All studies
Active not recruitingPHASE2INTERVENTIONAL

A Trial to Learn if the Combination of Fianlimab, Cemiplimab, and Chemotherapy is Safe and Works Better Than the Combination of Cemiplimab and Chemotherapy in Adult Patients With Non-Small Cell Lung Cancer That Can be Treated With Surgery

This research study is for adults with a type of lung cancer called non-small cell lung cancer that doctors believe can be treated with surgery. We want to find out if combining a new experimental drug called Fianlimab with two existing treatments, Cemiplimab and chemotherapy, is safer and more effective than Cemiplimab and chemotherapy alone. The study will look at how well this new combination works before and after surgery. We'll also be carefully checking for any side effects, how the body handles the drugs, and if the treatment impacts a person's quality of life. This is a Phase 2 study, meaning it's an early stage of testing new treatments.

At a glance

Status
Active not recruiting
Phase
PHASE2
Sponsor
Regeneron Pharmaceuticals
Enrolment target
195
Start
16 Jul 2024
Estimated completion
04 Nov 2029

What is this study about?

This study is about a type of lung cancer called non-small cell lung cancer. For some people, this cancer can be removed with an operation. Doctors are always looking for better ways to treat this cancer, especially around the time of surgery, to give people the best chance of recovery.

In this study, we're testing a new approach. Participants will receive a combination of medicines before and after their surgery. One group will get a new, experimental drug called Fianlimab, along with two other drugs, Cemiplimab and chemotherapy. Another group will receive Cemiplimab and chemotherapy, but without Fianlimab. The main goal is to compare these two groups to see if adding Fianlimab makes the treatment more effective and if it's safe.

The researchers will also be keeping a close eye on several other things, like any side effects people experience, how the body absorbs and processes these medicines, and whether the treatment affects their general well-being and quality of life. Understanding these aspects is crucial for developing better treatments in the future.

Key takeaways

  • This study is for adults with non-small cell lung cancer that can be surgically removed.
  • It compares a new drug combination with an existing one to see if it works better.
  • The new combination includes Fianlimab, Cemiplimab, and chemotherapy.
  • Researchers will monitor safety, effectiveness, and quality of life.
  • This is an early-stage study (Phase 2) testing new treatments.
  • Participation involves receiving medicines before and after surgery, with regular check-ups.

Who may be eligible?

To join this study, you must be an adult with newly diagnosed non-small cell lung cancer that your doctors believe can be fully removed by surgery. Your cancer should be at a specific stage (Stage II to IIIB, N2). We will also need to check some things about your cancer, like if a specific marker called PD-L1 is present, and make sure the cancer hasn't spread to distant parts of your body.

You also need to be generally in good health, with your body – including your blood, liver, and kidneys – working well. You shouldn't have had any other cancer treatments recently, nor should you have certain conditions like uncontrolled HIV or hepatitis, or a known heart problem called myocarditis. We'll also check for specific genetic changes in your tumour that are sometimes treated differently.

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 an adult aged 18 or over?
  2. Do you have newly diagnosed non-small cell lung cancer that your doctor says can be removed by surgery?
  3. Has your cancer not spread to distant parts of your body?
  4. Are your liver, kidney, and blood test results generally healthy?
  5. Have you not had any cancer treatment (like chemo or radiotherapy) in the last 3 years?
  6. Do you not have conditions like uncontrolled HIV, hepatitis, or a history of myocarditis (heart inflammation)?
Answer every question to see your result.

What does participation involve?

If you join this study, you will receive a combination of medicines (either Fianlimab, Cemiplimab, and chemotherapy, or Cemiplimab and chemotherapy) before and after your surgery. These medicines are given through an IV (a drip into your vein). You will have regular visits to the clinic for these treatments and to have check-ups. These check-ups will include blood tests, scans, and physical examinations to see how you are doing, how the treatment is working, and to monitor for any side effects. Researchers will also collect information on your quality of life. The total duration of your participation in the study, including follow-up after treatment, will be discussed in detail by your medical team.

Potential risks and benefits

Participating in a clinical trial may offer certain benefits, such as access to new experimental treatments not yet widely available. However, there are also potential risks, as the new drug combination may cause unexpected side effects or might not work as hoped. Your doctors will carefully discuss all known and potential risks with you. Remember, joining a study is always your choice, and you are free to withdraw at any time without affecting your future medical care.

Locations (123)

  • Clermont Oncology Center
    Verified postcode
    Clermont, United States
  • University of Illinois
    Verified postcode
    Chicago, United States
  • University of Kansas Cancer Center-Westwood
    Verified postcode
    Westwood, United States
  • Henry Ford Health System
    Verified postcode
    Detroit, United States
  • Mercy South
    Verified postcode
    St Louis, United States
  • University of Rochester
    Verified postcode
    Rochester, United States
  • Kaiser Permanente Northwest
    Verified postcode
    Portland, United States
  • Virginia Cancer Care Specialist, PC
    Verified postcode
    Fairfax, United States
  • Eastern Health
    Verified postcode
    Box Hill, Australia
  • St Vincent's Hospital
    Verified postcode
    Fitzroy, Australia
  • St John of God Murdoch Hospital
    Verified postcode
    Murdoch, Australia
  • Orlandi Oncologia
    Verified postcode
    Providencia, Chile

Common questions

What is Fianlimab?

Fianlimab is an experimental drug, meaning it's still being tested to see if it's safe and effective. It's not yet approved for general use.

What is Cemiplimab?

Cemiplimab is a type of immunotherapy medicine that helps your body's immune system fight cancer.

What does 'chemotherapy' involve?

Chemotherapy uses strong medicines to kill cancer cells or slow their growth. It's typically given through a drip into your vein.

What does 'resectable' cancer mean?

Resectable means that the doctors believe the cancer can be completely removed during an operation.

What is a 'Phase 2' study?

A Phase 2 study is an early stage clinical trial where researchers test if a new treatment is safe and effective in a larger group of people than in Phase 1.

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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