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NCT06472245PHASE3Recruiting

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

OSE Immunotherapeutics

Start Date

12/3/2024

Completion Date

12/15/2028

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

Age Range: 18 years to No maximum

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.

Interventions

DRUG

OSE2101

DRUG

Docetaxel

DEVICE

NGS HLAA2 assay

Interested in This Trial?

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Conditions

Patients With Non-Small Cell Lung Cancer

Locations

Clinical Research Advisors, LLC

Beverly Hills, California 90211

United States

Clinical Research Advisors - Encino

Encino, California 90211

United States

Clinical Research Advisors - West Hollywood

Los Angeles, California 90048

United States

Clinical Research Advisors - Korea Town

Los Angeles, California 90211

United States

SCL Health - Saint Joseph Hospital Cancer Center

Littleton, Colorado 80218

United States

Lutheran Medical Center - Cancer Centers of Colorado

Wheat Ridge, Colorado 80033-6013

United States

Eastern Connecticut Hematology and Oncology Associates

Norwich, Connecticut 06360

United States

Georgetown Lombardi Comprehensive Cancer Center

Washington D.C., District of Columbia 20007

United States

Comprehensive Hematology Oncology - Bradenton Clinic

Bradenton, Florida 34210

United States

Comprehensive Hematology Oncology - Brandon Clinic

Brandon, Florida 33511

United States

Cancer Specialists of North Florida - Fleming Island

Fleming Island, Florida 32003

United States

Cancer Specialists of North Florida - Riverside

Jacksonville, Florida 32204

United States

Cancer Specialists of North Florida Southside

Jacksonville, Florida 32207

United States

Cancer Specialists of North Florida - Northside

Jacksonville, Florida 32218

United States

Cancer Specialists of North Florida - Southpoint

Jacksonville, Florida 32256-6932

United States

Cancer Specialists of North Florida - Baptist South

Jacksonville, Florida 32258

United States

Cancer Specialists of North Florida

Jacksonville Beach, Florida 32250

United States

Comprehensive Hematology Oncology - Largo Clinic

Largo, Florida 33770

United States

Cancer Specialists of North Florida - Beaches

Neptune Beach, Florida 32266

United States

Comprehensive Hematology Oncology - Palm Harbor Clinic

Palm Harbor, Florida 34685

United States

Cancer Specialists Of North Florida - St. Augustine

Saint Augustine, Florida 32086

United States

Comprehensive Hematology Oncology - Bayfront Clinic

St. Petersburg, Florida 33709

United States

Comprehensive Hematology Oncology

St. Petersburg, Florida 33709

United States

Comprehensive Hematology Oncology - Trinity Clinic

Trinity, Florida 34655

United States

University of Illinois Cancer Center

Chicago, Illinois 60612

United States

Alliance for Multispecialty Research (AMR) - Kansas City Oncology

Merriam, Kansas 66204

United States

Mary Bird Perkins Cancer Center - Baton Rouge

Baton Rouge, Louisiana 70809

United States

Pontchartrain Cancer Center - Covington Office

Covington, Louisiana 70433

United States

Pontchartrain Cancer Center - Hammond Office

Hammond, Louisiana 70403-1452

United States

Ascension Saint Agnes Hospital

Baltimore, Maryland 21229

United States

University of Massachusetts Memorial Medical Center

Worcester, Massachusetts 01655

United States

Nebraska Hematology-Oncology - Revive Research Institute LLC

Lincoln, Nebraska 68506

United States

New York Cancer & Blood Specialists - Babylon Medical Oncology

Babylon, New York 11702

United States

Optum Medical Care - Carmel/Brewster Campus

