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

PHASE3RecruitingINTERVENTIONAL
Enrollment

363

Participants

Timeline

Start Date

December 3, 2024

Primary Completion Date

December 15, 2027

Study Completion Date

December 15, 2028

Conditions
Patients With Non-Small Cell Lung Cancer
Interventions
DRUG

OSE2101

OSE2101 is a peptidic cancer vaccine composed of nine epitopes restricted to HLA-A2 phenotype targeting the tumor associated antigens of P53, HER-2, CEA, MAGE-2 and MAGE-3, and one pan-HLA DR binding epitope (PADRE), all epitopes emulsified in Montanide ISA 51TM adjuvant.

DRUG

Docetaxel

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

DEVICE

NGS HLAA2 assay

Amp-HLA-A-CDx Tedopi for amplification of human genomic DNA (gDNA), LFK-CDx Tedopi kit (library full kit) for library preparation, NGSengine-CDx Tedopi software for analysis of NGS data files.

Trial Locations (205)

1121

ACTIVE_NOT_RECRUITING

Országos Korányi Pulmonológiai Intézet, Budapest

2930

RECRUITING

Algemeen Ziekenhuis Klina, Brasschaat

3000

ACTIVE_NOT_RECRUITING

Universitair Ziekenhuis Leuven - Campus Gasthuisberg, Leuven

3200

ACTIVE_NOT_RECRUITING

Mátrai Gyógyintézet, Gyöngyös

RECRUITING

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

3500

RECRUITING

Jessa Ziekenhuis - Campus Virga Jesse, Hasselt

8500

ACTIVE_NOT_RECRUITING

Algemeen Ziekenhuis Groeninge - Campus Kennedylaan, Kortrijk

8800

ACTIVE_NOT_RECRUITING

Algemeen Ziekenhuis Delta - Campus Rembert Torhout, Roeselare

RECRUITING

Algemeen Ziekenhuis Delta - Campus Rumbeke, Roeselare

9000

RECRUITING

Algemeen Ziekenhuis Maria Middelares, Ghent

10028

RECRUITING

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

ACTIVE_NOT_RECRUITING

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

10043

RECRUITING

Azienda Ospedaliero - Universitaria San Luigi Gonzaga, Orbassano

10469

ACTIVE_NOT_RECRUITING

New York Cancer & Blood Specialists - Eastchester Cancer Care Center, The Bronx

ACTIVE_NOT_RECRUITING

New York Cancer & Blood Specialists - Riverhead Medical Oncology, The Bronx

10509

ACTIVE_NOT_RECRUITING

Optum Medical Care - Carmel/Brewster Campus, Brewster

10549

ACTIVE_NOT_RECRUITING

Optum Medical Care - Mount Kisco Campus 90, Mount Kisco

11042

ACTIVE_NOT_RECRUITING

Clinical Research Alliance, Lake Success

ACTIVE_NOT_RECRUITING

New York Cancer & Blood Specialists - New Hyde Park, New Hyde Park

ACTIVE_NOT_RECRUITING

Optum Hematology Oncology - Lake Success, New Hyde Park

11201

ACTIVE_NOT_RECRUITING

Brooklyn Radiation Oncology, Brooklyn

11522

RECRUITING

Saint Savvas Anticancer - Oncological Hospital of Athens, Athens

11526

RECRUITING

Henry Dunant Hospital Center, Athens

11527

RECRUITING

General Hospital for Thoracic Diseases Sotiria, Athens

11702

ACTIVE_NOT_RECRUITING

New York Cancer & Blood Specialists - Babylon Medical Oncology, Babylon

11772

RECRUITING

New York Cancer & Blood Specialists - Patchogue Medical Oncology, Patchogue

11776

ACTIVE_NOT_RECRUITING

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

ACTIVE_NOT_RECRUITING

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

12524

ACTIVE_NOT_RECRUITING

Optum Medical Care - Fishkill Westage Campus, Fishkill

12601

ACTIVE_NOT_RECRUITING

Optum Medical Care - Poughkeepsie, Poughkeepsie

13015

RECRUITING

Hôpital Nord de Marseille, Marseille

13273

RECRUITING

Institut Paoli-Calmettes, Marseille

