AzTrials
AzTrials

Patients With Non-Small Cell Lung CancerPhase 3ARTEMIANCT06472245

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

A Phase 3 study testing OSE2101, Docetaxel and NGS HLAA2 assay in people with Patients With Non-Small Cell Lung Cancer, run by OSE Immunotherapeutics at 207 sites in 14 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Patients With Non-Small Cell Lung Cancer
What is being tested?
OSE2101, Docetaxel and NGS HLAA2 assay
Could I receive a placebo?
No, everyone receives an active treatment
How many people
363 participants
Where
207 sitesin 14 countries
Study dates
3 Dec 2024to 15 Dec 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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; 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.
  • Patients with secondary resistance to ICI;
  • Other inclusion and exclusion criteria will apply per protocol.

Who cannot join

None listed.

Trial locations and contacts

207 sites in 14 countries. Contact the study team or a site near you to ask about taking part.

Caroline Chevalier, MSc, MPH contact

+33 630 842 002

caroline.chevalier@ose-immuno.com

Bérangère Vasseur, MD contact

+33 676 448 160

berangere.vasseur@ose-immuno.com

207 sites in 14 countries

United States79 sites, 35 recruiting

  • New York Cancer & Blood Specialists - Babylon Medical Oncology

    Babylon, New York, 11702

    Active, not recruiting

  • Ascension Saint Agnes Hospital

    Baltimore, Maryland, 21229

    Recruiting

  • Mary Bird Perkins Cancer Center - Baton Rouge

    Baton Rouge, Louisiana, 70809

    Active, not recruiting

  • Clinical Research Advisors, LLC

    Beverly Hills, California, 90211

    Recruiting

  • Northwest Medical Specialties - Bonney Lake

    Bonney Lake, Washington, 98391

    Active, not recruiting

  • Comprehensive Hematology Oncology - Bradenton Clinic

    Bradenton, Florida, 34210

    Active, not recruiting

  • Comprehensive Hematology Oncology - Brandon Clinic

    Brandon, Florida, 33511

    Active, not recruiting

  • Optum Medical Care - Carmel/Brewster Campus

    Brewster, New York, 10509

    Terminated

  • Brooklyn Radiation Oncology

    Brooklyn, New York, 11201

    Terminated

  • Tennessee Oncology - Chattanooga - Medical Park II

    Chattanooga, Tennessee, 36404

    Active, not recruiting

  • Tennessee Oncology - Chattanooga - Downtown

    Chattanooga, Tennessee, 37403

    Recruiting

  • Tennessee Oncology - Chattanooga - GHCR Site I

    Chattanooga, Tennessee, 37403

    Recruiting

  • Tennessee Oncology - Chattanooga - Memorial Plaza

    Chattanooga, Tennessee, 37404

    Recruiting

  • University of Illinois Cancer Center

    Chicago, Illinois, 60612

    Recruiting

  • Tennessee Oncology - Cleveland Clinic

    Cleveland, Tennessee, 37311

    Recruiting

  • Tennessee Oncology - Cookeville Clinic

    Cookeville, Tennessee, 38501

    Active, not recruiting

  • Pontchartrain Cancer Center - Covington Office

    Covington, Louisiana, 70433

    Recruiting

  • Tennessee Oncology - Dickson Clinic

    Dickson, Tennessee, 37055

    Active, not recruiting

  • Clinical Research Advisors - Encino

    Encino, California, 90211

    Active, not recruiting

  • Northwest Medical Specialties - Federal Way

    Federal Way, Washington, 98003

    Active, not recruiting

  • Optum Medical Care - Fishkill Westage Campus

    Fishkill, New York, 12524

    Terminated

  • Cancer Specialists of North Florida - Fleming Island

    Fleming Island, Florida, 32003

    Recruiting

  • Tennessee Oncology - Franklin Clinic

    Franklin, Tennessee, 37067

    Recruiting

  • Tennessee Oncology - Gallatin Clinic

    Gallatin, Tennessee, 37066

    Active, not recruiting

