Trial of Therapeutic Cancer Vaccine OSE2101 in Patients With Non-Small Cell Lung Cancer and Secondary Resistance to Immune Checkpoint Inhibitor
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).
Checked against the public recordLast updated Jul 23, 2026 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 3
- Sponsor
- OSE Immunotherapeutics
- Interventions being studied
- Drug: OSE2101; Drug: Docetaxel; Device: NGS HLAA2 assay
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Clinical Research Advisors, LLCBeverly Hills, California
- Clinical Research Advisors - EncinoEncino, California
- Clinical Research Advisors - West HollywoodLos Angeles, California
- Clinical Research Advisors - Korea TownLos Angeles, California
- SCL Health - Saint Joseph Hospital Cancer CenterLittleton, Colorado
- Lutheran Medical Center - Cancer Centers of ColoradoWheat Ridge, Colorado
- Eastern Connecticut Hematology and Oncology AssociatesNorwich, Connecticut
- Georgetown Lombardi Comprehensive Cancer CenterWashington D.C., District of Columbia
- Comprehensive Hematology Oncology - Bradenton ClinicBradenton, Florida
- Comprehensive Hematology Oncology - Brandon ClinicBrandon, Florida
- Cancer Specialists of North Florida - Fleming IslandFleming Island, Florida
- Cancer Specialists of North Florida - RiversideJacksonville, Florida
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 23, 2026. Always confirm current availability with the study team.