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 study about?

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.

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.

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.

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.

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.

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 Study?

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 Study?

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

malignant pericardial effusion

thoracentesis

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.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country
Medical Center – University Of Freiburg	Freiburg Im Breisgau	Germany
Universitätsklinikum des Saarlandes – Homburg/Saar, Klinik für Urologie und Kinderurologie	Homburg	Germany
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
Hospital Universitario Virgen De La Victoria	Malaga	Spain
Hospital Alvaro Cunqueiro	Vigo	Spain
Hnliupsh Vcqq degnfrwc	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Germany	Not yet recruiting	29.01.2027
Spain	Not yet recruiting	29.01.2027

Trial locations

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.

Rilvegostomig is the experimental therapy being tested in this study. It is given as an IV infusion and is designed to work with the immune system to help the body recognize and fight lung cancer cells more effectively, either alone or together with other anticancer drugs.

Investigated Diseases:

Non-small cell lung cancer

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.

Trial ID:

2025-523599-21-00

Protocol code:

D702PC00001

Trial Phase:

Therapeutic exploratory (Phase II)

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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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?