NCT06472245

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).

Trial Health

88
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network
Enrollment
363

participants targeted

Target at P50-P75 for phase_3

Timeline
32mo left

Started Dec 2024

Typical duration for phase_3

Geographic Reach
14 countries

207 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress35%
Dec 2024Dec 2028

First Submitted

Initial submission to the registry

June 7, 2024

Completed
18 days until next milestone

First Posted

Study publicly available on registry

June 25, 2024

Completed
5 months until next milestone

Study Start

First participant enrolled

December 3, 2024

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2028

Last Updated

April 1, 2026

Status Verified

March 1, 2026

Enrollment Period

3 years

First QC Date

June 7, 2024

Last Update Submit

March 31, 2026

Conditions

Keywords

Immune Checkpoint InhibitorCancer vaccineNon-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (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

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

Study Arms (3)

Arm A: OSE2101

EXPERIMENTAL

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.

Drug: OSE2101Device: NGS HLAA2 assay

Arm B: Docetaxel

ACTIVE COMPARATOR

Unit dose: 75 mg/m2 Mode/Route: Intravenous infusion over 1 hour Regimen: One infusion every three weeks.

Drug: DocetaxelDevice: NGS HLAA2 assay

GenDx CDx Tedopi

OTHER

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.

Device: NGS HLAA2 assay

Interventions

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.

Arm A: OSE2101

Docetaxel is an antineoplastic agent that acts by disrupting the microtubular network in cells that is essential for mitotic and interphase cellular functions.

Arm B: Docetaxel

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.

Arm A: OSE2101Arm B: DocetaxelGenDx CDx Tedopi

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (207)

