Trial of Therapeutic Cancer Vaccine OSE2101 in Patients With Non-Small Cell Lung Cancer and Secondary Resistance to Immune Checkpoint Inhibitor
- Conditions
- Patients With Non-Small Cell Lung Cancer
- Interventions
- Registration Number
- NCT06472245
- Lead Sponsor
- OSE Immunotherapeutics
- Brief 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 363
- Male or female, aged ≥ 18 years
- Patients expressing HLA-A2 phenotype in blood by pre-screening central laboratory
- 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
- Patients with secondary resistance to ICI;
Other inclusion and exclusion criteria will apply per protocol.
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm A: OSE2101 NGS HLAA2 assay Unit dose: 1 mL corresponding to a total of 5 mg of the combination of peptides Mode/Route: Subcutaneous injection Regimen: One injection every three weeks for six cycles, then every eight weeks for the remainder of year one and, finally every twelve weeks until the end of second year. Arm B: Docetaxel NGS HLAA2 assay Unit dose: 75 mg/m2 Mode/Route: Intravenous infusion over 1 hour Regimen: One infusion every three weeks. GenDx CDx Tedopi NGS HLAA2 assay System of qualitative companion diagnostic devices, consisting of a polymerase chain reaction (PCR) assay Amp-HLA-A-CDx Tedopi, a DNA library preparation assay, LFK-CDx Tedopi and the software NGSengine-CDx Tedopi. Arm A: OSE2101 OSE2101 Unit dose: 1 mL corresponding to a total of 5 mg of the combination of peptides Mode/Route: Subcutaneous injection Regimen: One injection every three weeks for six cycles, then every eight weeks for the remainder of year one and, finally every twelve weeks until the end of second year. Arm B: Docetaxel Docetaxel Unit dose: 75 mg/m2 Mode/Route: Intravenous infusion over 1 hour Regimen: One infusion every three weeks.
- Primary Outcome Measures
Name Time Method OS defined as time from randomization to death From randomization date through study completion, an average of 3 years OS defined as time from randomization to death of any cause, censored until the data analysis cut-off date
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (205)
Hôpital Michallon
🇫🇷La Tronche, Rhône, France
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
Ascension Saint Agnes Hospital
🇺🇸Baltimore, Maryland, United States
University of Massachusetts Memorial Medical Center
🇺🇸Worcester, Massachusetts, United States
Mercy Health - Perrysburg Cancer Center
🇺🇸Perrysburg, Ohio, United States
Mercy Health - St. Anne Cancer Center
🇺🇸Toledo, Ohio, 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
Jessa Ziekenhuis - Campus Virga Jesse
🇧🇪Hasselt, Limburg, Belgium
Centre Intégré Universitaire de Santé et de Services Sociaux du Saguenay - Lac-Saint-Jean
🇨🇦Chicoutimi, Quebec, Canada
McGill University Health Centre
🇨🇦Montréal, Quebec, Canada
Hôpital Louis Pradel
🇫🇷Bron, Rhone-Alpes, France
Hôpital de la Croix Rousse
🇫🇷Lyon, Rhone-Alpes, France
Institut Sainte Catherine
🇫🇷Avignon, Vaucluse, France
Groupe Hospitalier Paris Saint-Joseph
🇫🇷Paris, Île-de-France, France
Hôpital Cochin
🇫🇷Paris, Île-de-France, France
Robert-Bosch-Krankenhaus
🇩🇪Stuttgart, Bade-Wurtemberg, Germany
Thoraxklinik-Heidelberg
🇩🇪Heidelberg, Baden-Wuerttemberg, Germany
Asklepios Fachkliniken München-Gauting
🇩🇪Gauting, Bayern, Germany
München Klinik Bogenhausen
🇩🇪München, Bayern, Germany
Klinikum Kassel
🇩🇪Kassel, Hessen, Germany
Universitätsklinikum Aachen
🇩🇪Aachen, Nordrhein-Westfalen, Germany
Universitätsklinikum Bonn
🇩🇪Bonn, Nordrhein-Westfalen, Germany
Universitätsklinikum Essen
🇩🇪Essen, Nordrhein-Westfalen, Germany
Universitätsklinikum Gießen und Marburg - Gießen
🇩🇪Homburg, Saarland, Germany
LungenClinic Grosshansdorf
🇩🇪Grosshansdorf, Schleswig-Holstein, Germany
Krankenhaus Martha-Maria Halle-Dölau
🇩🇪Halle, Sachsen-Anhalt, Germany
Charité - Universitätsmedizin Berlin
🇩🇪Berlin, Germany
Metropolitan Hospital
🇬🇷Piraeus, Athens, Greece
Henry Dunant Hospital Center
🇬🇷Athens, Attica, Greece
University General Hospital of Patras
🇬🇷Patra, Peloponnese, Greece
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
🇮🇹Napoli, Naples, Italy
Ospedale P. Pederzoli - Casa di Cura Privata S.p.A.