  • Northwest Medical Specialties - Gig Harbor

    Gig Harbor, Washington, 98332

    Recruiting

  • Bon Secours Hematology and Oncology

    Greenville, South Carolina, 29607

    Recruiting

  • Pontchartrain Cancer Center - Hammond Office

    Hammond, Louisiana, 70403-1452

    Recruiting

  • Tennessee Oncology - Hendersonville Clinic

    Hendersonville, Tennessee, 37075

    Active, not recruiting

  • Tennessee Oncology - Hermitage - Summit Clinic

    Hermitage, Tennessee, 37076

    Active, not recruiting

  • Cancer Specialists of North Florida - Riverside

    Jacksonville, Florida, 32204

    Recruiting

  • Cancer Specialists of North Florida Southside

    Jacksonville, Florida, 32207

    Recruiting

  • Cancer Specialists of North Florida - Northside

    Jacksonville, Florida, 32218

    Recruiting

  • Cancer Specialists of North Florida - Southpoint

    Jacksonville, Florida, 32256-6932

    Recruiting

  • Cancer Specialists of North Florida - Baptist South

    Jacksonville, Florida, 32258

    Active, not recruiting

  • Cancer Specialists of North Florida

    Jacksonville Beach, Florida, 32250

    Recruiting

  • Clinical Research Alliance

    Lake Success, New York, 11042

    Terminated

  • Comprehensive Hematology Oncology - Largo Clinic

    Largo, Florida, 33770

    Active, not recruiting

  • Tennessee Oncology - Lebanon Clinic

    Lebanon, Tennessee, 37090

    Active, not recruiting

  • Nebraska Hematology-Oncology - Revive Research Institute LLC

    Lincoln, Nebraska, 68506

    Recruiting

  • SCL Health - Saint Joseph Hospital Cancer Center

    Littleton, Colorado, 80218

    Withdrawn

  • Clinical Research Advisors - West Hollywood

    Los Angeles, California, 90048

    Active, not recruiting

  • Clinical Research Advisors - Korea Town

    Los Angeles, California, 90211

    Active, not recruiting

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

    Merriam, Kansas, 66204

    Withdrawn

  • Optum Medical Care - Mount Kisco Campus 90

    Mount Kisco, New York, 10549

    Terminated

  • Tennessee Oncology - Murfreesboro Clinic

    Murfreesboro, Tennessee, 37129

    Active, not recruiting

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

    Nashville, Tennessee, 37203

    Active, not recruiting

  • Tennessee Oncology - Nashville - Centennial Clinic - Medical Oncology

    Nashville, Tennessee, 37203

    Active, not recruiting

  • Tennessee Oncology - Nashville - Midtown Center for Blood Cancers

    Nashville, Tennessee, 37203

    Active, not recruiting

  • Tennessee Oncology - Nashville - St. Thomas Midtown Clinic

    Nashville, Tennessee, 37203

    Active, not recruiting

  • Tennessee Oncology - Nashville - St. Thomas West Clinic

    Nashville, Tennessee, 37205

    Recruiting

  • Tennessee Oncology - Nashville - Skyline Clinic

    Nashville, Tennessee, 37207

    Active, not recruiting

  • Tennessee Oncology - Nashville - Southern Hills Clinic

    Nashville, Tennessee, 37211

    Active, not recruiting

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

    Nashville, Tennessee, 37232

    Recruiting

  • Cancer Specialists of North Florida - Beaches

    Neptune Beach, Florida, 32266

    Active, not recruiting

  • New York Cancer & Blood Specialists - New Hyde Park

    New Hyde Park, New York, 11042

    Recruiting

  • Optum Hematology Oncology - Lake Success

    New Hyde Park, New York, 11042

    Terminated

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

    New York, New York, 10028

    Recruiting

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

    New York, New York, 10028

    Active, not recruiting

  • Eastern Connecticut Hematology and Oncology Associates

