Delayed or Upfront Brain RAdiotherapy in Treatment naïve Lung Cancer Patients With Asymptomatic or Minimally Symptomatic Brain Metastases and ALK rEarrangements
Recruiting now · Phase 1/Phase 2
Conditions studied: Lung Cancer, NSCLC, Brain Metastases
In brief
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.
Key facts
- Study ID
- NCT05987644
- Run by
- Joshua Palmer
- People needed
- 56
- Starts
- 2024-03-07
- Expected to finish
- 2029-02-28
- Last updated by the study team
- 2026-04-08
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- Subjects meeting any of the criteria below may not participate in the study:
- Active infection requiring systemic therapy.
- Malabsorption syndrome or other condition that would interfere with enteral absorption
- Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study).
- Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen, per treating physician discretion, are not eligible for this trial.
- Treatment with any investigational drug within 28 days prior to registration.
- Acute viral, autoimmune, alcoholic, or other types of acute hepatitis.
Where it is running
- Stanford University — Stanford, California, United States (enrolling)
- University of Colorado Cancer Center — Aurora, Colorado, United States (enrolling)
- Ohio State University Comprehensive Cancer Center — Columbus, Ohio, United States (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.