Clinical Research Advisors, LLC

Beverly Hills, California, 90211, United States

RECRUITING

Clinical Research Advisors - Encino

Encino, California, 90211, United States

ACTIVE NOT RECRUITING

Clinical Research Advisors - West Hollywood

Los Angeles, California, 90048, United States

ACTIVE NOT RECRUITING

Clinical Research Advisors - Korea Town

Los Angeles, California, 90211, United States

ACTIVE NOT RECRUITING

SCL Health - Saint Joseph Hospital Cancer Center

Littleton, Colorado, 80218, United States

WITHDRAWN

Lutheran Medical Center - Cancer Centers of Colorado

Wheat Ridge, Colorado, 80033-6013, United States

RECRUITING

Eastern Connecticut Hematology and Oncology Associates

Norwich, Connecticut, 06360, United States

RECRUITING

Georgetown Lombardi Comprehensive Cancer Center

Washington D.C., District of Columbia, 20007, United States

RECRUITING

Comprehensive Hematology Oncology - Bradenton Clinic

Bradenton, Florida, 34210, United States

ACTIVE NOT RECRUITING

Comprehensive Hematology Oncology - Brandon Clinic

Brandon, Florida, 33511, United States

ACTIVE NOT RECRUITING

Cancer Specialists of North Florida - Fleming Island

Fleming Island, Florida, 32003, United States

RECRUITING

Cancer Specialists of North Florida - Riverside

Jacksonville, Florida, 32204, United States

ACTIVE NOT RECRUITING

Cancer Specialists of North Florida Southside

Jacksonville, Florida, 32207, United States

ACTIVE NOT RECRUITING

Cancer Specialists of North Florida - Northside

Jacksonville, Florida, 32218, United States

ACTIVE NOT RECRUITING

Cancer Specialists of North Florida - Southpoint

Jacksonville, Florida, 32256-6932, United States

RECRUITING

Cancer Specialists of North Florida - Baptist South

Jacksonville, Florida, 32258, United States

ACTIVE NOT RECRUITING

Cancer Specialists of North Florida

Jacksonville Beach, Florida, 32250, United States

RECRUITING

Comprehensive Hematology Oncology - Largo Clinic

Largo, Florida, 33770, United States

ACTIVE NOT RECRUITING

Cancer Specialists of North Florida - Beaches

Neptune Beach, Florida, 32266, United States

ACTIVE NOT RECRUITING

Comprehensive Hematology Oncology - Palm Harbor Clinic

Palm Harbor, Florida, 34685, United States

ACTIVE NOT RECRUITING

Cancer Specialists Of North Florida - St. Augustine

Saint Augustine, Florida, 32086, United States

RECRUITING

Comprehensive Hematology Oncology - Bayfront Clinic

St. Petersburg, Florida, 33709, United States

ACTIVE NOT RECRUITING

Comprehensive Hematology Oncology

St. Petersburg, Florida, 33709, United States

RECRUITING

Comprehensive Hematology Oncology - Trinity Clinic

Trinity, Florida, 34655, United States

RECRUITING

University of Illinois Cancer Center

Chicago, Illinois, 60612, United States

RECRUITING

Alliance for Multispecialty Research (AMR) - Kansas City Oncology

Merriam, Kansas, 66204, United States

WITHDRAWN

Mary Bird Perkins Cancer Center - Baton Rouge

Baton Rouge, Louisiana, 70809, United States

ACTIVE NOT RECRUITING

Pontchartrain Cancer Center - Covington Office

Covington, Louisiana, 70433, United States

RECRUITING

Pontchartrain Cancer Center - Hammond Office

Hammond, Louisiana, 70403-1452, United States

RECRUITING

Ascension Saint Agnes Hospital

Baltimore, Maryland, 21229, United States

RECRUITING

University of Massachusetts Memorial Medical Center

Worcester, Massachusetts, 01655, United States

RECRUITING

Nebraska Hematology-Oncology - Revive Research Institute LLC

Lincoln, Nebraska, 68506, United States

RECRUITING

New York Cancer & Blood Specialists - Babylon Medical Oncology

Babylon, New York, 11702, United States

ACTIVE NOT RECRUITING

Optum Medical Care - Carmel/Brewster Campus

Brewster, New York, 10509, United States

TERMINATED

Brooklyn Radiation Oncology

Brooklyn, New York, 11201, United States

TERMINATED

Optum Medical Care - Fishkill Westage Campus

Fishkill, New York, 12524, United States

TERMINATED

Clinical Research Alliance

Lake Success, New York, 11042, United States

TERMINATED

Optum Medical Care - Mount Kisco Campus 90

Mount Kisco, New York, 10549, United States

TERMINATED

New York Cancer & Blood Specialists - New Hyde Park

New Hyde Park, New York, 11042, United States

