Tests a cancer vaccine, OSE2101, against docetaxel in lung cancer
Tests the OSE2101 vaccine against docetaxel in lung cancer that stopped responding to immunotherapy.
Plain-language title generated from the registry record
Registry title: Trial of Therapeutic Cancer Vaccine OSE2101 in Patients With Non-Small Cell Lung Cancer and Secondary Resistance to Immune Checkpoint Inhibitor
Key facts
- Where
- Coimbra, Lisbon, Porto, and Vila Nova de Gaia, PortugalSee the 5 sites
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Which best describes your lung cancer?
- Has the cancer spread to other parts of the body, or is it too advanced to be removed by surgery?
Source: NCT06472245, who can take part
Where in Portugal
- Unidade Local de Saude de CoimbraCoimbra, PortugalTaking people
- Hospital CUF DescobertasLisbon, PortugalTaking people
- Unidade Local de Saude de Santa Maria, E.P.E. - Hospital Pulido ValenteLisbon, PortugalTaking people
- Hospital CUF PortoPorto, PortugalTaking people
- Unidade Local de Saúde de Gaia/Espinho, E. P. EVila Nova de Gaia, PortugalTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- OSE Immunotherapeutics
- Trial code
- NCT06472245
- Record updated
- 2 October 2026
- Original description
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.Read full original descriptionShow less
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
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).
Inclusion: 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.