A study of rilvegostomig and ramucirumab in patients with advanced or metastatic non-small cell lung cancer

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What is this study about?

This study focuses on individuals with metastatic non-small cell lung cancer, a type of lung cancer that has spread to other parts of the body. The purpose of the study is to evaluate the safety and effectiveness of combining new cancer treatments. The medications being studied include ramucirumab, which is also known as Cyramza, and a new drug called rilvegostomig. These medications are administered through intravenous infusion, which means they are delivered directly into a vein.

The research is conducted in different stages to carefully monitor how the body reacts to these drug combinations. Initially, the focus is on determining the safest and most appropriate amount of medicine to give. Following this, the study expands to observe how well these combinations work in shrinking tumors. During the study, medical professionals will monitor various health indicators, such as vital signs and laboratory results, to ensure safety throughout the process.

Who Can Join the Study?

  • You must be at least 18 years old when you agree to join the study.
  • You must be able to understand the study details and provide your signed written consent, which is your formal agreement to participate.
  • You must be willing and able to follow all the rules of the study, including attending all scheduled appointments and receiving the treatments as planned.
  • You must have a confirmed diagnosis of non-small cell lung cancer (NSCLC), which is a common type of lung cancer, through a biopsy (a procedure where a small sample of tissue is removed to be examined under a microscope).
  • Your cancer must be at Stage IV, meaning it has spread to other parts of the body, and it cannot be treated with the goal of completely curing it.
  • You must have a performance status of 0 or 1, which means you are generally able to carry out daily activities and move around easily despite your illness.
  • You must have measurable disease, meaning the tumors in your body are large or clear enough to be tracked and measured using RECIST (a set of standard rules used by doctors to measure how much a tumor shrinks or grows).
  • Your doctor must believe you have a life expectancy of at least 12 weeks.
  • You must have adequate organ and marrow function, meaning your vital organs (like the heart, liver, or kidneys) and your bone marrow (the tissue inside bones that makes blood cells) are working well.
  • You must use contraception (methods to prevent pregnancy) that follows local laws for people in clinical trials.
  • Female participants who could become pregnant must have a negative pregnancy test at the start of the study and before each treatment.
  • Female participants who are sexually active with a partner who cannot have children must use a highly effective method of birth control throughout the study and for a period after the last treatment.
  • Female participants must not breastfeed and must not donate or use ova (eggs) during the study period.

Who Cannot Join the Study?

