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Delayed or Upfront Brain RAdiotherapy in Treatment naïve Lung Cancer Patients With Asymptomatic or Minimally Symptomatic Brain Metastases and ALK rEarrangements
Sponsor: Joshua Palmer
Summary
This study will consist of a Phase 1b and Phase 2 portion. The Phase 1b portion will enroll first followed by the Phase 2 portion. Each cycle of treatment = 28 days. Subjects will receive alectinib twice daily. Those in the Phase 1b portion will receive alectinib alone. Those in Phase 2 Arm A will receive alectinib alone. Those in Phase 2, Arm B will receive SRS + alectinib. A maximum of 25 cycles (2 years) of alectinib may be administered on study.
Official title: DURABLE: Delayed or Upfront Brain RAdiotherapy in Treatment naïve Lung Cancer Patients With Asymptomatic or Minimally Symptomatic Brain Metastases and rEarrangements
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
56
Start Date
2024-03-07
Completion Date
2029-02-28
Last Updated
2026-04-08
Healthy Volunteers
No
Conditions
Interventions
Alectinib
600mg taken orally, twice daily for 25 Cycles Cycle = 4 weeks (28 days)
Stereotactic Radiosurgery
SRS dose varies by brain met size and location
Locations (3)
Stanford University
Stanford, California, United States
University of Colorado Cancer Center
Aurora, Colorado, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States