Trial of Therapeutic Cancer Vaccine OSE2101 in Patients With Non-Small Cell Lung Cancer and Secondary Resistance to Immune Checkpoint Inhibitor

Condition(s) studied

Investigational drug(s) / intervention(s)

OSE2101: OSE2101 is a peptidic cancer vaccine composed of nine epitopes restricted to HLA-A2 phenotype targeting the tumor associated antigens of P53, HER-2, CEA, MAGE-2 and MAGE-3, and one pan-HLA DR binding epitope (PADRE), all epitopes emulsified in Montanide ISA 51TM adjuvant.

Docetaxel: Docetaxel is an antineoplastic agent that acts by disrupting the microtubular network in cells that is essential for mitotic and interphase cellular functions.

NGS HLAA2 assay: Amp-HLA-A-CDx Tedopi for amplification of human genomic DNA (gDNA), LFK-CDx Tedopi kit (library full kit) for library preparation, NGSengine-CDx Tedopi software for analysis of NGS data files.

Study summary

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).

Eligibility

Primary outcome measure(s)

• OS defined as time from randomization to death — From randomization date through study completion, an average of 3 years
  OS defined as time from randomization to death of any cause, censored until the data analysis cut-off date

Trial sites (207)

+ 167 more sites — see the full list on the official registry below.