Non Small Cell Lung Cancer Metastatic study: Osimertinib vs Stereotactic radiosurgery
Official title A Study of Stereotactic Radiosurgery (SRS) and Standard Treatment in People With Lung Cancer That Has Spread to the Brain
ClinicalTrials.gov ID: NCT06741085
What this study is testing
What is osimertinib?
This is an investigational oral medicine being studied for metastatic non-small cell lung cancer. It is designed to block specific signals in cancer cells that help them grow.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study aims to find out if treating brain tumors with focused radiation after three months of osimertinib (a cancer medicine) works better than taking osimertinib alone. It also checks how this treatment affects daily life.
- Who it's for
- People with non-small cell lung cancer that has spread to the brain.
- What's involved
- Participants will take osimertinib for three months. Some will then receive stereotactic radiosurgery (a precise type of radiation) for brain tumors. Everyone will fill out questionnaires about their quality of life.
- Time commitment
- The study involves at least three months of daily medication and additional visits for radiation and questionnaires.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Participant Screening
- Age ≥ 18 years
- Non-small cell lung cancer (NSCLC) with somatic activating mutation in EGFR diagnosis, confirmed at enrolling institution
- At least one intact brain metastasis at baseline prior to TKI therapy initiation, visible on MRI brain with contrast (but without a minimum diameter...
- Either TKI-naïve or started TKI ≤ 3-months prior (with documented start date and available imaging prior to TKI start) Participant
You likely can't join if
- Screening
- Unable to undergo contrast-enhanced MRI brain
- Prior brain-directed radiotherapy
- Evidence of leptomeningeal disease on MRI total spine and/or lumbar puncture cytology.
- Neurologic symptoms or presence of a lesion in the brainstem, motor strip, or other eloquent brain area that is felt to warrant immediate...
- Active hematologic malignancy or a second solid tumor histology with known CNS tropism
See the full eligibility criteria
- Participant Screening
- Age ≥ 18 years
- Non-small cell lung cancer (NSCLC) with somatic activating mutation in EGFR diagnosis, confirmed at enrolling institution
- At least one intact brain metastasis at baseline prior to TKI therapy initiation, visible on MRI brain with contrast (but without a minimum diameter requirement)
- Either TKI-naïve or started TKI ≤ 3-months prior (with documented start date and available imaging prior to TKI start) Participant
- Screening
- Unable to undergo contrast-enhanced MRI brain
- Prior brain-directed radiotherapy
- Evidence of leptomeningeal disease on MRI total spine and/or lumbar puncture cytology. The latter are not mandated by protocol but are rather at the discretion of the treating medical team as clinically indicated.
- Neurologic symptoms or presence of a lesion in the brainstem, motor strip, or other eloquent brain area that is felt to warrant immediate intervention with SRS
- Active hematologic malignancy or a second solid tumor histology with known CNS tropism
- Patients who have undergone a therapeutic craniotomy for resection of one or more symptomatic brain metastasis are ineligible unless one or more additional intact BM remain unresected, and meets size criteria (e.g., a...
- 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.
- Pregnant women or women who are breastfeeding or of childbearing potential. If the risk of contraception exists, male and female people must use highly effective contraception throughout the study and for at least 3...
- Progressive Disease (PD) with multiple lesions and/or other features that would warrant a change in systemic therapy, as determined by the primary treating provider
- Presence of BM not deemed safely treatable with SRS, as determined by a radiation oncologist
- Intracranial Complete Response (CR)
- More than 20 visible residual brain metastases at the time of enrollment (i.e. after initial treatment with TKI).
The study team makes the final eligibility decision.
Where it is enrolling
- Miami, Florida, United States
- Basking Ridge, New Jersey, United States
- Middletown, New Jersey, United States
- Montvale, New Jersey, United States
- Commack, New York, United States
- Harrison, New York, United States
- New York, New York, United States
- Rockville Centre, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Miami, Florida, United States; Basking Ridge, New Jersey, United States; Middletown, New Jersey, United States; Montvale, New Jersey, United States; Commack, New York, United States; Harrison, New York, United States and 2 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.