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RECRUITING Phase 3 ClinicalTrials.gov

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

Sponsor: OSE Immunotherapeutics • ClinicalTrials.gov ID: NCT06472245

Registry updated: 2026-10-02
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Description

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).

Interventions

  • OSE2101 (Drug)
    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.
  • Docetaxel (Drug)
    Docetaxel is an antineoplastic agent that acts by disrupting the microtubular network in cells that is essential for mitotic and interphase cellular functions.
  • NGS HLAA2 assay (Device)
    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.

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.

Conditions

Patients With Non-Small Cell Lung Cancer

Locations

  • Clinical Research Advisors, LLC — Beverly Hills, California, United States
  • Clinical Research Advisors - Encino — Encino, California, United States
  • Clinical Research Advisors - West Hollywood — Los Angeles, California, United States
  • Clinical Research Advisors - Korea Town — Los Angeles, California, United States
  • SCL Health - Saint Joseph Hospital Cancer Center — Littleton, Colorado, United States
  • Lutheran Medical Center - Cancer Centers of Colorado — Wheat Ridge, Colorado, United States
  • Eastern Connecticut Hematology and Oncology Associates — Norwich, Connecticut, United States
  • Georgetown Lombardi Comprehensive Cancer Center — Washington D.C., District of Columbia, United States
  • Comprehensive Hematology Oncology - Bradenton Clinic — Bradenton, Florida, United States
  • Comprehensive Hematology Oncology - Brandon Clinic — Brandon, Florida, United States
  • Cancer Specialists of North Florida - Fleming Island — Fleming Island, Florida, United States
  • Cancer Specialists of North Florida - Riverside — Jacksonville, Florida, United States
  • Cancer Specialists of North Florida Southside — Jacksonville, Florida, United States
  • Cancer Specialists of North Florida - Northside — Jacksonville, Florida, United States
  • Cancer Specialists of North Florida - Southpoint — Jacksonville, Florida, United States
  • Cancer Specialists of North Florida - Baptist South — Jacksonville, Florida, United States
  • Cancer Specialists of North Florida — Jacksonville Beach, Florida, United States
  • Comprehensive Hematology Oncology - Largo Clinic — Largo, Florida, United States
  • Cancer Specialists of North Florida - Beaches — Neptune Beach, Florida, United States
  • Comprehensive Hematology Oncology - Palm Harbor Clinic — Palm Harbor, Florida, United States
  • Cancer Specialists Of North Florida - St. Augustine — Saint Augustine, Florida, United States
  • Comprehensive Hematology Oncology - Bayfront Clinic — St. Petersburg, Florida, United States
  • Comprehensive Hematology Oncology — St. Petersburg, Florida, United States
  • Comprehensive Hematology Oncology - Trinity Clinic — Trinity, Florida, United States
  • University of Illinois Cancer Center — Chicago, Illinois, United States
  • Alliance for Multispecialty Research (AMR) - Kansas City Oncology — Merriam, Kansas, United States
  • Mary Bird Perkins Cancer Center - Baton Rouge — Baton Rouge, Louisiana, United States
  • Pontchartrain Cancer Center - Covington Office — Covington, Louisiana, United States
  • Pontchartrain Cancer Center - Hammond Office — Hammond, Louisiana, United States
  • Ascension Saint Agnes Hospital — Baltimore, Maryland, United States
