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Study of Crizotinib for ROS1 and MET Activated Lung Cancer

This study is investigating a drug named crizotinib, also known as XALKORI, for people with advanced non-small cell lung cancer that has spread. Specifically, it's for patients whose cancer has certain genetic changes called ROS1 or MET. Crizotinib is a type of chemotherapy already approved for other lung cancers with similar genetic changes. The main goal is to understand how effective crizotinib is at treating lung cancer with these particular ROS1 or MET changes. If you are eligible, you would take the study drug and have regular check-ups. The study involves several stages, including initial screening, taking the drug, and follow-up appointments to monitor your health and the treatment's effects.

De un vistazo

Estado
Reclutamiento
Fase
FASE2
Patrocinador
Red de Salud Universitaria, Toronto
Objetivo de inscripción
50
Inicio
03 Dec 2019
Estimación de finalización
01 Jun 2025

¿De qué trata este estudio?

This study is looking into a potential new treatment for a specific type of lung cancer called non-small cell lung cancer, especially when it has spread (which doctors call 'metastatic'). We know that some lung cancers have special changes, or 'mutations,' in their genes. This study focuses on cancers with changes in genes called ROS1 or MET.

The drug being tested is called crizotinib (you might also hear it called XALKORI). It's a type of medicine that targets these specific gene changes. Crizotinib is already approved in the UK for treating other types of lung cancer that have similar genetic changes. The main purpose of this study is to see how well crizotinib works for people whose lung cancer has ROS1 or MET gene changes, and to understand its effects.

Finding treatments that precisely target these genetic changes is really important because it can lead to more effective and personalised care for patients. This study aims to gather more information about crizotinib, which could help more people with this specific type of lung cancer in the future.

Puntos clave

  • This study is for advanced lung cancer with specific genetic changes.
  • It tests a drug called crizotinib, which targets these changes.
  • Participation involves regular check-ups and taking the study drug.
  • Your health will be closely monitored throughout the study and during follow-up.
  • The aim is to find more effective treatments for this type of lung cancer.

¿Quién puede ser elegible?

To join this study, you would need to be an adult, aged 18 or older, and have advanced non-small cell lung cancer that has spread and cannot be cured with surgery. Importantly, your cancer must have specific gene changes in either ROS1 or MET, which would be identified through tests. You should generally be in good health otherwise, able to manage daily activities, and have important organs like your heart and blood working well.

There are also some reasons why you might not be able to join. For example, if you have untreated cancer that has spread to your brain causing symptoms, or if you've recently had other cancer treatments like chemotherapy or radiotherapy, you might not be eligible. We would also need to check if you have any conditions or are taking any medicines that might interfere with crizotinib.

¿Podría este estudio ser adecuado para ti?

Responde estas preguntas rápidas para ver si puedes ser elegible. Esto es solo una guía: el equipo de investigación toma la decisión final.

  1. ¿Tienes 18 años o más?
  2. Do you have advanced non-small cell lung cancer that has spread?
  3. Have tests shown specific ROS1 or MET gene changes in your cancer?
  4. Are you generally well enough to go about your daily activities?
  5. Can you swallow tablets safely?
  6. Are you able to attend appointments regularly?
Responde cada pregunta para ver tu resultado.

¿En qué consiste la participación?

If you decide to join this study, it would begin with a 'screening period'. During this time, you'll have various tests and check-ups to make sure the study drug is right for you. This might involve several visits. If you are suitable, you’d then move into the 'study drug period', where you'll take crizotinib as prescribed. During this time, you would have regular appointments, likely about once a week at first, for further tests to monitor your health and see how the drug is working.

If you need to stop taking the study drug early for any reason, you'll have a final visit about a month later for safety check-ups. After stopping the drug, we would continue to monitor your cancer with scans every 8 weeks if your cancer hasn't progressed. Following all treatments and close monitoring, the study team will then call you approximately every three months to check on your general health. The total duration of your participation would depend on how your treatment progresses.

Riesgos y beneficios potenciales

Taking part in a clinical trial offers potential benefits, such as gaining access to a new treatment before it's widely available, and closely monitored medical care. However, there are also potential risks, as crizotinib is a medicine with possible side effects, some of which could be serious. The research team will explain all known side effects in detail. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Ubicaciones (1)

  • Centro de Cáncer Princess Margaret
    Código postal verificado
    Toronto, Canadá· Reclutamiento

Preguntas comunes

What is non-small cell lung cancer?

It's the most common type of lung cancer, and this study focuses on a type that has spread to other parts of the body.

What are ROS1 and MET gene changes?

These are specific changes in your cancer’s genes that can make it grow. The study drug, crizotinib, is designed to target these changes.

Is crizotinib a new drug?

Crizotinib is already approved for some types of lung cancer. This study is exploring if it works for other specific genetic changes.

Will I have to pay for the drug or tests?

No, all study-related drugs, tests, and medical visits are provided at no cost to you.

¿Puedo dejar de participar en el estudio en cualquier momento?

Yes, you are free to leave the study at any point, and your decision will not affect your future medical care.

Cómo obtener más información

Natasha Leighl, M.D.

Siempre hable con su médico de cabecera o especialista antes de decidir participar en un estudio.

¿Interesado en participar?

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Comparte tus detalles y el equipo de investigación para "Study of Crizotinib for ROS1 and MET Activated Lung Cancer…" se pondrá en contacto contigo si puedes ser elegible. Siempre habla con tu médico antes de aceptar participar.

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