- Hospital General Universitario Gregorio Marañon
-
Málaga, Spain, 29011
- Recruiting
- Hospital Regional Universitario de Malaga - Hospital General
-
Seville, Spain, 41009
- Recruiting
- Hospital Universitario Virgen Macarena
-
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Balearic Islands
-
Palma de Mallorca, Balearic Islands, Spain, 07198
- Recruiting
- Hospital Son Llatzer
-
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Barcelona
-
Badalona, Barcelona, Spain, 08916
- Active, not recruiting
- Hospital Germans Trias i Pujol
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L'Hospitalet de Llobregat, Barcelona, Spain, 08907
- Recruiting
- Institut Català d'Oncologia - Hospital Duran i Reynals (ICO L'Hospitalet)
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Biscay
-
Barakaldo, Biscay, Spain, 48903
- Recruiting
- Biocruces Bizkaia Instituto de Investigación Sanitaria
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La Coruña
-
A Coruña, La Coruña, Spain, 15006
- Recruiting
- Complejo Hospitalario Universitario A Coruña
-
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Las Palmas
-
Las Palmas de Gran Canaria, Las Palmas, Spain, 35016
- Recruiting
- Complejo Hospitalario Universitario Insular Materno Infantil
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Madrid
-
Majadahonda, Madrid, Spain, 28222
- Recruiting
- Hospital Universitario Puerta de Hierro - Majadahonda
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Malaga
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Marbella, Malaga, Spain, 29660
- Recruiting
- HC Marbella
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-
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England
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Leicester, England, United Kingdom, LE2 9LX
- Recruiting
- University Hospitals of Leicester NHS Trust
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Manchester, England, United Kingdom, M20 4BX
- Recruiting
- The Christie NHS Foundation Trust
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Metropolitan Borough of Wirral, England, United Kingdom, CH63 4JY
- Recruiting
- The Clatterbridge Cancer Centre NHS Foundation Trust
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Sutton, England, United Kingdom, SM2 5PT
- Recruiting
- The Royal Marsden NHS Foundation Trust
-
-
Scotland
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Aberdeen, Scotland, United Kingdom, AB25 2ZN
- Recruiting
- NHS Grampian
-
-
-
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California
-
Beverly Hills, California, United States, 90211
- Recruiting
- Clinical Research Advisors, LLC
-
Encino, California, United States, 90211
- Active, not recruiting
- Clinical Research Advisors - Encino
-
Los Angeles, California, United States, 90048
- Active, not recruiting
- Clinical Research Advisors - West Hollywood
-
Los Angeles, California, United States, 90211
- Active, not recruiting
- Clinical Research Advisors - Korea Town
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Colorado
-
Littleton, Colorado, United States, 80218
- Withdrawn
- SCL Health - Saint Joseph Hospital Cancer Center
-
Wheat Ridge, Colorado, United States, 80033-6013
- Recruiting
- Lutheran Medical Center - Cancer Centers of Colorado
-
-
Connecticut
-
Norwich, Connecticut, United States, 06360
- Recruiting
- Eastern Connecticut Hematology and Oncology Associates
-
-
District of Columbia
-
Washington D.C., District of Columbia, United States, 20007
- Recruiting
- Georgetown Lombardi Comprehensive Cancer Center
-
-
Florida
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Bradenton, Florida, United States, 34210
- Active, not recruiting
- Comprehensive Hematology Oncology - Bradenton Clinic
-
Brandon, Florida, United States, 33511
- Active, not recruiting
- Comprehensive Hematology Oncology - Brandon Clinic
-
Fleming Island, Florida, United States, 32003
- Recruiting
- Cancer Specialists of North Florida - Fleming Island
-
Jacksonville, Florida, United States, 32204
- Active, not recruiting
- Cancer Specialists of North Florida - Riverside
-
Jacksonville, Florida, United States, 32207
- Active, not recruiting
- Cancer Specialists of North Florida Southside
-
Jacksonville, Florida, United States, 32218
- Active, not recruiting
- Cancer Specialists of North Florida - Northside
-
Jacksonville, Florida, United States, 32258
- Active, not recruiting
- Cancer Specialists of North Florida - Baptist South
-
Jacksonville, Florida, United States, 32256-6932
- Recruiting
