RecruitingPhase 1Phase 2NCT05987644

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

Sponsor

Joshua Palmer

Enrollment

56 participants

Start Date

Mar 7, 2024

Study Type

INTERVENTIONAL

Conditions

Lung Cancer NSCLC Brain Metastases

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study compares two approaches for managing brain metastases in lung cancer patients with a specific gene change called an ALK rearrangement: treating the brain early with radiation versus waiting and using targeted therapy first. **You may be eligible if...** - You have lung cancer with an ALK gene rearrangement - You have brain metastases (cancer that has spread to the brain) that are not causing significant symptoms - You have not yet received treatment for this diagnosis **You may NOT be eligible if...** - Your brain metastases are causing significant symptoms requiring urgent treatment - You do not have an ALK rearrangement - You have already received treatment for your lung cancer or brain metastases Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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