  • University of Massachusetts Memorial Medical Center — Worcester, Massachusetts, United States
  • Nebraska Hematology-Oncology - Revive Research Institute LLC — Lincoln, Nebraska, United States
  • New York Cancer & Blood Specialists - Babylon Medical Oncology — Babylon, New York, United States
  • Optum Medical Care - Carmel/Brewster Campus — Brewster, New York, United States
  • Brooklyn Radiation Oncology — Brooklyn, New York, United States
  • Optum Medical Care - Fishkill Westage Campus — Fishkill, New York, United States
  • Clinical Research Alliance — Lake Success, New York, United States
  • Optum Medical Care - Mount Kisco Campus 90 — Mount Kisco, New York, United States
  • New York Cancer & Blood Specialists - New Hyde Park — New Hyde Park, New York, United States
  • Optum Hematology Oncology - Lake Success — New Hyde Park, New York, United States
  • New York Cancer & Blood Specialists - Cancer Center - Research Headquarters — New York, New York, United States
  • New York Cancer & Blood Specialists - Central Park Medical Oncology — New York, New York, United States
  • New York Cancer & Blood Specialists - Patchogue Medical Oncology — Patchogue, New York, United States
  • New York Cancer & Blood Specialists - Port Jefferson Medical Oncology — Port Jefferson Station, New York, United States
  • New York Cancer & Blood Specialists - Port Jefferson Station Medical Oncology — Port Jefferson Station, New York, United States
  • Optum Medical Care - Poughkeepsie — Poughkeepsie, New York, United States
  • New York Cancer & Blood Specialists - Eastchester Cancer Care Center — The Bronx, New York, United States
  • New York Cancer & Blood Specialists - Riverhead Medical Oncology — The Bronx, New York, United States
  • Mercy Health - Perrysburg Cancer Center — Perrysburg, Ohio, United States
  • Mercy Health - St. Anne Cancer Center — Toledo, Ohio, United States
  • Bon Secours Hematology and Oncology — Greenville, South Carolina, United States
  • Tennessee Oncology - Chattanooga - Medical Park II — Chattanooga, Tennessee, United States
  • Tennessee Oncology - Chattanooga - Downtown — Chattanooga, Tennessee, United States
  • Tennessee Oncology - Chattanooga - GHCR Site I — Chattanooga, Tennessee, United States
  • Tennessee Oncology - Chattanooga - Memorial Plaza — Chattanooga, Tennessee, United States
  • Tennessee Oncology - Cleveland Clinic — Cleveland, Tennessee, United States
  • Tennessee Oncology - Cookeville Clinic — Cookeville, Tennessee, United States
  • Tennessee Oncology - Dickson Clinic — Dickson, Tennessee, United States
  • Tennessee Oncology - Franklin Clinic — Franklin, Tennessee, United States
  • Tennessee Oncology - Gallatin Clinic — Gallatin, Tennessee, United States
  • Tennessee Oncology - Hendersonville Clinic — Hendersonville, Tennessee, United States
  • Tennessee Oncology - Hermitage - Summit Clinic — Hermitage, Tennessee, United States
  • Tennessee Oncology - Lebanon Clinic — Lebanon, Tennessee, United States
  • Tennessee Oncology - Murfreesboro Clinic — Murfreesboro, Tennessee, United States
  • Tennessee Oncology - Nashville - Centennial Center for Blood Cancers Clinic — Nashville, Tennessee, United States
  • Tennessee Oncology - Nashville - Centennial Clinic - Medical Oncology — Nashville, Tennessee, United States
  • Tennessee Oncology - Nashville - Midtown Center for Blood Cancers — Nashville, Tennessee, United States
  • Tennessee Oncology - Nashville - St. Thomas Midtown Clinic — Nashville, Tennessee, United States
