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Phase II Study of Neoadjuvant ivonescimab with Paclitaxel and Carboplatin in Stage IIA‑IIIB (T3N2) Non‑Small Cell Lung Cancer Patients

Registered drugNo placebo
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What is this trial about?

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

The trial involves patients with Non-small cell lung cancer that is at a stage where the tumor has grown locally and may involve nearby lymph nodes. The treatment being tested combines a new antibody called ivonescimab with standard chemotherapy drugs paclitaxel and carboplatin. The purpose of the study is to determine how often the combination results in no remaining tumor cells after the tumor is removed.

Participants receive the study drugs through an IV (intravenous) line over several weeks before surgery; this pre‑surgical approach is called neoadjuvant therapy. After the medication course, patients undergo the planned surgical removal of the lung tumor, and the removed tissue is examined to see if any cancer cells are still present. Following surgery, patients are monitored for a period of time to record any return of disease or other outcomes.

The research process

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

  1. Step 1

    Initial Visit and Baseline Assessments

    After joining the study, you will attend an initial clinic visit where the study team will confirm that you meet the eligibility criteria for stage IIA‑IIB‑IIIA or IIIB (T3N2) non‑small cell lung cancer.

    Baseline tests will be performed, including imaging studies to evaluate the size and location of the tumor, and a blood draw to measure circulating tumor DNA (ctDNA) levels before any treatment is given.

  2. Step 2

    Start of Neoadjuvant Treatment

    You will begin the neoadjuvant treatment phase, which is therapy given before surgery to shrink the tumor.

    On each treatment day, you will receive three intravenous (IV) medications:

    Ivonescimab at a dose of 20 mg per kilogram of body weight, administered as an IV injection.

    Paclitaxel at a dose of 200 mg per square meter of body‑surface area, administered as an IV injection.

    Carboplatin at a total dose of 750 mg, administered as an IV solution for infusion.

    The exact schedule (how often the treatment days occur and how many cycles are given) will follow the study protocol and will be explained to you by the study staff.

  3. Step 3

    Monitoring During Neoadjuvant Treatment

    During the treatment period, you will have regular clinic visits to check your health, review any side effects, and perform additional blood tests, including repeat ctDNA measurements.

    Imaging may be repeated as directed by the protocol to assess how the tumor is responding to the therapy.

  4. Step 4

    Surgical Removal of the Tumor

    When the study team determines that the neoadjuvant therapy is complete, you will undergo surgery to remove the lung tumor and nearby lymph nodes.

    The surgical specimen will be examined to determine whether a pathological complete response (pCR) has been achieved, meaning no residual cancer cells are found in the lung tissue or lymph nodes.

    The surgery will also be evaluated for an R0 resection, which indicates that no microscopic tumor remains at the edges of the removed tissue.

  5. Step 5

    Post‑Surgical Follow‑up and Long‑Term Monitoring

    After surgery, you will continue to be monitored for at least 12 months from the start of the neoadjuvant treatment.

    Follow‑up visits will include physical examinations, imaging studies, and blood tests to assess event‑free survival (EFS) – the time without disease progression, recurrence, or death – and overall survival (OS) – the time until death from any cause.

    Additional blood samples will be taken to evaluate the clearance of ctDNA after treatment, and to measure Measurable Residual Disease (MRD) after surgery and at six months.

    The collected data will also be used to explore whether baseline or post‑treatment genetic markers are linked to better survival outcomes.

Who can join the trial?

