RecruitingRecruiting
Trial of Therapeutic Cancer Vaccine OSE2101 in Patients With Non-Small Cell Lung Cancer and Secondary Resistance to Immune Checkpoint Inhibitor
NCT06472245 · OSE Immunotherapeutics
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
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
About this study
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
Inclusion Criteria:
1. Male or female, aged ≥ 18 years
2. Patients expressing HLA-A2 phenotype in blood by pre-screening central laboratory
3. 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.
4. Patients with secondary resistance to ICI;
Other inclusion and exclusion criteria will apply per protocol.
Study design
Enrollment target: 363 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2024-12-03
Estimated completion: 2028-12-15
Last updated: 2026-04-01
Interventions
Drug: OSE2101Drug: DocetaxelDevice: NGS HLAA2 assay
Primary outcomes
- • OS defined as time from randomization to death (From randomization date through study completion, an average of 3 years)
Sponsor
OSE Immunotherapeutics · industry
With: Exystat, Genome Diagnostics (GenDx)
Contacts & investigators
ContactCaroline Chevalier, MSc, MPH · contact · caroline.chevalier@ose-immuno.com · +33 630 842 002
ContactBérangère Vasseur, MD · contact · berangere.vasseur@ose-immuno.com · +33 676 448 160
All locations (207)
Clinical Research Advisors, LLCRecruiting
Beverly Hills, California, United States
Clinical Research Advisors - EncinoActive Not Recruiting
Encino, California, United States
Clinical Research Advisors - West HollywoodActive Not Recruiting
Los Angeles, California, United States
Clinical Research Advisors - Korea TownActive Not Recruiting
Los Angeles, California, United States
SCL Health - Saint Joseph Hospital Cancer CenterWithdrawn
Littleton, Colorado, United States
Lutheran Medical Center - Cancer Centers of ColoradoRecruiting
Wheat Ridge, Colorado, United States
Eastern Connecticut Hematology and Oncology AssociatesRecruiting
Norwich, Connecticut, United States
Georgetown Lombardi Comprehensive Cancer CenterRecruiting
Washington D.C., District of Columbia, United States
Comprehensive Hematology Oncology - Bradenton ClinicActive Not Recruiting
Bradenton, Florida, United States
Comprehensive Hematology Oncology - Brandon ClinicActive Not Recruiting
Brandon, Florida, United States
Cancer Specialists of North Florida - Fleming IslandRecruiting
Fleming Island, Florida, United States
Cancer Specialists of North Florida - RiversideActive Not Recruiting
Jacksonville, Florida, United States
Cancer Specialists of North Florida SouthsideActive Not Recruiting
Jacksonville, Florida, United States
Cancer Specialists of North Florida - NorthsideActive Not Recruiting
Jacksonville, Florida, United States
Cancer Specialists of North Florida - SouthpointRecruiting
Jacksonville, Florida, United States
Cancer Specialists of North Florida - Baptist SouthActive Not Recruiting
Jacksonville, Florida, United States
Cancer Specialists of North FloridaRecruiting
Jacksonville Beach, Florida, United States
Comprehensive Hematology Oncology - Largo ClinicActive Not Recruiting
Largo, Florida, United States
Cancer Specialists of North Florida - BeachesActive Not Recruiting
Neptune Beach, Florida, United States
Comprehensive Hematology Oncology - Palm Harbor ClinicActive Not Recruiting
Palm Harbor, Florida, United States
Cancer Specialists Of North Florida - St. AugustineRecruiting
Saint Augustine, Florida, United States
Comprehensive Hematology Oncology - Bayfront ClinicActive Not Recruiting
St. Petersburg, Florida, United States
Comprehensive Hematology OncologyRecruiting
St. Petersburg, Florida, United States
Comprehensive Hematology Oncology - Trinity ClinicRecruiting
Trinity, Florida, United States
University of Illinois Cancer CenterRecruiting
Chicago, Illinois, United States
Alliance for Multispecialty Research (AMR) - Kansas City OncologyWithdrawn
