Delayed or Upfront Brain RAdiotherapy in Treatment naïve Lung Cancer Patients With Asymptomatic or Minimally Symptomatic Brain Metastases and ALK rEarrangements

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.

NCT Number	NCT05987644
Lead Sponsor	Joshua Palmer Collaborators: Genentech, Inc.
Conditions	Lung Cancer, NSCLC, Brain Metastases
Enrollment	56 participants
Start Date	2024-03-07
Primary Completion	2028-02-28 (estimated)
Study Completion	2029-02-28 (estimated)
Updated on ClinicalTrials.gov	2026-04-08