Trial of Therapeutic Cancer Vaccine OSE2101 in Patients With Non-Small Cell Lung Cancer and Secondary Resistance to Immune Checkpoint Inhibitor
Start Date
12/3/2024
Completion Date
12/15/2028
Summary
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).
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
OSE2101
Docetaxel
NGS HLAA2 assay
Conditions
Locations
Clinical Research Advisors, LLC
Beverly Hills, California 90211
United States
Clinical Research Advisors - Encino
Encino, California 90211
United States
Clinical Research Advisors - West Hollywood
Los Angeles, California 90048
United States
Clinical Research Advisors - Korea Town
Los Angeles, California 90211
United States
SCL Health - Saint Joseph Hospital Cancer Center
Littleton, Colorado 80218
United States
Lutheran Medical Center - Cancer Centers of Colorado
Wheat Ridge, Colorado 80033-6013
United States
Eastern Connecticut Hematology and Oncology Associates
Norwich, Connecticut 06360
United States
Georgetown Lombardi Comprehensive Cancer Center
Washington D.C., District of Columbia 20007
United States
Comprehensive Hematology Oncology - Bradenton Clinic
Bradenton, Florida 34210
United States
Comprehensive Hematology Oncology - Brandon Clinic
Brandon, Florida 33511
United States
Cancer Specialists of North Florida - Fleming Island
Fleming Island, Florida 32003
United States
Cancer Specialists of North Florida - Riverside
Jacksonville, Florida 32204
United States
Cancer Specialists of North Florida Southside
Jacksonville, Florida 32207
United States
Cancer Specialists of North Florida - Northside
Jacksonville, Florida 32218
United States
Cancer Specialists of North Florida - Southpoint
Jacksonville, Florida 32256-6932
United States
Cancer Specialists of North Florida - Baptist South
Jacksonville, Florida 32258
United States
Cancer Specialists of North Florida
Jacksonville Beach, Florida 32250
United States
Comprehensive Hematology Oncology - Largo Clinic
Largo, Florida 33770
United States
Cancer Specialists of North Florida - Beaches
Neptune Beach, Florida 32266
United States
Comprehensive Hematology Oncology - Palm Harbor Clinic
Palm Harbor, Florida 34685
United States
Cancer Specialists Of North Florida - St. Augustine
Saint Augustine, Florida 32086
United States
Comprehensive Hematology Oncology - Bayfront Clinic
St. Petersburg, Florida 33709
United States
Comprehensive Hematology Oncology
St. Petersburg, Florida 33709
United States
Comprehensive Hematology Oncology - Trinity Clinic
Trinity, Florida 34655
United States
University of Illinois Cancer Center
Chicago, Illinois 60612
United States
Alliance for Multispecialty Research (AMR) - Kansas City Oncology
Merriam, Kansas 66204
United States
Mary Bird Perkins Cancer Center - Baton Rouge
Baton Rouge, Louisiana 70809
United States
Pontchartrain Cancer Center - Covington Office
Covington, Louisiana 70433
United States
Pontchartrain Cancer Center - Hammond Office
Hammond, Louisiana 70403-1452
United States
Ascension Saint Agnes Hospital
Baltimore, Maryland 21229
United States
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts 01655
United States
Nebraska Hematology-Oncology - Revive Research Institute LLC
Lincoln, Nebraska 68506
United States
New York Cancer & Blood Specialists - Babylon Medical Oncology