13353

ACTIVE_NOT_RECRUITING

Charité - Universitätsmedizin Berlin, Berlin

14004

RECRUITING

Hospital Universitario Reina Sofía, Córdoba

14341

ACTIVE_NOT_RECRUITING

Hospital CUF Porto, Porto

14564

RECRUITING

Agii Anargiri Cancer Hospital, Nea Kifissia

15006

RECRUITING

Complejo Hospitalario Universitario A Coruña, A Coruña

16132

RECRUITING

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

17007

RECRUITING

Hospital Universitari de Girona Dr. Josep Trueta, Girona

20007

RECRUITING

Georgetown Lombardi Comprehensive Cancer Center, Washington D.C.

20089

ACTIVE_NOT_RECRUITING

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

20132

NOT_YET_RECRUITING

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

20133

RECRUITING

Fondazione IRCCS - Istituto Nazionale dei Tumori, Milan

21229

RECRUITING

Ascension Saint Agnes Hospital, Baltimore

22927

ACTIVE_NOT_RECRUITING

LungenClinic Grosshansdorf, Großhansdorf

25030

RECRUITING

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

26504

RECRUITING

University General Hospital of Patras, Patra

27004

RECRUITING

Hospital Universitario Lucus Augusti, Lugo

28007

RECRUITING

Hospital General Universitario Gregorio Marañón, Madrid

28034

RECRUITING

Hospital Universitario Ramón y Cajal, Madrid

28046

RECRUITING

Hospital Universitario La Paz, Madrid

28100

RECRUITING

Azienda Ospedaliero-Universitaria Maggiore della Carità di Novara, Novara

28222

RECRUITING

Hospital Universitario Puerta de Hierro - Majadahonda, Majadahonda

29011

RECRUITING

Hospital Regional Universitario de Málaga - Hospital General, Málaga

29200

RECRUITING

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

29607

RECRUITING

Bon Secours Hematology and Oncology, Greenville

29660

RECRUITING

HC Marbella, Marbella

31059

RECRUITING

Hôpital Larrey, Toulouse

32003

ACTIVE_NOT_RECRUITING

Cancer Specialists of North Florida - Fleming Island, Fleming Island

32086

ACTIVE_NOT_RECRUITING

Cancer Specialists Of North Florida - St. Augustine, Saint Augustine

32204

ACTIVE_NOT_RECRUITING

Cancer Specialists of North Florida - Riverside, Jacksonville

32207

ACTIVE_NOT_RECRUITING

Cancer Specialists of North Florida Southside, Jacksonville

32218

ACTIVE_NOT_RECRUITING

Cancer Specialists of North Florida - Northside, Jacksonville

32250

RECRUITING

Cancer Specialists of North Florida, Jacksonville Beach

32258

ACTIVE_NOT_RECRUITING

Cancer Specialists of North Florida - Baptist South, Jacksonville

32266

ACTIVE_NOT_RECRUITING

Cancer Specialists of North Florida - Beaches, Neptune Beach

33511

ACTIVE_NOT_RECRUITING

Comprehensive Hematology Oncology - Brandon Clinic, Brandon

33709

ACTIVE_NOT_RECRUITING

Comprehensive Hematology Oncology - Bayfront Clinic, St. Petersburg

RECRUITING

Comprehensive Hematology Oncology, St. Petersburg

33770

ACTIVE_NOT_RECRUITING

Comprehensive Hematology Oncology - Largo Clinic, Largo

34125

ACTIVE_NOT_RECRUITING

Klinikum Kassel, Kassel

34210

ACTIVE_NOT_RECRUITING

Comprehensive Hematology Oncology - Bradenton Clinic, Bradenton

34295

RECRUITING

Hôpital Arnaud de Villeneuve, Montpellier

34655

RECRUITING

Comprehensive Hematology Oncology - Trinity Clinic, Trinity

34685

ACTIVE_NOT_RECRUITING

Comprehensive Hematology Oncology - Palm Harbor Clinic, Palm Harbor

35016

RECRUITING

Complejo Hospitalario Universitario Insular Materno Infantil, Las Palmas de Gran Canaria

