A Study of Cemiplimab Plus Chemotherapy Versus Cemiplimab Plus Chemotherapy Plus Other Cancer Treatments for Adult Patients With Operable Non-Small Cell Lung Cancer (NSCLC)
This study is for adults with a type of lung cancer called non-small cell lung cancer (NSCLC) that is found early, between stages II and IIIB, and where surgery is planned. Researchers want to find out if adding an extra medication (called REGN7075) to a standard treatment of cemiplimab and chemotherapy works better. They will compare how well these different combinations of treatments work before surgery. The study also aims to understand the side effects of these treatments, how they affect the type of surgery, how the drugs move through the body, and if the body makes antibodies against them. This helps doctors learn the best ways to treat this type of cancer.
At a glance
What is this study about?
This study is a clinical trial for adults who have been diagnosed with early-stage non-small cell lung cancer (NSCLC), specifically stages II to IIIB. This is when the cancer is still relatively localised and doctors believe it can be removed with an operation. The main goal of the study is to see if a new approach to treatment, given before surgery, can improve outcomes for patients. This new approach involves using an immunotherapy drug called cemiplimab, combined with standard chemotherapy, plus an additional, experimental drug called REGN7075.
Researchers will compare this three-drug combination to a two-drug combination of cemiplimab and chemotherapy alone. They want to find out if adding REGN7075 makes the treatment more effective. Effectiveness can mean things like shrinking the tumour more, making surgery easier, or preventing the cancer from coming back. It’s important to understand that REGN7075 is an investigational drug, meaning it’s still being studied and isn't yet a standard approved treatment.
Beyond simply comparing the treatments' effectiveness, the study also aims to learn more about them. This includes carefully monitoring any side effects to understand which treatment might cause more or fewer problems. They will also look at whether the treatment changes the kind of surgery a patient needs. Finally, researchers will study how the drugs behave in the body – for example, how much of the drug is in the blood and if the body develops a reaction to the drugs, which could affect how well they work.
Key takeaways
- This study is for adults with early-stage non-small cell lung cancer who are planned for surgery.
- It compares two pre-surgery treatment plans: cemiplimab + chemotherapy, or cemiplimab + chemotherapy + REGN7075.
- The main goal is to see if adding REGN7075 makes the treatment more effective.
- Researchers will also track side effects and how treatments affect surgery.
- Participating is voluntary, and you can withdraw at any time without affecting your care.
Who may be eligible?
To join this study, you must be an adult aged 18 or older with non-small cell lung cancer that is in stage II, IIIA, or IIIB. Importantly, your doctors must believe that your cancer can be removed through surgery. You'll need to have clear signs of your cancer that can be measured, and the study will require a sample of your tumour tissue. Your general health and fitness, often measured by something called an ECOG score, should be good (either 0 or 1), and your organs and blood should be working well.
There are also some reasons why you wouldn't be able to join. For example, if you've already received other cancer treatments like chemotherapy or radiotherapy for this particular lung cancer, you wouldn't be eligible. If your cancer has certain genetic changes (called EGFR or ALK mutations) or if you have severe numbness or tingling in your hands and feet (peripheral neuropathy), you also can't take part. You also shouldn't have another active cancer or certain heart conditions.
For some parts of the study, there are additional specific reasons why you might not be able to join. These include certain high levels of calcium in your blood or specific brain conditions that could be risky with the study treatment. The research team will go through all these details with you to make sure the study is a safe and suitable option.
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 an adult (18 or older)?
- Do you have stage II, IIIA, or IIIB non-small cell lung cancer?
- Has your doctor said that surgery is a planned treatment for your cancer?
- Have you not received any prior cancer treatment (like chemo or radiation) for this specific lung cancer?
- Are your general health, organ function, and blood tests within healthy limits for the study?
- Do you have no known severe existing nerve problems (like grade 2 or worse peripheral neuropathy)?
What does participation involve?
Taking part in this study would involve regular visits to the hospital or clinic. During these visits, you would receive the study medication (either the two-drug or three-drug combination) and have various tests and assessments. These might include blood tests to check your general health and how the study drugs are affecting you, as well as scans to see how your cancer is responding. You would also have physical examinations and answer questions about how you are feeling and any side effects you might be experiencing.
After you've completed the initial treatment phase and likely undergone surgery, there will be a follow-up period. This involves continued monitoring, which could include further check-ups, scans, and blood tests to track your health and look for any long-term effects of the treatment. The total duration of your participation in the study, including treatment and follow-up, will be explained in detail by the study team, but it typically lasts for many months or even a few years.
Potential risks and benefits
Locations (49)
- University of California IrvineVerified postcodeOrange, United States· Recruiting
- Orchard Healthcare Research Inc.Verified postcodeSkokie, United States· Recruiting
- Karmanos Cancer InstituteVerified postcodeDetroit, United States· Recruiting
- Detroit Clinical Research CenterVerified postcodeFarmington Hills, United States· Recruiting
- Morristown Medical CenterVerified postcodeMorristown, United States· Recruiting
- Rutgers Cancer Institute of New JerseyVerified postcodeNew Brunswick, United States· Recruiting
- Providence Portland Medical CenterVerified postcodePortland, United States· Recruiting
- University Of Nebraska Medical CenterVerified postcodePortland, United States· Recruiting
- Lifespan Cancer InstituteVerified postcodeProvidence, United States· Recruiting
- Prairie Lakes Healthcare SystemVerified postcodeWatertown, United States· Recruiting
- University of Tennessee Medical CenterVerified postcodeKnoxville, United States· Recruiting
- Sarah Cannon Research Institute (SCRI) Oncology PartnersVerified postcodeNashville, United States· Recruiting
Common questions
What is non-small cell lung cancer (NSCLC)?
It's the most common type of lung cancer. This study is for people with earlier stages of NSCLC where surgery is planned.
What is cemiplimab?
Cemiplimab is an immunotherapy drug. It helps your body's immune system fight cancer cells more effectively.
What is REGN7075?
REGN7075 is an experimental drug, meaning it's still being tested. We hope it might make the other treatments work even better.
Will I definitely get the new three-drug treatment?
Patients in this study will be randomly assigned to either receive cemiplimab plus chemotherapy, or cemiplimab plus chemotherapy plus REGN7075. You won't know which group you are in until after you join.
What if I feel unwell during the study?
You will be closely monitored, and any side effects or changes in your health will be managed by the study doctors. You can stop participating at any time.
How to find out more
Clinical Trials Administrator
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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