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A Global Study to Assess the Effects of Osimertinib in Participants With EGFRm Stage IA2-IA3 NSCLC Following Complete Tumour Resection
About
Brief 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.
Primary Purpose
Study Type
Phase
Eligibility
Gender
Healthy Volunteers
Minimum Age
Maximum Age
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
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Study Stats
Protocol No.
22-000562
Category
Lung Cancer
Principal Investigator
Contact
Location
- UCLA Santa Monica
- UCLA Torrance