35033

RECRUITING

Hôpital Pontchaillou, Rennes

35128

ACTIVE_NOT_RECRUITING

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

36404

ACTIVE_NOT_RECRUITING

Tennessee Oncology - Chattanooga - Medical Park II, Chattanooga

37045

ACTIVE_NOT_RECRUITING

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

37055

ACTIVE_NOT_RECRUITING

Tennessee Oncology - Dickson Clinic, Dickson

37066

ACTIVE_NOT_RECRUITING

Tennessee Oncology - Gallatin Clinic, Gallatin

37067

RECRUITING

Tennessee Oncology - Franklin Clinic, Franklin

37075

ACTIVE_NOT_RECRUITING

Tennessee Oncology - Hendersonville Clinic, Hendersonville

37076

ACTIVE_NOT_RECRUITING

Tennessee Oncology - Hermitage - Summit Clinic, Hermitage

37090

ACTIVE_NOT_RECRUITING

Tennessee Oncology - Lebanon Clinic, Lebanon

37129

ACTIVE_NOT_RECRUITING

Tennessee Oncology - Murfreesboro Clinic, Murfreesboro

37160

RECRUITING

Tennessee Oncology - Shelbyville Clinic, Shelbyville

37167

RECRUITING

Tennessee Oncology - Smyrna Clinic, Smyrna

37203

ACTIVE_NOT_RECRUITING

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

ACTIVE_NOT_RECRUITING

Tennessee Oncology - Nashville - Centennial Clinic - Medical Oncology, Nashville

ACTIVE_NOT_RECRUITING

Tennessee Oncology - Nashville - Midtown Center for Blood Cancers, Nashville

ACTIVE_NOT_RECRUITING

Tennessee Oncology - Nashville - St. Thomas Midtown Clinic, Nashville

37205

RECRUITING

Tennessee Oncology - Nashville - St. Thomas West Clinic, Nashville

37207

ACTIVE_NOT_RECRUITING

Tennessee Oncology - Nashville - Skyline Clinic, Nashville

37211

ACTIVE_NOT_RECRUITING

Tennessee Oncology - Nashville - Southern Hills Clinic, Nashville

37232

RECRUITING

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

37311

ACTIVE_NOT_RECRUITING

Tennessee Oncology - Cleveland Clinic, Cleveland

37403

RECRUITING

Tennessee Oncology - Chattanooga - Downtown, Chattanooga

ACTIVE_NOT_RECRUITING

Tennessee Oncology - Chattanooga - GHCR Site I, Chattanooga

37404

RECRUITING

Tennessee Oncology - Chattanooga - Memorial Plaza, Chattanooga

38501

ACTIVE_NOT_RECRUITING

Tennessee Oncology - Cookeville Clinic, Cookeville

38700

RECRUITING

Hôpital Michallon, La Tronche

41009

RECRUITING

Hospital Universitario Virgen Macarena, Seville

43551

ACTIVE_NOT_RECRUITING

Mercy Health - Perrysburg Cancer Center, Perrysburg

43623

ACTIVE_NOT_RECRUITING

Mercy Health - St. Anne Cancer Center, Toledo

44093

RECRUITING

Centre Hospitalier Universitaire De Nantes - Hôpital Nord Laennec, Nantes

44805

RECRUITING

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

45147

RECRUITING

Universitätsklinikum Essen, Essen

47014

ACTIVE_NOT_RECRUITING

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

47923

ACTIVE_NOT_RECRUITING

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

48903

RECRUITING

Biocruces Bizkaia Instituto de Investigación Sanitaria, Barakaldo

49325

RECRUITING

Centre Hospitalier (Ch) De Cholet, Cholet

52074

RECRUITING

Universitätsklinikum Aachen, Aachen

53100

RECRUITING

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

53127

ACTIVE_NOT_RECRUITING

Universitätsklinikum Bonn, Bonn

55100

ACTIVE_NOT_RECRUITING

Presidio Ospedaliero di Lucca, San Filippo

55236

RECRUITING

Clinic Agios Loukas, Thessaloniki

56126

ACTIVE_NOT_RECRUITING

Azienda Ospedaliero-Universitaria Pisana, Pisa

60612

RECRUITING

University of Illinois Cancer Center, Chicago

64109

RECRUITING

Centre Hospitalier de la Côte Basque, Bayonne

66204

WITHDRAWN

Alliance for Multispecialty Research (AMR) - Kansas City Oncology, Merriam

66421

ACTIVE_NOT_RECRUITING

Universitätsklinikum Gießen und Marburg - Gießen, Homburg

67091

RECRUITING

Nouvel Hôpital Civil, Strasbourg

68100

RECRUITING

Hôpital Emile Muller, Mulhouse

68506

RECRUITING

Nebraska Hematology-Oncology - Revive Research Institute LLC, Lincoln

69126

ACTIVE_NOT_RECRUITING

Thoraxklinik-Heidelberg, Heidelberg

69317

RECRUITING

Centre Hospitalier Lyon-Sud, Lyon

ACTIVE_NOT_RECRUITING

Hôpital de la Croix Rousse, Lyon

69500

ACTIVE_NOT_RECRUITING

Hôpital Louis Pradel, Bron

70376

RECRUITING

Robert-Bosch-Krankenhaus, Stuttgart

70433

RECRUITING

Pontchartrain Cancer Center - Covington Office, Covington

70809

ACTIVE_NOT_RECRUITING

Mary Bird Perkins Cancer Center - Baton Rouge, Baton Rouge

72037

RECRUITING

Centre Hospitalier Le Mans, Le Mans

73100

ACTIVE_NOT_RECRUITING

Ospedale Vito Fazzi Lecce, Lecce

75014

RECRUITING

Groupe Hospitalier Paris Saint-Joseph, Paris

ACTIVE_NOT_RECRUITING

Hôpital Cochin, Paris

75020

RECRUITING

Hôpital Tenon, Paris

80131

RECRUITING

Azienda Ospedaliera Universitaria - Università degli Studi della Campania Luigi Vanvitelli, Napoli