- Cancer Specialists of North Florida - Southpoint
-
Jacksonville Beach, Florida, United States, 32250
- Recruiting
- Cancer Specialists of North Florida
-
Largo, Florida, United States, 33770
- Active, not recruiting
- Comprehensive Hematology Oncology - Largo Clinic
-
Neptune Beach, Florida, United States, 32266
- Active, not recruiting
- Cancer Specialists of North Florida - Beaches
-
Palm Harbor, Florida, United States, 34685
- Active, not recruiting
- Comprehensive Hematology Oncology - Palm Harbor Clinic
-
Saint Augustine, Florida, United States, 32086
- Recruiting
- Cancer Specialists Of North Florida - St. Augustine
-
St. Petersburg, Florida, United States, 33709
- Recruiting
- Comprehensive Hematology Oncology
-
St. Petersburg, Florida, United States, 33709
- Active, not recruiting
- Comprehensive Hematology Oncology - Bayfront Clinic
-
Trinity, Florida, United States, 34655
- Recruiting
- Comprehensive Hematology Oncology - Trinity Clinic
-
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Illinois
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Chicago, Illinois, United States, 60612
- Recruiting
- University of Illinois Cancer Center
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Kansas
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Merriam, Kansas, United States, 66204
- Withdrawn
- Alliance for Multispecialty Research (AMR) - Kansas City Oncology
-
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Louisiana
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Baton Rouge, Louisiana, United States, 70809
- Active, not recruiting
- Mary Bird Perkins Cancer Center - Baton Rouge
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Covington, Louisiana, United States, 70433
- Recruiting
- Pontchartrain Cancer Center - Covington Office
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Hammond, Louisiana, United States, 70403-1452
- Recruiting
- Pontchartrain Cancer Center - Hammond Office
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Maryland
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Baltimore, Maryland, United States, 21229
- Recruiting
- Ascension Saint Agnes Hospital
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-
Massachusetts
-
Worcester, Massachusetts, United States, 01655
- Recruiting
- University of Massachusetts Memorial Medical Center
-
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Nebraska
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Lincoln, Nebraska, United States, 68506
- Recruiting
- Nebraska Hematology-Oncology - Revive Research Institute LLC
-
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New York
-
Babylon, New York, United States, 11702
- Active, not recruiting
- New York Cancer & Blood Specialists - Babylon Medical Oncology
-
Brewster, New York, United States, 10509
- Terminated
- Optum Medical Care - Carmel/Brewster Campus
-
Brooklyn, New York, United States, 11201
- Terminated
- Brooklyn Radiation Oncology
-
Fishkill, New York, United States, 12524
- Terminated
- Optum Medical Care - Fishkill Westage Campus
-
Lake Success, New York, United States, 11042
- Terminated
- Clinical Research Alliance
-
Mount Kisco, New York, United States, 10549
- Terminated
- Optum Medical Care - Mount Kisco Campus 90
-
New Hyde Park, New York, United States, 11042
- Active, not recruiting
- New York Cancer & Blood Specialists - New Hyde Park
-
New Hyde Park, New York, United States, 11042
- Terminated
- Optum Hematology Oncology - Lake Success
-
New York, New York, United States, 10028
- Recruiting
- New York Cancer & Blood Specialists - Cancer Center - Research Headquarters
-
New York, New York, United States, 10028
- Active, not recruiting
- New York Cancer & Blood Specialists - Central Park Medical Oncology
-
Patchogue, New York, United States, 11772
- Recruiting
- New York Cancer & Blood Specialists - Patchogue Medical Oncology
-
Port Jefferson Station, New York, United States, 11776
- Active, not recruiting
- New York Cancer & Blood Specialists - Port Jefferson Medical Oncology
-
Port Jefferson Station, New York, United States, 11776
- Active, not recruiting
- New York Cancer & Blood Specialists - Port Jefferson Station Medical Oncology
-
Poughkeepsie, New York, United States, 12601
- Terminated
- Optum Medical Care - Poughkeepsie
-
The Bronx, New York, United States, 10469
- Active, not recruiting
- New York Cancer & Blood Specialists - Eastchester Cancer Care Center
-
The Bronx, New York, United States, 10469
- Active, not recruiting
