drugset / Trial / NCT05987644

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

NCT05987644

Phase 1/2 Recruiting 56 enrolled Joshua Palmer Genentech, Inc. · collab
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2024-03-07
Primary completion
2028-02-28
Completion
2029-02-28

Drugs

EvaluationDrugModalityDoseRoute
Subject Alectinib Small molecule 600 mg Oral