Merriam, Kansas, United States
Mary Bird Perkins Cancer Center - Baton RougeActive Not Recruiting
Baton Rouge, Louisiana, United States
Pontchartrain Cancer Center - Covington OfficeRecruiting
Covington, Louisiana, United States
Pontchartrain Cancer Center - Hammond OfficeRecruiting
Hammond, Louisiana, United States
Ascension Saint Agnes HospitalRecruiting
Baltimore, Maryland, United States
University of Massachusetts Memorial Medical CenterRecruiting
Worcester, Massachusetts, United States
Nebraska Hematology-Oncology - Revive Research Institute LLCRecruiting
Lincoln, Nebraska, United States
New York Cancer & Blood Specialists - Babylon Medical OncologyActive Not Recruiting
Babylon, New York, United States
Optum Medical Care - Carmel/Brewster CampusTerminated
Brewster, New York, United States
Brooklyn Radiation OncologyTerminated
Brooklyn, New York, United States
Optum Medical Care - Fishkill Westage CampusTerminated
Fishkill, New York, United States
Clinical Research AllianceTerminated
Lake Success, New York, United States
Optum Medical Care - Mount Kisco Campus 90Terminated
Mount Kisco, New York, United States
New York Cancer & Blood Specialists - New Hyde ParkActive Not Recruiting
New Hyde Park, New York, United States
Optum Hematology Oncology - Lake SuccessTerminated
New Hyde Park, New York, United States
New York Cancer & Blood Specialists - Cancer Center - Research HeadquartersRecruiting
New York, New York, United States
New York Cancer & Blood Specialists - Central Park Medical OncologyActive Not Recruiting
New York, New York, United States
New York Cancer & Blood Specialists - Patchogue Medical OncologyRecruiting
Patchogue, New York, United States
New York Cancer & Blood Specialists - Port Jefferson Medical OncologyActive Not Recruiting
Port Jefferson Station, New York, United States
New York Cancer & Blood Specialists - Port Jefferson Station Medical OncologyActive Not Recruiting
Port Jefferson Station, New York, United States
Optum Medical Care - PoughkeepsieTerminated
Poughkeepsie, New York, United States
New York Cancer & Blood Specialists - Eastchester Cancer Care CenterActive Not Recruiting
The Bronx, New York, United States
New York Cancer & Blood Specialists - Riverhead Medical OncologyActive Not Recruiting
The Bronx, New York, United States
Mercy Health - Perrysburg Cancer CenterActive Not Recruiting
Perrysburg, Ohio, United States
Mercy Health - St. Anne Cancer CenterActive Not Recruiting
Toledo, Ohio, United States
Bon Secours Hematology and OncologyRecruiting
Greenville, South Carolina, United States
Tennessee Oncology - Chattanooga - Medical Park IIActive Not Recruiting
Chattanooga, Tennessee, United States
Tennessee Oncology - Chattanooga - DowntownRecruiting
Chattanooga, Tennessee, United States
Tennessee Oncology - Chattanooga - GHCR Site IRecruiting
Chattanooga, Tennessee, United States
Tennessee Oncology - Chattanooga - Memorial PlazaRecruiting
Chattanooga, Tennessee, United States
Tennessee Oncology - Cleveland ClinicRecruiting
Cleveland, Tennessee, United States
Tennessee Oncology - Cookeville ClinicActive Not Recruiting
Cookeville, Tennessee, United States
Tennessee Oncology - Dickson ClinicActive Not Recruiting
Dickson, Tennessee, United States
Tennessee Oncology - Franklin ClinicRecruiting
Franklin, Tennessee, United States
Tennessee Oncology - Gallatin ClinicActive Not Recruiting
Gallatin, Tennessee, United States
Tennessee Oncology - Hendersonville ClinicActive Not Recruiting
Hendersonville, Tennessee, United States
Tennessee Oncology - Hermitage - Summit ClinicActive Not Recruiting
Hermitage, Tennessee, United States
Tennessee Oncology - Lebanon ClinicActive Not Recruiting
Lebanon, Tennessee, United States
Tennessee Oncology - Murfreesboro ClinicActive Not Recruiting
Murfreesboro, Tennessee, United States
Tennessee Oncology - Nashville - Centennial Center for Blood Cancers ClinicActive Not Recruiting
