Trial of Therapeutic Cancer Vaccine OSE2101 in Patients With Non-Small Cell Lung Cancer and Secondary Resistance to Immune Checkpoint Inhibitor
NCT06472245
This study is recruiting at 35 US sites in 14 states, according to its ClinicalTrials.gov record last updated .
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).
Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov
Conditions studied
- Patients With Non-Small Cell Lung Cancer
Eligibility basics and study details
- Study type
- Interventional
- Phase
- Phase 3
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Sponsor
- OSE Immunotherapeutics
- Last updated on ClinicalTrials.gov
- October 2, 2026
These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.
US recruiting sites
California · 1
- Clinical Research Advisors, LLC · Beverly Hills, CA
Colorado · 1
- Lutheran Medical Center - Cancer Centers of Colorado · Wheat Ridge, CO
Connecticut · 1
- Eastern Connecticut Hematology and Oncology Associates · Norwich, CT
District of Columbia · 1
- Georgetown Lombardi Comprehensive Cancer Center · Washington D.C., DC
Florida · 9
- Cancer Specialists of North Florida - Fleming Island · Fleming Island, FL
- Cancer Specialists of North Florida - Northside · Jacksonville, FL
- Cancer Specialists of North Florida - Riverside · Jacksonville, FL
- Cancer Specialists of North Florida - Southpoint · Jacksonville, FL
- Cancer Specialists of North Florida Southside · Jacksonville, FL
- Cancer Specialists of North Florida · Jacksonville Beach, FL
- Cancer Specialists Of North Florida - St. Augustine · Saint Augustine, FL
- Comprehensive Hematology Oncology · St. Petersburg, FL
- Comprehensive Hematology Oncology - Trinity Clinic · Trinity, FL
Illinois · 1
- University of Illinois Cancer Center · Chicago, IL
Louisiana · 2
- Pontchartrain Cancer Center - Covington Office · Covington, LA
- Pontchartrain Cancer Center - Hammond Office · Hammond, LA
Maryland · 1
- Ascension Saint Agnes Hospital · Baltimore, MD
Massachusetts · 1
- University of Massachusetts Memorial Medical Center · Worcester, MA
Nebraska · 1
- Nebraska Hematology-Oncology - Revive Research Institute LLC · Lincoln, NE
New York · 3
- New York Cancer & Blood Specialists - New Hyde Park · New Hyde Park, NY
- New York Cancer & Blood Specialists - Cancer Center - Research Headquarters · New York, NY
- New York Cancer & Blood Specialists - Patchogue Medical Oncology · Patchogue, NY
South Carolina · 1
- Bon Secours Hematology and Oncology · Greenville, SC
Tennessee · 9
- Tennessee Oncology - Chattanooga - Downtown · Chattanooga, TN
- Tennessee Oncology - Chattanooga - GHCR Site I · Chattanooga, TN
- Tennessee Oncology - Chattanooga - Memorial Plaza · Chattanooga, TN
- Tennessee Oncology - Cleveland Clinic · Cleveland, TN
- Tennessee Oncology - Franklin Clinic · Franklin, TN
- Greco-Hainsworth Tennessee Oncology Centers for Research (GHCR) - Corporate · Nashville, TN
- Tennessee Oncology - Nashville - St. Thomas West Clinic · Nashville, TN
- Tennessee Oncology - Shelbyville Clinic · Shelbyville, TN
- Tennessee Oncology - Smyrna Clinic · Smyrna, TN
Washington · 3
- Northwest Medical Specialties - Gig Harbor · Gig Harbor, WA
- Northwest Medical Specialties - Puyallup Medical Oncology · Puyallup, WA
- Northwest Medical Specialties - Tacoma · Tacoma, WA
Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.