Poumon non à petites cellules

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TITRE (EN) A Phase III, Double-blind, Randomised, Placebo-Controlled, International Study to Assess the Efficacy and Safety of Adjuvant Osimertinib Versus Placebo in Participants With EGFR Mutation-positive Stage IA2-IA3 Non-small Cell Lung Cancer, Following Complete Tumour Resection
PROTOCOLE ID ADAURA2
CLINICAL TRIAL.gov ID NCT05120349
TYPE(S) DE CANCER Poumon non à petites cellules
PHASE Phase III
TYPE D'ÉTUDE Clinique
INSTITUTION CENTRE UNIVERSITAIRE DE SANTE MCGILL
1001 boul. Décarie
VILLE Montréal
INVESTIGATEUR(RICE) PRINCIPAL(E) Jonathan Spicer
COORDONATEUR(RICE) Nicola Raby
nicola.raby@muhc.mcgill.ca
514-934-1934 poste 34095
STATUT  Fermé
DATE D'ACTIVATION 2022-12-01
CRITÈRES D'ÉLIGIBILITÉ (EN)
  • Male or female, at least ≥ 18 years.
  • NSCLC, of non-squamous histology.
  • Stage IA2 or IA3 disease, based on TNM8 classification.
  • Complete surgical resection (R0) of the primary NSCLC by lobectomy, segmentectomy or sleeve resection.
  • Complete recovery from surgery at the time of randomisation. Study intervention cannot commence within 4 weeks following surgery. No more than 12 weeks may have elapsed between surgery and randomisation for participants.
  • World Health Organization performance status of 0 or 1.
  • Provision of tumour sample for central pathology assessment of pathologic risk factors and to assess EGFR mutation status prior to randomisation.
  • A tumour which harbours one of the 2 EGFR mutations (Ex19del, L858R) by cobas® EGFR Mutation Test v2 (Roche Diagnostics) or FoundationOne® test.
  • Minimum life expectancy of > 6 months.
  • Females must be using highly effective contraceptive measures, and must have a negative pregnancy test prior to start of dosing if of child-bearing potential, or must have evidence of non-child-bearing potential. Male subjects must be willing to use barrier contraception.
CRITÈRES D'EXCLUSION (EN)
  • Mixed small cell and non-small cell cancer history.
  • Participants with incomplete (R1/R2) resection, or who have undergone pneumonectomy, bilobectomy or only wedge resection.
  • Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses; or active infection including hepatitis B, hepatitis C and HIV.
  • History of another primary malignancy except for malignancy treated with curative intent with no known active disease ≥ 5 years before the first dose of study intervention and of low potential risk for recurrence.

  • Any of the following cardiac criteria:

    • Mean resting QTc interval > 470 ms, obtained from triplicate ECGs performed at screening.
    • Any abnormalities in rhythm, conduction, or morphology of resting ECG,
    • Any factors that increase the risk of QTc prolongation or risk of arrhythmic events.
  • History of interstitial lung disease.
  • Inadequate bone marrow reserve or organ function.
  • Any unresolved toxicities from prior therapy greater than CTCAE Grade 1 at the time of starting study intervention.
  • Prior treatment with any anticancer therapy for NSCLC (including chemotherapy, radiotherapy, immunotherapy, and EGFR-TKIs).
  • Major surgery or significant traumatic injury within 4 weeks of the first dose of study intervention.
  • Participants currently receiving medications or herbal supplements known to be strong inducers of CYP3A4.