    Norwich, Connecticut, 06360

    Recruiting

  • Comprehensive Hematology Oncology - Palm Harbor Clinic

    Palm Harbor, Florida, 34685

    Active, not recruiting

  • New York Cancer & Blood Specialists - Patchogue Medical Oncology

    Patchogue, New York, 11772

    Recruiting

  • Mercy Health - Perrysburg Cancer Center

    Perrysburg, Ohio, 43551

    Active, not recruiting

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

    Port Jefferson Station, New York, 11776

    Active, not recruiting

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

    Port Jefferson Station, New York, 11776

    Active, not recruiting

  • Optum Medical Care - Poughkeepsie

    Poughkeepsie, New York, 12601

    Terminated

  • Northwest Medical Specialties - Puyallup Medical Oncology

    Puyallup, Washington, 98373

    Recruiting

  • Cancer Specialists Of North Florida - St. Augustine

    Saint Augustine, Florida, 32086

    Recruiting

  • Tennessee Oncology - Shelbyville Clinic

    Shelbyville, Tennessee, 37160

    Recruiting

  • Tennessee Oncology - Smyrna Clinic

    Smyrna, Tennessee, 37167

    Recruiting

  • Comprehensive Hematology Oncology - Bayfront Clinic

    St. Petersburg, Florida, 33709

    Active, not recruiting

  • Comprehensive Hematology Oncology

    St. Petersburg, Florida, 33709

    Recruiting

  • Northwest Medical Specialties - Tacoma

    Tacoma, Washington, 98405

    Recruiting

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

    The Bronx, New York, 10469

    Active, not recruiting

  • New York Cancer & Blood Specialists - Riverhead Medical Oncology

    The Bronx, New York, 10469

    Active, not recruiting

  • Mercy Health - St. Anne Cancer Center

    Toledo, Ohio, 43623

    Active, not recruiting

  • Comprehensive Hematology Oncology - Trinity Clinic

    Trinity, Florida, 34655

    Recruiting

  • Georgetown Lombardi Comprehensive Cancer Center

    Washington D.C., District of Columbia, 20007

    Recruiting

  • Lutheran Medical Center - Cancer Centers of Colorado

    Wheat Ridge, Colorado, 80033-6013

    Recruiting

  • University of Massachusetts Memorial Medical Center

    Worcester, Massachusetts, 01655

    Recruiting

Other trials in United States

France31 sites, 30 recruiting

  • Institut Sainte Catherine

    Avignon, Vaucluse, 84000

    Recruiting

  • Centre Hospitalier de la Côte Basque

    Bayonne, Pyrénées-Atlantiques, 64109

    Recruiting

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

    Besançon, Doubs, 25030

    Recruiting

  • Hôpital Avicenne

    Bobigny, Île-de-France Region, 93000

    Recruiting

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

    Brest, Finistère, 29200

    Recruiting

  • Hôpital Louis Pradel

    Bron, Auvergne-Rhône-Alpes, 69500

    Active, not recruiting

  • Centre Hospitalier (Ch) De Cholet

    Cholet, Maine-et-Loire, 49325

    Recruiting

  • Centre Hospitalier Intercommunal de Créteil

    Créteil, Île-de-France Region, 94000

    Recruiting

  • Centre Hospitalier Départemental Vendée

    La Roche-sur-Yon, 85000

    Recruiting

  • Hôpital Michallon

    La Tronche, Rhône, 38700

    Recruiting

  • Centre Hospitalier Le Mans

    Le Mans, 72037

    Recruiting

  • Centre Hospitalier Universitaire Dupuytren 1

    Limoges, Haute-Vienne, 87000

    Recruiting

  • Centre Hospitalier Lyon-Sud

    Lyon, Auvergne-Rhône-Alpes, 69317

    Recruiting

  • Hôpital de la Croix Rousse

    Lyon, Auvergne-Rhône-Alpes, 69317

    Recruiting

  • Institut Paoli-Calmettes

    Marseille, Bouches-du-Rhône, 13273

    Recruiting

  • Hôpital Nord de Marseille

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

    Recruiting

  • Hôpital Arnaud de Villeneuve

