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Phase II Study of Gemcitabine Plus Ivonescimab in Adults with Advanced Non‑Small Cell Lung Cancer Resistant to Immunotherapy

Verified siteRegistered drugNo placebo
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What is this trial about?

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

advanced NSCLC is a type of lung cancer that has spread and is difficult to treat. The trial looks at a combination of two medicines given through a vein: the antibody ivonescimab and the chemotherapy drug gemcitabine. Both are delivered as an infusion, which means they are slowly poured into the bloodstream through a small tube.

The purpose of the study is to see whether adding these two medicines can overcome resistance that develops after treatment with immune checkpoint inhibitors. Participants will receive the infusion once every three weeks for several cycles, with regular visits to check how the cancer is responding and to watch for side effects. The study follows patients for several months after treatment ends.

Safety is closely watched; any unwanted effects are recorded and graded according to standard cancer‑treatment guidelines. The overall aim is to determine if this drug combination can shrink tumors and prolong the time before the disease gets worse.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Baseline Evaluation and Start of Treatment

    You will undergo a series of baseline tests that include a review of your medical history, a physical examination, blood laboratory tests, and imaging scans to document the current status of your lung cancer.

    The purpose of these assessments is to establish a reference point before you begin receiving the study medications.

  2. Step 2

    First Infusion Session

    You will receive ivonescimab at a dose of 20 mg per kilogram of body weight, administered by intravenous (IV) infusion, which means the medication is delivered directly into a vein through a needle.

    At the same time, you will receive gemcitabine at a dose of 1000 mg per square meter of body surface area, also given by IV infusion.

    Both medications are given as an injection in a fluid solution that is slowly infused over a period of time according to the study protocol.

  3. Step 3

    Repeated Treatment Cycles

    You will continue to receive the same combination of ivonescimab (20 mg/kg) and gemcitabine (1000 mg/m²) by IV infusion on each scheduled treatment day.

    The exact interval between each infusion (for example, every few weeks) will be determined by the study team and communicated to you before each cycle.

    All infusions are performed in a clinical setting where your vital signs are monitored throughout the procedure.

  4. Step 4

    Safety Monitoring Visits

    Before and after each infusion, you will have blood tests and a brief medical review to check for any side effects or changes in your health.

    The study team will assess common treatment‑related reactions and adjust care as needed to keep you safe.

  5. Step 5

    Imaging Assessments

    At regular intervals, you will undergo imaging scans such as CT or MRI to evaluate how the tumor is responding to the therapy.

    These scans are compared with the baseline images to determine whether the cancer is shrinking, staying the same, or growing.

  6. Step 6

    End of Treatment Evaluation

    Treatment will be stopped after a predefined number of cycles, if the disease progresses, or if side effects become unacceptable, as decided by the study physicians.

    A final set of assessments, including blood tests and imaging, will be performed to document the outcome of the therapy.

  7. Step 7

    Post‑Treatment Follow‑Up

    After the treatment phase ends, you will continue to attend follow‑up visits for a period of time to monitor your overall health and survival.

    These visits may include additional blood tests, physical examinations, and occasional imaging to track any long‑term effects of the study drugs.

Who can join the trial?

15 criteria

  • You must sign a written informed consent form that follows Swiss law and international research rules before any study procedures begin.
  • Your bone marrow function must be adequate, meaning your white‑blood‑cell count (neutrophils) is at least 1.5 × 10⁹/L, your platelet count is at least 100 × 10⁹/L, and your hemoglobin (the protein that carries oxygen) is at least 90 g/L.
  • Your liver (hepatic) function must be adequate: total bilirubin (a waste product) must be ≤ 1.5 times the normal limit (≤ 3.0 × normal if you have Gilbert’s disease), and liver enzymes called AST and ALT must be ≤ 2.5 times normal (or ≤ 5 × normal if you have liver metastases).
  • Your kidney (renal) function must be adequate, measured by an estimated glomerular filtration rate (eGFR) of at least 40 mL/min/1.73 m².
  • If you are a woman who could become pregnant, you must use a highly effective form of birth control, not be pregnant or nursing, have a negative pregnancy test, and avoid becoming pregnant during treatment and for 6 months after the last dose.
  • If you are a man, you must agree not to donate sperm or father a child during treatment and for 6 months after the last dose.
  • You must agree to take part in the study’s research projects and provide the required tissue or blood samples.
  • You must have confirmed squamous or non‑squamous metastatic non‑small cell lung cancer (mNSCLC) at stage IIIB‑IV that has progressed or returned during or after prior immunotherapy, chemotherapy, or combined treatments, and your doctor must have discussed other treatment options with you.
  • If you have brain or nervous‑system (CNS) metastases that have been treated and are stable, you are eligible provided the brain treatment finished at least 4 weeks before starting the study and scans (MRI or CT) show no new growth.
  • If you are living with HIV, you are eligible if your CD4+ T‑cell count is ≥ 350 cells/µL, you have had no serious AIDS‑related infections in the past year, and you are on antiretroviral therapy with a viral load < 400 copies/mL.
  • If you have had another cancer in the past, you may still join if that cancer is stable and does not need treatment now; this includes prostate cancer that is being treated with hormone therapy.
  • Your disease must be measurable according to RECIST v1.1, a standard set of rules for measuring tumor size.
  • You must have a newly taken or stored (no older than 3 months) tissue sample available for research before treatment begins.
  • You must be at least 18 years old.
  • Your overall health must be good enough to have an ECOG performance status of 0, 1, or 2, which rates how well you can carry out daily activities.

Who cannot join the trial?

