Active not recruitingPHASE3INTERVENTIONAL

eXalt3: Study Comparing X-396 (Ensartinib) to Crizotinib in ALK Positive Non-Small Cell Lung Cancer (NSCLC) Patients

This study, called eXalt3, is investigating a new treatment for a specific type of lung cancer known as ALK-positive non-small cell lung cancer. It compares a new medicine, X-396 (ensartinib), with a standard medicine, crizotinib. Researchers want to see which medicine is more effective at treating the cancer and which has fewer side effects. Participants would have previously received up to one course of chemotherapy but not any ALK-targeting drugs. The study will also look at how these medicines affect your quality of life. This research aims to find better ways to treat this particular kind of lung cancer.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Xcovery Holdings, Inc.

Enrolment target

290

Start

01 Jun 2016

Estimated completion

31 Dec 2025

Non-small Cell Lung Cancer

What is this study about?

If you have a type of lung cancer called ALK-positive non-small cell lung cancer, you might be interested in this research study. Your cancer has a specific change (mutation) in something called the ALK gene. This change can make the cancer grow and spread. Researchers are studying a new drug named X-396 (ensartinib) to see if it's a better treatment option than an existing drug, crizotinib. Both drugs are designed to target the ALK gene change.

The main goal of this study is to compare how well X-396 works against crizotinib in slowing down or shrinking the cancer. They will also carefully monitor any side effects to understand which drug is safer. Additionally, the study will look at how the treatments might affect your everyday life and general well-being.

By taking part, you could be helping doctors learn more about better ways to treat ALK-positive non-small cell lung cancer. This information could benefit many people in the future who are living with this condition.

Key takeaways

Compares two medicines for ALK-positive lung cancer.
Investigates a new drug, X-396 (ensartinib), against a standard one.
Looks at how well medicines work and their side effects.
Participants will have had some chemotherapy but no prior ALK drugs.
Aims to improve treatment for this specific lung cancer type.

Who may be eligible?

To join this study, you must have been diagnosed with advanced or recurring ALK-positive non-small cell lung cancer. This means your cancer has either spread or come back. It's important that your cancer has been confirmed as 'ALK-positive' by a special test. You might have had one course of chemotherapy for your cancer already, but you shouldn't have taken any ALK-targeting medicines before.

Doctors will also check your general health, including how well your organs like your kidneys and liver are working. You need to be able to swallow pills, and your overall physical condition should be good enough to take part. Even if you have cancer that has spread to your brain, you might still be able to join if you don't have severe symptoms from it.

The study is open to both men and women aged 18 and over. Your doctor will carefully review all the requirements with you to see if this study could be a good fit.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Do you have ALK-positive non-small cell lung cancer?
Have you had no more than one prior chemotherapy treatment?
Have you never taken an ALK-targeting medicine before?
Are you generally well enough to participate in a study?
Can you swallow oral medication (pills)?

Answer every question to see your result.

What does participation involve?

If you join the study, you'll be given either X-396 (ensartinib) or crizotinib, which are both taken as pills. You won't know which one you're getting, and neither will your doctor, to ensure the results are fair. You'll have regular hospital visits for check-ups, blood tests, and scans to see how the medicine is working and to monitor for any side effects. You'll also be asked to answer questionnaires about your quality of life. These visits will continue throughout your treatment and likely for a period after your main treatment ends, even if you stop taking the study medicine. The total duration of your participation will depend on how you respond to the treatment, but it will involve ongoing monitoring for some time.

Potential risks and benefits

Taking part in a clinical trial may offer potential benefits, such as accessing a new medicine before it's widely available or receiving close medical care and monitoring. However, there are also potential risks, as new medicines can have unexpected side effects that we don't fully understand yet. Crizotinib, the other study drug, also has known side effects. You might experience side effects from either treatment, which could be serious. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (72)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Moffitt Cancer Center
Verified postcode
Tampa, United States
University Cancer & Blood Center
Verified postcode
Athens, United States
Washington University School of Medicine
Verified postcode
St Louis, United States
Providence Portland Medical Center
Verified postcode
Portland, United States
Sanatorio Parque S.A.
Verified postcode
Rosario, Argentina
Border Medical Oncology Research Unit
Verified postcode
Albury, Australia
Chris O'Brien Lifehouse
Verified postcode
Camperdown, Australia
Chris O Brien Lifehouse
Verified postcode
Camperdown, Australia
Catholic University of Louvain (UCL) - Site Mont Godinne
Verified postcode
Yvoir, Belgium
Instituto do Câncer do Estado de São Paulo
Verified postcode
São Paulo, Brazil
Hospital de Câncer de Barretos - Fundação Pio XII
Verified postcode
São Paulo, Brazil
Hospital Haroldo Juaçaba - Instituto do Cancêr do Ceará
Verified postcode
Fortaleza, Brazil

Common questions

What is ALK-positive non-small cell lung cancer?

It's a type of lung cancer where the cancer cells have a specific gene change (called an ALK mutation) that helps them grow.

What are X-396 (ensartinib) and crizotinib?

These are both medicines designed to target the ALK gene change in lung cancer cells, aiming to stop the cancer from growing.

Will I know which treatment I'm getting?

No, in this type of study, neither you nor your doctor will know whether you're receiving X-396 or crizotinib. This is done to make sure the study results are fair and unbiased.

What if I get side effects?

Your health will be closely monitored throughout the study, and the study team will help manage any side effects you might experience.

How long will the study last for me?

The time you spend in the study can vary. You'll continue with treatment as long as it's helping and you're not having severe side effects, followed by ongoing check-ups.