    Montpellier, Hérault, 34295

    Recruiting

  • Hôpital Emile Muller

    Mulhouse, Grand Est, 68100

    Recruiting

  • Centre Hospitalier Régional Universitaire de Nancy

    Nancy, Grand Est, 54035

    Recruiting

  • Centre Hospitalier Universitaire De Nantes - Hôpital Nord Laennec

    Nantes, 44093

    Recruiting

  • Groupe Hospitalier Paris Saint-Joseph

    Paris, Île-de-France Region, 75014

    Recruiting

  • Hôpital Cochin

    Paris, Île-de-France Region, 75014

    Recruiting

  • Hôpital Tenon

    Paris, Île-de-France Region, 75020

    Recruiting

  • Hôpital Haut-Lévêque

    Pessac, New Aquitaine, 33604

    Recruiting

  • Centre Hospitalier Universitaire de Poitiers

    Poitiers, Vienne, 86021

    Recruiting

  • Hôpital Pontchaillou

    Rennes, Ille-et-Vilaine, 35033

    Recruiting

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

    Saint-Herblain, Loire-Atlantique, 44805

    Recruiting

  • Nouvel Hôpital Civil

    Strasbourg, Alsace, 67091

    Recruiting

  • Hôpital d'Instruction des Armées Sainte-Anne

    Toulon, Alpes-de-Haute-Provence, 83800

    Recruiting

  • Hôpital Larrey

    Toulouse, Midi-pyrenees, 31059

    Recruiting

  • Gustave Roussy

    Villejuif, Val-de-Marne, 94805

    Recruiting

Other trials in France

Spain20 sites, 20 recruiting

  • Complejo Hospitalario Universitario A Coruña

    A Coruña, La Coruña, 15006

    Recruiting

  • Hospital Germans Trias i Pujol

    Badalona, Barcelona, 08916

    Recruiting

  • Biocruces Bizkaia Instituto de Investigación Sanitaria

    Barakaldo, Biscay, 48903

    Recruiting

  • Clínica Mi Tres Torres

    Barcelona, 08017

    Recruiting

  • Hospital Universitari Dexeus

    Barcelona, 08028

    Recruiting

  • Hospital Universitari Vall d'Hebrón

    Barcelona, 08035

    Recruiting

  • Hospital Clinic de Barcelona

    Barcelona, 08036

    Recruiting

  • Hospital Universitario Reina Sofía

    Córdoba, 14004

    Recruiting

  • Hospital Universitari de Girona Dr. Josep Trueta

    Girona, 17007

    Recruiting

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

    L'Hospitalet de Llobregat, Barcelona, 08907

    Recruiting

  • Complejo Hospitalario Universitario Insular Materno Infantil

    Las Palmas de Gran Canaria, Las Palmas, 35016

    Recruiting

  • Hospital Universitario Lucus Augusti

    Lugo, 27004

    Recruiting

  • Hospital General Universitario Gregorio Marañón

    Madrid, 28007

    Recruiting

  • Hospital Universitario Ramón y Cajal

    Madrid, 28034

    Recruiting

  • Hospital Universitario La Paz

    Madrid, 28046

    Recruiting

  • Hospital Universitario Puerta de Hierro - Majadahonda

    Majadahonda, Madrid, 28222

    Recruiting

  • Hospital Regional Universitario de Málaga - Hospital General

    Málaga, 29011

    Recruiting

  • HC Marbella

    Marbella, Malaga, 29660

    Recruiting

  • Hospital Son Llàtzer

    Palma de Mallorca, Balearic Islands, 07198

    Recruiting

  • Hospital Universitario Virgen Macarena

    Seville, 41009

    Recruiting

Other trials in Spain

Italy17 sites, 15 recruiting

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

    Genova, 16132

    Recruiting

  • Ospedale Vito Fazzi Lecce

    Lecce, 73100

    Recruiting

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

    Legnago, Verona, 37045

    Recruiting

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

    Meldola, Forlì-Cesena, 47014

    Recruiting

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

    Milan, 20132

    Recruiting

  • Fondazione IRCCS - Istituto Nazionale dei Tumori

    Milan, 20133

    Recruiting

  • Azienda Ospedaliera Universitaria - Università degli Studi della Campania Luigi Vanvitelli