80218

NOT_YET_RECRUITING

SCL Health - Saint Joseph Hospital Cancer Center, Littleton

81925

NOT_YET_RECRUITING

München Klinik Bogenhausen, München

82131

RECRUITING

Asklepios Fachkliniken München-Gauting, Gauting

83800

RECRUITING

Hôpital d'Instruction des Armées Sainte-Anne, Toulon

84000

RECRUITING

Institut Sainte Catherine, Avignon

85000

RECRUITING

Centre Hospitalier Départemental Vendée, La Roche-sur-Yon

86021

ACTIVE_NOT_RECRUITING

Centre Hospitalier Universitaire de Poitiers, Poitiers

87000

RECRUITING

Centre Hospitalier Universitaire Dupuytren 1, Limoges

90048

ACTIVE_NOT_RECRUITING

Clinical Research Advisors - West Hollywood, Los Angeles

90211

ACTIVE_NOT_RECRUITING

Clinical Research Advisors, LLC, Beverly Hills

ACTIVE_NOT_RECRUITING

Clinical Research Advisors - Encino, Encino

ACTIVE_NOT_RECRUITING

Clinical Research Advisors - Korea Town, Los Angeles

93000

RECRUITING

Hôpital Avicenne, Bobigny

94000

RECRUITING

Centre Hospitalier Intercommunal de Créteil, Créteil

94805

RECRUITING

Gustave Roussy, Villejuif

98003

ACTIVE_NOT_RECRUITING

Northwest Medical Specialties - Federal Way, Federal Way

98332

ACTIVE_NOT_RECRUITING

Northwest Medical Specialties - Gig Harbor, Gig Harbor

98373

RECRUITING

Northwest Medical Specialties - Puyallup Medical Oncology, Puyallup

98391

ACTIVE_NOT_RECRUITING

Northwest Medical Specialties - Bonney Lake, Bonney Lake

98405

RECRUITING

Northwest Medical Specialties - Tacoma, Tacoma

200746

ACTIVE_NOT_RECRUITING

Centrul de Oncologie Sf Nectarie, Craiova

300239

RECRUITING

SC OncoMed SRL, Timișoara

400015

RECRUITING

Institutul Oncologic Prof. Dr. Ion Chiricuta, Cluj-Napoca

80033-6013

ACTIVE_NOT_RECRUITING

Lutheran Medical Center - Cancer Centers of Colorado, Wheat Ridge

06360

RECRUITING

Eastern Connecticut Hematology and Oncology Associates, Norwich

32256-6932

RECRUITING

Cancer Specialists of North Florida - Southpoint, Jacksonville

70403-1452

ACTIVE_NOT_RECRUITING

Pontchartrain Cancer Center - Hammond Office, Hammond

01655

ACTIVE_NOT_RECRUITING

University of Massachusetts Memorial Medical Center, Worcester

B-5000

RECRUITING

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

Unknown

ACTIVE_NOT_RECRUITING

Algemeen Ziekenhuis Delta - Campus Menen, Roeselare

G7H 5H6

RECRUITING

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

H4A 3J1

ACTIVE_NOT_RECRUITING

McGill University Health Centre, Montreal

G5L 5T1

RECRUITING

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

06120

RECRUITING

Krankenhaus Martha-Maria Halle-Dölau, Halle

