A Global Study to Assess the Effects of Osimertinib in Participants With EGFRm Stage IA2-IA3 NSCLC Following Complete Tumour Resection
- Trial number:
- NCT05120349
- Trial phase:
- 3
- Study type:
- Targeted therapy, Biomarker
- Overall status:
- Recruiting
Study start date
Scientific title
Summary
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.