🇮🇹Legnago, Verona, 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
Ospedale Busonera - Istituto Oncologico Veneto (IOV) - Padua
🇮🇹Padova, Italy
Azienda Ospedaliera San Camillo Forlanini
🇮🇹Rome, Italy
Azienda Ospedaliera Universitaria Senese - L'ospedale Santa Maria alle Scotte
🇮🇹Siena, Italy
Universitair Medisch Centrum Groningen
🇳🇱Groningen, Netherlands
Wielkopolskie Centrum Pulmonologii i Torakochirurgii im. Eugenii i Janusza Zeylandów
🇵🇱Poznan, Wielkopolskie, Poland
Hospital CUF Porto
🇵🇹Porto, Portugal
Unidade Local de Saúde de Coimbra
🇵🇹Coimbra, Portugal
Gustave Roussy
🇫🇷Villejuif, Val-de-Marne, France
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
Institut Català d'Oncologia - Hospital Duran i Reynals (ICO L'Hospitalet)
🇪🇸L'Hospitalet De Llobregat, Barcelona, Spain
Hospital Clinic de Barcelona
🇪🇸Barcelona, Spain
Hospital General Universitario Gregorio Marañón
🇪🇸Madrid, Spain
Comprehensive Hematology Oncology - Brandon Clinic
🇺🇸Brandon, Florida, United States
University Hospitals of Leicester NHS Trust
🇬🇧Leicester, England, United Kingdom
Eastern Connecticut Hematology and Oncology Associates
🇺🇸Norwich, Connecticut, United States
Georgetown Lombardi Comprehensive Cancer Center
🇺🇸Washington, District of Columbia, United States
Comprehensive Hematology Oncology - Bradenton Clinic
🇺🇸Bradenton, Florida, United States
Cancer Specialists of North Florida - Fleming Island
🇺🇸Fleming Island, Florida, United States
Cancer Specialists of North Florida
🇺🇸Jacksonville Beach, 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
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
🇺🇸Saint Petersburg, Florida, United States
Comprehensive Hematology Oncology
🇺🇸Saint 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
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
New York Cancer & Blood Specialists - Eastchester Cancer Care Center
🇺🇸Bronx, New York, United States
New York Cancer & Blood Specialists - Riverhead Medical Oncology
🇺🇸Bronx, 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
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 - Tacoma
🇺🇸Tacoma, Washington, United States
Algemeen Ziekenhuis Klina
🇧🇪Brasschaat, Antwerpen, Belgium
Universitair Ziekenhuis Leuven - Campus Gasthuisberg
🇧🇪Leuven, Flemish Brabant, Belgium
Algemeen Ziekenhuis Maria Middelares
🇧🇪Gent, 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
Centre Hospitalier Régional et Universitaire de Besançon - Hôpital Jean-Minjoz
🇫🇷Besançon Cedex, Doubs, France
Algemeen Ziekenhuis Delta - Campus Rumbeke
🇧🇪Roeselare, West-Vlaanderen, Belgium
Algemeen Ziekenhuis Delta - Campus Menen
🇧🇪Roeselare, West-Vlaanderen, Belgium
Centre Intégré de Santé et de Services Sociaux du Bas-Saint-Laurent
🇨🇦Rimouski, Quebec, Canada
Nouvel Hôpital Civil
🇫🇷Strasbourg cedex, Alsace, France
Centre Hospitalier Regional Universitaire Brest - Hopital de la Cavale Blanche
🇫🇷Brest, Finistère, France
Hôpital d'Instruction des Armées Sainte-Anne
🇫🇷Toulon Cedex 9, Alpes-de-Haute-Provence, France
Institut Paoli-Calmettes
🇫🇷Marseille cedex 9, Bouches-du-Rhône, France
Hôpital Emile Muller
🇫🇷Mulhouse, Grand Est, France
Centre Hospitalier Universitaire Dupuytren 1
🇫🇷Limoges, Haute-Vienne, France