Babylon, New York 11702
United States
Optum Medical Care - Carmel/Brewster Campus
Brewster, New York 10509
United States
Brooklyn Radiation Oncology
Brooklyn, New York 11201
United States
Optum Medical Care - Fishkill Westage Campus
Fishkill, New York 12524
United States
Clinical Research Alliance
Lake Success, New York 11042
United States
Optum Medical Care - Mount Kisco Campus 90
Mount Kisco, New York 10549
United States
New York Cancer & Blood Specialists - New Hyde Park
New Hyde Park, New York 11042
United States
Optum Hematology Oncology - Lake Success
New Hyde Park, New York 11042
United States
New York Cancer & Blood Specialists - Cancer Center - Research Headquarters
New York, New York 10028
United States
New York Cancer & Blood Specialists - Central Park Medical Oncology
New York, New York 10028
United States
New York Cancer & Blood Specialists - Patchogue Medical Oncology
Patchogue, New York 11772
United States
New York Cancer & Blood Specialists - Port Jefferson Medical Oncology
Port Jefferson Station, New York 11776
United States
New York Cancer & Blood Specialists - Port Jefferson Station Medical Oncology
Port Jefferson Station, New York 11776
United States
Optum Medical Care - Poughkeepsie
Poughkeepsie, New York 12601
United States
New York Cancer & Blood Specialists - Eastchester Cancer Care Center
The Bronx, New York 10469
United States
New York Cancer & Blood Specialists - Riverhead Medical Oncology
The Bronx, New York 10469
United States
Mercy Health - Perrysburg Cancer Center
Perrysburg, Ohio 43551
United States
Mercy Health - St. Anne Cancer Center
Toledo, Ohio 43623
United States
Bon Secours Hematology and Oncology
Greenville, South Carolina 29607
United States
Tennessee Oncology - Chattanooga - Medical Park II
Chattanooga, Tennessee 36404
United States
Tennessee Oncology - Chattanooga - Downtown
Chattanooga, Tennessee 37403
United States
Tennessee Oncology - Chattanooga - GHCR Site I
Chattanooga, Tennessee 37403
United States
Tennessee Oncology - Chattanooga - Memorial Plaza
Chattanooga, Tennessee 37404
United States
Tennessee Oncology - Cleveland Clinic
Cleveland, Tennessee 37311
United States
Tennessee Oncology - Cookeville Clinic
Cookeville, Tennessee 38501
United States
Tennessee Oncology - Dickson Clinic
Dickson, Tennessee 37055
United States
Tennessee Oncology - Franklin Clinic
Franklin, Tennessee 37067
United States
Tennessee Oncology - Gallatin Clinic
Gallatin, Tennessee 37066
United States
Tennessee Oncology - Hendersonville Clinic
Hendersonville, Tennessee 37075
United States
Tennessee Oncology - Hermitage - Summit Clinic
Hermitage, Tennessee 37076
United States
Tennessee Oncology - Lebanon Clinic
Lebanon, Tennessee 37090
United States
Tennessee Oncology - Murfreesboro Clinic
Murfreesboro, Tennessee 37129
United States
Tennessee Oncology - Nashville - Centennial Center for Blood Cancers Clinic
Nashville, Tennessee 37203
United States
Tennessee Oncology - Nashville - Centennial Clinic - Medical Oncology
Nashville, Tennessee 37203
United States
Tennessee Oncology - Nashville - Midtown Center for Blood Cancers
Nashville, Tennessee 37203
United States
Tennessee Oncology - Nashville - St. Thomas Midtown Clinic
Nashville, Tennessee 37203
United States
