Title 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
Protocole ID ARTEMIA
ClinicalTrials.gov ID NCT06472245
Cancer Type(s) Non Small Cells - Lung
Phase Phase III
Stage
Study Type Clinical
Drug OSE2101 versus docetaxel
Institution CISSS DU BAS-SAINT-LAURENT
   HOPITAL REGIONAL DE RIMOUSKI
      150 av. Rouleau, Rimouski, QC, G5L 5T1
City
Principal Investigator Dr. Marie-Claude Foley
Coordinator Isabelle Gagnon
418-724-3000 poste 8029
Status Recruiting
Activation Date
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 surgery or radiation, without EGFR, ALK and ROS1 gene alterations eligible for targeted therapy; 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's agreement
  • Patients with secondary resistance to ICI;
Other inclusion and exclusion criteria will apply per protocol.
Exclusion Criteria