- New York Cancer & Blood Specialists - Riverhead Medical Oncology
-
-
Ohio
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Perrysburg, Ohio, United States, 43551
- Active, not recruiting
- Mercy Health - Perrysburg Cancer Center
-
Toledo, Ohio, United States, 43623
- Active, not recruiting
- Mercy Health - St. Anne Cancer Center
-
-
South Carolina
-
Greenville, South Carolina, United States, 29607
- Recruiting
- Bon Secours Hematology and Oncology
-
-
Tennessee
-
Chattanooga, Tennessee, United States, 36404
- Active, not recruiting
- Tennessee Oncology - Chattanooga - Medical Park II
-
Chattanooga, Tennessee, United States, 37404
- Recruiting
- Tennessee Oncology - Chattanooga - Memorial Plaza
-
Chattanooga, Tennessee, United States, 37403
- Recruiting
- Tennessee Oncology - Chattanooga - Downtown
-
Chattanooga, Tennessee, United States, 37403
- Recruiting
- Tennessee Oncology - Chattanooga - GHCR Site I
-
Cleveland, Tennessee, United States, 37311
- Recruiting
- Tennessee Oncology - Cleveland Clinic
-
Cookeville, Tennessee, United States, 38501
- Active, not recruiting
- Tennessee Oncology - Cookeville Clinic
-
Dickson, Tennessee, United States, 37055
- Active, not recruiting
- Tennessee Oncology - Dickson Clinic
-
Franklin, Tennessee, United States, 37067
- Recruiting
- Tennessee Oncology - Franklin Clinic
-
Gallatin, Tennessee, United States, 37066
- Active, not recruiting
- Tennessee Oncology - Gallatin Clinic
-
Hendersonville, Tennessee, United States, 37075
- Active, not recruiting
- Tennessee Oncology - Hendersonville Clinic
-
Hermitage, Tennessee, United States, 37076
- Active, not recruiting
- Tennessee Oncology - Hermitage - Summit Clinic
-
Lebanon, Tennessee, United States, 37090
- Active, not recruiting
- Tennessee Oncology - Lebanon Clinic
-
Murfreesboro, Tennessee, United States, 37129
- Active, not recruiting
- Tennessee Oncology - Murfreesboro Clinic
-
Nashville, Tennessee, United States, 37203
- Active, not recruiting
- Tennessee Oncology - Nashville - Centennial Center for Blood Cancers Clinic
-
Nashville, Tennessee, United States, 37203
- Active, not recruiting
- Tennessee Oncology - Nashville - Centennial Clinic - Medical Oncology
-
Nashville, Tennessee, United States, 37203
- Active, not recruiting
- Tennessee Oncology - Nashville - Midtown Center for Blood Cancers
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Nashville, Tennessee, United States, 37203
- Active, not recruiting
- Tennessee Oncology - Nashville - St. Thomas Midtown Clinic
-
Nashville, Tennessee, United States, 37207
- Active, not recruiting
- Tennessee Oncology - Nashville - Skyline Clinic
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Nashville, Tennessee, United States, 37211
- Active, not recruiting
- Tennessee Oncology - Nashville - Southern Hills Clinic
-
Nashville, Tennessee, United States, 37232
- Recruiting
- Greco-Hainsworth Tennessee Oncology Centers for Research (GHCR) - Corporate
-
Nashville, Tennessee, United States, 37205
- Recruiting
- Tennessee Oncology - Nashville - St. Thomas West Clinic
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Shelbyville, Tennessee, United States, 37160
- Recruiting
- Tennessee Oncology - Shelbyville Clinic
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Smyrna, Tennessee, United States, 37167
- Recruiting
- Tennessee Oncology - Smyrna Clinic
-
-
Washington
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Bonney Lake, Washington, United States, 98391
- Active, not recruiting
- Northwest Medical Specialties - Bonney Lake
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Federal Way, Washington, United States, 98003
- Active, not recruiting
- Northwest Medical Specialties - Federal Way
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Gig Harbor, Washington, United States, 98332
- Recruiting
- Northwest Medical Specialties - Gig Harbor
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Puyallup, Washington, United States, 98373
- Recruiting
- Northwest Medical Specialties - Puyallup Medical Oncology
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Tacoma, Washington, United States, 98405
- Recruiting
- Northwest Medical Specialties - Tacoma
-
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Arm A: OSE2101
Unit dose: 1 mL corresponding to a total of 5 mg of the combination of peptides Mode/Route: Subcutaneous injection Regimen: One injection every three weeks for six cycles, then every eight weeks for the remainder of year one and, finally every twelve weeks until the end of second year.
