RecruitingPhase 3NCT06472245

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

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

Sponsor

OSE Immunotherapeutics

Enrollment

363 participants

Start Date

Dec 3, 2024

Study Type

INTERVENTIONAL

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

Min Age: 18 Years

Inclusion Criteria4

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;

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.

Locations(207)

Clinical Research Advisors, LLC

Beverly Hills, California, United States

Clinical Research Advisors - Encino

Encino, California, United States

Clinical Research Advisors - West Hollywood

Los Angeles, California, United States

Clinical Research Advisors - Korea Town

Los Angeles, California, United States

SCL Health - Saint Joseph Hospital Cancer Center

Littleton, Colorado, United States

Lutheran Medical Center - Cancer Centers of Colorado

Wheat Ridge, Colorado, United States

Eastern Connecticut Hematology and Oncology Associates

Norwich, Connecticut, United States

Georgetown Lombardi Comprehensive Cancer Center

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

Comprehensive Hematology Oncology - Bradenton Clinic

Bradenton, Florida, United States

Comprehensive Hematology Oncology - Brandon Clinic

Brandon, Florida, United States

Cancer Specialists of North Florida - Fleming Island

Fleming Island, Florida, United States

Cancer Specialists of North Florida - Riverside

Jacksonville, Florida, United States

Cancer Specialists of North Florida Southside

Jacksonville, Florida, United States

Cancer Specialists of North Florida - Northside

Jacksonville, Florida, United States

Cancer Specialists of North Florida - Southpoint

Jacksonville, Florida, United States

Cancer Specialists of North Florida - Baptist South

Jacksonville, Florida, United States

Cancer Specialists of North Florida

Jacksonville Beach, Florida, United States

Comprehensive Hematology Oncology - Largo Clinic

Largo, Florida, United States

Cancer Specialists of North Florida - Beaches

Neptune Beach, Florida, United States

Comprehensive Hematology Oncology - Palm Harbor Clinic

Palm Harbor, Florida, United States

Cancer Specialists Of North Florida - St. Augustine

Saint Augustine, Florida, United States

Comprehensive Hematology Oncology - Bayfront Clinic

St. Petersburg, Florida, United States

Comprehensive Hematology Oncology

St. Petersburg, Florida, United States

Comprehensive Hematology Oncology - Trinity Clinic

Trinity, Florida, United States

University of Illinois Cancer Center

Chicago, Illinois, United States

Alliance for Multispecialty Research (AMR) - Kansas City Oncology

Merriam, Kansas, United States

Mary Bird Perkins Cancer Center - Baton Rouge

Baton Rouge, Louisiana, United States

Pontchartrain Cancer Center - Covington Office

Covington, Louisiana, United States

Pontchartrain Cancer Center - Hammond Office

Hammond, Louisiana, United States

Ascension Saint Agnes Hospital

Baltimore, Maryland, United States

University of Massachusetts Memorial Medical Center

Worcester, Massachusetts, United States

Nebraska Hematology-Oncology - Revive Research Institute LLC

Lincoln, Nebraska, United States

New York Cancer & Blood Specialists - Babylon Medical Oncology

Babylon, New York, United States

Optum Medical Care - Carmel/Brewster Campus

Brewster, New York, United States

Brooklyn Radiation Oncology

Brooklyn, New York, United States

Optum Medical Care - Fishkill Westage Campus

Fishkill, New York, United States

Clinical Research Alliance

Lake Success, New York, United States

Optum Medical Care - Mount Kisco Campus 90

Mount Kisco, New York, United States

New York Cancer & Blood Specialists - New Hyde Park

New Hyde Park, New York, United States

Optum Hematology Oncology - Lake Success

New Hyde Park, New York, United States

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

New York, New York, United States

New York Cancer & Blood Specialists - Central Park Medical Oncology

New York, New York, United States

New York Cancer & Blood Specialists - Patchogue Medical Oncology

Patchogue, New York, United States

New York Cancer & Blood Specialists - Port Jefferson Medical Oncology

Port Jefferson Station, New York, United States

SC OncoMed SRL

Timișoara, Timiș County, Romania

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

Port Jefferson Station, New York, United States

Optum Medical Care - Poughkeepsie

Poughkeepsie, New York, United States

New York Cancer & Blood Specialists - Eastchester Cancer Care Center

The Bronx, New York, United States

New York Cancer & Blood Specialists - Riverhead Medical Oncology

The Bronx, New York, United States

Mercy Health - Perrysburg Cancer Center

Perrysburg, Ohio, United States

Mercy Health - St. Anne Cancer Center

Toledo, Ohio, United States

Bon Secours Hematology and Oncology

Greenville, South Carolina, United States

Tennessee Oncology - Chattanooga - Medical Park II

Chattanooga, Tennessee, United States

Tennessee Oncology - Chattanooga - Downtown

Chattanooga, Tennessee, United States

Tennessee Oncology - Chattanooga - GHCR Site I

Chattanooga, Tennessee, United States

Tennessee Oncology - Chattanooga - Memorial Plaza

Chattanooga, Tennessee, United States

Tennessee Oncology - Cleveland Clinic

Cleveland, Tennessee, United States

Tennessee Oncology - Cookeville Clinic

Cookeville, Tennessee, United States

Tennessee Oncology - Dickson Clinic

Dickson, Tennessee, United States

Tennessee Oncology - Franklin Clinic

Franklin, Tennessee, United States

Tennessee Oncology - Gallatin Clinic

Gallatin, Tennessee, United States

Tennessee Oncology - Hendersonville Clinic

Hendersonville, Tennessee, United States

Tennessee Oncology - Hermitage - Summit Clinic

Hermitage, Tennessee, United States

Tennessee Oncology - Lebanon Clinic

Lebanon, Tennessee, United States

Tennessee Oncology - Murfreesboro Clinic

Murfreesboro, Tennessee, United States

Tennessee Oncology - Nashville - Centennial Center for Blood Cancers Clinic