ACTIVE NOT RECRUITING

Optum Hematology Oncology - Lake Success

New Hyde Park, New York, 11042, United States

TERMINATED

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

New York, New York, 10028, United States

RECRUITING

New York Cancer & Blood Specialists - Central Park Medical Oncology

New York, New York, 10028, United States

ACTIVE NOT RECRUITING

New York Cancer & Blood Specialists - Patchogue Medical Oncology

Patchogue, New York, 11772, United States

RECRUITING

New York Cancer & Blood Specialists - Port Jefferson Medical Oncology

Port Jefferson Station, New York, 11776, United States

ACTIVE NOT RECRUITING

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

Port Jefferson Station, New York, 11776, United States

ACTIVE NOT RECRUITING

Optum Medical Care - Poughkeepsie

Poughkeepsie, New York, 12601, United States

TERMINATED

New York Cancer & Blood Specialists - Eastchester Cancer Care Center

The Bronx, New York, 10469, United States

ACTIVE NOT RECRUITING

New York Cancer & Blood Specialists - Riverhead Medical Oncology

The Bronx, New York, 10469, United States

ACTIVE NOT RECRUITING

Mercy Health - Perrysburg Cancer Center

Perrysburg, Ohio, 43551, United States

ACTIVE NOT RECRUITING

Mercy Health - St. Anne Cancer Center

Toledo, Ohio, 43623, United States

ACTIVE NOT RECRUITING

Bon Secours Hematology and Oncology

Greenville, South Carolina, 29607, United States

RECRUITING

Tennessee Oncology - Chattanooga - Medical Park II

Chattanooga, Tennessee, 36404, United States

ACTIVE NOT RECRUITING

Tennessee Oncology - Chattanooga - Downtown

Chattanooga, Tennessee, 37403, United States

RECRUITING

Tennessee Oncology - Chattanooga - GHCR Site I

Chattanooga, Tennessee, 37403, United States

RECRUITING

Tennessee Oncology - Chattanooga - Memorial Plaza

Chattanooga, Tennessee, 37404, United States

RECRUITING

Tennessee Oncology - Cleveland Clinic

Cleveland, Tennessee, 37311, United States

RECRUITING

Tennessee Oncology - Cookeville Clinic

Cookeville, Tennessee, 38501, United States

ACTIVE NOT RECRUITING

Tennessee Oncology - Dickson Clinic

Dickson, Tennessee, 37055, United States

ACTIVE NOT RECRUITING

Tennessee Oncology - Franklin Clinic

Franklin, Tennessee, 37067, United States

RECRUITING

Tennessee Oncology - Gallatin Clinic

Gallatin, Tennessee, 37066, United States

ACTIVE NOT RECRUITING

Tennessee Oncology - Hendersonville Clinic

Hendersonville, Tennessee, 37075, United States

ACTIVE NOT RECRUITING

Tennessee Oncology - Hermitage - Summit Clinic

Hermitage, Tennessee, 37076, United States

ACTIVE NOT RECRUITING

Tennessee Oncology - Lebanon Clinic

Lebanon, Tennessee, 37090, United States

ACTIVE NOT RECRUITING

Tennessee Oncology - Murfreesboro Clinic

Murfreesboro, Tennessee, 37129, United States

ACTIVE NOT RECRUITING

Tennessee Oncology - Nashville - Centennial Center for Blood Cancers Clinic

Nashville, Tennessee, 37203, United States

ACTIVE NOT RECRUITING

Tennessee Oncology - Nashville - Centennial Clinic - Medical Oncology

Nashville, Tennessee, 37203, United States

ACTIVE NOT RECRUITING

Tennessee Oncology - Nashville - Midtown Center for Blood Cancers

Nashville, Tennessee, 37203, United States

ACTIVE NOT RECRUITING

Tennessee Oncology - Nashville - St. Thomas Midtown Clinic

Nashville, Tennessee, 37203, United States

ACTIVE NOT RECRUITING

Tennessee Oncology - Nashville - St. Thomas West Clinic

Nashville, Tennessee, 37205, United States

RECRUITING

Tennessee Oncology - Nashville - Skyline Clinic

Nashville, Tennessee, 37207, United States

ACTIVE NOT RECRUITING

Tennessee Oncology - Nashville - Southern Hills Clinic

Nashville, Tennessee, 37211, United States

ACTIVE NOT RECRUITING

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

Nashville, Tennessee, 37232, United States

RECRUITING

Tennessee Oncology - Shelbyville Clinic

Shelbyville, Tennessee, 37160, United States

RECRUITING

Tennessee Oncology - Smyrna Clinic

Smyrna, Tennessee, 37167, United States

RECRUITING

Northwest Medical Specialties - Bonney Lake

Bonney Lake, Washington, 98391, United States

ACTIVE NOT RECRUITING

Northwest Medical Specialties - Federal Way

Federal Way, Washington, 98003, United States

