Cancer statistics, 2020.
Rebecca L Siegel, Kimberly D Miller, Ahmedin Jemal
https://pubmed.ncbi.nlm.nih.gov/31912902Actively Recruiting
Phase Not Applicable
Age: 18Years - 120Years
All Genders
ID05033691
A Multi-center, Open-label, Randomized Study to Evaluate Osimertinib With Early SRS Treatment Compared to 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
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating treatments for patients with EGFR-mutated non-small cell lung cancer (NSCLC) who have brain metastases that do not cause symptoms. This open-label randomized study compares continuing treatment with Osimertinib alone to combining Osimertinib with early stereotactic radiosurgery (SRS) to brain metastases. Osimertinib is a targeted therapy that crosses the blood-brain barrier and controls most brain metastases, but some remain visible on MRI two months after starting treatment. The study aims to see if adding early SRS improves brain control, cognitive function, and possibly overall survival. Participants will first receive Osimertinib for two months. Brain MRI scans will be done before starting and after two months of Osimertinib. Those still showing brain metastases without symptoms will be randomly assigned to either continue Osimertinib alone or receive SRS plus Osimertinib. The SRS is delivered as a precise radiation treatment to the brain lesions. Both groups will be followed regularly with scans and assessments. During the study, participants will undergo brain and whole-body imaging every three months after randomization to monitor disease progression. Researchers will also assess cognitive function, quality of life, time until whole brain radiation is needed, and overall survival. Close follow-up will help evaluate how well the treatments control the cancer in the brain and body, and their effects on patients' wellbeing over time.
CONDITIONS
Brief 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
Age: 18Years - 120Years
All Genders
Eligibility Criteria
You may qualify if you...
- Newly diagnosed metastatic NSCLC not suitable for curative surgery or radiotherapy
- Documented EGFR mutation sensitive to Osimertinib (including exon 19 del, L858R, G719X, L861G, S768I, T790M)
- Brain MRI showing fewer than 20 brain metastases at randomization
- Brain metastases are asymptomatic or cause only minor symptoms (ECOG performance status 62)
- ECOG performance status 62 and life expectancy of at least 6 months
- Eligible for and receiving Osimertinib at randomization
- Eligible for stereotactic radiosurgery (SRS) at randomization
- Provided written informed consent
- Male or female aged 18 years or older
- Females must use effective contraception until 6 weeks after last dose, not be breastfeeding, and have a negative pregnancy test or non-childbearing status
- Males must use barrier contraception until 4 months after last dose
You will not qualify if you...
- Prior treatment with anti-EGFR tyrosine kinase inhibitors
- Prior immunotherapy with checkpoint inhibitors for metastatic NSCLC
- Previous whole brain radiation therapy or stereotactic radiosurgery
- Use of medications or supplements that strongly induce CYP3A4 that cannot be stopped before Osimertinib
- Use of investigational drugs within five half-lives before study entry
- Use of chemotherapy or anticancer agents within 14 days before study entry
- Disease progression during Osimertinib treatment before randomization
- Spinal cord compression unless asymptomatic and stable
- Leptomeningeal disease
- Moderate or severe symptomatic brain metastases (Radiation Therapy Oncology Group grade 3 or 4)
- Severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding disorders, or active infections like hepatitis B, C, or HIV
- Severe nausea, vomiting, gastrointestinal diseases, inability to swallow Osimertinib, or prior major bowel surgery affecting drug absorption
- Involvement in study planning or conduct
- Investigator judgment that patient is unlikely to comply with study procedures or requirements
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Ongoing throughout the study duration
Participants start Osimertinib treatment. At 8 weeks, participants are randomized to either continue Osimertinib alone or receive stereotactic surgery (SRS) in addition to Osimertinib.
Visits at randomization, 2 months after randomization, then every 3 months
Follow-up
Duration - Up to study completion in 2026
Participants are monitored for brain and whole-body lesion changes, cognitive function, quality of life, and overall survival after treatment.
Visits every 3 months following treatment period
Trial Site Locations
Total: 1 location
1
Hadassah Ein Kerem Medical Center
Jerusalem, Israel, 9112001
Actively Recruiting
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Research Team
A
Amichay Meirovitz, MD, MBA
P
Philip Blumenfeld, MD
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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