Tennessee Oncology - Nashville - St. Thomas West Clinic
Nashville, Tennessee 37205
United States
Tennessee Oncology - Nashville - Skyline Clinic
Nashville, Tennessee 37207
United States
Tennessee Oncology - Nashville - Southern Hills Clinic
Nashville, Tennessee 37211
United States
Greco-Hainsworth Tennessee Oncology Centers for Research (GHCR) - Corporate
Nashville, Tennessee 37232
United States
Tennessee Oncology - Shelbyville Clinic
Shelbyville, Tennessee 37160
United States
Tennessee Oncology - Smyrna Clinic
Smyrna, Tennessee 37167
United States
Northwest Medical Specialties - Bonney Lake
Bonney Lake, Washington 98391
United States
Northwest Medical Specialties - Federal Way
Federal Way, Washington 98003
United States
Northwest Medical Specialties - Gig Harbor
Gig Harbor, Washington 98332
United States
Northwest Medical Specialties - Puyallup Medical Oncology
Puyallup, Washington 98373
United States
Northwest Medical Specialties - Tacoma
Tacoma, Washington 98405
United States
Algemeen Ziekenhuis Klina
Brasschaat, Antwerpen 2930
Belgium
Universitair Ziekenhuis Leuven - Campus Gasthuisberg
Leuven, Flemish Brabant 3000
Belgium
Jessa Ziekenhuis - Campus Virga Jesse
Hasselt, Limburg 3500
Belgium
Algemeen Ziekenhuis Maria Middelares
Ghent, Oost-Vlaaderen 9000
Belgium
Centre Hospitalier Universitaire Université Catholique de Louvain Namur - Site Sainte-Elisabeth
Namur, Wallonia B-5000
Belgium
Algemeen Ziekenhuis Groeninge - Campus Kennedylaan
Kortrijk, West-Vlaanderen 8500
Belgium
Algemeen Ziekenhuis Delta - Campus Rembert Torhout
Roeselare, West-Vlaanderen 8800
Belgium
Algemeen Ziekenhuis Delta - Campus Rumbeke
Roeselare, West-Vlaanderen 8800
Belgium
Algemeen Ziekenhuis Delta - Campus Menen
Roeselare, West-Vlaanderen
Belgium
Centre Intégré Universitaire de Santé et de Services Sociaux du Saguenay - Lac-Saint-Jean
Chicoutimi, Quebec G7H 5H6
Canada
McGill University Health Centre
Montreal, Quebec H4A 3J1
Canada
Centre Intégré de Santé et de Services Sociaux du Bas-Saint-Laurent
Rimouski, Quebec G5L 5T1
Canada
Hôpital d'Instruction des Armées Sainte-Anne
Toulon, Alpes-de-Haute-Provence 83800
France
Nouvel Hôpital Civil
Strasbourg, Alsace 67091
France
Hôpital Louis Pradel
Bron, Auvergne-Rhône-Alpes 69500
France
Centre Hospitalier Lyon-Sud
Lyon, Auvergne-Rhône-Alpes 69317
France
Hôpital de la Croix Rousse
Lyon, Auvergne-Rhône-Alpes 69317
France
Institut Paoli-Calmettes
Marseille, Bouches-du-Rhône 13273
France
Centre Hospitalier Régional et Universitaire de Besançon - Hôpital Jean-Minjoz
Besançon, Doubs 25030
France
Centre Hospitalier Regional Universitaire Brest - Hopital de la Cavale Blanche
Brest, Finistère 29200
France
Hôpital Emile Muller
Mulhouse, Grand Est 68100
France
Centre Hospitalier Régional Universitaire de Nancy
Nancy, Grand Est 54035
France
Centre Hospitalier Universitaire Dupuytren 1
Limoges, Haute-Vienne 87000
France
Hôpital Arnaud de Villeneuve
Montpellier, Hérault 34295
France
Hôpital Pontchaillou
Rennes, Ille-et-Vilaine 35033
France
Institut de Cancérologie de l'Ouest - Saint-Herblain - Site René Gauducheau
Saint-Herblain, Loire-Atlantique 44805
France
Centre Hospitalier (Ch) De Cholet
Cholet, Maine-et-Loire 49325
France
Hôpital Larrey
Toulouse, Midi-pyrenees 31059
France
Hôpital Haut-Lévêque
Pessac, New Aquitaine 33604
France
