Actively Recruiting
A Study to Evaluate the Efficacy of Osimertinib With Early Intervention SRS Treatment Compared to the Continuation of Osimertinib Alone, in Patients With EGFR Mutated NSCLC and Asymptomatic Brain Metastases
Led by Hadassah Medical Organization · Updated on 2021-09-05
162
Participants Needed
1
Research Sites
303 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study involves patients with EGFR-mutated NSCLC and asymptomatic brain metastases. This is an open-label, randomized study, comparing the continuation of Osimertinib treatment alone to Osimertinib treatment combined with early intervention stereotactic radiosurgery (SRS). The current first line of care for EGFR-mutated NSCLC is administration of Osimertinib, a small molecule that penetrates the blood brain barrier (BBB) well and controls majority, but not all, of the brain metastases. We hypothesize that relatively early intervention with SRS to brain metastases that are still visualized by MRI 2 months-post initiation of Osimertinib treatment, LUNG- will improve long term brain control, cognitive abilities and potentially overall survival. Patients with EGFR-mutated NSCLC and asymptomatic brain metastases will be treated with Osimertinib for 2 months. Brain MRI scans will be collected pre-Osimertinib and 2 months after treatment start. Patients with asymptomatic brain metastases present after 2 months of Osimertinib will be randomized into one of two study arms. Arm A patients will be treated with SRS while continuing Osimertinib, while arm B patients will continue with Osimertinib alone. Patients will be assessed based on brain and whole body progression by RECIST. Patients will also be assessed for CNS-PFS and body-PFS, cognitive function, Quality of life and overall survival status via routine follow-up tests.
CONDITIONS
Official Title
A Study to Evaluate the Efficacy of Osimertinib With Early Intervention SRS Treatment Compared to the Continuation of Osimertinib Alone, in Patients With EGFR Mutated NSCLC and Asymptomatic Brain Metastases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Newly diagnosed metastatic NSCLC not suitable for curative surgery or radiotherapy
- Documented EGFR mutation sensitive to Osimertinib
- MRI showing fewer than 20 brain metastases at randomization
- Asymptomatic or minor symptoms from brain metastases with ECOG performance status 2 or less
- ECOG performance status 2 or less and life expectancy of at least 6 months
- Eligible to receive Osimertinib at randomization
- Eligible for stereotactic radiosurgery at randomization
- Provided written informed consent
- Male or female aged 18 years or older
- Females must use contraception until 6 weeks after study treatment ends, not be breastfeeding, and have a negative pregnancy test or be confirmed non-childbearing
- Males must use barrier contraception until 4 months after study treatment ends
You will not qualify if you...
- Previous treatment with anti-EGFR TKI, checkpoint inhibitors for metastatic NSCLC, whole brain radiation or stereotactic radiosurgery
- Use of medications or supplements that strongly induce CYP3A4 and cannot be stopped before Osimertinib
- Use of investigational drugs within five half-lives or anticancer drugs within 14 days before study
- Systemic disease progression on Osimertinib between screening and randomization
- Spinal cord compression unless stable and without symptoms
- Leptomeningeal disease
- Moderate or severe symptomatic brain metastases requiring hospitalization
- Severe or uncontrolled systemic diseases including hypertension, active bleeding, or infections like hepatitis B, C, or HIV
- Nausea, vomiting, gastrointestinal issues, or inability to absorb Osimertinib adequately
- Involvement in study planning or conduct
- Unlikely to comply with study procedures or requirements
AI-Screening
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Trial Site Locations
Total: 1 location
1
Hadassah Ein Kerem Medical Center
Jerusalem, Israel, 9112001
Actively Recruiting
Research Team
A
Amichay Meirovitz, MD, MBA
CONTACT
P
Philip Blumenfeld, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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