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X-396

Clinical trials are investigating X-396 in people with ALK-positive non-small cell lung cancer. These studies aim to evaluate how well it works and how safe it is, especially compared with crizotinib. The main target group is patients who have had up to one prior chemotherapy regimen and no prior ALK tyrosine kinase inhibitor treatment.

Table of contents

Trial overview

The available trial is eXalt3, a study comparing X-396, also called ensartinib, with crizotinib in patients with ALK-positive non-small cell lung cancer (NSCLC).[1] It is an interventional study, which means researchers give study treatments and then measure the results.[1]

This trial is listed as Phase 3 and is authorised.[1] The planned enrollment is 288 patients.[1]

Who is being studied

The study is for people with ALK-positive NSCLC.[1] The brief summary says patients may have had up to 1 prior chemotherapy regimen and must have had no prior ALK tyrosine kinase inhibitor treatment.[1]

In simple terms, this means the trial is focused on patients whose lung cancer has a specific gene change and who have not yet been treated with this type of ALK-targeted medicine before.[1]

What the trial measures

The main outcome is progression-free survival (PFS).[1] This is the length of time before the cancer gets worse.[1]

PFS is assessed by independent radiology review (IRR) using RECIST v. 1.1 rules.[1] This means scan results are checked by independent experts using a standard method for measuring tumor changes.[1]

Treatment comparison in the study

The trial compares X-396 capsules with crizotinib capsules.[1] The intervention list includes X-396 capsules at 225 mg and XALKORI hard capsules at 200 mg or 250 mg.[1]

Because this is a comparison study, the main goal is to see whether X-396 provides better results than the active comparator, crizotinib, in this patient group.[1]

Trial design and phase

Phase 3 trials are larger studies that help show how well a treatment works and how safe it is in a defined patient group.[1] In this trial, the focus is on both efficacy and safety of X-396 versus crizotinib in ALK-positive NSCLC.[1]

The study design is important because it tests X-396 in a real treatment comparison, rather than only looking at the drug by itself.[1] This helps researchers understand whether X-396 may be a useful option for patients who meet the study criteria.[1]

Trial ID Phase Condition studied Status Enrollment
NCT02767804 Phase 3 ALK-positive non-small cell lung cancer (NSCLC) Authorised 288

FAQ

  • What is being studied in X-396 clinical trials? The trial is studying whether X-396 works better than crizotinib in ALK-positive non-small cell lung cancer. It also looks at safety.
  • Who can take part in the main X-396 trial? The study is for patients with ALK-positive non-small cell lung cancer. They may have had up to one prior chemotherapy regimen and must not have had a prior ALK tyrosine kinase inhibitor.
  • What phase is the X-396 trial? The main trial listed is Phase 3. Phase 3 studies compare treatments in a larger group of patients.
  • What condition is X-396 being tested for? X-396 is being tested for non-small cell lung cancer, also called NSCLC. The trial focuses on patients whose cancer is ALK-positive.
  • What result is the trial mainly measuring? The main result is progression-free survival, often shortened to PFS. This means how long patients live without the cancer getting worse.

Ongoing Clinical Trials on X-396

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

    Not recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium Czechia France Italy The Netherlands Poland +1

Glossary

  • ALK-positive: A cancer that has a change in the ALK gene. This change can help the cancer grow.
  • Non-small cell lung cancer (NSCLC): The most common type of lung cancer. It includes several lung cancer subtypes.
  • Chemotherapy: A type of cancer treatment that uses drugs to kill or slow cancer cells.
  • ALK tyrosine kinase inhibitor (ALK TKI): A medicine designed to block the ALK signal in cancer cells. In this trial, patients must not have had one before.
  • Phase 3: A late-stage clinical trial that compares treatments in a larger group of patients.
  • Interventional study: A trial where researchers give a treatment and measure its effects.
  • Progression-free survival (PFS): The length of time during and after treatment that the cancer does not get worse.
  • Independent radiology review (IRR): A review of scans by experts who are not part of the treatment team, used to judge results more fairly.
  • RECIST v. 1.1: A standard way to measure whether a tumor is shrinking, growing, or staying the same on scans.
  • Enrollment: The number of people planned to join a clinical trial.

References