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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

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.