Brewster, New York 10509

United States

Brooklyn Radiation Oncology

Brooklyn, New York 11201

United States

Optum Medical Care - Fishkill Westage Campus

Fishkill, New York 12524

United States

Clinical Research Alliance

Lake Success, New York 11042

United States

Optum Medical Care - Mount Kisco Campus 90

Mount Kisco, New York 10549

United States

New York Cancer & Blood Specialists - New Hyde Park

New Hyde Park, New York 11042

United States

Optum Hematology Oncology - Lake Success

New Hyde Park, New York 11042

United States

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

New York, New York 10028

United States

New York Cancer & Blood Specialists - Central Park Medical Oncology

New York, New York 10028

United States

New York Cancer & Blood Specialists - Patchogue Medical Oncology

Patchogue, New York 11772

United States

New York Cancer & Blood Specialists - Port Jefferson Medical Oncology

Port Jefferson Station, New York 11776

United States

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

Port Jefferson Station, New York 11776

United States

Optum Medical Care - Poughkeepsie

Poughkeepsie, New York 12601

United States

New York Cancer & Blood Specialists - Eastchester Cancer Care Center

The Bronx, New York 10469

United States

New York Cancer & Blood Specialists - Riverhead Medical Oncology

The Bronx, New York 10469

United States

Mercy Health - Perrysburg Cancer Center

Perrysburg, Ohio 43551

United States

Mercy Health - St. Anne Cancer Center

Toledo, Ohio 43623

United States

Bon Secours Hematology and Oncology

Greenville, South Carolina 29607

United States

Tennessee Oncology - Chattanooga - Medical Park II

Chattanooga, Tennessee 36404

United States

Tennessee Oncology - Chattanooga - Downtown

Chattanooga, Tennessee 37403

United States

Tennessee Oncology - Chattanooga - GHCR Site I

Chattanooga, Tennessee 37403

United States

Tennessee Oncology - Chattanooga - Memorial Plaza

Chattanooga, Tennessee 37404

United States

Tennessee Oncology - Cleveland Clinic

Cleveland, Tennessee 37311

United States

Tennessee Oncology - Cookeville Clinic

Cookeville, Tennessee 38501

United States

Tennessee Oncology - Dickson Clinic

Dickson, Tennessee 37055

United States

Tennessee Oncology - Franklin Clinic

Franklin, Tennessee 37067

United States

Tennessee Oncology - Gallatin Clinic

Gallatin, Tennessee 37066

United States

Tennessee Oncology - Hendersonville Clinic

Hendersonville, Tennessee 37075

United States

Tennessee Oncology - Hermitage - Summit Clinic

Hermitage, Tennessee 37076

United States

Tennessee Oncology - Lebanon Clinic

Lebanon, Tennessee 37090

United States

Tennessee Oncology - Murfreesboro Clinic

Murfreesboro, Tennessee 37129

United States

Tennessee Oncology - Nashville - Centennial Center for Blood Cancers Clinic

Nashville, Tennessee 37203

United States

Tennessee Oncology - Nashville - Centennial Clinic - Medical Oncology

Nashville, Tennessee 37203

United States

Tennessee Oncology - Nashville - Midtown Center for Blood Cancers

Nashville, Tennessee 37203

United States

Tennessee Oncology - Nashville - St. Thomas Midtown Clinic

Nashville, Tennessee 37203

United States

Tennessee Oncology - Nashville - St. Thomas West Clinic

Nashville, Tennessee 37205

United States

Tennessee Oncology - Nashville - Skyline Clinic

Nashville, Tennessee 37207

United States

Tennessee Oncology - Nashville - Southern Hills Clinic

Nashville, Tennessee 37211

United States

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

Nashville, Tennessee 37232

United States

Tennessee Oncology - Shelbyville Clinic

Shelbyville, Tennessee 37160