Hôpital Nord de Marseille
Marseille, Provence-Alpes-Côte d'Azur Region 13015
France
Centre Hospitalier de la Côte Basque
Bayonne, Pyrénées-Atlantiques 64109
France
Hôpital Michallon
La Tronche, Rhône 38700
France
Gustave Roussy
Villejuif, Val-de-Marne 94805
France
Institut Sainte Catherine
Avignon, Vaucluse 84000
France
Centre Hospitalier Universitaire de Poitiers
Poitiers, Vienne 86021
France
Centre Hospitalier Départemental Vendée
La Roche-sur-Yon, 85000
France
Centre Hospitalier Le Mans
Le Mans, 72037
France
Centre Hospitalier Universitaire De Nantes - Hôpital Nord Laennec
Nantes, 44093
France
Hôpital Avicenne
Bobigny, Île-de-France Region 93000
France
Centre Hospitalier Intercommunal de Créteil
Créteil, Île-de-France Region 94000
France
Groupe Hospitalier Paris Saint-Joseph
Paris, Île-de-France Region 75014
France
Hôpital Cochin
Paris, Île-de-France Region 75014
France
Hôpital Tenon
Paris, Île-de-France Region 75020
France
Thoraxklinik-Heidelberg
Heidelberg, Baden-Wurttemberg 69126
Germany
Robert-Bosch-Krankenhaus
Stuttgart, Baden-Wurttemberg 70376
Germany
Asklepios Fachkliniken München-Gauting
Gauting, Bavaria 82131
Germany
München Klinik Bogenhausen
München, Bavaria 81925
Germany
Klinikum Kassel
Kassel, Hesse 34125
Germany
Universitätsklinikum Aachen
Aachen, North Rhine-Westphalia 52074
Germany
Universitätsklinikum Bonn
Bonn, North Rhine-Westphalia 53127
Germany
Universitätsklinikum Essen
Essen, North Rhine-Westphalia 45147
Germany
Universitätsklinikum Gießen und Marburg - Gießen
Homburg, Saarland 66421
Germany
Krankenhaus Martha-Maria Halle-Dölau
Halle, Saxony-Anhalt 06120
Germany
LungenClinic Grosshansdorf
Großhansdorf, Schleswig-Holstein 22927
Germany
Charité - Universitätsmedizin Berlin
Berlin, 13353
Germany
Metropolitan Hospital
Piraeus, Athens 185 47
Greece
Saint Savvas Anticancer - Oncological Hospital of Athens
Athens, Attica 11522
Greece
Henry Dunant Hospital Center
Athens, Attica 11526
Greece
General Hospital for Thoracic Diseases Sotiria
Athens, Attica 11527
Greece
Agii Anargiri Cancer Hospital
Nea Kifissia, Attica 14564
Greece
Clinic Agios Loukas
Thessaloniki, Central Macedonia 55236
Greece
University General Hospital of Heraklion (PAGNI)
Heraklion, Crete 711 10
Greece
General Hospital of Thessaloniki Papageorgiou
Thessaloniki, Macedoni TK 56403
Greece
University General Hospital of Patras
Patra, Peloponnese 26504
Greece
Theagenio Anti-Cancer Hospital of Thessaloniki
Thessaloniki, Thessaloniki 546 39
Greece
University General Hospital of Larissa
Larissa, Thessaly 411 10
Greece
Mátrai Gyógyintézet
Gyöngyös, Heves County 3200
Hungary
Országos Korányi Pulmonológiai Intézet
Budapest, 1121
Hungary
Clinexpert Kft. telephelye, Bugát Pál Kórház - Phase I. Clinical Trial Site
Gyöngyös, 3200
Hungary
Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST
Meldola, Forlì-Cesena 47014
Italy
Presidio Ospedaliero di Lucca
San Filippo, Lucca 55100
Italy
Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Istituto Clinico Humanitas
Rozzano, Milan 20089
Italy
Azienda Ospedaliera Universitaria - Università degli Studi della Campania Luigi Vanvitelli
Naples, Naples 80131
Italy
Azienda Ospedaliero - Universitaria San Luigi Gonzaga
Orbassano, Torino 10043
Italy
Ospedale P. Pederzoli - Casa di Cura Privata S.p.A.
