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

Last updated: February 26, 2025
Sponsor: OSE Immunotherapeutics
Overall Status: Active - Recruiting

Phase

3

Condition

N/A

Treatment

Docetaxel

NGS HLAA2 assay

OSE2101

Clinical Study ID

NCT06472245
OSE2101C302
  • Ages > 18
  • All Genders

Study 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

Inclusion

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; 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's agreement

  4. Patients with secondary resistance to ICI;

Other inclusion and exclusion criteria will apply per protocol.

Study Design

Total Participants: 363
Treatment Group(s): 3
Primary Treatment: Docetaxel
Phase: 3
Study Start date:
December 03, 2024
Estimated Completion Date:
December 15, 2028

Connect with a study center

  • Algemeen Ziekenhuis Klina

    Brasschaat, Antwerpen 2930
    Belgium

    Site Not Available

  • Universitair Ziekenhuis Leuven - Campus Gasthuisberg

    Leuven, Flemish Brabant 3000
    Belgium

    Site Not Available

  • Algemeen Ziekenhuis Maria Middelares

    Gent, Oost-Vlaaderen 9000
    Belgium

    Active - Recruiting

  • Centre Hospitalier Universitaire Université Catholique de Louvain Namur - Site Sainte-Elisabeth

    Namur, Wallonia B-5000
    Belgium

    Active - Recruiting

  • Algemeen Ziekenhuis Groeninge - Campus Kennedylaan

    Kortrijk, West-Vlaanderen 8500
    Belgium

    Site Not Available

  • Algemeen Ziekenhuis Delta - Campus Menen

    Roeselare, West-Vlaanderen
    Belgium

    Site Not Available

  • Algemeen Ziekenhuis Delta - Campus Rembert Torhout

    Roeselare, West-Vlaanderen 8800
    Belgium

    Site Not Available

  • Algemeen Ziekenhuis Delta - Campus Rumbeke

    Roeselare, West-Vlaanderen 8800
    Belgium

    Active - Recruiting

  • Centre Intégré de Santé et de Services Sociaux du Bas-Saint-Laurent

    Rimouski, Quebec G5L 5T1
    Canada

    Site Not Available

  • Hôpital d'Instruction des Armées Sainte-Anne

    Toulon Cedex 9, Alpes-de-Haute-Provence 83800
    France

    Site Not Available

  • Nouvel Hôpital Civil

    Strasbourg cedex, Alsace 67091
    France

    Active - Recruiting

  • Institut Paoli-Calmettes

    Marseille cedex 9, Bouches-du-Rhône 13273
    France

    Active - Recruiting

  • Centre Hospitalier Régional et Universitaire de Besançon - Hôpital Jean-Minjoz

    Besançon Cedex, Doubs 25030
    France

    Active - Recruiting

  • Centre Hospitalier Regional Universitaire Brest - Hopital de la Cavale Blanche

    Brest, Finistère 29200
    France

    Site Not Available

  • Hôpital Emile Muller

    Mulhouse, Grand Est 68100
    France

    Active - Recruiting

  • Centre Hospitalier Universitaire Dupuytren 1

    Limoges, Haute-Vienne 87000
    France

    Active - Recruiting

  • Hôpital Arnaud de Villeneuve

    Montpellier, Hérault 34295
    France

    Site Not Available

  • Centre Hospitalier Intercommunal de Créteil

    Créteil, Ile-De-France 94000
