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RecruitingPHASE3INTERVENTIONAL

LUNAR-2: TTFields With Pembrolizumab + Platinum-based Chemotherapy for Metastatic NSCLC

The LUNAR-2 study is investigating a new treatment approach for people with advanced non-small cell lung cancer that has spread. This trial combines a device called NovoTTF-200T, which creates electric fields to disrupt cancer cells, with two existing cancer medicines: pembrolizumab (an immunotherapy) and platinum-based chemotherapy. The main aim is to see if this combination helps patients live longer and slows down the cancer's growth compared to just receiving pembrolizumab and chemotherapy. Researchers will also look at how effective the treatment is for different types of lung cancer. This study is for people who haven't had previous treatment for their advanced lung cancer.

At a glance

Status
Recruiting
Phase
PHASE3
Sponsor
NovoCure GmbH
Enrolment target
734
Start
31 Jul 2024
Estimated completion
01 Oct 2028

What is this study about?

The LUNAR-2 study is a clinical trial exploring a new way to treat advanced non-small cell lung cancer (NSCLC). This is a type of lung cancer that has spread to other parts of the body. The study combines two standard treatments – pembrolizumab (a medicine that helps your immune system fight cancer) and chemotherapy – with a new device called NovoTTF-200T. This device delivers 'Tumor Treating Fields' (TTFields).

TTFields are electrical impulses that are thought to disrupt cancer cells and stop them from dividing and growing. The NovoTTF-200T is a portable device that creates these fields. By adding TTFields to existing treatments, researchers hope to improve how well the treatments work and help people with advanced lung cancer live longer and keep their cancer from growing for longer periods.

The study will compare the new combination treatment (TTFields plus pembrolizumab and chemotherapy) to the standard treatment alone (pembrolizumab and chemotherapy). They will carefully track how long people live and for how long their cancer stays contained or shrinks. The study also aims to understand if this new treatment works differently for various types of lung cancer.

Key takeaways

  • This study combines a new device with standard lung cancer treatments.
  • It's for people newly diagnosed with advanced non-small cell lung cancer.
  • The main goal is to see if the new combination helps people live longer.
  • You would receive either the new combination or the standard treatment.
  • The study looks at overall health and how long the cancer is kept under control.
  • It's taking place in many hospitals around the world.

Who may be eligible?

To join this study, you generally need to be at least 18 years old (22 in the USA) and have non-small cell lung cancer that has spread to other parts of your body. Your cancer must have been recently diagnosed as advanced, meaning you haven't started treatment for it yet. If you had chemotherapy or radiotherapy for an earlier, non-spreading lung cancer more than a year ago, you might still be able to join.

Your general health also needs to be good enough for you to take part, which doctors call having a good 'performance status'. This means you should be able to carry out most of your daily activities without much difficulty. You'll also need certain blood test results to show key organs are working well.

There are also reasons you might not be able to join. For example, if your lung cancer has certain genetic changes for which specific targeted treatments are recommended, or if you have a mixed type of lung cancer. You also can't have had recent major surgery or certain types of radiotherapy too close to the start of the study.

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 or older (22 in the USA)?
  2. Have you been diagnosed with advanced non-small cell lung cancer that has spread?
  3. Have you NOT received any prior treatment for your advanced lung cancer?
  4. Are you generally well enough to do most daily activities, with a good performance status?
  5. Do you meet the necessary blood test results for healthy organ function?
Answer every question to see your result.

What does participation involve?

If you decide to take part in the LUNAR-2 study, you will receive either the new combination treatment (TTFields device plus pembrolizumab and chemotherapy) or the standard treatment (pembrolizumab and chemotherapy alone). This decision is made randomly, like flipping a coin. You will have regular hospital visits for your chemotherapy and pembrolizumab infusions, and to have check-ups and scans to see how your treatment is working. The TTFields device would be worn for a significant part of each day, delivered through patches on your skin. The total duration of your participation will depend on how you respond to the treatment and your doctors' guidance, but it involves ongoing treatment and monitoring.

Potential risks and benefits

Participating in this study might offer potential benefits, such as receiving a new treatment that could be more effective than standard care in slowing your cancer or helping you live longer. However, like all medical treatments, there are potential risks and side effects associated with chemotherapy, immunotherapy, and the TTFields device. Your doctors will explain these in detail. It's important to remember that you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (98)

  • Central Alabama Research
    Verified postcode
    Birmingham, United States· Recruiting
  • Western Regional Medical Center, LLC
    Verified postcode
    Goodyear, United States· Recruiting
  • St. Jude Herritage Medical Group
    Verified postcode
    Fullerton, United States· Recruiting
  • Hoag Family Cancer Institute - Hoag Memorial Hospital
    Verified postcode
    Newport Beach, United States· Recruiting
  • Sutter Institute for Medical Research
    Verified postcode
    Sacramento, United States· Recruiting
  • Florida Cancer Affiliates - Ocala Oncology
    Verified postcode
    Ocala, United States· Recruiting
  • Moffitt Cancer Center
    Verified postcode
    Tampa, United States· Recruiting
  • Northwest Oncology & Hematology
    Verified postcode
    Barrington, United States· Recruiting
  • Elmhurst Hospital Nancy Knowles Cancer Center
    Verified postcode
    Elmhurst, United States· Recruiting
  • Edward Cancer Center
    Verified postcode
    Naperville, United States· Recruiting
  • Cancer Treatment Centers of America (CTCA)
    Verified postcode
    Zion, United States· Recruiting
  • Parkview Packnett Family Cancer Institute
    Verified postcode
    Fort Wayne, United States· Recruiting

Common questions

What is non-small cell lung cancer?

It's the most common type of lung cancer, and 'metastatic' means it has spread to other parts of the body.

What are 'TTFields'?

They are gentle electrical fields created by a device called NovoTTF-200T, which aim to stop cancer cells from dividing.

What is Pembrolizumab?

It's a type of immunotherapy that helps your body's immune system recognise and fight cancer cells.

What does 'Platinum-based chemotherapy' mean?

It's a common type of cancer drug that uses platinum compounds to kill fast-growing cells, including cancer cells.

Will I know which treatment I'm getting?

Yes, this is an 'open-label' study, meaning both you and your doctors will know if you're receiving the TTFields device or not.

How to find out more

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

Interested in taking part?

Register your interest

Share your details and the research team for "LUNAR-2: TTFields With Pembrolizumab + Platinum-based Chemot…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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