Legnago, Verona 37045
Italy
Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale Policlinico San Martino
Genova, 16132
Italy
Ospedale Vito Fazzi Lecce
Lecce, 73100
Italy
Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San Raffaele
Milan, 20132
Italy
Fondazione IRCCS - Istituto Nazionale dei Tumori
Milan, 20133
Italy
Azienda Ospedaliero-Universitaria Maggiore della Carità di Novara
Novara, 28100
Italy
Ospedale Busonera - Istituto Oncologico Veneto (IOV) - Padua
Padova, 35128
Italy
Azienda Ospedaliero-Universitaria Pisana
Pisa, 56126
Italy
Azienda Unità Sanitaria Locale della Romagna - Ospedale Infermi di Rimini
Rimini, 47923
Italy
IRCCS Istituto Nazionale Tumori Regina Elena
Roma, 00144
Italy
Azienda Ospedaliera San Camillo Forlanini
Rome, 00152
Italy
Azienda Ospedaliera Universitaria Senese - L'ospedale Santa Maria alle Scotte
Siena, 53100
Italy
Radboud Universitair Medisch Centrum
Nijmegen, Gelderland 6525 GA
Netherlands
Erasmus Medisch Centrum
Rotterdam, South Holland 3015 GD
Netherlands
Universitair Medisch Centrum Groningen
Groningen, 9713 GZ
Netherlands
Przychodnia Lekarska KOMED Roman Karaszewski
Konin, Greater Poland Voivodeship 62-500
Poland
Wielkopolskie Centrum Pulmonologii i Torakochirurgii im. Eugenii i Janusza Zeylandów
Poznan, Greater Poland Voivodeship 60-569
Poland
Centrum Onkologii Im. Prof. F. Łukaszczyka w Bydgoszczy
Bydgoszcz, Kuyavian-Pomeranian Voivodeship 85-796
Poland
Uniwersytecki Szpital Kliniczny Nr 4 w Lublinie
Lublin, Lublin Voivodeship 20-090
Poland
Instytut Centrum Zdrowia Matki Polki
Lodz, Lódzkie 93-338
Poland
Uniwersyteckie Centrum Kliniczne w Gdańsku
Gdansk, Pomeranian Voivodeship 80-210
Poland
Unidade Local de Saúde de Coimbra
Coimbra, 3000-075
Portugal
Hospital CUF Descobertas
Lisbon, 1769-001
Portugal
Unidade Local de Saúde de Santa Maria, E. P. E. - Hospital Pulido Valente
Lisbon, 1769-001
Portugal
Hospital CUF Porto
Porto, 14341
Portugal
Unidade Local de Saúde de Gaia/Espinho, E. P. E
Vila Nova de Gaia, 4434-502
Portugal
Institutul Oncologic Prof. Dr. Ion Chiricuta
Cluj-Napoca, Cluj 400015
Romania
Centrul de Oncologie Sf Nectarie
Craiova, Dolj 200746
Romania
SC OncoMed SRL
Timișoara, Timiș County 300239
Romania
Hospital Son Llàtzer
Palma de Mallorca, Balearic Islands 07198
Spain
Hospital Germans Trias i Pujol
Badalona, Barcelona 08916
Spain
Institut Català d'Oncologia - Hospital Duran i Reynals (ICO L'Hospitalet)
L'Hospitalet de Llobregat, Barcelona 08907
Spain
Biocruces Bizkaia Instituto de Investigación Sanitaria
Barakaldo, Biscay 48903
Spain
Complejo Hospitalario Universitario A Coruña
A Coruña, La Coruña 15006
Spain
Complejo Hospitalario Universitario Insular Materno Infantil
Las Palmas de Gran Canaria, Las Palmas 35016
Spain
Hospital Universitario Puerta de Hierro - Majadahonda
Majadahonda, Madrid 28222
Spain
HC Marbella
Marbella, Malaga 29660
Spain
Clínica Mi Tres Torres
Barcelona, 08017
Spain
Hospital Universitari Dexeus
Barcelona, 08028
Spain
Hospital Universitari Vall d'Hebrón
Barcelona, 08035
Spain
Hospital Clinic de Barcelona
Barcelona, 08036
Spain
Hospital Universitario Reina Sofía
Córdoba, 14004
Spain
Hospital Universitari de Girona Dr. Josep Trueta
Girona, 17007
Spain
Hospital Universitario Lucus Augusti
Lugo, 27004
Spain
Hospital General Universitario Gregorio Marañón
Madrid, 28007
Spain
Hospital Universitario Ramón y Cajal
Madrid, 28034
Spain
Hospital Universitario La Paz
Madrid, 28046
Spain
Hospital Regional Universitario de Málaga - Hospital General
Málaga, 29011
Spain
Hospital Universitario Virgen Macarena
Seville, 41009
Spain
University Hospitals of Leicester NHS Trust
Leicester, England LE2 9LX
United Kingdom
The Christie NHS Foundation Trust
Manchester, England M20 4BX
United Kingdom
The Clatterbridge Cancer Centre NHS Foundation Trust
Metropolitan Borough of Wirral, England CH63 4JY
United Kingdom
The Royal Marsden NHS Foundation Trust
Sutton, England SM2 5PT
United Kingdom
NHS Grampian
Aberdeen, Scotland AB25 2ZN
United Kingdom