  • You cannot participate if you have certain genetic changes in your cancer cells, such as EGFR mutations, ALK fusions, ROS1, NTRK fusions, or BRAF V600E mutations, which are specific patterns in your DNA that allow for other targeted treatments.
  • You are excluded if your cancer includes small cell or neuroendocrine types of cancer cells.
  • The investigator (the main doctor in charge of the study) may decide you cannot join if they believe you cannot follow the study rules or requirements.
  • You cannot join if you have uncontrolled systemic diseases, which are serious health issues affecting your whole body, such as uncontrolled hypertension (high blood pressure), active bleeding, or an ongoing infection.
  • People with interstitial lung disease or pneumonitis (inflammation of the lung tissue) are not eligible.
  • You are excluded if you have unstable or painful venous thromboembolism (blood clots in the veins) or serious long-term gastrointestinal (stomach or intestinal) issues that cause diarrhea.
  • People with active skin diseases, psychiatric illness (mental health conditions), or substance abuse issues are excluded.
  • You cannot participate if you have already been enrolled in this specific study before.
  • Females who are currently pregnant, breast-feeding, or planning to become pregnant are not allowed to join.
  • If you have previously had a stem cell, bone marrow, allogenic tissue (tissue from another person), or solid organ transplant, you cannot participate.
  • You are excluded if you have a history of another primary malignancy (a different type of cancer), unless it was successfully treated and has been gone for at least 2 years.
  • People with heart problems such as arrhythmia (irregular heartbeat), cardiomyopathy (heart muscle disease), congestive heart failure, or a myocardial infarction (heart attack) within the last 6 months are excluded.
  • If you have an autoimmune disease (where the body attacks its own healthy cells) that required systemic treatment (medicine that travels through the whole body) in the last 5 years, you cannot join.
  • You are excluded if you have spinal cord compression (pressure on the spinal cord).
  • If you have persistent toxicities (lasting side effects) from previous cancer treatments that are severe, you may be excluded, though some stable, mild side effects like neuropathy (nerve damage causing tingling or numbness) may be allowed.
  • People with symptomatic brain metastases (cancer that has spread to the brain and is causing symptoms) are not eligible.
  • You cannot participate if you have recently received certain anti-cancer agents (cancer medicines), such as cytotoxic treatment (drugs that kill cells) within the last 21 days or biological products (medicines made from living organisms) within the last 28 days.
  • Recent palliative radiotherapy (radiation used to relieve symptoms rather than cure) or major surgery within the last few weeks may prevent participation.
  • If you have received a live attenuated vaccine (a weakened version of a germ used in a vaccine) within the last 30 days, you cannot join.
  • You are excluded if you have participated in another clinical study using a study drug within the last 12 months.
  • You cannot join if you are currently enrolled in another interventional clinical trial (a study where a drug or treatment is given).
  • Staff members involved in planning or conducting this study are not allowed to participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Centre Antoine Lacassagne Nice France
Institut Jules Bordet Anderlecht Belgium
Warminsko-Mazurskie Centrum Chorob Pluc W Olsztynie Olsztyn Poland
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum) Munich Germany
Istituto Europeo Di Oncologia S.r.l. Milan Italy
Hospital Universitario 12 De Octubre Madrid Spain
Fundacion Instituto Valenciano De Oncologia Valencia Spain
Instytut Centrum Zdrowia Matki Polki Lodz Poland
Hospital Universitario Ramon Y Cajal Madrid Spain
Hospital Clinico Universitario De Valencia Valencia Spain
Universitaetsklinikum Regensburg AöR Regensburg Germany
ASST Grande Ospedale Metropolitano Niguarda Milan Italy
Azienda Ospedaliero-Universitaria San Luigi Gonzaga Orbassano Italy
Fondazione IRCCS Policlinico San Matteo Pavia Italy
Hospital Clinic De Barcelona Barcelona Spain
Hospital Universitario Quironsalud Madrid Pozuelo De Alarcon Spain
Jessa Ziekenhuis Hasselt Belgium
Centre Hospitalier Universitaire De Nantes Nantes France
Netherlands Cancer Institute Amsterdam The Netherlands
Ljvfd Uaixcchsytdc Mdzdrlq Czztklp (ayhqz Leiden The Netherlands
Uizeinfuhizw Mjezjkp Cqkfaao Gnacighrb Groningen The Netherlands
Ifwepyia Cyufcg Ddoiimhkqnbyvkoan L'hospitalet De Llobregat Spain
Cgijck Hplvivlcmqa Ef Ukhabaylnsofv Du Lwlqioq Limoges France
Adnkxmvqki Pspnyzaj Hxvtusak Ds Mwohgqbkx Marseille France
Uiqqtdhuvyecchyeubxnq Mgvuvslk Atx Munster Germany
Ubufntfgaqlwseyqedbun Wlbellcac Auf Wuerzburg Germany
Idyjhqdm Bxyfakxb Bordeaux France
Hzduuqjy Vlfm dkffemvt Barcelona Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not yet recruiting
15.04.2026
France France
Not yet recruiting
15.04.2026
Germany Germany
Not yet recruiting
15.04.2026
Italy Italy
Not yet recruiting
15.04.2026
Poland Poland
Not yet recruiting
15.04.2026
Spain Spain
Not yet recruiting
15.04.2026
The Netherlands The Netherlands
Not yet recruiting
15.04.2026

Trial locations

Investigated drugs:

Ramucirumab is a medication given through a vein that works by targeting and blocking certain proteins that help tumors grow new blood vessels, which can help slow down the growth of cancer.

Rilvegostomig is a medication given through a vein that is being studied for its ability to fight cancer cells.

Metastatic non-small cell lung cancer – This is a type of cancer that begins in the cells of the lung and has spread to other parts of the body. The disease typically starts in the main airways or the lung tissue itself. As it progresses, cancer cells break away from the original site and travel through the blood or lymphatic system. These cells can then form new tumors in distant organs such as the liver, bones, or brain. The growth of these tumors can interfere with the normal functions of the affected organs.

Trial ID:
2024-519786-22-01
Protocol code:
D702KC00001
NCT ID:
NCT06996782
Trial Phase:
Human Pharmacology (Phase I) – Other

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