28 criteria

  • Having cancer that has spread to the brain and causes symptoms such as headaches, seizures, or neurological problems (symptomatic brain metastases).
  • Using steroid medicines (called corticosteroids) as a pre‑treatment for the chemotherapy drug gemcitabine.
  • Taking medicines that suppress the immune system, such as interferon or methotrexate, within the last 28 days, except for steroid sprays or creams applied locally.
  • Having a tumor that has grown into a major blood vessel (major blood‑vessel tumor invasion).
  • Having had a small medical procedure (other than placing a central line or port for medication) within the last 3 days.
  • Recent serious heart problems, including unstable chest pain (unstable angina), heart attack (myocardial infarction), moderate or severe heart failure (NYHA grade 2 or higher), major blood‑vessel disease such as a risky aortic aneurysm, or heart rhythm problems that needed hospital care in the past year.
  • Recent serious stomach or intestinal problems, such as varices (enlarged veins), severe ulcers, wounds that do not heal, fistulas (abnormal connections), abscesses, or bleeding in the digestive tract within the past 6 months.
  • Recent blood‑clot events, such as arterial or severe venous clots (grade 3 or higher), mini‑strokes (transient ischemic attack), strokes, severe high‑blood‑pressure emergencies, or related brain swelling within the past 6 months.
  • Having a flare‑up of chronic obstructive pulmonary disease (COPD) within the last 4 weeks.
  • Recent serious gastrointestinal problems, such as a hole in the gut, a fistula, a blockage that required feeding through a vein, or major bowel surgery (partial removal of colon or large part of the small intestine) within the past 6 months.
  • Taking any other medicines that are known to be unsafe to use together with the study drugs.
  • Previously receiving gemcitabine together with any immunotherapy drug.
  • Being allergic or having a strong reaction to gemcitabine, ivonescimab, or any ingredient in these medicines.
  • Having a tendency to bleed or a clotting disorder, or having significant bleeding (such as coughing up more than a small amount of fresh blood, or frequent nosebleeds) within the last 4 weeks, or using full‑dose blood thinners that are not stable.
  • Having high blood pressure that remains uncontrolled despite medication, with systolic pressure 150 mm Hg or higher or diastolic pressure 100 mm Hg or higher.
  • Having an active autoimmune disease or lung disease that needs systemic treatment (such as strong steroids over 10 mg daily or other immune‑suppressing drugs) within the last 2 years.
  • Having nerve damage (peripheral neuropathy) that is moderate or worse (grade 2 or higher).
  • Having fluid buildup that causes symptoms, such as fluid around the lungs (pleural effusion), around the heart (pericardial effusion), or in the abdomen (ascites), unless it is being managed with a permanent drainage catheter.
  • Having had non‑infectious pneumonia that required systemic steroids, or having current interstitial lung disease (a group of lung disorders that cause scarring).
  • Having inflammatory bowel disease, such as Crohn’s disease or ulcerative colitis, or chronic severe diarrhea.
  • Any other serious medical, mental, family, or living situation that the doctor believes would make the study unsafe or difficult to follow.
  • Having tumor growth that continued within the first 8 weeks after starting first‑line treatment.
  • Having certain genetic changes in the tumor, such as activating EGFR or ALK mutations, or other targetable genetic alterations.
  • Using other cancer‑fighting drugs or receiving radiation therapy at the same time.
  • Having major surgery within the last 28 days before joining the trial.
  • Having an active, serious infection that needs treatment through an IV line.
  • Having a history of tuberculosis, a primary immune‑system deficiency, organ transplant from another person, or having received a live weakened‑virus vaccine.
  • Having a previous episode of interstitial lung disease or severe lung inflammation (pneumonitis).
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Investigated drugs

  • ivonescimab

    is an experimental medicine being studied as a type of immunotherapy. It is given through an IV infusion and is designed to help the body’s immune system recognize and attack the cancer cells in advanced non‑small cell lung cancer that no longer respond to other immune‑checkpoint drugs. In this trial the drug is tested to see if it can improve the ability of the immune system to control the tumor when used together with chemotherapy.

  • gemcitabine

    is an established chemotherapy drug that works by stopping cancer cells from growing and dividing. It is also given by IV infusion. In this study gemcitabine is used together with ivonescimab to try to shrink or slow the growth of lung cancer that has become resistant to earlier immune‑checkpoint treatments. The combination aims to give patients a better chance of controlling the disease.

What is already known about the treatment

  • Ivonescimab

    Ivonescimab is administered by intravenous infusion as an injection and is currently an experimental monoclonal antibody being studied in clinical trials for advanced non‑small cell lung cancer that has progressed after immune‑checkpoint therapy. It works by attaching to a protein that lets tumors hide from the immune system, helping the body’s defenses recognize and attack the cancer. Its pharmacological class is an immune‑checkpoint inhibitor monoclonal antibody.

  • Gemcitabine

    Gemcitabine is given as an intravenous infusion solution and is an approved chemotherapy drug commonly used for several cancers, including advanced non‑small cell lung cancer. It works by blocking the building blocks needed for DNA, which stops cancer cells from multiplying. Its pharmacological class is a nucleoside analog antimetabolite.

Investigated diseases

Advanced non‑small cell lung cancer - It is a cancer that starts in the cells lining the airways of the lungs. In the advanced stage the tumor has grown large and often spreads beyond the lung to nearby lymph nodes or distant organs. The disease typically progresses from a localized tumor to widespread involvement over time. Cancer cells may continue to multiply, causing increasing size of the primary mass and new metastatic sites. Symptoms can become more pronounced as the disease advances.

Trial detailsLast updated 2 Nov 2026
Age18+ yearsPhasePhase IITrial ID2026-526043-36-00Protocol codeSAKK 18/25Estimated enrolment47 patientsSponsorCancer Trials Ireland

sourced from the EU Clinical Trials Register and site verification

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