    France

    Active - Recruiting

  • Hôpital Avicenne

    Bobigny, Ile-de-France 93000
    France

    Active - Recruiting

  • Hôpital Tenon

    Paris, Ile-de-France 75020
    France

    Site Not Available

  • Hôpital Pontchaillou

    Rennes cedex 9, Ille-et-Vilaine 35033
    France

    Active - Recruiting

  • Institut de Cancérologie de l'Ouest - Saint-Herblain - Site René Gauducheau

    Saint-Herblain, Loire-Atlantique 44805
    France

    Active - Recruiting

  • Centre Hospitalier (Ch) De Cholet

    Cholet, Maine-et-Loire 49325
    France

    Site Not Available

  • Hôpital Larrey

    Toulouse cedex 9, Midi-pyrenees 31059
    France

    Active - Recruiting

  • Hôpital Nord de Marseille

    Marseille, Provence Alpes Cote d´Azur 13015
    France

    Site Not Available

  • Centre Hospitalier de la Côte Basque

    Bayonne, Pyrénées-Atlantiques 64109
    France

    Site Not Available

  • Centre Hospitalier Lyon-Sud

    Lyon, Rhone-alpes 69317
    France

    Site Not Available

  • Hôpital Michallon

    La Tronche, Rhône 38700
    France

    Active - Recruiting

  • Gustave Roussy

    Villejuif, Val-de-Marne 94805
    France

    Site Not Available

  • Centre Hospitalier Universitaire de Poitiers

    Poitiers, Vienne 86021
    France

    Site Not Available

  • Centre Hospitalier Départemental Vendée

    La Roche-sur-Yon, 85000
    France

    Active - Recruiting

  • Centre Hospitalier Le Mans

    Le Mans, 72037
    France

    Active - Recruiting

  • Centre Hospitalier Universitaire De Nantes - Hôpital Nord Laennec

    Nantes, 44093
    France

    Active - Recruiting

  • General Hospital for Thoracic Diseases Sotiria

    Athens, Attica 11527
    Greece

    Site Not Available

  • Saint Savvas Anticancer - Oncological Hospital of Athens

    Athens, Attica 11522
    Greece

    Active - Recruiting

  • Agii Anargiri Cancer Hospital

    Néa Kifisiá, Attica 14564
    Greece

    Active - Recruiting

  • Clinic Agios Loukas

    Thessaloniki, Central Macedonia 55236
    Greece

    Active - Recruiting

  • University General Hospital of Heraklion (PAGNI)

    Heraklion, Crete 711 10
    Greece

    Active - Recruiting

  • General Hospital of Thessaloniki Papageorgiou

    Thessaloniki, Macedoni TK 56403
    Greece

    Site Not Available

  • Theagenio Anti-Cancer Hospital of Thessaloniki

    Thessaloníki, Thessaloniki 546 39
    Greece

    Site Not Available

  • University General Hospital of Larissa

    Larissa, Thessaly 411 10
    Greece

    Active - Recruiting

  • Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST

    Meldola, Forlì-Cesena 47014
    Italy

    Site Not Available

  • Presidio Ospedaliero di Lucca

    San Filippo, Lucca 55100
    Italy

    Site Not Available

  • Azienda Ospedaliero - Universitaria San Luigi Gonzaga

    Orbassano, Torino 10043
    Italy

    Site Not Available

  • Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale Policlinico San Martino

