Trial of Therapeutic Cancer Vaccine OSE2101 in Patients With Non-Small Cell Lung Cancer and Secondary Resistance to Immune Checkpoint Inhibitor
Recruiting now · Phase 3
Conditions studied: Patients With Non-Small Cell Lung Cancer
In brief
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).
Key facts
- Study ID
- NCT06472245
- Run by
- OSE Immunotherapeutics
- People needed
- 363
- Starts
- 2024-12-03
- Expected to finish
- 2028-12-15
- Last updated by the study team
- 2026-07-23
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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;
- Other inclusion and exclusion criteria will apply per protocol.
Where it is running
- Bon Secours Hematology and Oncology — Greenville, South Carolina, United States (enrolling)
- Tennessee Oncology - Chattanooga - GHCR Site I — Chattanooga, Tennessee, United States (enrolling)
- University of Massachusetts Memorial Medical Center — Worcester, Massachusetts, United States (enrolling)
- New York Cancer & Blood Specialists - Patchogue Medical Oncology — Patchogue, New York, United States (enrolling)
- Tennessee Oncology - Chattanooga - Downtown — Chattanooga, Tennessee, United States (enrolling)
- Eastern Connecticut Hematology and Oncology Associates — Norwich, Connecticut, United States (enrolling)
- Pontchartrain Cancer Center - Covington Office — Covington, Louisiana, United States (enrolling)
- Ascension Saint Agnes Hospital — Baltimore, Maryland, United States (enrolling)
- New York Cancer & Blood Specialists - New Hyde Park — New Hyde Park, New York, United States (enrolling)
- New York Cancer & Blood Specialists - Cancer Center - Research Headquarters — New York, New York, United States (enrolling)
- Cancer Specialists of North Florida - Riverside — Jacksonville, Florida, United States (enrolling)
- Lutheran Medical Center - Cancer Centers of Colorado — Wheat Ridge, Colorado, United States (enrolling)
- Cancer Specialists of North Florida - Northside — Jacksonville, Florida, United States (enrolling)
- Cancer Specialists of North Florida - Southpoint — Jacksonville, Florida, United States (enrolling)
- Georgetown Lombardi Comprehensive Cancer Center — Washington D.C., District of Columbia, United States (enrolling)
- Cancer Specialists of North Florida — Jacksonville Beach, Florida, United States (enrolling)
- Clinical Research Advisors, LLC — Beverly Hills, California, United States (enrolling)
- Pontchartrain Cancer Center - Hammond Office — Hammond, Louisiana, United States (enrolling)
- Nebraska Hematology-Oncology - Revive Research Institute LLC — Lincoln, Nebraska, United States (enrolling)
- Cancer Specialists Of North Florida - St. Augustine — Saint Augustine, Florida, United States (enrolling)
- Cancer Specialists of North Florida - Fleming Island — Fleming Island, Florida, United States (enrolling)
- Comprehensive Hematology Oncology — St. Petersburg, Florida, United States (enrolling)
- Comprehensive Hematology Oncology - Trinity Clinic — Trinity, Florida, United States (enrolling)
- University of Illinois Cancer Center — Chicago, Illinois, United States (enrolling)
- Tennessee Oncology - Chattanooga - Memorial Plaza — Chattanooga, Tennessee, United States (enrolling)
Full record on ClinicalTrials.gov
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