ACTIVE NOT RECRUITING

Northwest Medical Specialties - Gig Harbor

Gig Harbor, Washington, 98332, United States

RECRUITING

Northwest Medical Specialties - Puyallup Medical Oncology

Puyallup, Washington, 98373, United States

RECRUITING

Northwest Medical Specialties - Tacoma

Tacoma, Washington, 98405, United States

RECRUITING

Algemeen Ziekenhuis Klina

Brasschaat, Antwerpen, 2930, Belgium

RECRUITING

Universitair Ziekenhuis Leuven - Campus Gasthuisberg

Leuven, Flemish Brabant, 3000, Belgium

RECRUITING

Jessa Ziekenhuis - Campus Virga Jesse

Hasselt, Limburg, 3500, Belgium

RECRUITING

Algemeen Ziekenhuis Maria Middelares

Ghent, Oost-Vlaaderen, 9000, Belgium

RECRUITING

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

Namur, Wallonia, B-5000, Belgium

RECRUITING

Algemeen Ziekenhuis Groeninge - Campus Kennedylaan

Kortrijk, West-Vlaanderen, 8500, Belgium

ACTIVE NOT RECRUITING

Algemeen Ziekenhuis Delta - Campus Rembert Torhout

Roeselare, West-Vlaanderen, 8800, Belgium

ACTIVE NOT RECRUITING

Algemeen Ziekenhuis Delta - Campus Rumbeke

Roeselare, West-Vlaanderen, 8800, Belgium

RECRUITING

Algemeen Ziekenhuis Delta - Campus Menen

Roeselare, West-Vlaanderen, Belgium

ACTIVE NOT RECRUITING

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

Chicoutimi, Quebec, G7H 5H6, Canada

RECRUITING

McGill University Health Centre

Montreal, Quebec, H4A 3J1, Canada

TERMINATED

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

Rimouski, Quebec, G5L 5T1, Canada

RECRUITING

Hôpital d'Instruction des Armées Sainte-Anne

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

RECRUITING

Nouvel Hôpital Civil

Strasbourg, Alsace, 67091, France

RECRUITING

Hôpital Louis Pradel

Bron, Auvergne-Rhône-Alpes, 69500, France

ACTIVE NOT RECRUITING

Centre Hospitalier Lyon-Sud

Lyon, Auvergne-Rhône-Alpes, 69317, France

RECRUITING

Hôpital de la Croix Rousse

Lyon, Auvergne-Rhône-Alpes, 69317, France

ACTIVE NOT RECRUITING

Institut Paoli-Calmettes

Marseille, Bouches-du-Rhône, 13273, France

RECRUITING

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

Besançon, Doubs, 25030, France

RECRUITING

Centre Hospitalier Regional Universitaire Brest - Hopital de la Cavale Blanche

Brest, Finistère, 29200, France

RECRUITING

Hôpital Emile Muller

Mulhouse, Grand Est, 68100, France

RECRUITING

Centre Hospitalier Régional Universitaire de Nancy

Nancy, Grand Est, 54035, France

RECRUITING

Centre Hospitalier Universitaire Dupuytren 1

Limoges, Haute-Vienne, 87000, France

RECRUITING

Hôpital Arnaud de Villeneuve

Montpellier, Hérault, 34295, France

RECRUITING

Hôpital Pontchaillou

Rennes, Ille-et-Vilaine, 35033, France

RECRUITING

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

Saint-Herblain, Loire-Atlantique, 44805, France

RECRUITING

Centre Hospitalier (Ch) De Cholet

Cholet, Maine-et-Loire, 49325, France

RECRUITING

Hôpital Larrey

Toulouse, Midi-pyrenees, 31059, France

RECRUITING

Hôpital Haut-Lévêque

Pessac, Nouvelle-Aquitaine, 33604, France

RECRUITING

Hôpital Nord de Marseille

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

RECRUITING

Centre Hospitalier de la Côte Basque

Bayonne, Pyrénées-Atlantiques, 64109, France

RECRUITING

Hôpital Michallon

La Tronche, Rhône, 38700, France

RECRUITING

Gustave Roussy

Villejuif, Val-de-Marne, 94805, France

RECRUITING

Institut Sainte Catherine

Avignon, Vaucluse, 84000, France

RECRUITING

Centre Hospitalier Universitaire de Poitiers

Poitiers, Vienne, 86021, France

RECRUITING

Centre Hospitalier Départemental Vendée

La Roche-sur-Yon, 85000, France

RECRUITING

Centre Hospitalier Le Mans

Le Mans, 72037, France

RECRUITING

Centre Hospitalier Universitaire De Nantes - Hôpital Nord Laennec

Nantes, 44093, France

RECRUITING

Hôpital Avicenne

Bobigny, Île-de-France Region, 93000, France

RECRUITING

Centre Hospitalier Intercommunal de Créteil

Créteil, Île-de-France Region, 94000, France

RECRUITING

Groupe Hospitalier Paris Saint-Joseph

Paris, Île-de-France Region, 75014, France

RECRUITING

Hôpital Cochin

Paris, Île-de-France Region, 75014, France

RECRUITING

Hôpital Tenon

Paris, Île-de-France Region, 75020, France

RECRUITING

Thoraxklinik-Heidelberg

Heidelberg, Baden-Wurttemberg, 69126, Germany