  • Tennessee Oncology - Nashville - St. Thomas West Clinic — Nashville, Tennessee, United States
  • Tennessee Oncology - Nashville - Skyline Clinic — Nashville, Tennessee, United States
  • Tennessee Oncology - Nashville - Southern Hills Clinic — Nashville, Tennessee, United States
  • Greco-Hainsworth Tennessee Oncology Centers for Research (GHCR) - Corporate — Nashville, Tennessee, United States
  • Tennessee Oncology - Shelbyville Clinic — Shelbyville, Tennessee, United States
  • Tennessee Oncology - Smyrna Clinic — Smyrna, Tennessee, United States
  • Northwest Medical Specialties - Bonney Lake — Bonney Lake, Washington, United States
  • Northwest Medical Specialties - Federal Way — Federal Way, Washington, United States
  • Northwest Medical Specialties - Gig Harbor — Gig Harbor, Washington, United States
  • Northwest Medical Specialties - Puyallup Medical Oncology — Puyallup, Washington, United States
  • Northwest Medical Specialties - Tacoma — Tacoma, Washington, United States
  • Algemeen Ziekenhuis Klina — Brasschaat, Antwerpen, Belgium
  • Universitair Ziekenhuis Leuven - Campus Gasthuisberg — Leuven, Flemish Brabant, Belgium
  • Jessa Ziekenhuis - Campus Virga Jesse — Hasselt, Limburg, Belgium
  • Algemeen Ziekenhuis Maria Middelares — Ghent, Oost-Vlaaderen, Belgium
  • Centre Hospitalier Universitaire Université Catholique de Louvain Namur - Site Sainte-Elisabeth — Namur, Wallonia, Belgium
  • Algemeen Ziekenhuis Groeninge - Campus Kennedylaan — Kortrijk, West-Vlaanderen, Belgium
  • Algemeen Ziekenhuis Delta - Campus Rembert Torhout — Roeselare, West-Vlaanderen, Belgium
  • Algemeen Ziekenhuis Delta - Campus Rumbeke — Roeselare, West-Vlaanderen, 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, Canada
  • McGill University Health Centre — Montreal, Quebec, Canada
  • Centre Intégré de Santé et de Services Sociaux du Bas-Saint-Laurent — Rimouski, Quebec, Canada
  • Hôpital d'Instruction des Armées Sainte-Anne — Toulon, Alpes-de-Haute-Provence, France
  • Nouvel Hôpital Civil — Strasbourg, Alsace, France
  • Hôpital Louis Pradel — Bron, Auvergne-Rhône-Alpes, France
  • Centre Hospitalier Lyon-Sud — Lyon, Auvergne-Rhône-Alpes, France
  • Hôpital de la Croix Rousse — Lyon, Auvergne-Rhône-Alpes, France
  • Institut Paoli-Calmettes — Marseille, Bouches-du-Rhône, France
  • Centre Hospitalier Régional et Universitaire de Besançon - Hôpital Jean-Minjoz — Besançon, Doubs, France
  • Centre Hospitalier Regional Universitaire Brest - Hopital de la Cavale Blanche — Brest, Finistère, France
  • Hôpital Emile Muller — Mulhouse, Grand Est, France
  • Centre Hospitalier Régional Universitaire de Nancy — Nancy, Grand Est, France
  • Centre Hospitalier Universitaire Dupuytren 1 — Limoges, Haute-Vienne, France
  • Hôpital Arnaud de Villeneuve — Montpellier, Hérault, France
  • Hôpital Pontchaillou — Rennes, Ille-et-Vilaine, France
  • Institut de Cancérologie de l'Ouest - Saint-Herblain - Site René Gauducheau — Saint-Herblain, Loire-Atlantique, France
  • Centre Hospitalier (Ch) De Cholet — Cholet, Maine-et-Loire, France
  • Hôpital Larrey — Toulouse, Midi-pyrenees, France
  • Hôpital Haut-Lévêque — Pessac, New Aquitaine, France
  • Hôpital Nord de Marseille — Marseille, Provence-Alpes-Côte d'Azur Region, France
  • Centre Hospitalier de la Côte Basque — Bayonne, Pyrénées-Atlantiques, France
  • Hôpital Michallon — La Tronche, Rhône, France
  • Gustave Roussy — Villejuif, Val-de-Marne, France
  • Institut Sainte Catherine — Avignon, Vaucluse, France
