Can a Direct-to-Brain chemo route outsmart resistant lung cancer?

NCT ID NCT07778940

First seen Aug 21, 2026 · Last updated Aug 21, 2026

Summary

This phase II trial is testing whether giving the chemotherapy drug thiotepa directly into the spinal fluid—via a small device called an Ommaya reservoir—can help control cancer that has spread to the lining of the brain and spinal cord (leptomeningeal metastases) in people with non-small cell lung cancer that no longer responds to EGFR-targeted therapy. The study will enroll about 50 adults aged 18 to 75. Participants receive thiotepa injections through the reservoir in a step-down schedule: twice a week for a month, then weekly for a month, then monthly for four months. The main goal is to see how well the treatment shrinks or controls cancer in the brain, and to check that it is safe to give this way.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance
thiotepa (a chemotherapy drug) given directly into the spinal fluid through a small device (Ommaya reservoir) placed under the scalp
What this could lead to
If it works, this could offer a new way to control cancer spread to the brain and spinal cord in people with EGFR-TKI-resistant lung cancer, potentially improving outcomes.
What could go wrong
This is a small, early-phase study, so results may not be conclusive. The drug is given directly into the spinal fluid, which carries risks like infection, headache, or nerve damage, and it may not control the cancer effectively.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin, China

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