RECRUITING

Robert-Bosch-Krankenhaus

Stuttgart, Baden-Wurttemberg, 70376, Germany

RECRUITING

Asklepios Fachkliniken München-Gauting

Gauting, Bavaria, 82131, Germany

RECRUITING

München Klinik Bogenhausen

München, Bavaria, 81925, Germany

ACTIVE NOT RECRUITING

Klinikum Kassel

Kassel, Hesse, 34125, Germany

ACTIVE NOT RECRUITING

Universitätsklinikum Aachen

Aachen, North Rhine-Westphalia, 52074, Germany

RECRUITING

Universitätsklinikum Bonn

Bonn, North Rhine-Westphalia, 53127, Germany

RECRUITING

Universitätsklinikum Essen

Essen, North Rhine-Westphalia, 45147, Germany

RECRUITING

Universitätsklinikum Gießen und Marburg - Gießen

Homburg, Saarland, 66421, Germany

RECRUITING

Krankenhaus Martha-Maria Halle-Dölau

Halle, Saxony-Anhalt, 06120, Germany

RECRUITING

LungenClinic Grosshansdorf

Großhansdorf, Schleswig-Holstein, 22927, Germany

RECRUITING

Charité - Universitätsmedizin Berlin

Berlin, 13353, Germany

RECRUITING

Metropolitan Hospital

Piraeus, Athens, 185 47, Greece

RECRUITING

Saint Savvas Anticancer - Oncological Hospital of Athens

Athens, Attica, 11522, Greece

RECRUITING

Henry Dunant Hospital Center

Athens, Attica, 11526, Greece

RECRUITING

General Hospital for Thoracic Diseases Sotiria

Athens, Attica, 11527, Greece

RECRUITING

Agii Anargiri Cancer Hospital

Nea Kifissia, Attica, 14564, Greece

RECRUITING

Clinic Agios Loukas

Thessaloniki, Central Macedonia, 55236, Greece

RECRUITING

University General Hospital of Heraklion (PAGNI)

Heraklion, Crete, 711 10, Greece

RECRUITING

General Hospital of Thessaloniki Papageorgiou

Thessaloniki, Macedoni, TK 56403, Greece

ACTIVE NOT RECRUITING

University General Hospital of Patras

Patra, Peloponnese, 26504, Greece

RECRUITING

Theagenio Anti-Cancer Hospital of Thessaloniki

Thessaloniki, Thessaloniki, 546 39, Greece

RECRUITING

University General Hospital of Larissa

Larissa, Thessaly, 411 10, Greece

RECRUITING

Mátrai Gyógyintézet

Gyöngyös, Heves County, 3200, Hungary

ACTIVE NOT RECRUITING

Országos Korányi Pulmonológiai Intézet

Budapest, 1121, Hungary

RECRUITING

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

Gyöngyös, 3200, Hungary

RECRUITING

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

Meldola, Forlì-Cesena, 47014, Italy

RECRUITING

Presidio Ospedaliero di Lucca

San Filippo, Lucca, 55100, Italy

RECRUITING

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

Rozzano, Milan, 20089, Italy

ACTIVE NOT RECRUITING

Azienda Ospedaliera Universitaria - Università degli Studi della Campania Luigi Vanvitelli

Naples, Naples, 80131, Italy

RECRUITING

Azienda Ospedaliero - Universitaria San Luigi Gonzaga

Orbassano, Torino, 10043, Italy

RECRUITING

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

Legnago, Verona, 37045, Italy

RECRUITING

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

Genova, 16132, Italy

RECRUITING

Ospedale Vito Fazzi Lecce

Lecce, 73100, Italy

ACTIVE NOT RECRUITING

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

Milan, 20132, Italy

RECRUITING

Fondazione IRCCS - Istituto Nazionale dei Tumori

Milan, 20133, Italy

RECRUITING

Azienda Ospedaliero-Universitaria Maggiore della Carità di Novara

Novara, 28100, Italy

RECRUITING

Ospedale Busonera - Istituto Oncologico Veneto (IOV) - Padua

Padua, 35128, Italy

RECRUITING

Azienda Ospedaliero-Universitaria Pisana

Pisa, 56126, Italy

RECRUITING

Azienda Unità Sanitaria Locale della Romagna - Ospedale Infermi di Rimini

Rimini, 47923, Italy

ACTIVE NOT RECRUITING

IRCCS Istituto Nazionale Tumori Regina Elena

Roma, 00144, Italy

RECRUITING

Azienda Ospedaliera San Camillo Forlanini

Rome, 00152, Italy

RECRUITING

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

Siena, 53100, Italy

RECRUITING

Radboud Universitair Medisch Centrum

Nijmegen, Gelderland, 6525 GA, Netherlands

RECRUITING

Erasmus Medisch Centrum

Rotterdam, South Holland, 3015 GD, Netherlands

RECRUITING

Universitair Medisch Centrum Groningen

Groningen, 9713 GZ, Netherlands

RECRUITING

Przychodnia Lekarska KOMED Roman Karaszewski

Konin, Greater Poland Voivodeship, 62-500, Poland

RECRUITING

Wielkopolskie Centrum Pulmonologii i Torakochirurgii im. Eugenii i Janusza Zeylandów

