Last updated 2 months ago
A Global Study to Assess the Effects of Osimertinib in Participants With EGFRm Stage IA2-IA3 NSCLC Following Complete Tumour Resection
385 patients around the world
Available in Argentina
This is a Phase III, double-blind, randomised, placebo-controlled, 2-arm, international
study assessing the efficacy and safety of adjuvant osimertinib versus placebo in
participants with stage IA2-IA3 EGFRm Non-Small Cell Lung Cancer, who have previously
undergone complete tumour resection. All participants must have had a tumour which
harbours one of the 2 common EGFR mutations known to be associated with EGFR-TKI
sensitivity (Ex19del, L858R).
Eligible participants will be randomised in a 1:1 ratio to one of the 2 intervention
arms: osimertinib 80 mg or matching placebo, once daily for 3 years unless
discontinuation criteria is met.
AstraZeneca
7Research sites
385Patients around the world
This study is for people with
Lung cancer
Non-small cell lung carcinoma
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- 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, bilobectomy, 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.
- Mixed small cell and non-small cell cancer history.Participants with incomplete (R1/R2) resection, or who have undergone pneumonectomy or only wedge resection.Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses; or active infection including HCV and HIV or active uncontrolled HBV infection.History of another primary malignancy, including any known or suspected synchronous primary lung cancer 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 QTcF 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 QTcF 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.
Sites
CEMIC - Hospital Universitario Sede Saavedra - CABA, Buenos Aires
Recruiting
Instituto de Diagnóstico e Investigaciones Metabólicas - IDIM - sede centro - CABA
Recruiting
Instituto Médico de la Fundación Estudios Clínicos - Rosario
Recruiting
Fundación Intecnus
Recruiting
Fundación Médica de Río Negro y Neuquén - Cipolletti
Recruiting
Hospital Italiano de La Plata
Recruiting
Sanatorio Británico - Rosario
Recruiting
StudyADAURA2
SponsorAstraZeneca
Study typeInterventional
Conditions
Non-small cell lung carcinomaLung cancer
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT05120349
