NCT05987644

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

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 56 (estimated)
• Sponsor: Joshua Palmer · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lung Cancer
• NSCLC
• Brain Metastases

Interventions

Type	Name	Description
DRUG	Alectinib	600mg taken orally, twice daily for 25 Cycles Cycle = 4 weeks (28 days)
RADIATION	Stereotactic Radiosurgery	SRS dose varies by brain met size and location

Timeline

• Start date: 2024-03-07
• Primary completion: 2028-02-28
• Completion: 2029-02-28
• First posted: 2023-08-14
• Last updated: 2026-04-08

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study