Randomized, Multicenter, Phase III, Open-Label Study of Alectinib Versus Crizotinib In Treatment-Naive Anaplastic Lymphoma Kinase-Positive Advanced Non-Small Cell Lung Cancer
This Phase III study looked at two medicines, Alecensa (alectinib) and XALKORI (crizotinib), for adults with a specific kind of advanced lung cancer called ALK-positive non-small cell lung cancer. This refers to lung cancer that has a particular genetic change (ALK-positive) and has started to spread (advanced). The study focused on people who hadn't received treatment for this cancer yet. The main aim was to find out if Alecensa was better than XALKORI at stopping the cancer from growing or spreading. Researchers also checked how these drugs affected patients' quality of life, their symptoms, and any side effects. This type of study helps doctors understand the best way to treat this cancer.
At a glance
What is this study about?
This research study, called a Phase III trial, is looking at a specific type of advanced lung cancer called ALK-positive non-small cell lung cancer. "Non-small cell lung cancer" is the most common type of lung cancer, and "advanced" means the cancer has spread. "ALK-positive" means tests have shown a particular change in the cancer cells that can be targeted by certain medicines.
The study compared two different medications: Alectinib (known by its brand name, Alecensa) and Crizotinib (known by its brand name, XALKORI). Both of these drugs are designed to target the ALK-positive change in the cancer cells. The main goal was to see if Alecensa was better than XALKORI at stopping the cancer from growing or spreading for people who haven't had previous treatment for their advanced ALK-positive lung cancer.
Beyond simply measuring cancer growth, the researchers also looked at many other important aspects. They wanted to understand how each drug affected the patients' overall health, how long they lived, if the cancer spread to the brain (which is a concern with lung cancer), how their lung cancer symptoms changed, and their general quality of life. They also carefully monitored any side effects to understand the safety of each treatment.
Key takeaways
- Compares two treatments (Alecensa vs. XALKORI) for ALK-positive advanced lung cancer.
- For patients who haven't had prior treatment for their advanced cancer.
- Aims to see which drug stops cancer growth more effectively.
- Also looks at how treatments affect quality of life, symptoms, and side effects.
- Participants will know which drug they receive (open-label study).
- Suitable for adults aged 18 and over.
Who may be eligible?
To join this study, people generally needed to be adults, aged 18 or over. There was no upper age limit for taking part.
The study was specifically for individuals diagnosed with advanced non-small cell lung cancer that has been identified as "ALK-positive." This means a specific genetic test on the cancer cells showed the ALK change.
Crucially, participants should not have received any previous treatment for their advanced ALK-positive lung cancer. This helps the researchers understand the effects of Alecensa and XALKORI as a first-line treatment.
- Are you 18 years old or older?
- Do you have advanced non-small cell lung cancer?
- Has your cancer been tested and confirmed as 'ALK-positive'?
- Have you NOT received any previous treatment specifically for your advanced ALK-positive lung cancer?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you join this study, you would receive either Alecensa or XALKORI, typically in capsule form. The doctors and study team would decide which medicine you receive, and it would be a random choice, like flipping a coin. You would have regular visits to the clinic for medical check-ups, blood tests, and scans to see how the treatment is working and to monitor your health.
During these visits, you’ll be asked questions about any symptoms you're experiencing and how you're feeling overall, as well as filling out questionnaires about your quality of life. This helps the study team understand the full picture of your health while on the treatment. The study would involve taking the medication and attending follow-up appointments for as long as the treatment is benefiting you, or until unacceptable side effects occur. The total duration of participation varies, but long-term follow-up for overall survival is often part of such studies.
Potential risks and benefits
Locations (4)
- —Poland
- —Spain
- —Portugal
- —Italy
Common questions
What does 'ALK-positive' mean?
It means your lung cancer cells have a specific genetic change (a faulty ALK gene) that can be targeted by certain medicines like those in this study.
What's the difference between Alecensa and XALKORI?
Both are medicines designed to treat ALK-positive lung cancer, but they are different drugs. This study is comparing them to see which works better.
What is a 'Phase III' study?
A Phase III study is a large study that compares a new treatment with an existing one (or a placebo) to see if it's better, and to confirm its safety and effectiveness before it's widely used.
Will I know which drug I'm getting?
Yes, this is an 'open-label' study, which means both you and your study doctor will know whether you are receiving Alecensa or XALKORI.
What if the cancer spreads to my brain during the study?
The study specifically monitors for 'Time to CNS Progression', which tracks how long it takes for cancer to potentially spread to the brain and spinal cord, an important consideration for lung cancer patients.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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