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A study to evaluate the safety and effectiveness of rilvegostomig, ramucirumab, and a drug combination in adults with advanced or metastatic non-small cell lung cancer

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study aims to evaluate the safety and effectiveness of different combinations of new medicines in individuals with Non-Small Cell Lung Cancer. This type of cancer is a common form of lung cancer that starts in the cells located in the outer parts of the lungs. The study focuses on patients whose cancer is locally advanced, meaning it has grown into nearby tissues, or metastatic, which means the cancer has spread to other parts of the body.

Participants may receive combinations of several medications, including the experimental drug rilvegostomig and the medication ramucirumab. Other medicines that may be part of the treatment plan include mycophenolate mofetil and infliximab. These medications are administered through different methods, such as oral pills taken by mouth or IV infusion, which is a process where medicine is delivered directly into a vein through a tube.

During the study, the way the body processes these drugs and how the immune system reacts to them will be monitored. The research will look at how well the treatments work by observing changes in the size of tumors and how long the cancer remains stable. Researchers will also track any adverse events, which are unwanted or harmful side effects that may occur during treatment.

The research process

The trial runs in 2 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Background medication administration
You will take mycophenolate mofetil, which is a medication taken by mouth (oral). the amount to be taken is 3 grams.
You will also receive infliximab through an intravenous infusion (a liquid passed into a vein through a needle or tube). the dose is 5 mg/kg, which means 5 milligrams for every kilogram of your body weight.
Step 2
Test medication administration
You will receive rilvegostomig through an intravenous infusion. the dose is 999 milligrams.
You will also receive ramucirumab through an intravenous infusion. the dose is 10 mg/kg, which means 10 milligrams for every kilogram of your body weight.

Who can join the trial?

10 criteria

You must be 18 years of age or older when you sign the consent form, which is the document that explains the study to you.
You must have a WHO/ECOG performance status of 0 or 1, which is a scale used by doctors to measure how well you can perform daily activities and how much your illness affects your physical abilities.
You must have at least one target lesion, which is a specific area of a tumor that doctors can easily see and measure using scans to track if the treatment is working.
You must have adequate bone marrow and organ function, meaning your blood-forming tissues and your vital organs like your liver or kidneys are working well enough to handle the study treatment.
You must have a life expectancy of at least 12 weeks.
You must be able to provide acceptable tumor tissue for testing.
For certain parts of the study, you must have advanced or metastatic Non-Small Cell Lung Cancer, which means the cancer is either in an advanced stage or has spread to other parts of the body.
For certain parts of the study, you must have a PD-L1 TC level of at least 1%, which is a measurement of a specific protein found on cancer cells that helps the immune system recognize the tumor.
For certain parts of the study, you must not have EGFR mutations or ALK rearrangements, which are specific genetic changes in the cancer cells that might require different types of treatment.
For certain parts of the study, you must not have any other actionable genomic alterations, which are known genetic changes in the cancer that can be treated with specific, targeted medicines.

Who cannot join the trial?

14 criteria

Any severe or uncontrolled systemic diseases, which are illnesses that affect the entire body rather than just one part, if the doctor believes participating would be unsafe or make it hard to follow the study rules.
Having used immune-mediated therapy, which is a type of treatment that uses the body's immune system to fight cancer, in the past.
A history of uncontrolled hypertension, meaning high blood pressure that is not well-managed by medicine.
Having active bleeding diseases, high risks of bleeding, or disorders of coagulation, which means problems with how your blood clots.
Using any other anti-cancer treatment at the same time as this study.
Having received a live, attenuated vaccine, which is a type of vaccine containing a weakened version of a germ, within 30 days before the first study dose.
Having active or prior documented autoimmune or inflammatory disorders, which are conditions where the body's immune system attacks its own healthy cells or causes swelling.
Having persistent toxicities, which are ongoing side effects or harmful effects from previous cancer treatments, rated as Grade 2 or higher on the standard medical scale (meaning moderate to severe side effects), excluding hair loss.
Having spinal cord compression (pressure on the spinal cord) or leptomeningeal carcinomatosis (cancer that has spread to the protective layers surrounding the brain and spinal cord) for certain parts of the study.
Having unstable brain metastases, which are areas of cancer that have spread to the brain and are changing or growing.
A history of having another primary malignancy, which means a different type of cancer that started in another part of the body.
Having an active infection, including tuberculosis (TB), HIV, Hepatitis B (HBV), or Hepatitis C (HCV).
Having uncontrolled or significant cardiac disease, which refers to serious heart problems that are not stable.
Having previously received systemic chemotherapy, chemoradiation, or immunotherapy for advanced non-small cell lung cancer for certain parts of the study.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Centre Hospitalier Universitaire De Rennes
Verified
Rennes, France
Istituto Europeo Di Oncologia S.r.l.
Responsive
Milan, Italy
Istituto Oncologico Veneto
Responsive
Padua, Italy

Trial locations

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Investigated drugs

Rilvegostomig
is an experimental drug being tested in this study to see if it can help fight cancer cells in people with non-small cell lung cancer.
Ramucirumab
is a medication used in this trial to help stop the growth of blood vessels that supply tumors, which can help slow down the progression of cancer.

What is already known about the treatment

Mycophenolate mofetil
This medication is taken by mouth in tablet form and is already widely used in medical practice. It is classified as an immunosuppressant, which means it helps prevent the body's immune system from attacking itself. It works by blocking a specific enzyme that certain immune cells need to multiply, thereby reducing the immune response.
Rilvegostomig
This is an investigational drug administered through a slow drip into a vein. It belongs to a class of medications known as bispecific antibodies, which are being studied for their ability to treat various cancers. At a molecular level, it is designed to act like a bridge, simultaneously attaching to a cancer cell and an immune cell to help the immune system recognize and destroy the tumor.
Ramucirumab
This medication is given as an intravenous infusion and is currently an established treatment used in clinical medicine. It is classified as an angiogenesis inhibitor, which means it targets the growth of new blood vessels. It works by binding to specific proteins on the surface of blood vessels, preventing them from receiving the signals that tell them to grow and feed the tumor.
Infliximab
This drug is administered through an intravenous infusion and is a well-known medication used to treat various inflammatory conditions. It belongs to a class of drugs called monoclonal antibodies that target specific proteins in the immune system. It works by attaching to and neutralizing a protein called tumor necrosis factor, which is a key messenger that causes inflammation in the body.

Investigated diseases

Non-Small Cell Lung Cancer - This is a type of cancer that starts in the cells of the lungs. It is the most common form of lung cancer and is characterized by cells that do not look like the usual mucus-producing cells found in the airways. The disease typically begins in the outer parts of the lungs or in the large airways. As it progresses, the abnormal cells can grow and spread into nearby tissues or other parts of the body.