  • Centre Hospitalier Universitaire de Poitiers — Poitiers, Vienne, France
  • Centre Hospitalier Départemental Vendée — La Roche-sur-Yon, France
  • Centre Hospitalier Le Mans — Le Mans, France
  • Centre Hospitalier Universitaire De Nantes - Hôpital Nord Laennec — Nantes, France
  • Hôpital Avicenne — Bobigny, Île-de-France Region, France
  • Centre Hospitalier Intercommunal de Créteil — Créteil, Île-de-France Region, France
  • Groupe Hospitalier Paris Saint-Joseph — Paris, Île-de-France Region, France
  • Hôpital Cochin — Paris, Île-de-France Region, France
  • Hôpital Tenon — Paris, Île-de-France Region, France
  • Thoraxklinik-Heidelberg — Heidelberg, Baden-Wurttemberg, Germany
  • Robert-Bosch-Krankenhaus — Stuttgart, Baden-Wurttemberg, Germany
  • Asklepios Fachkliniken München-Gauting — Gauting, Bavaria, Germany
  • München Klinik Bogenhausen — München, Bavaria, Germany
  • Klinikum Kassel — Kassel, Hesse, Germany
  • Universitätsklinikum Aachen — Aachen, North Rhine-Westphalia, Germany
  • Universitätsklinikum Bonn — Bonn, North Rhine-Westphalia, Germany
  • Universitätsklinikum Essen — Essen, North Rhine-Westphalia, Germany
  • Universitätsklinikum Gießen und Marburg - Gießen — Homburg, Saarland, Germany
  • Krankenhaus Martha-Maria Halle-Dölau — Halle, Saxony-Anhalt, Germany
  • LungenClinic Grosshansdorf — Großhansdorf, Schleswig-Holstein, Germany
  • Charité - Universitätsmedizin Berlin — Berlin, Germany
  • Metropolitan Hospital — Piraeus, Athens, Greece
  • Saint Savvas Anticancer - Oncological Hospital of Athens — Athens, Attica, Greece
  • Henry Dunant Hospital Center — Athens, Attica, Greece
  • General Hospital for Thoracic Diseases Sotiria — Athens, Attica, Greece
  • Agii Anargiri Cancer Hospital — Nea Kifissia, Attica, Greece
  • Clinic Agios Loukas — Thessaloniki, Central Macedonia, Greece
  • University General Hospital of Heraklion (PAGNI) — Heraklion, Crete, Greece
  • General Hospital of Thessaloniki Papageorgiou — Thessaloniki, Macedoni, Greece
  • University General Hospital of Patras — Patra, Peloponnese, Greece
  • Theagenio Anti-Cancer Hospital of Thessaloniki — Thessaloniki, Thessaloniki, Greece
  • University General Hospital of Larissa — Larissa, Thessaly, Greece
  • Mátrai Gyógyintézet — Gyöngyös, Heves County, Hungary
  • Országos Korányi Pulmonológiai Intézet — Budapest, Hungary
  • Clinexpert Kft. telephelye, Bugát Pál Kórház - Phase I. Clinical Trial Site — Gyöngyös, Hungary
  • Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST — Meldola, Forlì-Cesena, Italy
  • Presidio Ospedaliero di Lucca — San Filippo, Lucca, Italy
  • Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Istituto Clinico Humanitas — Rozzano, Milan, Italy
  • Azienda Ospedaliera Universitaria - Università degli Studi della Campania Luigi Vanvitelli — Naples, Naples, Italy
  • Azienda Ospedaliero - Universitaria San Luigi Gonzaga — Orbassano, Torino, Italy
  • Ospedale P. Pederzoli - Casa di Cura Privata S.p.A. — Legnago, Verona, Italy
  • Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale Policlinico San Martino — Genova, Italy
  • Ospedale Vito Fazzi Lecce — Lecce, Italy
  • Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San Raffaele — Milan, Italy
  • Fondazione IRCCS - Istituto Nazionale dei Tumori — Milan, Italy
  • Azienda Ospedaliero-Universitaria Maggiore della Carità di Novara — Novara, Italy
  • Ospedale Busonera - Istituto Oncologico Veneto (IOV) - Padua — Padova, Italy
  • Azienda Ospedaliero-Universitaria Pisana — Pisa, Italy