Nashville, Tennessee, United States
Tennessee Oncology - Nashville - Centennial Clinic - Medical OncologyActive Not Recruiting
Nashville, Tennessee, United States
Tennessee Oncology - Nashville - Midtown Center for Blood CancersActive Not Recruiting
Nashville, Tennessee, United States
Tennessee Oncology - Nashville - St. Thomas Midtown ClinicActive Not Recruiting
Nashville, Tennessee, United States
Tennessee Oncology - Nashville - St. Thomas West ClinicRecruiting
Nashville, Tennessee, United States
Tennessee Oncology - Nashville - Skyline ClinicActive Not Recruiting
Nashville, Tennessee, United States
Tennessee Oncology - Nashville - Southern Hills ClinicActive Not Recruiting
Nashville, Tennessee, United States
Greco-Hainsworth Tennessee Oncology Centers for Research (GHCR) - CorporateRecruiting
Nashville, Tennessee, United States
Tennessee Oncology - Shelbyville ClinicRecruiting
Shelbyville, Tennessee, United States
Tennessee Oncology - Smyrna ClinicRecruiting
Smyrna, Tennessee, United States
Northwest Medical Specialties - Bonney LakeActive Not Recruiting
Bonney Lake, Washington, United States
Northwest Medical Specialties - Federal WayActive Not Recruiting
Federal Way, Washington, United States
Northwest Medical Specialties - Gig HarborRecruiting
Gig Harbor, Washington, United States
Northwest Medical Specialties - Puyallup Medical OncologyRecruiting
Puyallup, Washington, United States
Northwest Medical Specialties - TacomaRecruiting
Tacoma, Washington, United States
Algemeen Ziekenhuis KlinaRecruiting
Brasschaat, Antwerpen, Belgium
Universitair Ziekenhuis Leuven - Campus GasthuisbergRecruiting
Leuven, Flemish Brabant, Belgium
Jessa Ziekenhuis - Campus Virga JesseRecruiting
Hasselt, Limburg, Belgium
Algemeen Ziekenhuis Maria MiddelaresRecruiting
Ghent, Oost-Vlaaderen, Belgium
Centre Hospitalier Universitaire Université Catholique de Louvain Namur - Site Sainte-ElisabethRecruiting
Namur, Wallonia, Belgium
Algemeen Ziekenhuis Groeninge - Campus KennedylaanActive Not Recruiting
Kortrijk, West-Vlaanderen, Belgium
Algemeen Ziekenhuis Delta - Campus Rembert TorhoutActive Not Recruiting
Roeselare, West-Vlaanderen, Belgium
Algemeen Ziekenhuis Delta - Campus RumbekeRecruiting
Roeselare, West-Vlaanderen, Belgium
Algemeen Ziekenhuis Delta - Campus MenenActive Not Recruiting
Roeselare, West-Vlaanderen, Belgium
Centre Intégré Universitaire de Santé et de Services Sociaux du Saguenay - Lac-Saint-JeanRecruiting
Chicoutimi, Quebec, Canada
McGill University Health CentreTerminated
Montreal, Quebec, Canada
Centre Intégré de Santé et de Services Sociaux du Bas-Saint-LaurentRecruiting
Rimouski, Quebec, Canada
Hôpital d'Instruction des Armées Sainte-AnneRecruiting
Toulon, Alpes-de-Haute-Provence, France
Nouvel Hôpital CivilRecruiting
Strasbourg, Alsace, France
Hôpital Louis PradelActive Not Recruiting
Bron, Auvergne-Rhône-Alpes, France
Centre Hospitalier Lyon-SudRecruiting
Lyon, Auvergne-Rhône-Alpes, France
Hôpital de la Croix RousseActive Not Recruiting
Lyon, Auvergne-Rhône-Alpes, France
Institut Paoli-CalmettesRecruiting
Marseille, Bouches-du-Rhône, France
Centre Hospitalier Régional et Universitaire de Besançon - Hôpital Jean-MinjozRecruiting
Besançon, Doubs, France
Centre Hospitalier Regional Universitaire Brest - Hopital de la Cavale BlancheRecruiting
Brest, Finistère, France
Hôpital Emile MullerRecruiting
Mulhouse, Grand Est, France
Centre Hospitalier Régional Universitaire de NancyRecruiting
Nancy, Grand Est, France
Centre Hospitalier Universitaire Dupuytren 1Recruiting
Limoges, Haute-Vienne, France
Hôpital Arnaud de VilleneuveRecruiting
Montpellier, Hérault, France
Hôpital PontchaillouRecruiting
Rennes, Ille-et-Vilaine, France
Institut de Cancérologie de l'Ouest - Saint-Herblain - Site René GauducheauRecruiting
Saint-Herblain, Loire-Atlantique, France
Centre Hospitalier (Ch) De CholetRecruiting
Cholet, Maine-et-Loire, France
Hôpital LarreyRecruiting
