Delayed or Upfront Brain RAdiotherapy in Treatment naïve Lung Cancer Patients With Asymptomatic or Minimally Symptomatic Brain Metastases and ALK rEarrangements
{ "Study for Lung Cancer with Brain Metastases and ALK Rearrangements", "This study is for people with non-small cell lung cancer (NSCLC) that has spread to the brain (brain metastases) and has a specific genetic change called an ALK rearrangement. Participants will receive alectinib, a targeted drug, taken by mouth twice daily. Some participants in the second part of the study will also receive Stereotactic Radiosurgery (SRS), a type of radiation therapy for brain tumors. The study aims to see how well these treatments control the cancer in the brain and how safe they are. To join, you must be at least 18 years old and have an ALK rearrangement. The study is currently unclear on its recruitment status.", "design": "This study has two parts, Phase 1b and Phase 2, and plans to enroll 56 participants. Some participants will receive alectinib alone, while others will receive alectinib plus SRS.", "commitments": "You would take alectinib twice daily for up to 25 cycles (about 2 years). Each cycle of treatment lasts 28 days.", "compensation": "Not stated in the trial record.", "follow_up": "The study will look at neurological status and control of brain disease at 12 months for the Phase 2 portion, and safety and feasibility at 6 months for the Phase 1b portion.", }
- Study design
- Not specified.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Not specified.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Delayed or Upfront Brain RAdiotherapy in Treatment naïve Lung Cancer Patients With Asymptomatic or Minimally Symptomatic Brain Metastases and ALK rEarrangements
At a glance
Conditions
Where it's being run
3 sites across 3 statesStudy leadership
- Joshua D Palmer, MD · PRINCIPAL_INVESTIGATOR · The Ohio State University Comprehensive Cancer Center
Who to contact
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What this trial measures
- Phase 2: Neurological status and control of CNS disease at 12 months compared to alectinib plus SRS in patients with ≤15 CNS metastases12 months
Neurological status will be measured by a composite endpoint of: -Inntracranial progression(icPD) by RANO-BM criteria or death during the first 12 months. OR -Symptomatic radiation necrosis during the first 12 months. Symptomatic radiation necrosis is defined as requiring initiation of or increased dose of steroids or resulting in seizures or requirement of AEDs or requirement of hospitalization or surgery. OR -Cognitive decline, defined as 1 standard deviation decline from baseline cognitive function during the first 12 months.
- Phase 1b: Safety and Feasibility6 months
Safety and feasibility will be assessed by frequency of Dose Limiting Toxicities.