22 criteria

  • You must have a diagnosis of non‑small cell lung cancer (NSCLC) that has never been treated before, and the cancer must be in stage IIA, IIB, IIIA, or IIIB (only the specific T3N2 pattern as defined by the lung cancer staging manual).
  • You need to have had a PET scan and a brain CT or MRI before joining the study to confirm that the cancer has not spread to distant parts of the body.
  • A chest CT scan must show at least one tumor that can be measured, using the standard RECIST v1.1 criteria (a system that defines how big a tumor must be to be counted).
  • You must have had a bronchoscopy (a thin tube with a camera placed into the airway) within the last 3 months, and if the PET scan showed suspicious lymph nodes, a tissue sample must be confirmed by procedures such as mediastinoscopy, EBUS, EUS, or fibrobronchoscopy.
  • Your overall health level, measured by the ECOG performance status, must be 0 or 1 (meaning you are fully active or able to do light work).
  • You must be at least 18 years old at the time you join the trial.
  • You need to be able to follow the study plan, take the medication as instructed, and attend all follow‑up visits.
  • You must have a life expectancy of at least 12 weeks (about three months).
  • Recent blood tests must show adequate bone‑marrow and organ function, including:
    • Neutrophils ≥ 1.5 × 10⁹/L
    • Lymphocytes ≥ 0.5 × 10⁹/L
    • Platelets ≥ 100 × 10⁹/L
    • Hemoglobin ≥ 10 g/dL
    • Coagulation times (prothrombin or aPTT) ≤ 1.5 times the normal limit (unless you are on a stable dose of blood thinners)
    • Liver enzymes (AST, ALT, GGT, alkaline phosphatase) ≤ 2.5 times the normal limit
    • Serum bilirubin ≤ 1.5 times the normal limit (up to 3 times if you have Gilbert disease)
    • Kidney function: serum creatinine ≤ 1.5 times the normal limit or creatinine clearance ≥ 50 mL/min
    • Urine protein less than 2+ (or < 1 g in a 24‑hour collection)
    • Your lung function must be good enough: predicted postoperative FEV1 (the amount of air you can force out in one second) and DLCO (the ability of your lungs to transfer oxygen) each need to be > 40 % of the normal value. If either is lower, an oxygen‑consumption test must show a result above 15 ml/kg/min or > 30 % of predicted.
    • If you are a woman who could become pregnant, you must have a negative pregnancy test taken within 8 days before starting the study drug.
    • Women of child‑bearing potential and men with partners who could become pregnant must agree to use a highly effective form of contraception (failure rate < 1 % per year) and continue using it for the required time after the last dose (6 months for women, 3 months for men). Women must not donate eggs, and men must not donate sperm for at least 6 months after the last dose.
    • Men must always use a condom in addition to another birth‑control method because the study drug may interact with contraception.
    • All participants must be fully informed that the study is investigational and must sign a written informed consent form before any study procedures begin.

Who cannot join the trial?

28 criteria

  • Patients who have a change (mutation) or extra copies (amplification) in the epidermal growth factor receptor (EGFR) gene or any alteration of the ALK oncogene. These are specific genetic changes that can affect tumor behavior.
  • Patients with known alterations in the STK‑11 gene, MDM2 amplifications, or ROS1 translocations. These are additional genetic abnormalities that may influence treatment response.
  • Patients who have lost more than 10 % of their body weight in the past three months.
  • Patients who have already received anti‑cancer drugs, chest radiation, or surgery for lung cancer before joining the study.
  • Patients who have another active cancer that requires treatment at the same time.
  • Patients with a previous cancer (except certain skin cancers and a few early‑stage cancers) unless they have been completely free of disease for at least two years and need no further therapy.
  • Patients with an active, known, or suspected autoimmune disease (the body’s immune system attacks its own tissues), except for conditions such as vitiligo, type I diabetes, or hypothyroidism that are well‑controlled with medication.
  • Patients who need systemic treatment with corticosteroids higher than 10 mg of prednisone daily or other strong immune‑suppressing medicines within the last 14 days (inhaled or skin‑applied steroids are allowed).
  • Patients who have fluid around the lungs (pleural effusion) or around the heart (pericardial effusion) that suggests the cancer has spread, unless this can be proven otherwise.
  • Patients with untreated or uncontrolled heart problems, such as unstable chest pain, heart failure, a heart attack in the past year, serious heart rhythm issues, or a left‑ventricular ejection fraction (LVEF) of 50 % or lower.
  • Patients with significant pulmonary hypertension (high pressure in the lung arteries), defined as a mean pulmonary artery pressure above 30 mmHg.
  • Patients with a history of major medical conditions, including unstable angina, recent heart attack, severe heart failure, dangerous blood‑vessel problems, serious stomach or intestinal ulcers, recent major bleeding, serious blood clots, recent stroke, severe high‑blood‑pressure crises, recent worsening of chronic obstructive pulmonary disease (COPD), or recent major gastrointestinal surgery.
  • Patients who have bleeding tendencies or clotting disorders, recent significant bleeding (such as coughing up blood or nosebleeds), or who are using blood‑thinners that are not stable at the required therapeutic levels.
  • Patients with poorly controlled high blood pressure, with repeated readings of systolic ≥ 150 mmHg or diastolic ≥ 100 mmHg despite medication.
  • Patients with HIV infection who have a CD4 count below 350 cells/µL, a viral load above 50 copies/mL, are not on antiretroviral therapy, started therapy less than four weeks ago, or had an AIDS‑defining infection in the past year.
  • Patients who test positive for active hepatitis B surface antigen or for hepatitis C RNA, indicating current infection.
  • Patients with an active tuberculosis infection.
  • Patients who had a severe infection within the four weeks before enrollment, such as hospitalization for infection, bloodstream infection (bacteremia), or severe pneumonia.
  • Patients who underwent a major surgical procedure (other than a diagnostic test) within the 28 days before enrollment or who are expected to need such surgery during the study.
  • Patients with a history of inflammatory bowel disease (such as Crohn’s disease or ulcerative colitis) or chronic diarrhea.
  • Patients with any other disease, metabolic problem, physical‑exam finding, or laboratory result that makes the investigational drug unsafe or could affect the study results.
  • Patients who have a medical, mental, neurological, or psychological condition that, in the investigator’s opinion, would prevent them from understanding the study information or following study procedures.
  • Patients who have taken any other investigational drug with therapeutic intent within the 28 days before starting the study treatment.
  • Patients with uncontrolled additional health problems that could interfere with following the trial protocol.
  • Women who are pregnant or are breastfeeding.
  • Men or women who could become pregnant and are not willing to use an effective method of contraception during the study.
  • Patients who received a live (or live‑attenuated) vaccine within four weeks before randomization or who are scheduled to receive one during the study (inactivated vaccines are allowed).
  • Patients with a history of lung scarring diseases such as idiopathic pulmonary fibrosis, drug‑induced pneumonitis, interstitial lung disease, or evidence of active lung inflammation on the baseline chest CT scan.
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Investigated drugs

