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Safety and efficacy of Rilvegostomig with drug combination in adult patients with unresectable stage III non‑small cell lung cancer undergoing chemoradiotherapy

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What is this trial about?

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

The study focuses on adults with advanced, unresectable Non-small Cell Lung Cancer that cannot be removed by surgery and is classified as Stage III. The investigation evaluates a newer form of immunotherapy called Rilvegostomig, which is given through an IV line. In addition to the test drug, participants may receive standard chemotherapy agents such as pemetrexed, carboplatin, paclitaxel, mycophenolate mofetil, cisplatin and infliximab.

The main aim is to determine how safe and tolerable the new immunotherapy is when used alone or together with the other anticancer medicines. Participants will receive the assigned treatment during several weekly infusion sessions, followed by regular clinic visits for health checks and routine scans to see how the disease is responding.

During the study, blood samples are taken to measure the amount of the immunotherapy in the bloodstream and to check for any immune reactions against the drug, while imaging tests are performed to monitor tumor size. All observations are used to evaluate safety and any side‑effects that may occur.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Baseline assessments
After you join the study, you will undergo initial medical examinations, laboratory tests, and imaging scans to document the status of your lung cancer and overall health.
These assessments provide the information needed to determine eligibility for the treatment phases that follow.
Step 2
Initiation of concurrent chemoradiotherapy
You will begin radiation therapy to the chest combined with chemotherapy that is given through a vein (intravenous infusion).
The radiation schedule follows the protocol and is delivered over several weeks while chemotherapy is administered on the same days.
Step 3
Chemotherapy cycles
Each chemotherapy cycle is given every three weeks and includes several drugs:
cisplatin 75 mg/m2 administered intravenously on day 1 of the cycle; the dose is calculated based on your body surface area (square meters).
pemetrexed given intravenously; the exact dose is specified in the study protocol.
carboplatin given intravenously; the exact dose is specified in the study protocol.
paclitaxel given intravenously; the exact dose is specified in the study protocol.
mycophenolate mofetil taken orally; the exact dose is specified in the study protocol.
infliximab administered as an intravenous infusion; the dose is expressed in milligrams per kilogram of body weight and is defined by the protocol.
The number of cycles you receive is defined by the study design and may continue for several months.
Step 4
Immunotherapy administration
As part of the study, you will receive rilvegostomig, an investigational immunotherapy drug, by intravenous infusion.
The dose is given in milligrams and is defined by the protocol; it is administered on day 1 of each chemotherapy cycle.
The frequency matches the chemotherapy schedule (every three weeks) and continues for the duration specified in the study.
Step 5
Post‑treatment follow‑up
After the last cycle of chemotherapy and immunotherapy, you will undergo regular follow‑up visits that include imaging studies and laboratory tests.
These visits are used to monitor the safety of the treatments, assess any side effects, and evaluate the response of the cancer to the therapy.
Follow‑up continues for the period defined by the study protocol.

Who can join the trial?

11 criteria

Be diagnosed with non‑small cell lung cancer (NSCLC) that has been confirmed by looking at cells under a microscope (histology) or by testing cells (cytology).
Have stage III lung cancer that cannot be removed by surgery and is suitable for combined chemotherapy and radiation (called concurrent chemoradiation) according to standard staging rules.
Test results must show that the cancer does NOT have certain gene changes called EGFR mutations or ALK rearrangements, which can affect treatment choices.
Testing must also show that the cancer does NOT have ROS1 or RET gene rearrangements, as determined by the local laboratory.
Be able to receive a standard chemotherapy regimen that contains a platinum drug (platinum‑based) together with radiation therapy totaling 60 Gy (a unit of radiation dose) given in 30 daily sessions using photon beams.
Have an ECOG performance status of 0 or 1, meaning you are fully active (0) or able to carry out light work (1) without significant limitation.
Have a known result for the tumor’s PD‑L1 expression and have a sample of the tumor tissue available to confirm that result.
Have at least one tumor spot that can be measured accurately on a CT or MRI scan: the spot must be at least 10 mm long (or a lymph node at least 15 mm in short side) so it can be tracked over time.
Have adequate function of major organs (such as liver, kidneys, and bone marrow) as shown by standard blood tests, meaning the body can handle the study treatments.
Be an adult (generally 18 years of age or older) and able to give informed consent.
Both men and women are eligible to take part in the study.

Who cannot join the trial?

