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Taking people in GermanyPhase 3

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
Aachen, Berlin, Bonn, Essen, Gauting, Großhansdorf, Halle, Heidelberg, Homburg, Kassel, München, and Stuttgart, GermanySee the 12 sites
Phase
Phase 3

AI summary: who the study is looking for

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with metastatic non-small cell lung cancer who test positive for HLA-A2 and whose cancer stopped responding to an immune checkpoint inhibitor.

Age
18 years or older
Sex
Men and women
Disease stage
Squamous or non-squamous non-small cell lung cancer, metastatic at entry, that cannot be treated with definite surgery or radiation.
Earlier treatment
Secondary resistance to an immune checkpoint inhibitor (ICI).
Biomarker or test result
HLA-A2 phenotype in blood. No EGFR, ALK or ROS1 gene changes that can be treated with targeted therapy. For squamous cancer, molecular tests are not required if age is 50 or older and smoker of 15 pack years or more.

Main reasons for not taking part

  • EGFR, ALK or ROS1 gene changes that can be treated with targeted therapy
  • Other exclusion criteria apply per the protocol

Read by machine on 12 November 2026.

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 Germany

  • Universitätsklinikum AachenAachen, GermanyContact: Caroline Chevalier, MSc, MPHNo longer taking part
  • Charité Universitätsmedizin BerlinBerlin, GermanyContact: Caroline Chevalier, MSc, MPHTaking people
  • Universitätsklinikum BonnBonn, GermanyContact: Caroline Chevalier, MSc, MPHTaking people
  • Universitätsklinikum EssenEssen, GermanyContact: Caroline Chevalier, MSc, MPHTaking people
  • Asklepios Fachkliniken München-GautingGauting, GermanyContact: Caroline Chevalier, MSc, MPHTaking people
  • LungenClinic GrosshansdorfGroßhansdorf, GermanyContact: Caroline Chevalier, MSc, MPHTaking people
  • Krankenhaus Martha-Maria Halle-DolauHalle, GermanyContact: Caroline Chevalier, MSc, MPHTaking people
  • Thoraxklinik HeidelbergHeidelberg, GermanyContact: Caroline Chevalier, MSc, MPHTaking people
  • Universitätsklinikum Gießen und Marburg - GießenHomburg, GermanyContact: Caroline Chevalier, MSc, MPHTaking people
  • Klinikum KasselKassel, GermanyContact: Caroline Chevalier, MSc, MPHNo longer taking part
  • Munchen Klinik BogenhausenMünchen, GermanyContact: Caroline Chevalier, MSc, MPHTaking people
  • Robert Bosch KrankenhausStuttgart, GermanyContact: Caroline Chevalier, MSc, MPHTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Trial details

Who runs it
OSE Immunotherapeutics
Trial code
NCT06472245
Record updated
12 November 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.

ClinicalTrials.gov NCT06472245