|
OSE2101 is a peptidic cancer vaccine composed of nine epitopes restricted to HLA-A2 phenotype targeting the tumor associated antigens of P53, HER-2, CEA, MAGE-2 and MAGE-3, and one pan-HLA DR binding epitope (PADRE), all epitopes emulsified in Montanide ISA 51TM adjuvant.
Amp-HLA-A-CDx Tedopi for amplification of human genomic DNA (gDNA), LFK-CDx Tedopi kit (library full kit) for library preparation, NGSengine-CDx Tedopi software for analysis of NGS data files.
|
|
Active Comparator: Arm B: Docetaxel
Unit dose: 75 mg/m2 Mode/Route: Intravenous infusion over 1 hour Regimen: One infusion every three weeks.
|
Amp-HLA-A-CDx Tedopi for amplification of human genomic DNA (gDNA), LFK-CDx Tedopi kit (library full kit) for library preparation, NGSengine-CDx Tedopi software for analysis of NGS data files.
Docetaxel is an antineoplastic agent that acts by disrupting the microtubular network in cells that is essential for mitotic and interphase cellular functions.
|
|
Other: GenDx CDx Tedopi
System of qualitative companion diagnostic devices, consisting of a polymerase chain reaction (PCR) assay Amp-HLA-A-CDx Tedopi, a DNA library preparation assay, LFK-CDx Tedopi and the software NGSengine-CDx Tedopi.
|
Amp-HLA-A-CDx Tedopi for amplification of human genomic DNA (gDNA), LFK-CDx Tedopi kit (library full kit) for library preparation, NGSengine-CDx Tedopi software for analysis of NGS data files.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
OS defined as time from randomization to death
Time Frame: From randomization date through study completion, an average of 3 years
|
OS defined as time from randomization to death of any cause, censored until the data analysis cut-off date
|
From randomization date through study completion, an average of 3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 3, 2024
Primary Completion (Estimated)
December 15, 2027
Study Completion (Estimated)
December 15, 2028
Study Registration Dates
First Submitted
June 7, 2024
First Submitted That Met QC Criteria
June 21, 2024
First Posted (Actual)
June 25, 2024
Study Record Updates
Last Update Posted (Actual)
April 1, 2026
Last Update Submitted That Met QC Criteria
March 31, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Site
- Neoplasms
- Respiratory Tract Diseases
- Lung Diseases
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Lung Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Organic Chemicals
- Hydrocarbons
- Cycloparaffins
- Hydrocarbons, Alicyclic
- Hydrocarbons, Cyclic
- Terpenes
- Taxoids
- Cyclodecanes
- Diterpenes
- Docetaxel
Other Study ID Numbers
- OSE2101C302
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
Second Affiliated Hospital of Xi'an Jiaotong UniversityXijing Hospital; First Affiliated Hospital Xi'an Jiaotong University; Shanxi... and other collaboratorsUnknownPatients With Non-small Cell Lung CancerChina
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-
OSE ImmunotherapeuticsRecruitingDose-finding and Dose Expansion Study of OSE-279 in Subjects With Advanced Solid Tumors or LymphomasLymphoma | NSCLC (Non-small Cell Lung Cancer) | Solid Advanced TumorFrance, Belgium, Spain
-
ARCAGY/ GINECO GROUPMerck Sharp & Dohme LLC; OSE ImmunotherapeuticsActive, not recruitingRelapsed Ovarian Cancer | Platinum-sensitive Ovarian CancerFrance, Belgium, Germany
-
OSE ImmunotherapeuticsTerminatedNon Small Cell Lung CancerFrance, Spain, Israel, United States, United Kingdom, Italy, Poland, Czechia, Germany, Hungary
-
GERCOR - Multidisciplinary Oncology Cooperative...OSE ImmunotherapeuticsActive, not recruitingMetastatic Cancer | Pancreatic Ductal Adenocarcinoma | Locally Advanced CancerFrance