    Genova, 16132
    Italy

    Active - Recruiting

  • Azienda Ospedaliero-Universitaria Maggiore della Carità di Novara

    Novara, 28100
    Italy

    Site Not Available

  • Azienda Ospedaliero-Universitaria Pisana

    Pisa, 56126
    Italy

    Site Not Available

  • Azienda Unità Sanitaria Locale della Romagna - Ospedale Infermi di Rimini

    Rimini, 47923
    Italy

    Site Not Available

  • IRCCS Istituto Nazionale Tumori Regina Elena

    Roma, 00144
    Italy

    Site Not Available

  • Radboud Universitair Medisch Centrum

    Nijmegen, Gelderland 6525 GA
    Netherlands

    Active - Recruiting

  • Erasmus Medisch Centrum

    Rotterdam, Zuid-Holland 3015 GD
    Netherlands

    Site Not Available

  • Instytut Centrum Zdrowia Matki Polki

    Łódź, Lódzkie 93-338
    Poland

    Site Not Available

  • Uniwersyteckie Centrum Kliniczne w Gdańsku

    Gdańsk, Pomorskie 80-210
    Poland

    Site Not Available

  • Hospital CUF Descobertas

    Lisboa, 1769-001
    Portugal

    Site Not Available

  • Unidade Local de Saúde de Santa Maria, E. P. E. - Hospital Pulido Valente

    Lisboa, 1769-001
    Portugal

    Site Not Available

  • Centrul de Oncologie Sf Nectarie

    Craiova, Dolj 200746
    Romania

    Site Not Available

  • SC OncoMed SRL

    Timisoara, Timis 300239
    Romania

    Site Not Available

  • Hospital Son Llàtzer

    Palma De Mallorca, Balearic Islands 07198
    Spain

    Site Not Available

  • Hospital Germans Trias i Pujol

    Badalona, Barcelona 08916
    Spain

    Site Not Available

  • Biocruces Bizkaia Instituto de Investigación Sanitaria

    Barakaldo, Biscay 48903
    Spain

    Active - Recruiting

  • Complejo Hospitalario Universitario A Coruña

    A Coruña, La Coruña 15006
    Spain

    Site Not Available

  • Complejo Hospitalario Universitario Insular Materno Infantil

    Las Palmas De Gran Canaria, Las Palmas 35016
    Spain

    Active - Recruiting

  • Hospital Universitario Puerta de Hierro - Majadahonda

    Majadahonda, Madrid 28222
    Spain

    Active - Recruiting

  • HC Marbella

    Marbella, Malaga 29660
    Spain

    Active - Recruiting

  • Clínica Mi Tres Torres

    Barcelona, 08017
    Spain

    Site Not Available

  • Hospital Universitari Dexeus

    Barcelona, 08028
    Spain

    Site Not Available

  • Hospital Universitari Vall d'Hebrón

    Barcelona, 08035
    Spain

    Active - Recruiting

  • Hospital Universitario Reina Sofía

    Córdoba, 14004
    Spain

    Active - Recruiting

  • Hospital Universitari de Girona Dr. Josep Trueta

    Girona, 17007
    Spain

    Active - Recruiting

  • Hospital Universitario Lucus Augusti

    Lugo, 27004
    Spain

    Active - Recruiting

  • Hospital Universitario La Paz

    Madrid, 28046
    Spain

    Active - Recruiting

  • Hospital Universitario Ramón y Cajal

    Madrid, 28034
    Spain

    Site Not Available

  • Hospital Regional Universitario de Málaga - Hospital General

    Málaga, 29011
    Spain

    Active - Recruiting

  • Hospital Universitario Virgen Macarena

    Sevilla, 41009
    Spain

    Active - Recruiting

  • The Christie NHS Foundation Trust

    Manchester, England M20 4BX
    United Kingdom

    Active - Recruiting

  • The Royal Marsden NHS Foundation Trust

    Sutton, England SM2 5PT
    United Kingdom

    Active - Recruiting

  • The Clatterbridge Cancer Centre NHS Foundation Trust

    Wirral, England CH63 4JY
    United Kingdom

    Site Not Available

  • NHS Grampian

    Aberdeen, Scotland AB25 2ZN
    United Kingdom

    Site Not Available

  • Eastern Connecticut Hematology and Oncology Associates

    Norwich, Connecticut 06360
    United States

    Active - Recruiting

  • Georgetown Lombardi Comprehensive Cancer Center

    Washington, District of Columbia 20007
    United States

    Active - Recruiting

  • Comprehensive Hematology Oncology - Bradenton Clinic

    Bradenton, Florida 34210
    United States

    Site Not Available

  • Comprehensive Hematology Oncology - Brandon Clinic

    Brandon, Florida 33511
    United States

    Site Not Available

  • Cancer Specialists of North Florida - Fleming Island

