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Trial of Therapeutic Cancer Vaccine OSE2101 in Patients With Non-Small Cell Lung Cancer and Secondary Resistance to Immune Checkpoint Inhibitor
Sponsor: OSE Immunotherapeutics
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).
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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
363
Start Date
2024-12-03
Completion Date
2028-12-15
Last Updated
2026-10-02
Healthy Volunteers
No
Conditions
Interventions
OSE2101
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
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
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.
Locations (207)
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