    Naples, Naples, 80131

    Recruiting

  • Azienda Ospedaliero-Universitaria Maggiore della Carità di Novara

    Novara, 28100

    Recruiting

  • Azienda Ospedaliero - Universitaria San Luigi Gonzaga

    Orbassano, Torino, 10043

    Recruiting

  • Ospedale Busonera - Istituto Oncologico Veneto (IOV) - Padua

    Padova, 35128

    Recruiting

  • Azienda Ospedaliero-Universitaria Pisana

    Pisa, 56126

    Recruiting

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

    Rimini, 47923

    Active, not recruiting

  • IRCCS Istituto Nazionale Tumori Regina Elena

    Roma, 00144

    Recruiting

  • Azienda Ospedaliera San Camillo Forlanini

    Rome, 00152

    Recruiting

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

    Rozzano, Milan, 20089

    Active, not recruiting

  • Presidio Ospedaliero di Lucca

    San Filippo, Lucca, 55100

    Recruiting

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

    Siena, 53100

    Recruiting

Other trials in Italy

Germany12 sites, 10 recruiting

  • Universitätsklinikum Aachen

    Aachen, North Rhine-Westphalia, 52074

    Terminated

  • Charité - Universitätsmedizin Berlin

    Berlin, 13353

    Recruiting

  • Universitätsklinikum Bonn

    Bonn, North Rhine-Westphalia, 53127

    Recruiting

  • Universitätsklinikum Essen

    Essen, North Rhine-Westphalia, 45147

    Recruiting

  • Asklepios Fachkliniken München-Gauting

    Gauting, Bavaria, 82131

    Recruiting

  • LungenClinic Grosshansdorf

    Großhansdorf, Schleswig-Holstein, 22927

    Recruiting

  • Krankenhaus Martha-Maria Halle-Dölau

    Halle, Saxony-Anhalt, 06120

    Recruiting

  • Thoraxklinik-Heidelberg

    Heidelberg, Baden-Wurttemberg, 69126

    Recruiting

  • Universitätsklinikum Gießen und Marburg - Gießen

    Homburg, Saarland, 66421

    Recruiting

  • Klinikum Kassel

    Kassel, Hesse, 34125

    Active, not recruiting

  • München Klinik Bogenhausen

    München, Bavaria, 81925

    Recruiting

  • Robert-Bosch-Krankenhaus

    Stuttgart, Baden-Wurttemberg, 70376

    Recruiting

Other trials in Germany

Greece11 sites, 10 recruiting

  • Saint Savvas Anticancer - Oncological Hospital of Athens

    Athens, Attica, 11522

    Recruiting

  • Henry Dunant Hospital Center

    Athens, Attica, 11526

    Recruiting

  • General Hospital for Thoracic Diseases Sotiria

    Athens, Attica, 11527

    Recruiting

  • University General Hospital of Heraklion (PAGNI)

