All studies
Active not recruitingPHASE2, PHASE3INTERVENTIONAL

A Study to Learn if a Combination of Fianlimab and Cemiplimab Versus Cemiplimab Alone is More Effective for Adult Participants With Advanced Non-Small Cell Lung Cancer (NSCLC)

This research is testing a new combination treatment for people with advanced non-small cell lung cancer (NSCLC). We want to find out if combining a new experimental drug, fianlimab, with an existing medication, cemiplimab, is more effective than cemiplimab on its own. The study will also carefully check for any side effects from these drugs, measure how much of the medication is in your body over time, and see if your immune system creates responses that could affect the treatment. Importantly, we also want to understand if this new treatment can improve your quality of life. This is a crucial step in finding better ways to treat advanced lung cancer.

At a glance

Status
Active not recruiting
Phase
PHASE2, PHASE3
Sponsor
Regeneron Pharmaceuticals
Enrolment target
850
Start
30 Jun 2023
Estimated completion
05 Feb 2032

What is this study about?

This study is investigating a new way to treat advanced non-small cell lung cancer, which is the most common type of lung cancer. Sometimes, when cancer is advanced, it means it has spread and can be harder to treat. Researchers are specifically looking at two medicines: fianlimab and cemiplimab. Cemiplimab is a type of immunotherapy, which helps your body's own immune system fight cancer. Fianlimab is an experimental drug, meaning it's still being tested and is not yet available for general use.

The main goal is to see if giving fianlimab together with cemiplimab works better than giving cemiplimab by itself to shrink the cancer or slow its growth. We also want to understand if the combination causes different or more serious side effects. Researchers will be closely monitoring participants throughout the study to make sure safe and effective care is provided.

Beyond just looking at how well the treatments work and their side effects, the study will also address other important questions. For example, they'll check how the body processes the study drugs, how long they stay in your system, and if your immune system reacts to them in a way that might change how well they work. A key part of the research also involves finding out if these treatments can improve how you feel day-to-day and your overall quality of life.

Key takeaways

  • This study is for people with advanced non-small cell lung cancer.
  • It compares a new drug combination (fianlimab + cemiplimab) against cemiplimab alone.
  • The main goals are to check how well it works, its side effects, and impact on quality of life.
  • Participation involves receiving treatment and regular check-ups.
  • You might get the new combination or cemiplimab only.
  • You can stop participating at any time.

Who may be eligible?

To join this study, you would typically need to have advanced non-small cell lung cancer that hasn't been treated with previous medicines for its advanced stage. Doctors would need to be able to measure your cancer on scans like CT or MRI. You also need to be well enough to take part in the study, meaning you are generally active and able to perform daily tasks with ease.

There are also some specific medical requirements, such as having certain levels of a marker called PD-L1 in your cancer cells. Researchers will test for this. Your body's organs and blood counts also need to be working well enough to safely receive the treatment.

Certain conditions would prevent you from joining the study. For example, if you have active or untreated cancer spread to your brain or spinal cord, or if you've never smoked (defined as smoking 100 cigarettes or less in your lifetime).

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. Have you been diagnosed with advanced non-small cell lung cancer?
  2. Have you not received prior treatment for your advanced lung cancer?
  3. Are you generally well and able to carry out most daily activities?
  4. Does your doctor think your cancer could be measured on a scan?
  5. Do you not have active, untreated cancer spread to your brain or spinal cord?
  6. Have you smoked more than 100 cigarettes in your lifetime?
Answer every question to see your result.

What does participation involve?

If you decide to join this study, you'll receive either the combination of fianlimab and cemiplimab, or cemiplimab on its own. The treatments are usually given through a drip (intravenous infusion). You would have regular visits to the clinic for these treatments and for check-ups, which include blood tests, physical exams, and scans to monitor your cancer. Researchers will also ask you questions about how you're feeling and your quality of life. The exact number of visits and the full duration of your participation will be discussed in detail by the study team, but it will involve ongoing assessments and follow-up.

Potential risks and benefits

Participating in this study might offer a potential benefit by giving you access to a new experimental treatment that could be more effective than standard care, especially if the combination of drugs works better for your type of cancer. However, as with any medication, there are potential risks and side effects, some of which might be serious, and the study cannot guarantee that the treatment will work for you. The study team will explain all known and potential side effects in detail. Remember, joining a study is always your choice, and you are free to withdraw at any time without affecting your medical care.

Locations (106)

  • Arizona Clinical Research Center
    Verified postcode
    Tucson, United States
  • Yuma Regional Medical Center
    Verified postcode
    Yuma, United States
  • Emad Ibrahim, MD, Inc.
    Verified postcode
    Redlands, United States
  • Eastern CT Hematology and Oncology Associates
    Verified postcode
    Norwich, United States
  • Clermont Oncology Center
    Verified postcode
    Clermont, United States
  • Miami Veterans Administration HealthCare System
    Verified postcode
    Miami, United States
  • Mid Florida Hematology and Oncology Center
    Verified postcode
    Orange City, United States
  • Pinellas Hematology and Oncology
    Verified postcode
    St. Petersburg, United States
  • Tallahassee Memorial Healthcare
    Verified postcode
    Tallahassee, United States
  • Moffitt Cancer Center
    Verified postcode
    Tampa, United States
  • University of Illinois
    Verified postcode
    Chicago, United States
  • Mary Bird Perkins Cancer Center
    Verified postcode
    Baton Rouge, United States

Common questions

What is Non-Small Cell Lung Cancer (NSCLC)?

It's the most common type of lung cancer. 'Advanced' means it has spread to other parts of the body or grown beyond the lungs.

What are fianlimab and cemiplimab?

Cemiplimab is an approved immunotherapy that helps your body fight cancer. Fianlimab is an experimental drug being tested alongside cemiplimab.

Why is this study important?

It helps us learn if a new combination of drugs can be a more effective treatment for advanced lung cancer, potentially improving outcomes for patients.

Will I definitely get the new combination drug?

You will either receive the combination of fianlimab and cemiplimab or cemiplimab on its own. Which treatment you receive is decided randomly.

What if I change my mind during the study?

You are free to leave the study at any time, for any reason, without it affecting your future medical care.

How to find out more

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

Discussion

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