Active not recruitingPHASE3INTERVENTIONAL

A Study to Compare the Efficacy and Safety of Entrectinib and Crizotinib in Participants With Advanced or Metastatic ROS1 Non-small Cell Lung Cancer (NSCLC) With and Without Central Nervous System (CNS) Metastases

This study is looking at two different medications, entrectinib and crizotinib, for people with a type of advanced lung cancer called non-small cell lung cancer (NSCLC). This specific lung cancer has a genetic change called ROS1. The main goal is to find out which of these medicines is more effective at treating the cancer and which has fewer side effects. This includes patients whose cancer has spread to the brain or spine. Participants will take one of the medicines by mouth every day, and doctors will monitor their health until the treatment is no longer working, side effects are too severe, or they decide to stop. This research is important for improving treatments for this specific type of lung cancer.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Hoffmann-La Roche

Enrolment target

220

Start

30 Sep 2021

Estimated completion

26 Jun 2028

Carcinoma, Non-Small-Cell Lung

What is this study about?

This study is investigating a type of lung cancer called non-small cell lung cancer, which is the most common kind of lung cancer. Specifically, it's for people whose cancer is advanced, meaning it has spread, and has a particular genetic change known as a ROS1 rearrangement. This genetic change makes these cancer cells behave differently and can mean certain treatments are more effective.

The study aims to compare two different medications: entrectinib and crizotinib. Both of these are 'targeted therapies,' which means they are designed to specifically attack cancer cells with the ROS1 change, rather than affecting all cells like traditional chemotherapy. Doctors want to understand which of these two medicines works best at shrinking the cancer and stopping it from growing, and which one has fewer unwanted side effects. This research is particularly interested in people whose cancer has spread to the brain or spinal cord, as this can be a difficult area to treat.

By comparing these two treatments, researchers hope to find better ways to help people with this specific type of lung cancer. This could lead to more effective treatments and an improved quality of life for patients in the future. It's a key step in personalising cancer treatment, matching the right drug to the right genetic changes in a patient's cancer.

Key takeaways

Compares two oral medications (entrectinib and crizotinib) for advanced lung cancer.
Specifically for non-small cell lung cancer with a ROS1 gene change.
Includes patients whose cancer has spread to the brain or spinal cord.
Aims to find out which medicine is safer and more effective.
Participants take medication daily and have regular check-ups.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To join this study, you would need to be an adult (18 years or older) with advanced non-small cell lung cancer that has a specific genetic change called ROS1. You shouldn't have been treated with any ROS1-targeting drugs or chemotherapy for your advanced cancer before. Also, your cancer needs to be actively measurable by doctors.

Even if your cancer has spread to your brain or spine, you might still be able to join. You need to be well enough to take part, meaning you have a life expectancy of at least 12 weeks and your body's main organs (blood, kidneys, liver) are working properly. If you've had major surgery or serious injuries, you'd need to have recovered for at least 28 days before starting. You also need to be able to swallow capsules whole.

If you're a woman who could become pregnant, you'll need to agree to use effective contraception during the study and for some time after your last dose. Similarly, men will need to use contraception and agree not to donate sperm. People who have had severe side effects from previous treatments (unless it's hair loss, tiredness, nausea, or loss of appetite) are generally not able to join.

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.

Are you 18 years or older?
Do you have advanced non-small cell lung cancer with a ROS1 genetic change?
Have you *not* had prior targeted therapy or chemotherapy for your advanced lung cancer?
Are you generally well and able to swallow capsules whole?
If you are a woman of childbearing potential, are you able to use effective contraception?
If you are a man, are you able to use contraception and not donate sperm?

Answer every question to see your result.

What does participation involve?

If you join this study, you would be provided with either entrectinib or crizotinib. Both are medications taken as capsules by mouth. You would take your assigned medication every day, following the instructions given by your study doctor. This treatment will continue for as long as it's helping you and you're not experiencing too many side effects. This could be weeks, months, or even longer.

Throughout the study, you'll have regular appointments with the study team. These visits will involve blood tests, physical examinations, and scans to check how the medicine is working and to monitor for any side effects. The study team will explain exactly how often these visits will be. You have the right to stop taking part in the study at any time, for any reason, without it affecting your medical care.

Potential risks and benefits

Taking part in this study could offer the potential benefit of receiving an active treatment for your particular type of lung cancer, which might help to control your disease. You would also be closely monitored by medical professionals throughout the study. However, like all medications, entrectinib and crizotinib can have side effects, which could be mild or more serious. The study team will explain all known potential side effects to you before you decide to join. It is always your right to leave the study at any time, and you don't have to give a reason, and this decision will not affect your future medical care.

Locations (61)

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

Oncocentro Serviços Médicos e Hospitalares Ltda
Verified postcode
Fortaleza, Brazil
Hospital Sao Rafael - HSR
Verified postcode
Salvador, Brazil
Hospitais Integrados da Gavea S/A
Verified postcode
Brasília, Brazil
Centro de Pesquisa e Ensino em Oncologia de Santa Catarina - CEPEN
Verified postcode
Florianópolis, Brazil
Hospital de Cancer de Barretos
Verified postcode
Barretos, Brazil
Instituto do Cancer do Estado de Sao Paulo - ICESP
Verified postcode
São Paulo, Brazil
Oncoclinicas Rio de Janeiro S.A.
Verified postcode
Rio de Janeiro, Brazil
Jilin Cancer Hospital
Verified postcode
Changchun, China
The Second Xiangya Hospital of Central South University
Verified postcode
Changsha, China
Hunan Cancer Hospital
Verified postcode
Changsha, China
West China Hospital, Sichuan University
Verified postcode
Chengdu, China
The First Affiliated Hospital of Guangzhou Medical University
Verified postcode
Guangzhou, China

Common questions

What is ROS1 non-small cell lung cancer?

It's a type of advanced lung cancer where the cancer cells have a specific genetic change called a ROS1 rearrangement. This change can make the cancer respond to particular targeted medicines.

What are entrectinib and crizotinib?

They are both targeted therapy medicines that come in capsule form. They work by blocking signals that cancer cells with the ROS1 change need to grow.

Can I join if my cancer has spread to my brain?

Yes, this study is open to people whose lung cancer has spread to their brain or spinal cord, as long as it's measurable.

Will I know which medicine I'm getting?

The study design means participants will be randomly assigned to either entrectinib or crizotinib. The study team will tell you more about this process.

How long will I be on the treatment?

You will continue taking the medicine as long as it is working for you, and you are not experiencing significant side effects. This period can vary for each person.