    Heraklion, Crete, 711 10

    Recruiting

  • University General Hospital of Larissa

    Larissa, Thessaly, 411 10

    Recruiting

  • Agii Anargiri Cancer Hospital

    Nea Kifissia, Attica, 14564

    Recruiting

  • University General Hospital of Patras

    Patra, Peloponnese, 26504

    Recruiting

  • Metropolitan Hospital

    Piraeus, Athens, 185 47

    Recruiting

  • Clinic Agios Loukas

    Thessaloniki, Central Macedonia, 55236

    Recruiting

  • General Hospital of Thessaloniki Papageorgiou

    Thessaloniki, Macedoni, TK 56403

    Active, not recruiting

  • Theagenio Anti-Cancer Hospital of Thessaloniki

    Thessaloniki, Thessaloniki, 546 39

    Recruiting

Other trials in Greece

Belgium9 sites, 7 recruiting

  • Algemeen Ziekenhuis Klina

    Brasschaat, Antwerpen, 2930

    Recruiting

  • Algemeen Ziekenhuis Maria Middelares

    Ghent, Oost-Vlaaderen, 9000

    Recruiting

  • Jessa Ziekenhuis - Campus Virga Jesse

    Hasselt, Limburg, 3500

    Recruiting

  • Algemeen Ziekenhuis Groeninge - Campus Kennedylaan

    Kortrijk, West-Vlaanderen, 8500

    Recruiting

  • Universitair Ziekenhuis Leuven - Campus Gasthuisberg

    Leuven, Flemish Brabant, 3000

    Recruiting

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

    Namur, Wallonia, B-5000

    Recruiting

  • Algemeen Ziekenhuis Delta - Campus Rembert Torhout

    Roeselare, West-Vlaanderen, 8800

    Active, not recruiting

  • Algemeen Ziekenhuis Delta - Campus Rumbeke

    Roeselare, West-Vlaanderen, 8800

    Recruiting

  • Algemeen Ziekenhuis Delta - Campus Menen

    Roeselare, West-Vlaanderen

    Active, not recruiting

Other trials in Belgium

Poland6 sites, 6 recruiting

  • Centrum Onkologii Im. Prof. F. Łukaszczyka w Bydgoszczy

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-796

    Recruiting

  • Uniwersyteckie Centrum Kliniczne w Gdańsku

    Gdansk, Pomeranian Voivodeship, 80-210

    Recruiting

  • Przychodnia Lekarska KOMED Roman Karaszewski

    Konin, Greater Poland Voivodeship, 62-500

    Recruiting

  • Instytut Centrum Zdrowia Matki Polki

    Lodz, Lódzkie, 93-338

    Recruiting

  • Uniwersytecki Szpital Kliniczny Nr 4 w Lublinie

    Lublin, Lublin Voivodeship, 20-090

    Recruiting

  • Wielkopolskie Centrum Pulmonologii i Torakochirurgii im. Eugenii i Janusza Zeylandów

    Poznan, Greater Poland Voivodeship, 60-569

    Recruiting

Other trials in Poland

Portugal5 sites, 5 recruiting

  • Unidade Local de Saúde de Coimbra

    Coimbra, 3000-075

    Recruiting

  • Hospital CUF Descobertas

    Lisbon, 1769-001

    Recruiting

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

    Lisbon, 1769-001

    Recruiting

  • Hospital CUF Porto

    Porto, 14341

    Recruiting

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

    Vila Nova de Gaia, 4434-502

    Recruiting

Other trials in Portugal

United Kingdom5 sites, 5 recruiting

  • NHS Grampian

    Aberdeen, Scotland, AB25 2ZN

    Recruiting

  • University Hospitals of Leicester NHS Trust

    Leicester, England, LE2 9LX

    Recruiting

  • The Christie NHS Foundation Trust

    Manchester, England, M20 4BX

    Recruiting

  • The Clatterbridge Cancer Centre NHS Foundation Trust

    Metropolitan Borough of Wirral, England, CH63 4JY

    Recruiting

  • The Royal Marsden NHS Foundation Trust

    Sutton, England, SM2 5PT

    Recruiting

Other trials in United Kingdom

Canada3 sites, 2 recruiting

  • Centre Intégré Universitaire de Santé et de Services Sociaux du Saguenay - Lac-Saint-Jean