United States

Tennessee Oncology - Smyrna Clinic

Smyrna, Tennessee 37167

United States

Northwest Medical Specialties - Bonney Lake

Bonney Lake, Washington 98391

United States

Northwest Medical Specialties - Federal Way

Federal Way, Washington 98003

United States

Northwest Medical Specialties - Gig Harbor

Gig Harbor, Washington 98332

United States

Northwest Medical Specialties - Puyallup Medical Oncology

Puyallup, Washington 98373

United States

Northwest Medical Specialties - Tacoma

Tacoma, Washington 98405

United States

Algemeen Ziekenhuis Klina

Brasschaat, Antwerpen 2930

Belgium

Universitair Ziekenhuis Leuven - Campus Gasthuisberg

Leuven, Flemish Brabant 3000

Belgium

Jessa Ziekenhuis - Campus Virga Jesse

Hasselt, Limburg 3500

Belgium

Algemeen Ziekenhuis Maria Middelares

Ghent, Oost-Vlaaderen 9000

Belgium

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

Namur, Wallonia B-5000

Belgium

Algemeen Ziekenhuis Groeninge - Campus Kennedylaan

Kortrijk, West-Vlaanderen 8500

Belgium

Algemeen Ziekenhuis Delta - Campus Rembert Torhout

Roeselare, West-Vlaanderen 8800

Belgium

Algemeen Ziekenhuis Delta - Campus Rumbeke

Roeselare, West-Vlaanderen 8800

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 G7H 5H6

Canada

McGill University Health Centre

Montreal, Quebec H4A 3J1

Canada

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

Rimouski, Quebec G5L 5T1

Canada

Hôpital d'Instruction des Armées Sainte-Anne

Toulon, Alpes-de-Haute-Provence 83800

France

Nouvel Hôpital Civil

Strasbourg, Alsace 67091

France

Hôpital Louis Pradel

Bron, Auvergne-Rhône-Alpes 69500

France

Centre Hospitalier Lyon-Sud

Lyon, Auvergne-Rhône-Alpes 69317

France

Hôpital de la Croix Rousse

Lyon, Auvergne-Rhône-Alpes 69317

France

Institut Paoli-Calmettes

Marseille, Bouches-du-Rhône 13273

France

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

Besançon, Doubs 25030

France

Centre Hospitalier Regional Universitaire Brest - Hopital de la Cavale Blanche

Brest, Finistère 29200

France

Hôpital Emile Muller

Mulhouse, Grand Est 68100

France

Centre Hospitalier Régional Universitaire de Nancy

Nancy, Grand Est 54035

France

Centre Hospitalier Universitaire Dupuytren 1

Limoges, Haute-Vienne 87000

France

Hôpital Arnaud de Villeneuve

Montpellier, Hérault 34295

France

Hôpital Pontchaillou

Rennes, Ille-et-Vilaine 35033

France

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

Saint-Herblain, Loire-Atlantique 44805

France

Centre Hospitalier (Ch) De Cholet

Cholet, Maine-et-Loire 49325

France

Hôpital Larrey

Toulouse, Midi-pyrenees 31059

France

Hôpital Haut-Lévêque

Pessac, New Aquitaine 33604

France

Hôpital Nord de Marseille

Marseille, Provence-Alpes-Côte d'Azur Region 13015

France

Centre Hospitalier de la Côte Basque

Bayonne, Pyrénées-Atlantiques 64109

France

Hôpital Michallon

La Tronche, Rhône 38700

France

Gustave Roussy

Villejuif, Val-de-Marne 94805

France

Institut Sainte Catherine

Avignon, Vaucluse 84000

France

Centre Hospitalier Universitaire de Poitiers

Poitiers, Vienne 86021

France

Centre Hospitalier Départemental Vendée

La Roche-sur-Yon, 85000

France

Centre Hospitalier Le Mans

Le Mans, 72037

France

Centre Hospitalier Universitaire De Nantes - Hôpital Nord Laennec

Nantes, 44093

France

Hôpital Avicenne

Bobigny, Île-de-France Region 93000

France

Centre Hospitalier Intercommunal de Créteil

Créteil, Île-de-France Region 94000

France

Groupe Hospitalier Paris Saint-Joseph

Paris, Île-de-France Region 75014

France

Hôpital Cochin

Paris, Île-de-France Region 75014

France

Hôpital Tenon

Paris, Île-de-France Region 75020

France

Thoraxklinik-Heidelberg

