Testing a new drug with or without targeted radiation for lung cancer spread to the brain

Plain-English translation of NCT05800223 on ClinicalTrials.gov ↗ · Source last updated April 2023 · Translation generated June 2026 · How we translate trials

Phase 3 — Testing in thousands of people, comparing the treatment against what doctors currently use. This is the last big step before approval.

What is this trial?

This study is testing a medication called to treat brain tumors that have spread from a specific type of lung cancer. The trial compares three approaches: taking the medication alone, starting the medication and then adding focused radiation therapy right away, or waiting to see how the medication works first before adding radiation therapy later. The goal is to find out which combination works best and is safest for patients.

When lung cancer spreads to the brain, it becomes much harder to treat and can seriously affect quality of life. This trial wants to find out whether adding targeted radiation to this new medication helps patients live longer and feel better, or if the medication alone is enough.

Do you qualify?

You likely qualify if…

you are between 18 and 75 years old
you have been diagnosed with a specific type of lung cancer that has spread to your brain (with little or no symptoms like headaches or seizures that are controlled with medication)
your cancer has the specific EGFR genetic mutation that this medication targets
you have not received other cancer drugs for at least 3 months before joining (though you may have had chemotherapy as part of earlier treatment)
you are in good overall health with an expected survival of at least 12 weeks, and your blood counts, liver, and kidney function are healthy

You likely don't qualify if…

you have already received radiation therapy to your brain
you have had more than 10 tumors in your brain or brainstem
you are currently participating in another clinical trial or received another experimental drug within the past 4 weeks
you have previously been treated with a different type of targeted drug for EGFR mutations
you have had major surgery or significant trauma within the past 4 weeks

What participation looks like

If you join this trial, you will take the medication by mouth once daily. Depending on which group you are randomly assigned to, you may also receive focused radiation therapy either right away or after your first follow-up scans show how well the medication is working on its own. You will have regular check-up visits with brain imaging scans to monitor how you are responding to treatment. The study involves 300 patients across multiple hospitals in China, and your doctors will carefully watch for any side effects throughout your participation.

AI-generated summary from trial data · Jun 10, 2026 · Not medical advice

Trial locations(1 site)

China

Fudan University Shanghai Cancer Center, Shanghai, Shanghai Municipality