    Fleming Island, Florida 32003
    United States

    Site Not Available

  • Cancer Specialists of North Florida - Baptist South

    Jacksonville, Florida 32258
    United States

    Site Not Available

  • Cancer Specialists of North Florida - Northside

    Jacksonville, Florida 32218
    United States

    Site Not Available

  • Cancer Specialists of North Florida - Riverside

    Jacksonville, Florida 32204
    United States

    Site Not Available

  • Cancer Specialists of North Florida - Southpoint

    Jacksonville, Florida 32256-6932
    United States

    Site Not Available

  • Cancer Specialists of North Florida Southside

    Jacksonville, Florida 32207
    United States

    Site Not Available

  • Cancer Specialists of North Florida

    Jacksonville Beach, Florida 32250
    United States

    Site Not Available

  • Comprehensive Hematology Oncology - Largo Clinic

    Largo, Florida 33770
    United States

    Site Not Available

  • Cancer Specialists of North Florida - Beaches

    Neptune Beach, Florida 32266
    United States

    Site Not Available

  • Comprehensive Hematology Oncology - Palm Harbor Clinic

    Palm Harbor, Florida 34685
    United States

    Site Not Available

  • Cancer Specialists Of North Florida - St. Augustine

    Saint Augustine, Florida 32086
    United States

    Site Not Available

  • Comprehensive Hematology Oncology

    Saint Petersburg, Florida 33709
    United States

    Active - Recruiting

  • Comprehensive Hematology Oncology - Bayfront Clinic

    Saint Petersburg, Florida 33709
    United States

    Site Not Available

  • Comprehensive Hematology Oncology - Trinity Clinic

    Trinity, Florida 34655
    United States

    Site Not Available

  • University of Illinois Cancer Center

    Chicago, Illinois 60612
    United States

    Active - Recruiting

  • Alliance for Multispecialty Research (AMR) - Kansas City Oncology

    Merriam, Kansas 66204
    United States

    Site Not Available

  • Mary Bird Perkins Cancer Center - Baton Rouge

    Baton Rouge, Louisiana 70809
    United States

    Site Not Available

  • Pontchartrain Cancer Center - Covington Office

    Covington, Louisiana 70433
    United States

    Site Not Available

  • Pontchartrain Cancer Center - Hammond Office

    Hammond, Louisiana 70403-1452
    United States

    Site Not Available

  • NHO Revive Research Institute LLC

    Lincoln, Nebraska 68506
    United States

    Site Not Available

  • Nebraska Hematology-Oncology - Revive Research Institute LLC

    Lincoln, Nebraska 68506
    United States

    Active - Recruiting

  • New York Cancer & Blood Specialists - Babylon Medical Oncology

    Babylon, New York 11702
    United States

    Site Not Available

  • Optum Medical Care - Carmel/Brewster Campus

    Brewster, New York 10509
    United States

    Site Not Available

  • New York Cancer & Blood Specialists - Eastchester Cancer Care Center

    Bronx, New York 10469
    United States

    Active - Recruiting

  • Brooklyn Radiation Oncology

    Brooklyn, New York 11201
    United States

    Site Not Available

  • Optum Medical Care - Fishkill Westage Campus

    Fishkill, New York 12524
    United States

    Site Not Available

  • Clinical Research Alliance

    Lake Success, New York 11042
    United States

    Site Not Available

  • Optum Hematology Oncology - Lake Success

    Lake Success, New York 11042
    United States

    Site Not Available

  • Optum Medical Care - Mount Kisco Campus 90

    Mount Kisco, New York 10549
    United States

    Site Not Available

  • New York Cancer & Blood Specialists - New Hyde Park

    New Hyde Park, New York 11042
    United States

    Site Not Available

  • Optum Hematology Oncology - Lake Success

    New Hyde Park, New York 11042
    United States

    Site Not Available

  • New York Cancer & Blood Specialists - Cancer Center - Research Headquarters

    New York, New York 10028
    United States

    Active - Recruiting

  • New York Cancer & Blood Specialists - Central Park Medical Oncology

    New York, New York 10028
    United States