9 criteria

You have a type of lung cancer called small cell or a related type called neuroendocrine, or a very rare form such as the sarcomatoid variant.
The cancer has grown into the main blood vessels near the heart, such as the aorta, the superior or inferior vena cava, or other vessels inside the heart sac.
malignant pleural effusion) or around the heart (malignant pericardial effusion), which would need to be checked by removing fluid with a needle (called thoracentesis or pericardiocentesis).
You have a history of lung scarring diseases such as idiopathic pulmonary fibrosis, other forms of interstitial lung disease (ILD), or radiation‑related lung inflammation that needed steroid medication, or you currently show signs of these conditions on imaging. This also includes conditions called organizing pneumonia or drug‑induced lung inflammation.
You have previously received an organ transplant or an allogeneic stem cell transplant (a transplant from another person).
You have had another type of cancer that is not completely cured, unless it was a low‑risk skin cancer that was fully removed or a pre‑cancerous condition that was treated successfully at least two years ago.
You have an autoimmune or inflammatory disease that requires ongoing treatment with medicines that affect the whole body.
You have already had chemotherapy or radiation treatment for this lung cancer, or you have had radiation to any area that included lung tissue.
You have previously been treated with drugs that target the immune system, such as anti‑PD‑1, anti‑PD‑L1, anti‑TIGIT, or similar immune‑regulating therapies.

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Verified sites

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

Goethe University Frankfurt
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Frankfurt, Germany
Hospital Universitario Fundacion Jimenez Diaz
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Madrid, Spain
Hospital Universitario Virgen De La Victoria
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Malaga, Spain

Trial locations

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Investigated drugs

PEMETREXED
is a chemotherapy drug that helps stop cancer cells from growing and dividing. In this study it is given through a vein (IV) as part of the standard treatment plan for lung cancer.
CARBOPLATIN
is another chemotherapy medication that works by damaging the DNA of cancer cells, which slows their growth. It is also administered intravenously and is part of the usual chemotherapy regimen used in the trial.
PACITAXEL
is a chemotherapy agent that interferes with the way cancer cells divide, helping to shrink tumors. It is given by IV infusion and is included in the background treatment for participants.
MYCOPHENOLATE MOFETIL
is a medication taken by mouth that suppresses the immune system. In the trial it is used to help prevent the body from rejecting the cancer treatment or from developing severe immune reactions.
CISPLATIN
is a chemotherapy drug that damages the DNA of cancer cells, making it harder for them to multiply. It is delivered through an IV and is part of the standard chemotherapy used in the study.
INFLIXIMAB
is a medicine that blocks a protein called TNF‑alpha, which can reduce inflammation and modulate the immune system. In this trial it is given by IV infusion and is part of the background therapy to support the immune‑based treatment approach.

What is already known about the treatment

pemetrexed
It is given by intravenous infusion and is an approved cancer drug. It is used mainly for non‑small cell lung cancer and mesothelioma. It works by blocking enzymes that help cancer cells build DNA, which stops them from growing. It belongs to the antifolate class of chemotherapy agents.
carboplatin
This drug is administered by intravenous injection and is a standard treatment in oncology. It is approved for use in several cancers, including lung cancer. It damages the DNA of cancer cells, preventing them from multiplying. It is classified as a platinum‑based chemotherapy agent.
rilvegostomig
Delivered as an intravenous infusion solution, this medication is currently investigational and being tested in clinical trials. It is aimed at treating non‑small cell lung cancer. It targets a specific protein on cancer cells to help the immune system recognize and attack the tumor. It falls under the category of targeted immunotherapy agents.
paclitaxel
Given by intravenous injection, paclitaxel is an approved drug for many cancers such as lung, breast, and ovarian cancer. It works by stabilizing tiny structures inside cells, which stops the cells from dividing. This action leads to cancer cell death. It is a taxane‑type chemotherapy medication.
mycophenolate mofetil
This medication is taken orally and is an approved immunosuppressant used to prevent organ rejection and treat some autoimmune conditions. It interferes with a key step in making DNA for immune cells, reducing their activity. By doing so, it lowers the immune response. It is classified as an immunosuppressive agent.
cisplatin
Administered by intravenous injection, cisplatin is a widely used, approved chemotherapy drug for many cancers, including lung cancer. It forms cross‑links in the DNA of cancer cells, which triggers cell death. This stops tumor growth. It belongs to the platinum‑based chemotherapy class.

Investigated diseases

Non-small Cell Lung Cancer - It is a group of lung cancers that begin in the cells lining the large airways of the lungs. The disease usually starts as a small tumor that can grow larger over time, invading nearby lung tissue. As it advances, cancer cells may spread to nearby lymph nodes and later travel through the bloodstream to other parts of the body. The progression is typically slower than that of small cell lung cancer, but it can still lead to widespread involvement if not controlled.