Recruiting

Phase 3

OSE2101Trial of Therapeutic Cancer Vaccine OSE2101 in Patients With Non-Small Cell Lung Cancer and Secondary Resistance to Immune Checkpoint Inhibitor

Sponsor:

OSE Immunotherapeutics

Code:

NCT06472245

Conditions

Patients With Non-Small Cell Lung Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

OSE2101

Docetaxel

NGS HLAA2 assay

Study Details

Brief 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).

Conditions

Patients With Non-Small Cell Lung Cancer

Study ID

NCT06472245

Start date

Dec 3, 2024

Status verified date

Jul, 2026

Completion date

Dec 15, 2028

Anticipated

Primary completion date

Dec 15, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

363 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

active comparator: Arm B: Docetaxel

Unit dose: 75 mg/m2 Mode/Route: Intravenous infusion over 1 hour Regimen: One infusion every three weeks.

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.

Interventions

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.

Docetaxel

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

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.

Primary outcome measure

OS defined as time from randomization to death [ Time Frame: From randomization date through study completion, an average of 3 years ]

Central Contacts and Locations

Central contacts

Caroline Chevalier, MSc, MPH

+33 630 842 002 caroline.chevalier@ose-immuno.com

Bérangère Vasseur, MD

+33 676 448 160 berangere.vasseur@ose-immuno.com

Locations

Clinical Research Advisors, LLC

Recruiting

Beverly Hills, California, United States, 90211

Lutheran Medical Center - Cancer Centers of Colorado

Recruiting

Wheat Ridge, Colorado, United States, 80033-6013

Eastern Connecticut Hematology and Oncology Associates

Recruiting

Norwich, Connecticut, United States, 06360

Georgetown Lombardi Comprehensive Cancer Center

Recruiting

Washington D.C., District of Columbia, United States, 20007

Cancer Specialists of North Florida - Fleming Island

Recruiting

Fleming Island, Florida, United States, 32003

Cancer Specialists of North Florida - Riverside

Recruiting

Jacksonville, Florida, United States, 32204

Cancer Specialists of North Florida - Northside

Recruiting

Jacksonville, Florida, United States, 32218

Cancer Specialists of North Florida - Southpoint

Recruiting

Jacksonville, Florida, United States, 32256-6932

Cancer Specialists of North Florida

Recruiting

Jacksonville Beach, Florida, United States, 32250

Cancer Specialists Of North Florida - St. Augustine

Recruiting

Saint Augustine, Florida, United States, 32086

Comprehensive Hematology Oncology

Recruiting

St. Petersburg, Florida, United States, 33709

Comprehensive Hematology Oncology - Trinity Clinic

Recruiting

Trinity, Florida, United States, 34655

University of Illinois Cancer Center

Recruiting

Chicago, Illinois, United States, 60612

Pontchartrain Cancer Center - Covington Office

Recruiting

Covington, Louisiana, United States, 70433

Pontchartrain Cancer Center - Hammond Office

Recruiting

Hammond, Louisiana, United States, 70403-1452

Ascension Saint Agnes Hospital

Recruiting

Baltimore, Maryland, United States, 21229

University of Massachusetts Memorial Medical Center

Recruiting

Worcester, Massachusetts, United States, 01655

Nebraska Hematology-Oncology - Revive Research Institute LLC

Recruiting

Lincoln, Nebraska, United States, 68506

New York Cancer & Blood Specialists - New Hyde Park

Recruiting

New Hyde Park, New York, United States, 11042

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

Recruiting

New York, New York, United States, 10028

New York Cancer & Blood Specialists - Patchogue Medical Oncology

Recruiting

Patchogue, New York, United States, 11772

Bon Secours Hematology and Oncology

Recruiting

Greenville, South Carolina, United States, 29607

Tennessee Oncology - Chattanooga - Downtown

Recruiting

Chattanooga, Tennessee, United States, 37403

Tennessee Oncology - Chattanooga - GHCR Site I

Recruiting

Chattanooga, Tennessee, United States, 37403

Tennessee Oncology - Chattanooga - Memorial Plaza

Recruiting

Chattanooga, Tennessee, United States, 37404

Tennessee Oncology - Cleveland Clinic

Recruiting

Cleveland, Tennessee, United States, 37311

Tennessee Oncology - Franklin Clinic

Recruiting

Franklin, Tennessee, United States, 37067

Tennessee Oncology - Nashville - St. Thomas West Clinic

Recruiting

Nashville, Tennessee, United States, 37205

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

Recruiting

Nashville, Tennessee, United States, 37232

Tennessee Oncology - Shelbyville Clinic

Recruiting

Shelbyville, Tennessee, United States, 37160

Tennessee Oncology - Smyrna Clinic

Recruiting

Smyrna, Tennessee, United States, 37167

Northwest Medical Specialties - Gig Harbor

Recruiting

Gig Harbor, Washington, United States, 98332

Northwest Medical Specialties - Puyallup Medical Oncology

Recruiting

Puyallup, Washington, United States, 98373

Northwest Medical Specialties - Tacoma

Recruiting

Tacoma, Washington, United States, 98405

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

Recruiting

Chicoutimi, Quebec, Canada, G7H 5H6

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

Recruiting

Rimouski, Quebec, Canada, G5L 5T1

More Information

Sponsor

OSE Immunotherapeutics

Last update posted

Jul 23, 2026

Last verified

Jul, 2026

Keywords

Immune Checkpoint Inhibitor
Cancer vaccine
Non-Small Cell Lung Cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by OSE Immunotherapeutics on 2026-07-23.