Heidelberg, Baden-Wurttemberg 69126

Germany

Robert-Bosch-Krankenhaus

Stuttgart, Baden-Wurttemberg 70376

Germany

Asklepios Fachkliniken München-Gauting

Gauting, Bavaria 82131

Germany

München Klinik Bogenhausen

München, Bavaria 81925

Germany

Klinikum Kassel

Kassel, Hesse 34125

Germany

Universitätsklinikum Aachen

Aachen, North Rhine-Westphalia 52074

Germany

Universitätsklinikum Bonn

Bonn, North Rhine-Westphalia 53127

Germany

Universitätsklinikum Essen

Essen, North Rhine-Westphalia 45147

Germany

Universitätsklinikum Gießen und Marburg - Gießen

Homburg, Saarland 66421

Germany

Krankenhaus Martha-Maria Halle-Dölau

Halle, Saxony-Anhalt 06120

Germany

LungenClinic Grosshansdorf

Großhansdorf, Schleswig-Holstein 22927

Germany

Charité - Universitätsmedizin Berlin

Berlin, 13353

Germany

Metropolitan Hospital

Piraeus, Athens 185 47

Greece

Saint Savvas Anticancer - Oncological Hospital of Athens

Athens, Attica 11522

Greece

Henry Dunant Hospital Center

Athens, Attica 11526

Greece

General Hospital for Thoracic Diseases Sotiria

Athens, Attica 11527

Greece

Agii Anargiri Cancer Hospital

Nea Kifissia, Attica 14564

Greece

Clinic Agios Loukas

Thessaloniki, Central Macedonia 55236

Greece

University General Hospital of Heraklion (PAGNI)

Heraklion, Crete 711 10

Greece

General Hospital of Thessaloniki Papageorgiou

Thessaloniki, Macedoni TK 56403

Greece

University General Hospital of Patras

Patra, Peloponnese 26504

Greece

Theagenio Anti-Cancer Hospital of Thessaloniki

Thessaloniki, Thessaloniki 546 39

Greece

University General Hospital of Larissa

Larissa, Thessaly 411 10

Greece

Mátrai Gyógyintézet

Gyöngyös, Heves County 3200

Hungary

Országos Korányi Pulmonológiai Intézet

Budapest, 1121

Hungary

Clinexpert Kft. telephelye, Bugát Pál Kórház - Phase I. Clinical Trial Site

Gyöngyös, 3200

Hungary

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

Meldola, Forlì-Cesena 47014

Italy

Presidio Ospedaliero di Lucca

San Filippo, Lucca 55100

Italy

Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Istituto Clinico Humanitas

Rozzano, Milan 20089

Italy

Azienda Ospedaliera Universitaria - Università degli Studi della Campania Luigi Vanvitelli

Naples, Naples 80131

Italy

Azienda Ospedaliero - Universitaria San Luigi Gonzaga

Orbassano, Torino 10043

Italy

Ospedale P. Pederzoli - Casa di Cura Privata S.p.A.

Legnago, Verona 37045

Italy

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

Genova, 16132

Italy

Ospedale Vito Fazzi Lecce

Lecce, 73100

Italy

Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San Raffaele

Milan, 20132

Italy

Fondazione IRCCS - Istituto Nazionale dei Tumori

Milan, 20133

Italy

Azienda Ospedaliero-Universitaria Maggiore della Carità di Novara

Novara, 28100

Italy

Ospedale Busonera - Istituto Oncologico Veneto (IOV) - Padua

Padova, 35128

Italy

Azienda Ospedaliero-Universitaria Pisana

Pisa, 56126

Italy

Azienda Unità Sanitaria Locale della Romagna - Ospedale Infermi di Rimini

Rimini, 47923

Italy

IRCCS Istituto Nazionale Tumori Regina Elena

Roma, 00144

Italy

Azienda Ospedaliera San Camillo Forlanini

Rome, 00152

Italy

Azienda Ospedaliera Universitaria Senese - L'ospedale Santa Maria alle Scotte

Siena, 53100

Italy

Radboud Universitair Medisch Centrum

Nijmegen, Gelderland 6525 GA

Netherlands

Erasmus Medisch Centrum

Rotterdam, South Holland 3015 GD

Netherlands

Universitair Medisch Centrum Groningen

Groningen, 9713 GZ

Netherlands

Przychodnia Lekarska KOMED Roman Karaszewski

Konin, Greater Poland Voivodeship 62-500

Poland

Wielkopolskie Centrum Pulmonologii i Torakochirurgii im. Eugenii i Janusza Zeylandów

