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

Fast replyRegistered drugNo placebo
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What is this trial about?

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

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.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Participation in the study

    The trial involves receiving combinations of novel anti-cancer medications through an intravenous infusion, which means the medicine is delivered directly into a vein.

    The medications used in the study include cyramza (ramucirumab) and rilvegostomig, both provided as a solution for infusion.

  2. Step 2

    Part a: safety evaluation

    During this stage, the focus is on monitoring how the body reacts to the combination of new drugs to determine the most appropriate dose.

    Regular monitoring is conducted through physical examinations, checking vital signs (such as blood pressure and heart rate), and performing electrocardiograms (ECGs, which are tests that record the electrical activity of the heart).

    Laboratory tests are performed to check laboratory findings, which include analyzing blood or other fluids to monitor health and safety.

  3. Step 3

    Part b: dose expansion and effectiveness assessment

    This stage continues to monitor safety and tolerability, which refers to how well the body handles the medication and if any adverse events (side effects or unexpected medical occurrences) happen.

    The effectiveness of the treatment is assessed to see if there is an objective response, meaning a measurable change in the size or status of the cancer.

    Monitoring remains consistent with the previous stage, including physical examinations, vital signs, electrocardiograms, and laboratory findings.

Who can join the trial?

13 criteria

  • 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 trial?

22 criteria

  • 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.
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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.

What is already known about the treatment

  • Ramucirumab

    This medication is an anti-cancer drug administered as a solution through an intravenous infusion into a vein. It is currently approved and widely used in medical practice to treat certain types of cancer, including stomach and lung cancer. The drug works by attaching itself to specific receptors on the surface of blood vessels to block the signals that allow tumors to grow new blood supplies. As a targeted therapy, it helps starve the cancer of the nutrients it needs to expand.

  • Rilvegostomig

    This substance is an experimental cancer treatment delivered to the patient via an intravenous infusion. It is currently being studied in clinical research and is not yet a standard treatment in general medical practice. The medication works at a molecular level by binding to specific proteins on the surface of cancer cells to trigger the body's immune system to attack them. It is classified as an immunotherapy agent designed to help the body recognize and fight advanced cancer cells.

Investigated diseases

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 detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-519786-22-01Protocol codeD702KC00001Estimated enrolment189 patientsSponsorAstraZeneca AB

sourced from the EU Clinical Trials Register and site verification

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