  • ivonescimab

    is an experimental medication being tested for the first time in this study. It is given through a vein (intravenously) and is designed to help the body’s immune system recognize and attack lung cancer cells. In the trial, patients receive ivonescimab before surgery to see if it can increase the amount of tumor that disappears.

  • paclitaxel

    is a well‑known chemotherapy drug that stops cancer cells from growing and dividing. It is also given through a vein and is used together with other medicines in this study. The goal of paclitaxel in the trial is to shrink the lung tumor before the patient has surgery.

  • carboplatin

    is another common chemotherapy drug that works by damaging the DNA inside cancer cells, which stops them from multiplying. Like the other drugs, it is given intravenously and is combined with paclitaxel and ivonescimab as part of the pre‑surgery (neoadjuvant) treatment. The purpose of carboplatin is to help reduce the size of the tumor so that surgery can be more successful.

What is already known about the treatment

  • Ivonescimab

    It is given by intravenous injection as a single‑dose infusion. The drug is still experimental and is being studied in clinical trials for non‑small cell lung cancer. It works by attaching to a protein on cancer cells that helps the immune system recognize and attack the tumor. It belongs to the class of monoclonal‑antibody immunotherapies.

  • Paclitaxel

    It is administered by intravenous injection, usually as a short infusion. Paclitaxel is an approved chemotherapy drug that is used to treat many cancers, including non‑small cell lung cancer. It works by locking the tiny tubes inside cells that pull them apart, which stops cancer cells from dividing. It is classified as a taxane chemotherapy agent.

  • Carboplatin

    It is given as an intravenous infusion solution. Carboplatin is an approved chemotherapy drug used for several cancers such as non‑small cell lung cancer. It works by attaching to the DNA inside cells, causing damage that prevents cancer cells from copying themselves. It belongs to the class of platinum‑based chemotherapy agents.

Investigated diseases

Non-small cell lung cancer (NSCLC) - Non-small cell lung cancer is a type of lung cancer that begins in the cells lining the airways. It generally grows more slowly than small cell lung cancer. The tumor can spread from the lung to nearby lymph nodes and later to other organs such as the brain, liver, or bones. As it enlarges, it may cause symptoms like cough, shortness of breath, or chest discomfort. If the disease advances, it moves from a localized stage to more widespread involvement.
Trial detailsLast updated 14 Nov 2026
Age18+ yearsPhasePhase IITrial ID2026-525303-27-00Protocol codeSABINE GECP 25/01Estimated enrolment8 patientsSponsorFundacion GECP

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