A Study of Stereotactic Radiosurgery (SRS) and Standard Treatment in People With Lung Cancer That… (NCT06741085) | Clinical Trial Compass
RecruitingPhase 2
A Study of Stereotactic Radiosurgery (SRS) and Standard Treatment in People With Lung Cancer That Has Spread to the Brain
United States56 participantsStarted 2024-12-13
Plain-language summary
The researchers are doing this study is to find out whether treating brain metastasis with SRS after 3 months of therapy with osimertinib is better than treating with osimertinib alone in people with NSCLC. The researchers will also look at how the study intervention impacts participants' quality of life. The researchers will measure quality of life by having participants complete questionnaires.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Participant Inclusion Criteria: 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 Exclusion Criteria: 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 patient with removal of a 3cm symptomatic brain metastasis, but has an additional visible lesion remaining post-operatively, remains eligible for the study).
* Judgment by the investigator that the patient should not…