Trial of Therapeutic Cancer Vaccine OSE2101 in Patients With Non-Small Cell Lung Cancer and Secondary Resistance to Immune Checkpoint Inhibitor
Recruiting · NCT06472245 · Interventional (participants receive a specific treatment) · Lead sponsor: OSE Immunotherapeutics
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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).
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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;
- ther inclusion and
Exclusion criteria
- will apply per protocol.
Where it is running
60 locations listed across 16 US states.
- 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
- 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
Showing 60 of 207 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →