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.
Patients in both arms of this study will receive standard of care (SOC) systemic therapy which includes a backbone of an FDA-approved CNS-active TKI targeting mutant EGFR, specifically osimertinib.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
56
oral EGFR-TKI
0-20mm-18Gy x 1, 21Gy x 1 ,9Gy x 3 20mm or larger- 9Gy x 3, 6Gy x 5, 5Gy x 5
BAPTIST ALLIANCE - MCI (Data Collection Only)
Miami, Florida, United States
RECRUITINGMemorial Sloan Kettering Basking Ridge (All Protocol Activities)
Basking Ridge, New Jersey, United States
RECRUITINGMemorial Sloan Kettering Monmouth (All Protocol Activities)
Middletown, New Jersey, United States
RECRUITINGMemorial Sloan Kettering Bergen (All Protocol Activities)
Montvale, New Jersey, United States
RECRUITINGMemorial Sloan Kettering Suffolk - Commack (All Protocol Activities)
Commack, New York, United States
RECRUITINGMemorial Sloan Kettering Westchester (All Protocol Activities)
Harrison, New York, United States
RECRUITINGMemorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, United States
RECRUITINGMemorial Sloan Kettering Nassau (All Protocol Activities)
Rockville Centre, New York, United States
RECRUITINGintracranial progression-free survival (iPFS)
Intracranial progression will be assessed at 3-month intervals and is defined as a ≥20% increase in sum longest distance relative to nadir for target lesions (up to a max of 5 lesions; must include at least one lesion increased in size by an absolute value of 5mm), unequivocal progression of non-target lesions, and/or the presence of new lesions, as defined by the RANO-BM working group criteria
Time frame: 3 months
Time to CNS progression
defined as ≥20% increase in sum longest distance relative to nadir for target lesions (up to a max of 5 lesions; must include at least one lesion increased in size by an absolute value of 5mm), unequivocal progression of non-target lesions, and/or the presence of new lesions, as per RANO-BM (22). Death from any cause will be considered a competing risk.
Time frame: 9 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.