Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
British Columbia Cancer Agency
With
AstraZeneca
Princess Margaret Hospital, Canada
Sunnybrook Health Sciences Centre
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Able to provide written informed consent by patient or legally acceptable representative
Meets the criteria in the approved regulatory indication for first line treatment with osimertinib and agree to the restrictions, monitoring, and dose-adjustment criteria stipulated in the associated product label
Epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations (either alone or in combination with other EGFR mutations)
No prior systemic therapy except neoadjuvant, adjuvant or concurrent chemotherapy given greater than 3 months prior to enrollment on study
Asymptomatic or minimally symptomatic brain metastases (ie. Headache, nausea, or seizure responsive to dexamethasone/analgesic/antiepileptic on stable doses of medications for a minimum of 3 days)
Brain metastases must meet the following criteria on a diagnostic MRI: at least one lesion can be classified as measurable disease per RANO-BM, ≤ 10 brain or brainstem metastases, ≤ 30 mm and brainstem metastases must be ≤ 5 mm, metastases \> 5 mm from the optic nerve or chiasm
ECOG performance status 0-2
Life expectancy \> 6 months
Willing to abstain from sexual activity or willing to use double-barrier method during sexual intercourse
You may not be if
Previous treatment with osimertinib, or any other EGFR TKI
Patient with symptomatic brain metastases causing any neurologic deficit (not including headache, nausea, or medically controlled seizure)
Multiple sclerosis
Pacemaker or MRI-incompatible metal in the body
Allergy to gadolinium MRI contrast
Brain metastasis requiring surgery for decompression
Leptomeningeal disease
Previous cranial RT, or surgery for brain metastases
Uncontrolled systemic lupus erythematosis, scleroderma or other connective tissue disorders considered a contraindication for radiotherapy
Active cancer from another anatomical site within 5 years (non-melanomatous skin and cervical cancers permitted)
Any medical or non-medical issue that would render patient unable to reliably complete regular QOL and neurocognitive assessments
Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements
Treatment with an investigational drug within five half-lives of the compound or 3 months, whichever is greater
Patients with symptomatic CNS metastases who are neurologically unstable
Patients currently receiving (or unable to stop use prior to receiving the first dose of study treatment) medications or herbal supplements known to be potent inducers of cytochrome P450 (CYP) 3A4
Patients taking any drugs that are known to prolong QT interval that can't be withdrawn prior to Osimertinib
Pregnant or breastfeeding
Clareo Health | Study of Osimertinib + SRS vs Osimertinib Alone for Brain Metastases in EGFR Positive Patients With NSCLC
