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Study Comparing Ensartinib and Crizotinib for Patients with ALK-Positive Non-Small Cell Lung Cancer

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a type of lung cancer known as Non-Small Cell Lung Cancer (NSCLC) that is positive for a specific mutation called Anaplastic Lymphoma Kinase (ALK). The study is comparing two treatments: Ensartinib, also known by its code name X-396, and Crizotinib, which is marketed under the name XALKORI. Both medications are taken orally in capsule form. The purpose of the study is to evaluate how effective and safe these treatments are for patients with this specific type of lung cancer.

Participants in the study will receive either Ensartinib or Crizotinib. The study will monitor the progress of the disease and any side effects experienced by the participants. The trial will last for a period of time, during which participants will have regular check-ups and assessments to track their health and the cancer's response to the treatment. The study aims to determine which medication is more effective in controlling the cancer and improving the quality of life for patients.

This trial is important for understanding the best treatment options for patients with ALK-positive NSCLC. By comparing these two medications, researchers hope to find the most effective way to manage this type of lung cancer and provide better outcomes for patients. Participants will be closely monitored throughout the study to ensure their safety and to gather valuable information about the treatments being tested.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, confirmation of an ALK-positive diagnosis is required. This is done through a test approved by the FDA. The test is performed centrally after a local test confirms ALK positivity.

    Randomization into the study occurs after receiving confirmation of ALK positivity from the central lab.

  2. Step 2

    Treatment assignment

    Participants are randomly assigned to receive either ensartinib or crizotinib.

    Ensartinib is also known as X-396.

  3. Step 3

    Medication administration

    If assigned to crizotinib, the medication is taken orally in the form of hard capsules. The available dosages are 200 mg and 250 mg.

    The specific dosage and frequency of administration are determined by the study protocol.

  4. Step 4

    Monitoring and assessments

    Regular monitoring and assessments are conducted to evaluate the effectiveness and safety of the treatment.

    Progression-free survival is assessed by independent radiology review based on specific criteria.

  5. Step 5

    Completion of study

    The study is estimated to conclude by December 31, 2025.

    Participants will continue to be monitored for overall survival and other secondary endpoints, such as response rates and quality of life assessments.

Who can join the trial?

14 criteria

  • Patients must have a confirmed diagnosis of advanced or recurrent **Non-Small Cell Lung Cancer (NSCLC)** that is **ALK-positive**. This means the cancer has a specific genetic change called ALK, confirmed by a test.
  • Patients can have received up to one previous chemotherapy treatment for cancer that has spread, which may include additional therapy to maintain health.
  • Patients must have cancer that can be measured using specific guidelines called **RECIST v. 1.1**.
  • Patients must be willing and able to follow the trial procedures and attend follow-up appointments.
  • Patients must understand the trial and provide written consent to participate.
  • Patients in France must be part of the French Social Security system and have the associated rights and coverage.
  • Patients must have an **ECOG Performance Status** score between 0 and 2, which measures their ability to perform daily activities.
  • Patients must have a life expectancy of at least 12 weeks.
  • Patients must be able to swallow and keep down oral medication.
  • Patients must have adequate organ function, which includes specific levels of blood cells, liver enzymes, and kidney function.
  • Patients can have brain metastases (cancer spread to the brain) if they do not have symptoms at the start of the study. If they have symptoms, they must complete treatment for brain metastases at least 14 days before starting the study and not need increasing doses of steroids.
  • Men with partners who can become pregnant must agree to use birth control during the study and for 90 days after the last dose of medication.
  • Women who cannot become pregnant or who agree to use birth control during the study and for 90 days after the last dose of medication must have a negative pregnancy test before starting the trial.
  • Patients must be at least 18 years old.

Who cannot join the trial?

5 criteria

  • Patients who have received more than one prior chemotherapy treatment.
  • Patients who have previously been treated with an ALK tyrosine kinase inhibitor (TKI). This is a type of medication used to treat certain types of cancer.
  • Patients who do not have ALK-positive Non-Small Cell Lung Cancer (NSCLC). This means the cancer cells have a specific change in the ALK gene.
  • Patients who are not within the specified age range for the study.
  • Patients who are part of a vulnerable population that the study is not designed to include.
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Investigated drugs

  • Ensartinib

    is a medication being studied for its effectiveness in treating patients with a specific type of lung cancer known as ALK-positive non-small cell lung cancer (NSCLC). It works by targeting and blocking the activity of a protein called ALK, which can help stop the growth of cancer cells.

  • Crizotinib

    is another medication used in the study for treating ALK-positive non-small cell lung cancer. It also targets the ALK protein, aiming to slow down or stop the growth of cancer cells. This medication is being compared to ensartinib to see which one is more effective and safer for patients.

What is already known about the treatment

  • Ensartinib

    Ensartinib is administered orally in the form of tablets. It is currently being studied in clinical trials for its effectiveness in treating patients with ALK-positive non-small cell lung cancer (NSCLC). The main therapeutic indication for ensartinib is to target and inhibit the activity of the anaplastic lymphoma kinase (ALK) protein, which is involved in the growth of cancer cells. By blocking this protein, ensartinib aims to slow down or stop the progression of cancer. It is classified as a tyrosine kinase inhibitor, a type of medication that interferes with specific enzymes involved in cancer cell growth.

  • Crizotinib

    Crizotinib is also taken orally in tablet form. It is an established medication used in the treatment of ALK-positive non-small cell lung cancer (NSCLC) and is being compared to ensartinib in clinical trials. Crizotinib works by inhibiting the ALK protein, which plays a role in the development and spread of cancer cells. This action helps to control the growth of cancer. Crizotinib is classified as a tyrosine kinase inhibitor, targeting specific enzymes that contribute to cancer cell proliferation.

Investigated diseases

Non-Small Cell Lung Cancer – Non-Small Cell Lung Cancer (NSCLC) is a type of lung cancer that includes several subtypes, such as adenocarcinoma, squamous cell carcinoma, and large cell carcinoma. It is the most common type of lung cancer, accounting for about 85% of all cases. NSCLC typically grows and spreads more slowly than small cell lung cancer. The disease often begins in the cells lining the air passages and can spread to other parts of the body. Symptoms may include a persistent cough, chest pain, and shortness of breath. As the disease progresses, it may lead to more severe respiratory issues and other systemic symptoms.
Trial detailsLast updated 4 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-513454-29-00Protocol codeX396-CLI-301Estimated enrolment288 patientsSponsorXcovery Holding Co. LLC

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).