Toulouse, Midi-pyrenees, France
Hôpital Haut-LévêqueRecruiting
Pessac, New Aquitaine, France
Hôpital Nord de MarseilleRecruiting
Marseille, Provence-Alpes-Côte d'Azur Region, France
Centre Hospitalier de la Côte BasqueRecruiting
Bayonne, Pyrénées-Atlantiques, France
Hôpital MichallonRecruiting
La Tronche, Rhône, France
Gustave RoussyRecruiting
Villejuif, Val-de-Marne, France
Institut Sainte CatherineRecruiting
Avignon, Vaucluse, France
Centre Hospitalier Universitaire de PoitiersRecruiting
Poitiers, Vienne, France
Centre Hospitalier Départemental VendéeRecruiting
La Roche-sur-Yon, France
Centre Hospitalier Le MansRecruiting
Le Mans, France
Centre Hospitalier Universitaire De Nantes - Hôpital Nord LaennecRecruiting
Nantes, France
Hôpital AvicenneRecruiting
Bobigny, Île-de-France Region, France
Centre Hospitalier Intercommunal de CréteilRecruiting
Créteil, Île-de-France Region, France
Groupe Hospitalier Paris Saint-JosephRecruiting
Paris, Île-de-France Region, France
Hôpital CochinRecruiting
Paris, Île-de-France Region, France
Hôpital TenonRecruiting
Paris, Île-de-France Region, France
Thoraxklinik-HeidelbergRecruiting
Heidelberg, Baden-Wurttemberg, Germany
Robert-Bosch-KrankenhausRecruiting
Stuttgart, Baden-Wurttemberg, Germany
Asklepios Fachkliniken München-GautingRecruiting
Gauting, Bavaria, Germany
München Klinik BogenhausenActive Not Recruiting
München, Bavaria, Germany
Klinikum KasselActive Not Recruiting
Kassel, Hesse, Germany
Universitätsklinikum AachenRecruiting
Aachen, North Rhine-Westphalia, Germany
Universitätsklinikum BonnRecruiting
Bonn, North Rhine-Westphalia, Germany
Universitätsklinikum EssenRecruiting
Essen, North Rhine-Westphalia, Germany
Universitätsklinikum Gießen und Marburg - GießenRecruiting
Homburg, Saarland, Germany
Krankenhaus Martha-Maria Halle-DölauRecruiting
Halle, Saxony-Anhalt, Germany
LungenClinic GrosshansdorfRecruiting
Großhansdorf, Schleswig-Holstein, Germany
Charité - Universitätsmedizin BerlinRecruiting
Berlin, Germany
Metropolitan HospitalRecruiting
Piraeus, Athens, Greece
Saint Savvas Anticancer - Oncological Hospital of AthensRecruiting
Athens, Attica, Greece
Henry Dunant Hospital CenterRecruiting
Athens, Attica, Greece
General Hospital for Thoracic Diseases SotiriaRecruiting
Athens, Attica, Greece
Agii Anargiri Cancer HospitalRecruiting
Nea Kifissia, Attica, Greece
Clinic Agios LoukasRecruiting
Thessaloniki, Central Macedonia, Greece
University General Hospital of Heraklion (PAGNI)Recruiting
Heraklion, Crete, Greece
General Hospital of Thessaloniki PapageorgiouActive Not Recruiting
Thessaloniki, Macedoni, Greece
University General Hospital of PatrasRecruiting
Patra, Peloponnese, Greece
Theagenio Anti-Cancer Hospital of ThessalonikiRecruiting
Thessaloniki, Thessaloniki, Greece
University General Hospital of LarissaRecruiting
Larissa, Thessaly, Greece
Mátrai GyógyintézetActive Not Recruiting
Gyöngyös, Heves County, Hungary
Országos Korányi Pulmonológiai IntézetRecruiting
Budapest, Hungary
Clinexpert Kft. telephelye, Bugát Pál Kórház - Phase I. Clinical Trial SiteRecruiting
Gyöngyös, Hungary
Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRSTRecruiting
Meldola, Forlì-Cesena, Italy
Presidio Ospedaliero di LuccaRecruiting
San Filippo, Lucca, Italy
Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Istituto Clinico HumanitasActive Not Recruiting
Rozzano, Milan, Italy
Azienda Ospedaliera Universitaria - Università degli Studi della Campania Luigi VanvitelliRecruiting
Naples, Naples, Italy
Azienda Ospedaliero - Universitaria San Luigi GonzagaRecruiting
Orbassano, Torino, Italy
Ospedale P. Pederzoli - Casa di Cura Privata S.p.A.Recruiting
Legnago, Verona, Italy
Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale Policlinico San MartinoRecruiting
Genova, Italy
Ospedale Vito Fazzi LecceActive Not Recruiting
Lecce, Italy
Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San RaffaeleRecruiting
Milan, Italy
