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).
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
Plus 1 other study approaches.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Oct 2, 2026 · Source: ClinicalTrials.gov
The study is currently accepting participants.
Interventional
Locations may change over time.
Study sponsor
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
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
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
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: Oct 2, 2026. Always confirm current availability with the study team.