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Active not recruitingPHASE2INTERVENTIONAL

Activity of Lorlatinib Based on ALK Resistance Mutations Detected on Blood in ALK Positive NSCLC Patients

This research is for people in the UK with a type of advanced non-small cell lung cancer (NSCLC) called ALK-positive lung cancer. Often, after initial treatments with ALK inhibitor drugs, the cancer can start to grow again because it develops resistance. This can be due to new changes (mutations) in the ALK gene within the cancer cells. This study focuses on a drug called lorlatinib, which is already approved to treat ALK-positive lung cancer when it has become resistant to other ALK inhibitor drugs. Researchers want to understand if specific gene changes, picked up from blood tests, can help identify which patients might benefit most from taking lorlatinib. This could potentially lead to more personalised and effective treatment choices in the future.

At a glance

Status
Active not recruiting
Phase
PHASE2
Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
Enrolment target
68
Start
17 Nov 2020
Estimated completion
01 Nov 2024

What is this study about?

This study is particularly for people living with a form of lung cancer called non-small cell lung cancer (NSCLC) that carries a specific genetic change known as an ALK rearrangement. For these patients, standard treatment often involves special drugs called ALK inhibitors, which are designed to target this specific change and help control the cancer.

However, over time, the cancer can become clever. It might adapt to these drugs and start growing again, a process known as developing resistance. This resistance often happens because the cancer cells develop new genetic changes, or 'mutations', sometimes in the very same ALK gene that the drugs were targeting. To understand why a treatment has stopped working, doctors usually need to check for these new changes. Traditionally, this meant taking another tissue sample (a biopsy), which can be uncomfortable or risky. Thankfully, new blood tests have been developed that can help find these genetic changes more easily.

Lorlatinib is a medicine that is already approved and used when ALK-positive lung cancer has become resistant to other ALK inhibitor drugs. It works by targeting the ALK gene. This study wants to use these newer blood tests to see if finding specific genetic changes in the blood can help doctors understand which patients will respond best to lorlatinib. The aim is to find out if certain genetic patterns mean lorlatinib is more likely to be an effective treatment for an individual.

Key takeaways

  • This study is for ALK-positive non-small cell lung cancer that has become resistant to other ALK inhibitor drugs.
  • It tests the drug lorlatinib, which is already used for this condition.
  • Researchers want to see if blood tests for genetic changes can predict who benefits most from lorlatinib.
  • The goal is more personalised and effective treatment for patients.
  • Participation involves regular check-ups, blood tests, and scans.

Who may be eligible?

To join the main part of this study, you would need to be at least 18 years old and have an advanced type of non-small cell lung cancer (NSCLC) that has an ALK gene change. Your cancer also needs to have started growing again after having received at least one other type of ALK inhibitor drug.

You would also need to be well enough to take part, as assessed by your doctor, and have cancer that can be measured on scans. Before starting, doctors would need to confirm that your cancer cells have the ALK gene change, usually through past tests like FISH or IHC.

There's also an optional part of the study for people who are currently doing well on a second-generation ALK inhibitor. For this, you would need to have been on your current ALK inhibitor for at least 6 months (if you previously took crizotinib) or 12 months (if crizotinib was not your first ALK inhibitor).

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.

  1. Are you 18 years or older?
  2. Do you have advanced ALK-positive non-small cell lung cancer?
  3. Has your cancer started growing again after treatment with another ALK inhibitor drug?
  4. Are you well enough to take part in a clinical study?
Answer every question to see your result.

What does participation involve?

The detailed involvement in this study isn't fully described in the summary, but typically, taking part in a clinical trial involves a series of hospital visits. These visits will likely include regular check-ups with the study team, blood tests to monitor your health and look for genetic changes, and imaging scans (like CT or MRI) to see how the cancer is responding to treatment. You would be taking lorlatinib medication as part of the study. There would be an initial screening phase to ensure you meet all the criteria, followed by regular treatment and assessment periods. After treatment, there would usually be a follow-up period to monitor your long-term health. The total duration of participation varies depending on individual response and the study's design.

Potential risks and benefits

Taking part in any clinical trial comes with potential benefits and risks. A potential benefit of this study could be access to lorlatinib, a drug already known to be effective for resistant ALK-positive lung cancer, under close medical supervision. The study also helps advance our understanding of how to tailor treatments more precisely, which could benefit future patients. However, like all medications, lorlatinib can have side effects, and some tests involve minor inconveniences or risks, such as blood draws or exposure to radiation from scans. Your doctors will explain all known side effects and risks to you in detail. You are always free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (26)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Institut Jules Bordet-Hopital Universitaire ULB
    Verified postcode
    Brussels, Belgium
  • Cliniques Universitaires Saint-Luc
    Verified postcode
    Brussels, Belgium
  • Universitair Ziekenhuis Antwerpen
    Verified postcode
    Edegem, Belgium
  • CHU-UCL Namur - CHU Mont Godinne - UCL Namur
    Verified postcode
    Yvoir, Belgium
  • Centre Hospitalier Avignon
    Verified postcode
    Avignon, France
  • Assistance Publique Hopitaux Paris - Hopital Avicenne
    Verified postcode
    Bobigny, France
  • CHU de Brest
    Verified postcode
    Brest, France
  • Centre Hopitalier Intercommunal De Creteil
    Verified postcode
    Créteil, France
  • Gustave Roussy
    Verified postcode
    Villejuif, France
  • King Hussein Cancer Center
    Verified postcode
    Amman, Jordan
  • The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis
    Verified postcode
    Amsterdam, Netherlands
  • Academisch Ziekenhuis Maastricht
    Verified postcode
    Maastricht, Netherlands

Common questions

What is ALK-positive NSCLC?

It's a type of lung cancer where the cancer cells have a specific gene change called an ALK rearrangement, which can make the cancer grow.

What are ALK inhibitors?

These are targeted drugs designed to block the ALK gene change, helping to control the growth of ALK-positive lung cancer.

Why do cancers become resistant to treatment?

Cancer cells can adapt and change over time, sometimes developing new genetic changes (mutations) that allow them to bypass the effects of the drug.

What is lorlatinib?

Lorlatinib is an ALK inhibitor drug that is used when ALK-positive lung cancer has become resistant to other ALK inhibitor treatments.

How will the study check for genetic changes?

The study will use blood tests to look for new genetic changes in the cancer cells that might be causing resistance to previous treatments.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

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