    Chicoutimi, Quebec, G7H 5H6

    Recruiting

  • McGill University Health Centre

    Montreal, Quebec, H4A 3J1

    Terminated

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

    Rimouski, Quebec, G5L 5T1

    Recruiting

Other trials in Canada

Hungary3 sites, 2 recruiting

  • Országos Korányi Pulmonológiai Intézet

    Budapest, 1121

    Recruiting

  • Mátrai Gyógyintézet

    Gyöngyös, Heves County, 3200

    Terminated

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

    Gyöngyös, 3200

    Recruiting

Other trials in Hungary

Netherlands3 sites, 3 recruiting

  • Universitair Medisch Centrum Groningen

    Groningen, 9713 GZ

    Recruiting

  • Radboud Universitair Medisch Centrum

    Nijmegen, Gelderland, 6525 GA

    Recruiting

  • Erasmus Medisch Centrum

    Rotterdam, South Holland, 3015 GD

    Recruiting

Other trials in Netherlands

Romania3 sites, 3 recruiting

  • Institutul Oncologic Prof. Dr. Ion Chiricuta

    Cluj-Napoca, Cluj, 400015

    Recruiting

  • Centrul de Oncologie Sf Nectarie

    Craiova, Dolj, 200746

    Recruiting

  • SC OncoMed SRL

    Timișoara, Timiș County, 300239

    Recruiting

Other trials in Romania

About this study

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

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).

Being tested
OSE2101, Docetaxel, NGS HLAA2 assay
Keywords
Immune Checkpoint Inhibitor, Cancer vaccine, Non-Small Cell Lung Cancer
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OSE2101Drug

    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.

  • DocetaxelDrug

    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 assayDevice

    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.

Study groups in NCT06472245
Study groupRoleWhat they receive
Arm A: OSE2101ExperimentalUnit 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.
Receives: Drug: OSE2101; Device: NGS HLAA2 assay
Arm B: DocetaxelActive comparatorUnit dose: 75 mg/m2 Mode/Route: Intravenous infusion over 1 hour Regimen: One infusion every three weeks.
Receives: Drug: Docetaxel; Device: NGS HLAA2 assay
GenDx CDx TedopiOtherSystem 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.
Receives: Device: NGS HLAA2 assay

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. OS defined as time from randomization to death

    OS defined as time from randomization to death of any cause, censored until the data analysis cut-off date

    Measured: From randomization date through study completion, an average of 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jun 2024
  2. Study start3 Dec 2024
  3. Primary completion15 Dec 2027 (estimated)
  4. Study completion15 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
363 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06472245
Sponsor's protocol ID
OSE2101C302
Acronym
ARTEMIA
Status last verified
Oct 2026
First submitted
7 Jun 2024
Last updated
2 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
Yes
Individual data sharing
Undecided

Publications

  • Besse B, Felip E, Garcia Campelo R, Cobo M, Mascaux C, Madroszyk A, Cappuzzo F, Hilgers W, Romano G, Denis F, Viteri S, Debieuvre D, Galetta D, Baldini E, Razaq M, Robinet G, Maio M, Delmonte A, Roch B, Masson P, Schuette W, Zer A, Remon J, Costantini D, Vasseur B, Dziadziuszko R, Giaccone G; ATALANTE-1 study group. Randomized open-label controlled study of cancer vaccine OSE2101 versus chemotherapy in HLA-A2-positive patients with advanced non-small-cell lung cancer with resistance to immunotherapy: ATALANTE-1. Ann Oncol. 2023 Oct;34(10):920-933. doi: 10.1016/j.annonc.2023.07.006. Epub 2023 Sep 11.

    PubMed 37704166

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing OSE2101, Docetaxel and NGS HLAA2 assay in people with Patients With Non-Small Cell Lung Cancer, run by OSE Immunotherapeutics at 207 sites in 14 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 207 sites in United States, France, Spain, Italy, Germany and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Caroline Chevalier, MSc, MPH (+33 630 842 002, caroline.chevalier@ose-immuno.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

OS defined as time from randomization to death (time frame: From randomization date through study completion, an average of 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06472245, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.

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