Active not recruitingPHASE3INTERVENTIONAL

A Study Of Lorlatinib Versus Crizotinib In First Line Treatment Of Patients With ALK-Positive NSCLC

This research study is looking at advanced non-small cell lung cancer (NSCLC) that has a specific genetic change called ALK-positive. If you have this type of cancer and haven't had treatment for its advanced stage, this study might be for you. Researchers want to compare two medicines, lorlatinib and crizotinib, to see which is more effective. The main goal is to find out if lorlatinib can keep the cancer from growing or spreading for a longer time than crizotinib. They will also look at how long people live with each treatment. Essentially, it's about finding the best initial treatment for this particular kind of lung cancer.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Pfizer

Enrolment target

296

Start

27 Apr 2017

Estimated completion

31 Dec 2028

Carcinoma, Non-Small-Cell Lung

Results

Results from this study

Posted April 2021

Results have been published for this study.

Primary outcome

Progression-Free Survival (PFS) Based on Blinded Independent Central Review (BICR) Assessment

PFS was defined as the time from randomization to the date of the first documentation of progressive disease as assessed by the independent radiologist or death due to any cause, whichever occurred first. PFS (in months) was calculated as (date of event or censoring-randomization+1)/30.4375. Progressive disease is defined per RECIST version 1.1, as at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of the longest dimensions of the target lesions taking as a reference the smallest sum of the longest dimensions recorded since the treatment started, or the appearance of 1 or more new lesions.

Full results on the registry

What is this study about?

This study is for people diagnosed with a specific kind of advanced lung cancer called ALK-positive non-small cell lung cancer (NSCLC). Advanced means the cancer has spread from where it started. ALK-positive refers to a particular genetic change in the cancer cells that can be targeted by certain medicines. If you have this type of cancer and haven't yet received treatment for your advanced disease, you might be able to take part.

The main purpose of this study is to compare two different medicines, lorlatinib and crizotinib. Both are designed to target the ALK change in cancer cells. The researchers want to see if one drug is better than the other at stopping the cancer from growing or spreading. They will mostly focus on how long people live without their cancer getting worse, but will also look at how long people live overall.

By comparing these two treatments as a first step for ALK-positive NSCLC, the study hopes to improve how this type of cancer is treated in the future. The findings could help doctors decide which medicine is the best starting treatment option for patients like you.

Key takeaways

Compares two existing treatments for ALK-positive lung cancer.
Aims to find which drug is better at stopping cancer growth for longer.
For patients who have not had prior treatment for advanced ALK-positive NSCLC.
Regular medical check-ups and scans will monitor your health.
Your participation could help improve future cancer treatments.

Who may be eligible?

To join this study, you would generally need to be at least 18 years old and have a confirmed diagnosis of locally advanced or spread ALK-positive non-small cell lung cancer. This means your cancer has spread or is advanced, and we need a sample of your cancer tissue. You also shouldn't have had any other drug treatment for your advanced lung cancer yet.

There are also some health requirements to make sure it's safe for you to take part. For example, your general health, including your blood, liver, kidney, and pancreas, needs to be working well. If you have cancer that has spread to your brain, you might still be able to join if it's not causing symptoms and you don't need steroid medication for it.

However, there are reasons why you might not be able to join. These include recent major surgery or radiation treatment, current serious infections, certain heart conditions, a history of serious lung problems or pancreatitis, or other active cancers. Also, if you're taking certain medications or herbal remedies that might interfere with the study drugs, you wouldn't be able to participate. The medical team will check all these carefully to ensure your safety.

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 I have locally advanced or metastatic ALK-positive non-small cell lung cancer?
Have I had drug treatment for my advanced lung cancer before? (You shouldn't have)
Am I at least 18 years old?
Is my general health, including blood, liver, and kidney function, considered good by my doctor?
Do I have any other major health issues like recent surgery, serious infections, or certain heart conditions?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be assigned to receive either lorlatinib or crizotinib. Both are medications taken by mouth. You would have regular visits to the hospital or clinic for check-ups, blood tests, and scans (like CT or MRI) to monitor your health and how the treatment is working. The study team will explain the exact schedule of visits and tests.

You'll continue taking the study medication and attending these appointments for as long as the treatment is helping and you're not experiencing severe side effects. After you stop the study medication, you'll have follow-up appointments to track your health and well-being for a period. The total time you're involved in the study can vary depending on your individual response to treatment, but the follow-up period could last for several years.

Potential risks and benefits

Taking part in this study could offer potential benefits, such as receiving a new and potentially more effective treatment for your ALK-positive lung cancer. You would also be closely monitored by a specialist medical team, and your participation contributes to advancing our understanding of how to better treat this disease for future patients. However, like all medications, the study drugs may cause side effects, some of which could be serious. The medical team will discuss all known potential risks with you in detail. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (166)

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

Florida Cancer Specialists
Verified postcode
Altamonte Springs, United States
Florida Cancer Specialists
Verified postcode
Brandon, United States
Florida Cancer Specialists
Verified postcode
Clearwater, United States
Florida Cancer Specialists
Verified postcode
Gainesville, United States
Florida Cancer Specialists
Verified postcode
Largo, United States
Florida Cancer Specialists
Verified postcode
Lecanto, United States
Florida Cancer Specialists
Verified postcode
Orange City, United States
Florida Cancer Specialists
Verified postcode
Orlando, United States
Florida Cancer Specialists
Verified postcode
Spring Hill, United States
Florida Cancer Specialists
Verified postcode
St. Petersburg, United States
Florida Cancer Specialists
Verified postcode
Tampa, United States
Florida Cancer Specialists
Verified postcode
Tavares, United States

Common questions

What is ALK-positive NSCLC?

It's a specific type of lung cancer where the cancer cells have a particular genetic change called ALK, which helps the cancer grow. NSCLC stands for non-small cell lung cancer, the most common type of lung cancer.

What do 'lorlatinib' and 'crizotinib' do?

Both are targeted therapies. They are medicines designed to block the ALK genetic change, which can help stop the cancer from growing.

Will I know which drug I am receiving?

In this type of study (called a 'blinded' study), neither you nor your study doctor usually know which specific drug you are receiving to ensure the results are fair.

What does 'progression-free survival' mean?

It's the length of time you live with the disease without it getting worse or spreading. This is a common way researchers measure how well a new cancer treatment is working.

What happens if the treatment doesn't work?

The study team will closely monitor your health. If the treatment isn't working or side effects become too severe, they will discuss other treatment options with you for your ongoing care.