New ALK inhibitor ensartinib tested in first human trial for lung cancer

NCT ID NCT01625234

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a new oral drug called ensartinib (X-396) for the first time in humans. It involved 131 people with advanced solid tumors, including those with ALK-positive non-small cell lung cancer. The goal was to find the safest dose and see if the drug could shrink tumors. The trial had two parts: a dose-finding phase and an expansion phase focused on ALK-positive lung cancer patients.

What this could mean

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

Active substance

Ensartinib (X-396), an oral ALK inhibitor drug

What this could lead to

If it works, this could provide a new treatment option for people with ALK-positive non-small cell lung cancer that has stopped responding to other therapies.

What could go wrong

This is an early first-in-human study, so the drug may not prove effective or may cause unexpected side effects. Results are preliminary and need confirmation in larger trials.

Disclaimer Read more

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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Conditions

The condition(s) this trial relates to.

neoplasm non-small cell lung carcinoma

As listed by the trial registrant

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

Contacts and locations

Locations

  • City of Hope National Med Ctr

    Duarte, California, 91010, United States

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • Moffitt Cancer Center

    Tampa, Florida, 33612, United States

  • New York University Langone Medical Center

    New York, New York, 10016, United States

  • Providence Portland Medical Center

    Portland, Oregon, 97213, United States

  • Stanford University

    Stanford, California, 94305, United States

  • Tennessee Oncology, PLLC

    Nashville, Tennessee, 37203, United States

  • UCSD Moores Cancer Center

    La Jolla, California, 92093, United States

  • University of Southern California Norris Comprehensive Cancer Center

    Los Angeles, California, 90033, United States

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • University of Wisconsin Carbone Cancer Ctr

    Madison, Wisconsin, 53792, United States

  • Vanderbilt University

    Nashville, Tennessee, 37240, United States

  • Walter Reed National Military Medical Center

    Bethesda, Maryland, 20889, United States

  • Washington University School of Medicine

    St Louis, Missouri, 63110, United States