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New pill targets tough cancers in early trial

NCT ID NCT05256290

First seen Jan 04, 2026 · Last updated Jun 19, 2026 · Updated 31 times

Summary

This early-stage trial is testing an oral drug called silevertinib (BDTX-1535) in about 200 adults with advanced non-small cell lung cancer or glioblastoma that have certain EGFR mutations. The study has two parts: first finding a safe dose, then checking if the drug shrinks tumors. It is still recruiting for the second phase.

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This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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Contacts and locations

Locations

  • Banner MD Anderson Cancer Center

    Gilbert, Arizona, 85234, United States

  • Cedars Sinai Medical Center

    Los Angeles, California, 90048, United States

  • City of Hope Huntington Beach

    Huntington Beach, California, 92648, United States

  • City of Hope Orange County Lennar Foundation Cancer Center

    Irvine, California, 92618, United States

  • Columbia University Irving Medical Center

    New York, New York, 10032, United States

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02115, United States

  • Fred Hutchinson Cancer Center/University of Washington

    Seattle, Washington, 98109, United States

  • Inova Schar Cancer Institute

    Fairfax, Virginia, 22031, United States

  • Johns Hopkins Bayview Medical Center

    Baltimore, Maryland, 21224, United States

  • Mayo Clinic- Jacksonville

    Jacksonville, Florida, 32224, United States

  • Mayo Clinic- Rochester

    Rochester, Minnesota, 55905, United States

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10021, United States

  • Miami Cancer Institute - Baptist Health South Florida

    Miami, Florida, 33176, United States

  • Montefiore Medical Center

    The Bronx, New York, 10461, United States

  • Next Ocology

    Fairfax, Virginia, 22031, United States

  • Robert H. Lurie Comprehensive Cancer Center at Northwestern University

    Chicago, Illinois, 60611, United States

  • Sibley Memorial Hospital Johns Hopkins Medicine

    Washington D.C., District of Columbia, 20016, United States

  • Siteman Cancer Center

    St Louis, Missouri, 63110, United States

  • Tennessee Oncology

    Nashville, Tennessee, 37203, United States

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • UHP- University of Hawaii Cancer Center

    Honolulu, Hawaii, 96813, United States

  • UNC Hospitals - Lineberger Comprehensive Cancer Center

    Chapel Hill, North Carolina, 27514, United States

  • University of Alabama

    Birmingham, Alabama, 35294, United States

  • University of Kansas Cancer Center

    Fairway, Kansas, 66205, United States

  • University of Pittsburgh Medical Center - Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232, United States

What this could mean

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

Active substance

silevertinib (BDTX-1535), an oral drug that targets certain EGFR mutations in cancer cells

What this could lead to

If successful, this could provide a new treatment option for people with advanced lung cancer or glioblastoma that has specific EGFR mutations.

What could go wrong

This is an early-phase trial with a small number of participants, so the drug may not prove effective or safe enough for wider use. Side effects are possible, and it is not yet known if it improves survival.

Conditions

The condition(s) this trial relates to.

brain cancer glioblastoma lung carcinoma lung neoplasm metastatic malignant neoplasm non-small cell lung carcinoma non-small cell squamous lung carcinoma

As listed by the trial registrant

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