Fondazione IRCCS - Istituto Nazionale dei TumoriRecruiting
Milan, Italy
Azienda Ospedaliero-Universitaria Maggiore della Carità di NovaraRecruiting
Novara, Italy
Ospedale Busonera - Istituto Oncologico Veneto (IOV) - PaduaRecruiting
Padova, Italy
Azienda Ospedaliero-Universitaria PisanaRecruiting
Pisa, Italy
Azienda Unità Sanitaria Locale della Romagna - Ospedale Infermi di RiminiActive Not Recruiting
Rimini, Italy
IRCCS Istituto Nazionale Tumori Regina ElenaRecruiting
Roma, Italy
Azienda Ospedaliera San Camillo ForlaniniRecruiting
Rome, Italy
Azienda Ospedaliera Universitaria Senese - L'ospedale Santa Maria alle ScotteRecruiting
Siena, Italy
Radboud Universitair Medisch CentrumRecruiting
Nijmegen, Gelderland, Netherlands
Erasmus Medisch CentrumRecruiting
Rotterdam, South Holland, Netherlands
Universitair Medisch Centrum GroningenRecruiting
Groningen, Netherlands
Przychodnia Lekarska KOMED Roman KaraszewskiRecruiting
Konin, Greater Poland Voivodeship, Poland
Wielkopolskie Centrum Pulmonologii i Torakochirurgii im. Eugenii i Janusza ZeylandówRecruiting
Poznan, Greater Poland Voivodeship, Poland
Centrum Onkologii Im. Prof. F. Łukaszczyka w BydgoszczyRecruiting
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
Uniwersytecki Szpital Kliniczny Nr 4 w LublinieRecruiting
Lublin, Lublin Voivodeship, Poland
Instytut Centrum Zdrowia Matki PolkiRecruiting
Lodz, Lódzkie, Poland
Uniwersyteckie Centrum Kliniczne w GdańskuRecruiting
Gdansk, Pomeranian Voivodeship, Poland
Unidade Local de Saúde de CoimbraRecruiting
Coimbra, Portugal
Hospital CUF DescobertasActive Not Recruiting
Lisbon, Portugal
Unidade Local de Saúde de Santa Maria, E. P. E. - Hospital Pulido ValenteRecruiting
Lisbon, Portugal
Hospital CUF PortoActive Not Recruiting
Porto, Portugal
Unidade Local de Saúde de Gaia/Espinho, E. P. ERecruiting
Vila Nova de Gaia, Portugal
Institutul Oncologic Prof. Dr. Ion ChiricutaRecruiting
Cluj-Napoca, Cluj, Romania
Centrul de Oncologie Sf NectarieRecruiting
Craiova, Dolj, Romania
SC OncoMed SRLRecruiting
Timișoara, Timiș County, Romania
Hospital Son LlàtzerRecruiting
Palma de Mallorca, Balearic Islands, Spain
Hospital Germans Trias i PujolActive Not Recruiting
Badalona, Barcelona, Spain
Institut Català d'Oncologia - Hospital Duran i Reynals (ICO L'Hospitalet)Recruiting
L'Hospitalet de Llobregat, Barcelona, Spain
Biocruces Bizkaia Instituto de Investigación SanitariaRecruiting
Barakaldo, Biscay, Spain
Complejo Hospitalario Universitario A CoruñaRecruiting
A Coruña, La Coruña, Spain
Complejo Hospitalario Universitario Insular Materno InfantilRecruiting
Las Palmas de Gran Canaria, Las Palmas, Spain
Hospital Universitario Puerta de Hierro - MajadahondaRecruiting
Majadahonda, Madrid, Spain
HC MarbellaRecruiting
Marbella, Malaga, Spain
Clínica Mi Tres TorresRecruiting
Barcelona, Spain
Hospital Universitari DexeusRecruiting
Barcelona, Spain
Hospital Universitari Vall d'HebrónRecruiting
Barcelona, Spain
Hospital Clinic de BarcelonaRecruiting
Barcelona, Spain
Hospital Universitario Reina SofíaRecruiting
Córdoba, Spain
Hospital Universitari de Girona Dr. Josep TruetaRecruiting
Girona, Spain
Hospital Universitario Lucus AugustiRecruiting
Lugo, Spain
Hospital General Universitario Gregorio MarañónRecruiting
Madrid, Spain
Hospital Universitario Ramón y CajalRecruiting
Madrid, Spain
Hospital Universitario La PazRecruiting
Madrid, Spain
Hospital Regional Universitario de Málaga - Hospital GeneralRecruiting
Málaga, Spain
Hospital Universitario Virgen MacarenaRecruiting
Seville, Spain
University Hospitals of Leicester NHS TrustRecruiting
Leicester, England, United Kingdom
The Christie NHS Foundation TrustRecruiting
Manchester, England, United Kingdom
The Clatterbridge Cancer Centre NHS Foundation TrustRecruiting
Metropolitan Borough of Wirral, England, United Kingdom
The Royal Marsden NHS Foundation TrustRecruiting
Sutton, England, United Kingdom
NHS GrampianRecruiting
Aberdeen, Scotland, United Kingdom