Poznan, Greater Poland Voivodeship, 60-569, Poland

RECRUITING

Centrum Onkologii Im. Prof. F. Łukaszczyka w Bydgoszczy

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-796, Poland

RECRUITING

Uniwersytecki Szpital Kliniczny Nr 4 w Lublinie

Lublin, Lublin Voivodeship, 20-090, Poland

RECRUITING

Instytut Centrum Zdrowia Matki Polki

Lodz, Lódzkie, 93-338, Poland

RECRUITING

Uniwersyteckie Centrum Kliniczne w Gdańsku

Gdansk, Pomeranian Voivodeship, 80-210, Poland

RECRUITING

Unidade Local de Saúde de Coimbra

Coimbra, 3000-075, Portugal

RECRUITING

Hospital CUF Descobertas

Lisbon, 1769-001, Portugal

ACTIVE NOT RECRUITING

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

Lisbon, 1769-001, Portugal

RECRUITING

Hospital CUF Porto

Porto, 14341, Portugal

ACTIVE NOT RECRUITING

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

Vila Nova de Gaia, 4434-502, Portugal

RECRUITING

Institutul Oncologic Prof. Dr. Ion Chiricuta

Cluj-Napoca, Cluj, 400015, Romania

RECRUITING

Centrul de Oncologie Sf Nectarie

Craiova, Dolj, 200746, Romania

RECRUITING

SC OncoMed SRL

Timișoara, Timiș County, 300239, Romania

RECRUITING

Hospital Son Llàtzer

Palma de Mallorca, Balearic Islands, 07198, Spain

RECRUITING

Hospital Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

ACTIVE NOT RECRUITING

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

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

RECRUITING

Biocruces Bizkaia Instituto de Investigación Sanitaria

Barakaldo, Biscay, 48903, Spain

RECRUITING

Complejo Hospitalario Universitario A Coruña

A Coruña, La Coruña, 15006, Spain

RECRUITING

Complejo Hospitalario Universitario Insular Materno Infantil

Las Palmas de Gran Canaria, Las Palmas, 35016, Spain

RECRUITING

Hospital Universitario Puerta de Hierro - Majadahonda

Majadahonda, Madrid, 28222, Spain

RECRUITING

HC Marbella

Marbella, Malaga, 29660, Spain

RECRUITING

Clínica Mi Tres Torres

Barcelona, 08017, Spain

RECRUITING

Hospital Universitari Dexeus

Barcelona, 08028, Spain

RECRUITING

Hospital Universitari Vall d'Hebrón

Barcelona, 08035, Spain

RECRUITING

Hospital Clinic de Barcelona

Barcelona, 08036, Spain

RECRUITING

Hospital Universitario Reina Sofía

Córdoba, 14004, Spain

RECRUITING

Hospital Universitari de Girona Dr. Josep Trueta

Girona, 17007, Spain

RECRUITING

Hospital Universitario Lucus Augusti

Lugo, 27004, Spain

RECRUITING

Hospital General Universitario Gregorio Marañón

Madrid, 28007, Spain

RECRUITING

Hospital Universitario Ramón y Cajal

Madrid, 28034, Spain

RECRUITING

Hospital Universitario La Paz

Madrid, 28046, Spain

RECRUITING

Hospital Regional Universitario de Málaga - Hospital General

Málaga, 29011, Spain

RECRUITING

Hospital Universitario Virgen Macarena

Seville, 41009, Spain

RECRUITING

University Hospitals of Leicester NHS Trust

Leicester, England, LE2 9LX, United Kingdom

RECRUITING

The Christie NHS Foundation Trust

Manchester, England, M20 4BX, United Kingdom

RECRUITING

The Clatterbridge Cancer Centre NHS Foundation Trust

Metropolitan Borough of Wirral, England, CH63 4JY, United Kingdom

RECRUITING

The Royal Marsden NHS Foundation Trust

Sutton, England, SM2 5PT, United Kingdom

RECRUITING

NHS Grampian

Aberdeen, Scotland, AB25 2ZN, United Kingdom

RECRUITING

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Docetaxel

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Central Study Contacts

Caroline Chevalier, MSc, MPH

CONTACT

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 7, 2024

First Posted

June 25, 2024

Study Start

December 3, 2024

Primary Completion (Estimated)

December 15, 2027

Study Completion (Estimated)

December 15, 2028

Last Updated

April 1, 2026

Record last verified: 2026-03

Locations