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
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).
Arms & interventions
- DrugOSE2101
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.
- DrugDocetaxel
Docetaxel is an antineoplastic agent that acts by disrupting the microtubular network in cells that is essential for mitotic and interphase cellular functions.
- DeviceNGS 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.
Outcome measures
Primary
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
Time frame: From randomization date through study completion, an average of 3 years
Eligibility criteria
Study locations (79)
Clinical Research Advisors, LLC
Beverly Hills, California, 90211
Clinical Research Advisors - Encino
Encino, California, 90211
Clinical Research Advisors - West Hollywood
Los Angeles, California, 90048
Clinical Research Advisors - Korea Town
Los Angeles, California, 90211
SCL Health - Saint Joseph Hospital Cancer Center
Littleton, Colorado, 80218
Lutheran Medical Center - Cancer Centers of Colorado
Wheat Ridge, Colorado, 80033-6013
Eastern Connecticut Hematology and Oncology Associates
Norwich, Connecticut, 06360
Georgetown Lombardi Comprehensive Cancer Center
Washington D.C., District of Columbia, 20007
Comprehensive Hematology Oncology - Bradenton Clinic
Bradenton, Florida, 34210
Comprehensive Hematology Oncology - Brandon Clinic
Brandon, Florida, 33511
Cancer Specialists of North Florida - Fleming Island
Fleming Island, Florida, 32003
Cancer Specialists of North Florida - Riverside
Jacksonville, Florida, 32204
Cancer Specialists of North Florida Southside
Jacksonville, Florida, 32207
Cancer Specialists of North Florida - Northside
Jacksonville, Florida, 32218
Cancer Specialists of North Florida - Southpoint
Jacksonville, Florida, 32256-6932
Cancer Specialists of North Florida - Baptist South
Jacksonville, Florida, 32258
Cancer Specialists of North Florida
Jacksonville Beach, Florida, 32250
Comprehensive Hematology Oncology - Largo Clinic
Largo, Florida, 33770
Cancer Specialists of North Florida - Beaches
Neptune Beach, Florida, 32266
Comprehensive Hematology Oncology - Palm Harbor Clinic
Palm Harbor, Florida, 34685
Cancer Specialists Of North Florida - St. Augustine
Saint Augustine, Florida, 32086
Comprehensive Hematology Oncology - Bayfront Clinic
St. Petersburg, Florida, 33709
Comprehensive Hematology Oncology
St. Petersburg, Florida, 33709
Comprehensive Hematology Oncology - Trinity Clinic
Trinity, Florida, 34655
University of Illinois Cancer Center
Chicago, Illinois, 60612
Alliance for Multispecialty Research (AMR) - Kansas City Oncology
Merriam, Kansas, 66204
Mary Bird Perkins Cancer Center - Baton Rouge
Baton Rouge, Louisiana, 70809
Pontchartrain Cancer Center - Covington Office
Covington, Louisiana, 70433
Pontchartrain Cancer Center - Hammond Office
Hammond, Louisiana, 70403-1452
Ascension Saint Agnes Hospital
Baltimore, Maryland, 21229
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, 01655
Nebraska Hematology-Oncology - Revive Research Institute LLC
Lincoln, Nebraska, 68506
New York Cancer & Blood Specialists - Babylon Medical Oncology
Babylon, New York, 11702
Optum Medical Care - Carmel/Brewster Campus
Brewster, New York, 10509
Brooklyn Radiation Oncology
Brooklyn, New York, 11201
Optum Medical Care - Fishkill Westage Campus
Fishkill, New York, 12524
Clinical Research Alliance
Lake Success, New York, 11042
