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).

Trial Details

NCT ID
NCT06472245
Phase
PHASE3
Sponsor
OSE Immunotherapeutics
Status
RECRUITING
Cancer Type
Lung Cancer
Interventions
  • OSE2101
  • Docetaxel
  • NGS HLAA2 assay
Locations (sample)
  • Beverly Hills, California, United States|34.07362,-118.40036
  • Encino, California, United States|34.15917,-118.50119
  • Los Angeles, California, United States|34.05223,-118.24368
  • Los Angeles, California, United States|34.05223,-118.24368
  • Littleton, Colorado, United States|39.61332,-105.01665

Key Eligibility Criteria

  • 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…
  • Patients with secondary resistance to ICI;

For full eligibility, visit ClinicalTrials.gov.

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