  • Azienda Unità Sanitaria Locale della Romagna - Ospedale Infermi di Rimini — Rimini, Italy
  • IRCCS Istituto Nazionale Tumori Regina Elena — Roma, Italy
  • Azienda Ospedaliera San Camillo Forlanini — Rome, Italy
  • Azienda Ospedaliera Universitaria Senese - L'ospedale Santa Maria alle Scotte — Siena, Italy
  • Radboud Universitair Medisch Centrum — Nijmegen, Gelderland, Netherlands
  • Erasmus Medisch Centrum — Rotterdam, South Holland, Netherlands
  • Universitair Medisch Centrum Groningen — Groningen, Netherlands
  • Przychodnia Lekarska KOMED Roman Karaszewski — Konin, Greater Poland Voivodeship, Poland
  • Wielkopolskie Centrum Pulmonologii i Torakochirurgii im. Eugenii i Janusza Zeylandów — Poznan, Greater Poland Voivodeship, Poland
  • Centrum Onkologii Im. Prof. F. Łukaszczyka w Bydgoszczy — Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
  • Uniwersytecki Szpital Kliniczny Nr 4 w Lublinie — Lublin, Lublin Voivodeship, Poland
  • Instytut Centrum Zdrowia Matki Polki — Lodz, Lódzkie, Poland
  • Uniwersyteckie Centrum Kliniczne w Gdańsku — Gdansk, Pomeranian Voivodeship, Poland
  • Unidade Local de Saúde de Coimbra — Coimbra, Portugal
  • Hospital CUF Descobertas — Lisbon, Portugal
  • Unidade Local de Saúde de Santa Maria, E. P. E. - Hospital Pulido Valente — Lisbon, Portugal
  • Hospital CUF Porto — Porto, Portugal
  • Unidade Local de Saúde de Gaia/Espinho, E. P. E — Vila Nova de Gaia, Portugal
  • Institutul Oncologic Prof. Dr. Ion Chiricuta — Cluj-Napoca, Cluj, Romania
  • Centrul de Oncologie Sf Nectarie — Craiova, Dolj, Romania
  • SC OncoMed SRL — Timișoara, Timiș County, Romania
  • Hospital Son Llàtzer — Palma de Mallorca, Balearic Islands, Spain
  • Hospital Germans Trias i Pujol — Badalona, Barcelona, Spain
  • Institut Català d'Oncologia - Hospital Duran i Reynals (ICO L'Hospitalet) — L'Hospitalet de Llobregat, Barcelona, Spain
  • Biocruces Bizkaia Instituto de Investigación Sanitaria — Barakaldo, Biscay, Spain
  • Complejo Hospitalario Universitario A Coruña — A Coruña, La Coruña, Spain
  • Complejo Hospitalario Universitario Insular Materno Infantil — Las Palmas de Gran Canaria, Las Palmas, Spain
  • Hospital Universitario Puerta de Hierro - Majadahonda — Majadahonda, Madrid, Spain
  • HC Marbella — Marbella, Malaga, Spain
  • Clínica Mi Tres Torres — Barcelona, Spain
  • Hospital Universitari Dexeus — Barcelona, Spain
  • Hospital Universitari Vall d'Hebrón — Barcelona, Spain
  • Hospital Clinic de Barcelona — Barcelona, Spain
  • Hospital Universitario Reina Sofía — Córdoba, Spain
  • Hospital Universitari de Girona Dr. Josep Trueta — Girona, Spain
  • Hospital Universitario Lucus Augusti — Lugo, Spain
  • Hospital General Universitario Gregorio Marañón — Madrid, Spain
  • Hospital Universitario Ramón y Cajal — Madrid, Spain
  • Hospital Universitario La Paz — Madrid, Spain
  • Hospital Regional Universitario de Málaga - Hospital General — Málaga, Spain
  • Hospital Universitario Virgen Macarena — Seville, Spain
  • University Hospitals of Leicester NHS Trust — Leicester, England, United Kingdom
  • The Christie NHS Foundation Trust — Manchester, England, United Kingdom
  • The Clatterbridge Cancer Centre NHS Foundation Trust — Metropolitan Borough of Wirral, England, United Kingdom
  • The Royal Marsden NHS Foundation Trust — Sutton, England, United Kingdom
  • NHS Grampian — Aberdeen, Scotland, United Kingdom
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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