A Global Study to Assess the Effects of Osimertinib in Participants With EGFRm Stage IA2-IA3 NSCLC Following Complete Tumour Resection
18 Years and older, Male and Female
D516FC00001 (primary)
NCI-2022-03173
Summary
This is a global study to assess the effects of osimertinib in participants with EGFRm stage
IA2-IA3 non-small cell lung cancer following complete tumour resection.
Objectives
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.
Eligibility
- 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.
Treatment Sites in Georgia
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