185 47

RECRUITING

Metropolitan Hospital, Piraeus

711 10

RECRUITING

University General Hospital of Heraklion (PAGNI), Heraklion

TK 56403

ACTIVE_NOT_RECRUITING

General Hospital of Thessaloniki Papageorgiou, Thessaloniki

546 39

RECRUITING

Theagenio Anti-Cancer Hospital of Thessaloniki, Thessaloniki

411 10

RECRUITING

University General Hospital of Larissa, Larissa

00144

ACTIVE_NOT_RECRUITING

IRCCS Istituto Nazionale Tumori Regina Elena, Roma

00152

ACTIVE_NOT_RECRUITING

Azienda Ospedaliera San Camillo Forlanini, Rome

6525 GA

RECRUITING

Radboud Universitair Medisch Centrum, Nijmegen

3015 GD

RECRUITING

Erasmus Medisch Centrum, Rotterdam

9713 GZ

ACTIVE_NOT_RECRUITING

Universitair Medisch Centrum Groningen, Groningen

62-500

ACTIVE_NOT_RECRUITING

Przychodnia Lekarska KOMED Roman Karaszewski, Konin

60-569

ACTIVE_NOT_RECRUITING

Wielkopolskie Centrum Pulmonologii i Torakochirurgii im. Eugenii i Janusza Zeylandów, Poznan

85-796

RECRUITING

Centrum Onkologii Im. Prof. F. Łukaszczyka w Bydgoszczy, Bydgoszcz

20-090

RECRUITING

Uniwersytecki Szpital Kliniczny Nr 4 w Lublinie, Lublin

93-338

RECRUITING

Instytut Centrum Zdrowia Matki Polki, Lodz

80-210

RECRUITING

Uniwersyteckie Centrum Kliniczne w Gdańsku, Gdansk

3000-075

ACTIVE_NOT_RECRUITING

Unidade Local de Saúde de Coimbra, Coimbra

1769-001

ACTIVE_NOT_RECRUITING

Hospital CUF Descobertas, Lisbon

ACTIVE_NOT_RECRUITING

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

4434-502

ACTIVE_NOT_RECRUITING

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

07198

ACTIVE_NOT_RECRUITING

Hospital Son Llàtzer, Palma de Mallorca

08916

ACTIVE_NOT_RECRUITING

Hospital Germans Trias i Pujol, Badalona

08907

RECRUITING

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

08017

RECRUITING

Clínica Mi Tres Torres, Barcelona

08028

RECRUITING

Hospital Universitari Dexeus, Barcelona

08035

RECRUITING

Hospital Universitari Vall d'Hebrón, Barcelona

08036

RECRUITING

Hospital Clinic de Barcelona, Barcelona

LE2 9LX

ACTIVE_NOT_RECRUITING

University Hospitals of Leicester NHS Trust, Leicester

M20 4BX

RECRUITING

The Christie NHS Foundation Trust, Manchester

CH63 4JY

RECRUITING

The Clatterbridge Cancer Centre NHS Foundation Trust, Metropolitan Borough of Wirral

SM2 5PT

RECRUITING

The Royal Marsden NHS Foundation Trust, Sutton

AB25 2ZN

RECRUITING

NHS Grampian, Aberdeen

Sponsors
All Listed Sponsors
collaborator

Exystat

OTHER

collaborator

Genome Diagnostics (GenDx)

UNKNOWN

lead

OSE Immunotherapeutics

INDUSTRY