Poznan, Greater Poland Voivodeship 60-569

Poland

Centrum Onkologii Im. Prof. F. Łukaszczyka w Bydgoszczy

Bydgoszcz, Kuyavian-Pomeranian Voivodeship 85-796

Poland

Uniwersytecki Szpital Kliniczny Nr 4 w Lublinie

Lublin, Lublin Voivodeship 20-090

Poland

Instytut Centrum Zdrowia Matki Polki

Lodz, Lódzkie 93-338

Poland

Uniwersyteckie Centrum Kliniczne w Gdańsku

Gdansk, Pomeranian Voivodeship 80-210

Poland

Unidade Local de Saúde de Coimbra

Coimbra, 3000-075

Portugal

Hospital CUF Descobertas

Lisbon, 1769-001

Portugal

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

Lisbon, 1769-001

Portugal

Hospital CUF Porto

Porto, 14341

Portugal

Unidade Local de Saúde de Gaia/Espinho, E. P. E

Vila Nova de Gaia, 4434-502

Portugal

Institutul Oncologic Prof. Dr. Ion Chiricuta

Cluj-Napoca, Cluj 400015

Romania

Centrul de Oncologie Sf Nectarie

Craiova, Dolj 200746

Romania

SC OncoMed SRL

Timișoara, Timiș County 300239

Romania

Hospital Son Llàtzer

Palma de Mallorca, Balearic Islands 07198

Spain

Hospital Germans Trias i Pujol

Badalona, Barcelona 08916

Spain

Institut Català d'Oncologia - Hospital Duran i Reynals (ICO L'Hospitalet)

L'Hospitalet de Llobregat, Barcelona 08907

Spain

Biocruces Bizkaia Instituto de Investigación Sanitaria

Barakaldo, Biscay 48903

Spain

Complejo Hospitalario Universitario A Coruña

A Coruña, La Coruña 15006

Spain

Complejo Hospitalario Universitario Insular Materno Infantil

Las Palmas de Gran Canaria, Las Palmas 35016

Spain

Hospital Universitario Puerta de Hierro - Majadahonda

Majadahonda, Madrid 28222

Spain

HC Marbella

Marbella, Malaga 29660

Spain

Clínica Mi Tres Torres

Barcelona, 08017

Spain

Hospital Universitari Dexeus

Barcelona, 08028

Spain

Hospital Universitari Vall d'Hebrón

Barcelona, 08035

Spain

Hospital Clinic de Barcelona

Barcelona, 08036

Spain

Hospital Universitario Reina Sofía

Córdoba, 14004

Spain

Hospital Universitari de Girona Dr. Josep Trueta

Girona, 17007

Spain

Hospital Universitario Lucus Augusti

Lugo, 27004

Spain

Hospital General Universitario Gregorio Marañón

Madrid, 28007

Spain

Hospital Universitario Ramón y Cajal

Madrid, 28034

Spain

Hospital Universitario La Paz

Madrid, 28046

Spain

Hospital Regional Universitario de Málaga - Hospital General

Málaga, 29011

Spain

Hospital Universitario Virgen Macarena

Seville, 41009

Spain

University Hospitals of Leicester NHS Trust

Leicester, England LE2 9LX

United Kingdom

The Christie NHS Foundation Trust

Manchester, England M20 4BX

United Kingdom

The Clatterbridge Cancer Centre NHS Foundation Trust

Metropolitan Borough of Wirral, England CH63 4JY

United Kingdom

The Royal Marsden NHS Foundation Trust

Sutton, England SM2 5PT

United Kingdom

NHS Grampian

Aberdeen, Scotland AB25 2ZN

United Kingdom