Poumon non à petites cellules

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TITRE (EN) A Phase III, Two-Arm, Parallel, Randomized, Multi-Center, Open-Label, Global Study to Determine the Efficacy of Volrustomig (MEDI5752) Plus Chemotherapy Versus Pembrolizumab Plus Chemotherapy for First-Line Treatment of Patients With Metastatic Non-Small Cell Lung Cancer (mNSCLC).
PROTOCOLE ID eVOLVE-Lung02
CLINICAL TRIAL.gov ID NCT05984277
TYPE(S) DE CANCER Poumon non à petites cellules
PHASE Phase III
TYPE D'ÉTUDE Clinique
INSTITUTION CIUSSS DU SAGUENAY – LAC-SAINT-JEAN
305, rue Saint-Vallier, CP 5006
VILLE Chicoutimi
INVESTIGATEUR(RICE) PRINCIPAL(E) Marc Trudeau
COORDONATEUR(RICE) Sabrina Côté
sabrina.cote.inf@ssss.gouv.qc.ca
418-541-1000 poste 3065
STATUT  Actif en recrutement
CRITÈRES D'ÉLIGIBILITÉ (EN)
  • Histologically or cytologically documented squamous or non-squamous NSCLC.
  • Stage IV NSCLC (according to Version 8 of the IASLC Staging Manual in Thoracic Oncology 2016), not amenable to curative surgery or radiation.
  • Absence of sensitizing EGFR mutations and ALK and ROS1 rearrangements.
  • Absence of documented tumor genomic alteration results from tests conducted as part of standard local practice in any other actionable driver oncogenes for which there are locally approved targeted first-line therapies.
CRITÈRES D'EXCLUSION (EN)
  • Mixed small-cell lung cancer and NSCLC histology or sarcomatoid variant. Rare subtypes are excluded.
  • Spinal cord compression.
  • Symptomatic brain metastases. Brain metastases may be treated or untreated, but participants must be asymptomatic and off steroids for at least 14 days prior to start of study intervention. A minimum of 2 weeks must have elapsed between the end of whole brain radiotherapy and study enrollment.

  • History of another primary malignancy except for:

    • Malignancy treated with curative intent with no known active disease ≥ 2 years before the first dose of study intervention and of low potential risk for recurrence.
    • Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
    • Adequately treated carcinoma in situ without evidence of disease.
  • As judged by the investigator, any condition that would interfere with evaluation of the study intervention or interpretation of participant safety or study results.