Centre Hospitalier Intercommunal de Créteil
🇫🇷Créteil, Ile-De-France, France
Centre Hospitalier (Ch) De Cholet
🇫🇷Cholet, Maine-et-Loire, France
Hôpital Arnaud de Villeneuve
🇫🇷Montpellier, Hérault, France
Hôpital Avicenne
🇫🇷Bobigny, Ile-de-France, France
Hôpital Tenon
🇫🇷Paris, Ile-de-France, France
Hôpital Larrey
🇫🇷Toulouse cedex 9, Midi-pyrenees, France
Hôpital Nord de Marseille
🇫🇷Marseille, Provence Alpes Cote d´Azur, France
Centre Hospitalier de la Côte Basque
🇫🇷Bayonne, Pyrénées-Atlantiques, France
Hôpital Pontchaillou
🇫🇷Rennes cedex 9, Ille-et-Vilaine, France
Institut de Cancérologie de l'Ouest - Saint-Herblain - Site René Gauducheau
🇫🇷Saint-Herblain, Loire-Atlantique, France
Centre Hospitalier Lyon-Sud
🇫🇷Lyon, Rhone-alpes, 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
Saint Savvas Anticancer - Oncological Hospital of Athens
🇬🇷Athens, Attica, Greece
General Hospital for Thoracic Diseases Sotiria
🇬🇷Athens, Attica, Greece
Agii Anargiri Cancer Hospital
🇬🇷Néa Kifisiá, Attica, Greece
University General Hospital of Heraklion (PAGNI)
🇬🇷Heraklion, Crete, Greece
General Hospital of Thessaloniki Papageorgiou
🇬🇷Thessaloniki, Macedoni, Greece
Theagenio Anti-Cancer Hospital of Thessaloniki
🇬🇷Thessaloníki, Thessaloniki, Greece
University General Hospital of Larissa
🇬🇷Larissa, Thessaly, Greece
Mátrai Gyógyintézet
🇭🇺Gyöngyös, Heves, Hungary
Clinic Agios Loukas
🇬🇷Thessaloniki, Central Macedonia, Greece
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
Azienda Ospedaliero - Universitaria San Luigi Gonzaga
🇮🇹Orbassano, Torino, Italy
Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale Policlinico San Martino
🇮🇹Genova, Italy
Azienda Ospedaliero-Universitaria Maggiore della Carità di Novara
🇮🇹Novara, 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
Radboud Universitair Medisch Centrum
🇳🇱Nijmegen, Gelderland, Netherlands
Erasmus Medisch Centrum
🇳🇱Rotterdam, Zuid-Holland, Netherlands
Centrum Onkologii Im. Prof. F. Łukaszczyka w Bydgoszczy
🇵🇱Bydgoszcz, Kujawsko-pomorskie, Poland
Uniwersytecki Szpital Kliniczny Nr 4 w Lublinie
🇵🇱Lublin, Lubelskie, Poland
Instytut Centrum Zdrowia Matki Polki
🇵🇱Łódź, Lódzkie, Poland
Uniwersyteckie Centrum Kliniczne w Gdańsku
🇵🇱Gdańsk, Pomorskie, Poland
Przychodnia Lekarska KOMED Roman Karaszewski
🇵🇱Konin, Wielkopolskie, Poland
Hospital CUF Descobertas
🇵🇹Lisboa, Portugal
Unidade Local de Saúde de Santa Maria, E. P. E. - Hospital Pulido Valente
🇵🇹Lisboa, Portugal
Centrul de Oncologie Sf Nectarie
🇷🇴Craiova, Dolj, Romania
SC OncoMed SRL
🇷🇴Timisoara, Timis, Romania
Hospital Son Llàtzer
🇪🇸Palma De Mallorca, Balearic Islands, Spain
Hospital Germans Trias i Pujol
🇪🇸Badalona, 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 Universitario Reina Sofía
🇪🇸Córdoba, Spain
Hospital Universitari de Girona Dr. Josep Trueta
🇪🇸Girona, Spain
Hospital Universitario Lucus Augusti
🇪🇸Lugo, 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
🇪🇸Sevilla, Spain
The Christie NHS Foundation Trust
🇬🇧Manchester, England, United Kingdom
The Royal Marsden NHS Foundation Trust
🇬🇧Sutton, England, United Kingdom
The Clatterbridge Cancer Centre NHS Foundation Trust
🇬🇧Wirral, England, United Kingdom
NHS Grampian
🇬🇧Aberdeen, Scotland, United Kingdom