Optum Medical Care - Mount Kisco Campus 90
Mount Kisco, New York, 10549
New York Cancer & Blood Specialists - New Hyde Park
New Hyde Park, New York, 11042
Optum Hematology Oncology - Lake Success
New Hyde Park, New York, 11042
New York Cancer & Blood Specialists - Cancer Center - Research Headquarters
New York, New York, 10028
New York Cancer & Blood Specialists - Central Park Medical Oncology
New York, New York, 10028
New York Cancer & Blood Specialists - Patchogue Medical Oncology
Patchogue, New York, 11772
New York Cancer & Blood Specialists - Port Jefferson Medical Oncology
Port Jefferson Station, New York, 11776
New York Cancer & Blood Specialists - Port Jefferson Station Medical Oncology
Port Jefferson Station, New York, 11776
Optum Medical Care - Poughkeepsie
Poughkeepsie, New York, 12601
New York Cancer & Blood Specialists - Eastchester Cancer Care Center
The Bronx, New York, 10469
New York Cancer & Blood Specialists - Riverhead Medical Oncology
The Bronx, New York, 10469
Mercy Health - Perrysburg Cancer Center
Perrysburg, Ohio, 43551
Mercy Health - St. Anne Cancer Center
Toledo, Ohio, 43623
Bon Secours Hematology and Oncology
Greenville, South Carolina, 29607
Tennessee Oncology - Chattanooga - Medical Park II
Chattanooga, Tennessee, 36404
Tennessee Oncology - Chattanooga - Downtown
Chattanooga, Tennessee, 37403
Tennessee Oncology - Chattanooga - GHCR Site I
Chattanooga, Tennessee, 37403
Tennessee Oncology - Chattanooga - Memorial Plaza
Chattanooga, Tennessee, 37404
Tennessee Oncology - Cleveland Clinic
Cleveland, Tennessee, 37311
Tennessee Oncology - Cookeville Clinic
Cookeville, Tennessee, 38501
Tennessee Oncology - Dickson Clinic
Dickson, Tennessee, 37055
Tennessee Oncology - Franklin Clinic
Franklin, Tennessee, 37067
Tennessee Oncology - Gallatin Clinic
Gallatin, Tennessee, 37066
Tennessee Oncology - Hendersonville Clinic
Hendersonville, Tennessee, 37075
Tennessee Oncology - Hermitage - Summit Clinic
Hermitage, Tennessee, 37076
Tennessee Oncology - Lebanon Clinic
Lebanon, Tennessee, 37090
Tennessee Oncology - Murfreesboro Clinic
Murfreesboro, Tennessee, 37129
Tennessee Oncology - Nashville - Centennial Center for Blood Cancers Clinic
Nashville, Tennessee, 37203
Tennessee Oncology - Nashville - Centennial Clinic - Medical Oncology
Nashville, Tennessee, 37203
Tennessee Oncology - Nashville - Midtown Center for Blood Cancers
Nashville, Tennessee, 37203
Tennessee Oncology - Nashville - St. Thomas Midtown Clinic
Nashville, Tennessee, 37203
Tennessee Oncology - Nashville - St. Thomas West Clinic
Nashville, Tennessee, 37205
Tennessee Oncology - Nashville - Skyline Clinic
Nashville, Tennessee, 37207
Tennessee Oncology - Nashville - Southern Hills Clinic
Nashville, Tennessee, 37211
Greco-Hainsworth Tennessee Oncology Centers for Research (GHCR) - Corporate
Nashville, Tennessee, 37232
Tennessee Oncology - Shelbyville Clinic
Shelbyville, Tennessee, 37160
Tennessee Oncology - Smyrna Clinic
Smyrna, Tennessee, 37167
Northwest Medical Specialties - Bonney Lake
Bonney Lake, Washington, 98391
Northwest Medical Specialties - Federal Way
Federal Way, Washington, 98003
Northwest Medical Specialties - Gig Harbor
Gig Harbor, Washington, 98332
Northwest Medical Specialties - Puyallup Medical Oncology
Puyallup, Washington, 98373
Northwest Medical Specialties - Tacoma
Tacoma, Washington, 98405
References
- 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)