    Site Not Available

  • New York Cancer & Blood Specialists - Patchogue Medical Oncology

    Patchogue, New York 11772
    United States

    Active - Recruiting

  • New York Cancer & Blood Specialists - Port Jefferson Medical Oncology

    Port Jefferson Station, New York 11776
    United States

    Site Not Available

  • New York Cancer & Blood Specialists - Port Jefferson Station Medical Oncology

    Port Jefferson Station, New York 11776
    United States

    Site Not Available

  • Optum Medical Care - Poughkeepsie

    Poughkeepsie, New York 12601
    United States

    Site Not Available

  • Brooklyn Radiation Oncology

    Richmond Hill, New York 11418
    United States

    Site Not Available

  • New York Cancer & Blood Specialists - Riverhead Medical Oncology

    Riverhead, New York 11901
    United States

    Site Not Available

  • New York Cancer & Blood Specialists - Research Headquarters

    Shirley, New York 11967
    United States

    Site Not Available

  • Bon Secours Hematology and Oncology

    Greenville, South Carolina 29607
    United States

    Site Not Available

  • Tennessee Oncology - Chattanooga - Downtown

    Chattanooga, Tennessee 37403
    United States

    Site Not Available

  • Tennessee Oncology - Chattanooga - GHCR Site I

    Chattanooga, Tennessee 37403
    United States

    Site Not Available

  • Tennessee Oncology - Chattanooga - Medical Park II

    Chattanooga, Tennessee 36404
    United States

    Site Not Available

  • Tennessee Oncology - Chattanooga - Memorial Plaza

    Chattanooga, Tennessee 37404
    United States

    Site Not Available

  • Tennessee Oncology - Cleveland Clinic

    Cleveland, Tennessee 37311
    United States

    Site Not Available

  • Tennessee Oncology - Cookeville Clinic

    Cookeville, Tennessee 38501
    United States

    Site Not Available

  • Tennessee Oncology - Dickson Clinic

    Dickson, Tennessee 37055
    United States

    Site Not Available

  • Tennessee Oncology - Franklin Clinic

    Franklin, Tennessee 37067
    United States

    Site Not Available

  • Tennessee Oncology - Gallatin Clinic

    Gallatin, Tennessee 37066
    United States

    Site Not Available

  • Tennessee Oncology - Hendersonville Clinic

    Hendersonville, Tennessee 37075
    United States

    Site Not Available

  • Tennessee Oncology - Hermitage - Summit Clinic

    Hermitage, Tennessee 37076
    United States

    Site Not Available

  • Tennessee Oncology - Lebanon Clinic

    Lebanon, Tennessee 37090
    United States

    Site Not Available

  • Tennessee Oncology - Murfreesboro Clinic

    Murfreesboro, Tennessee 37129
    United States

    Site Not Available

  • Greco-Hainsworth Tennessee Oncology Centers for Research (GHCR) - Corporate

    Nashville, Tennessee 37232
    United States

    Active - Recruiting

  • Tennessee Oncology - Nashville - Centennial Center for Blood Cancers Clinic

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • Tennessee Oncology - Nashville - Centennial Clinic - Medical Oncology

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • Tennessee Oncology - Nashville - Midtown Center for Blood Cancers

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • Tennessee Oncology - Nashville - Skyline Clinic

    Nashville, Tennessee 37207
    United States

    Site Not Available

  • Tennessee Oncology - Nashville - Southern Hills Clinic

    Nashville, Tennessee 37211
    United States

    Site Not Available

  • Tennessee Oncology - Nashville - St. Thomas Midtown Clinic

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • Tennessee Oncology - Nashville - St. Thomas West Clinic

    Nashville, Tennessee 37205
    United States

    Site Not Available

  • Tennessee Oncology - Shelbyville Clinic

    Shelbyville, Tennessee 37160
    United States

    Active - Recruiting

  • Tennessee Oncology - Smyrna Clinic

    Smyrna, Tennessee 37167
    United States

    Site Not Available

  • Northwest Medical Specialties - Tacoma

    Tacoma, Washington 98405
    United States

    Site Not Available

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