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

Purpose

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).

Condition

  • Patients With Non-Small Cell Lung Cancer

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. Male or female, aged ≥ 18 years 2. Patients expressing HLA-A2 phenotype in blood by pre-screening central laboratory 3. 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. 4. Patients with secondary resistance to ICI; Other inclusion and

Exclusion Criteria

will apply per protocol.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Arm A: OSE2101 		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: 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.
  • 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.
Active Comparator
Arm B: Docetaxel 		Unit dose: 75 mg/m2 Mode/Route: Intravenous infusion over 1 hour Regimen: One infusion every three weeks.
  • 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.
Other
GenDx CDx Tedopi 		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
    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.

Recruiting Locations

Clinical Research Advisors, LLC
Beverly Hills, California 90211

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

Cancer Specialists of North Florida - Fleming Island
Fleming Island, Florida 32003

Cancer Specialists of North Florida - Southpoint
Jacksonville, Florida 32256-6932

Cancer Specialists of North Florida
Jacksonville Beach, Florida 32250

Cancer Specialists Of North Florida - St. Augustine
Saint Augustine, Florida 32086

Comprehensive Hematology Oncology
St. Petersburg, Florida 33709

Comprehensive Hematology Oncology - Trinity Clinic
Trinity, Florida 34655

University of Illinois Cancer Center
Chicago, Illinois 60612

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 - Cancer Center - Research Headquarters
New York, New York 10028

New York Cancer & Blood Specialists - Patchogue Medical Oncology
Patchogue, New York 11772

Bon Secours Hematology and Oncology
Greenville, South Carolina 29607

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 - Franklin Clinic
Franklin, Tennessee 37067

Tennessee Oncology - Nashville - St. Thomas West Clinic
Nashville, Tennessee 37205

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 - Gig Harbor
Gig Harbor, Washington 98332

Northwest Medical Specialties - Puyallup Medical Oncology
Puyallup, Washington 98373

Northwest Medical Specialties - Tacoma
Tacoma, Washington 98405

More Details

Status
Recruiting
Sponsor
OSE Immunotherapeutics

Study Contact

Caroline Chevalier, MSc, MPH
+33 630 842 002
caroline.chevalier@ose-immuno.com