Trials / Recruiting
RecruitingNCT06472245
Trial of Therapeutic Cancer Vaccine OSE2101 in Patients With Non-Small Cell Lung Cancer and Secondary Resistance to Immune Checkpoint Inhibitor
A Randomised, Open-label, Phase 3 Trial Comparing the Efficacy and Safety of OSE2101 Versus Docetaxel in HLA-A2 Positive Patients With Metastatic Non-Small Cell Lung Cancer (NSCLC) With Secondary Resistance to Immune Checkpoint Inhibitor
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 363 (estimated)
- Sponsor
- OSE Immunotherapeutics · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
| 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. |
Timeline
- Start date
- 2024-12-03
- Primary completion
- 2027-12-15
- Completion
- 2028-12-15
- First posted
- 2024-06-25
- Last updated
- 2026-04-01
Locations
207 sites across 14 countries: United States, Belgium, Canada, France, Germany, Greece, Hungary, Italy, Netherlands, Poland, Portugal, Romania, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06472245. Inclusion in this directory is not an endorsement.