TITRE (EN) 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
CLINICAL TRIAL.gov ID NCT06472245
TYPE(S) DE CANCER Poumon non à petites cellules
PHASE Phase III
TYPE D'ÉTUDE Clinique
INSTITUTION CSSS DE RIMOUSKI-NEIGETTE
150 av. Rouleau
(418) 724-3000
VILLE Rimouski
INVESTIGATEUR(RICE) PRINCIPAL(E) Marie-Claude Foley
COORDONATEUR(RICE) Isabelle Gagnon
isabelle.gagnon0109.cisssbsl@ssss.gouv.qc.ca
418-724-3000 poste 8029
STATUT  Actif en recrutement
CRITÈRES D'ÉLIGIBILITÉ (EN)
  • 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.

CRITÈRES D'EXCLUSION (EN)