Active not recruitingPHASE3INTERVENTIONAL

A Study of Selpercatinib (LY3527723) in Participants With Advanced or Metastatic RET Fusion-Positive Non-Small Cell Lung Cancer

This clinical trial is investigating a new medication called selpercatinib for a specific type of lung cancer known as non-small cell lung cancer (NSCLC). This particular cancer has a change in a gene called RET, and the cancer has spread to other parts of the body. The main goal of the study is to find out if selpercatinib is more effective and safer than the usual standard treatments. Some participants will receive selpercatinib, while others will get a standard treatment. If participants receiving the standard treatment find their cancer growing, they might have the option to switch to selpercatinib. This helps researchers understand the best way to treat this specific kind of lung cancer.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Eli Lilly and Company

Enrolment target

261

Start

17 Feb 2020

Estimated completion

01 Jun 2030

Non-Small Cell Lung Cancer

What is this study about?

This study is looking at a new drug called selpercatinib for a type of lung cancer that has started to spread within the body. This cancer is specifically non-small cell lung cancer (NSCLC), and it has a particular genetic change called a 'RET fusion'. This means there's a change in how a certain gene works in the cancer cells.

The main aim of this research is to see if selpercatinib is a helpful and safe treatment for people with this specific type of lung cancer, compared to the treatments doctors already use. Scientists want to understand if this new drug can help slow down the cancer or shrink it, and if it causes fewer side effects than current options. Some people in the study will get the new drug, and others will get one of the standard treatments for lung cancer. The doctors will then compare how well both groups do.

An important part of this study is that if someone receiving standard treatment finds their cancer is getting worse, they might have the chance to switch over and try selpercatinib. This helps ensure that more people have access to the new drug if it seems beneficial. Ultimately, this research hopes to find better ways to treat non-small cell lung cancer that has a RET fusion.

Key takeaways

This study evaluates a new drug, selpercatinib, for a specific type of spreading lung cancer.
It's for non-small cell lung cancer with a 'RET gene fusion'.
It compares the new drug to standard cancer treatments.
If on standard treatment, you might switch to the new drug if your cancer worsens.
It aims to find safer and more effective treatment options.

Who may be eligible?

To join this study, your doctor would need to confirm that you have non-small cell lung cancer that has spread and that surgery or radiation isn't suitable for you. Your cancer must also have a specific genetic change called a 'RET gene fusion,' which doctors can find by testing your tumour or blood. You should generally be feeling well and able to carry out most daily activities, with good results from routine blood tests for your liver, kidneys, and blood cells.

There are also some reasons why you might not be able to join. For instance, if you've recently had major surgery or radiation treatment, or if you have certain heart problems or other serious ongoing health issues that aren't well controlled. You also wouldn't be able to join if you have other types of cancer in specific situations, or if you are pregnant or breastfeeding. It's important to be able to swallow capsules for the study medication.

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 you have non-small cell lung cancer that has spread?
Has your doctor confirmed your cancer has a 'RET gene fusion'?
Are you generally feeling well and able to be fairly active?
Are you able to swallow capsules?
Do you have good results from your routine blood tests (liver, kidney, blood count)?
Are you currently not pregnant or breastfeeding?

Answer every question to see your result.

What does participation involve?

Taking part in this study would involve regular visits to the clinic for check-ups, blood tests, and scans to monitor your health and how the treatment is working. You would be given either the new drug, selpercatinib, which you would take as capsules, or one of the standard cancer treatments. The specific details of how often you visit and what assessments are done would be explained fully by the study team.

If you are a man or woman who could have children, you would need to agree to use effective birth control during the study and for six months after your last dose of treatment. The total duration of your participation would depend on how your treatment is progressing and your individual health, but there would be follow-up appointments even after you stop taking the study medication to ensure your well-being. The study team will provide all the necessary information and support throughout your involvement.

Potential risks and benefits

Participating in this study might offer the potential benefit of accessing a new treatment, selpercatinib, which could be more effective for your specific type of lung cancer than current options. This type of research helps us learn more about new ways to fight cancer. However, as with any medication, there are potential risks and side effects that could occur with both selpercatinib and the standard treatments. These will be fully explained to you by the study team. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (196)

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

Centro de Oncología e Investigación de Buenos Aires
Verified postcode
Berazategui, Argentina
Fundacion CENIT para la Investigacion en Neurociencias
Unverified
Caba, Argentina
Clinica Viedma
Verified postcode
Viedma, Argentina
Alexander Fleming
Unverified
Ciudad de Buenos Aires, Argentina
Clínica El Castaño
Verified postcode
San Juan, Argentina
Chris O'Brien Lifehouse
Verified postcode
Camperdown, Australia
Calvary Mater Newcastle
Verified postcode
Waratah, Australia
Westmead Hospital
Verified postcode
Westmead, Australia
Monash Health
Verified postcode
Clayton, Australia
Peter MacCallum Cancer Centre
Verified postcode
Melbourne, Australia
St Vincent's Hospital
Verified postcode
Melbourne, Australia
Peninsula Oncology Centre
Verified postcode
Frankston, Australia

Common questions

What is 'Non-Small Cell Lung Cancer'?

It's the most common type of lung cancer, and 'non-small cell' refers to how the cancer cells look under a microscope.

What is a 'RET fusion'?

It's a specific change in the genes within the cancer cells that can make them grow. This study is for people whose cancer has this particular change.

What is 'standard treatment' in this study?

It refers to medicines commonly used by doctors to treat lung cancer, which could include chemotherapy (like carboplatin or cisplatin) or immunotherapy (like pembrolizumab).

Can I switch treatments if the first one doesn't work?

Yes, if you're on the standard treatment arm and your cancer progresses, you might have the option to switch over to selpercatinib.

How long will I be in the study?

The length of time you're in the study will depend on how your treatment is working and your health, but there will be follow-up after you stop treatment.