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Phase 3 Study of Ivonescimab Versus Durvalumab as Consolidation Therapy in Patients with Unresectable Stage III Non‑Small Cell Lung Cancer After Chemoradiation

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

The study looks at people with locally advanced, unresectable Non‑Small Cell Lung Cancer (stage III) who have finished a combined chemotherapy and radiation treatment that uses platinum drugs. After that, they will receive either the experimental medicine ivonescimab or the approved medicine durvalumab (known as IMFINZI) given by infusion into a vein. The purpose of the study is to see which medicine keeps the cancer from growing for a longer time.

Participants will be assigned to one of the two medicines and will receive regular infusions over several months while doctors check for side effects and overall health. Throughout the study, scans of the chest will be done to see if the cancer returns or spreads, and blood tests will be taken to monitor safety and how the drug behaves in the body. The study will also collect information on how long participants live, how the tumor responds, and any changes in quality‑of‑life scores.

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

    Baseline Assessments

    After joining the study, you will undergo baseline examinations that include a medical history review, physical examination, blood tests, and imaging scans to document the status of your lung cancer.

    These assessments create a reference point for evaluating the effect of the study medication during the trial.

  2. Step 2

    First Intravenous Infusion

    You will receive an intravenous infusion of the assigned study drug, either ivonescimab or durvalumab. Both are given as a solution for infusion that is administered through a vein.

    The exact dose amount is defined by the study protocol and is prepared by the clinical staff before each infusion.

  3. Step 3

    Repeated Infusion Schedule

    Subsequent infusions of the same medication are given repeatedly according to the study schedule. The frequency (for example, every two weeks) and total duration of treatment are specified in the protocol and continue until the planned end of therapy, disease progression, or unacceptable side effects.

    Each infusion is performed in a clinical setting where vital signs and immediate reactions are monitored.

  4. Step 4

    Regular Monitoring Visits

    During the treatment period, you will attend regular visits that include imaging studies (such as CT scans) to evaluate tumor size, laboratory tests to check organ function, and questionnaires that assess quality of life and lung‑cancer symptoms.

    These visits allow the research team to assess progression‑free survival, overall health, and any adverse events that may occur.

  5. Step 5

    End‑of‑Treatment Assessment

    When the planned treatment course is completed, or if the disease progresses or side effects become unacceptable, a final assessment is performed. This includes a comprehensive imaging review, laboratory evaluation, and documentation of any lasting effects.

    The results contribute to the study’s analysis of overall survival, response rates, and safety.

Who can join the trial?

5 criteria

  • Must have a confirmed diagnosis of non‑small cell lung cancer (NSCLC) that is locally advanced and cannot be removed by surgery (Stage III). This confirmation comes from a tissue or cell test.
  • Must have completed a combined treatment of platinum‑based chemotherapy given at the same time as radiation therapy before the first dose of the study drug. The last chemotherapy dose must be given at the same time as, or before, the last radiation dose; extra chemotherapy after radiation is not allowed, though chemotherapy before the combined treatment is acceptable.
  • Must have a test result for the protein PD‑L1 in the tumor, with any level reported (any tumor proportion score or tumor cell score).
  • Must not have shown the cancer getting worse (called disease progression) after the definitive combined chemo‑radiation, as measured by the standard imaging rules known as RECIST 1.1.
  • Must be 18 years old or older at the time of enrollment.

Who cannot join the trial?

7 criteria

  • Tests that examine tissue (histologic) or cells (cytopathologic) show a different kind of lung cancer called small cell lung carcinoma.
  • You are receiving or have received a treatment that combines chemotherapy and radiation one after the other (sequential chemoradiation (CRT)) for locally advanced non‑small cell lung cancer.
  • You are currently taking any cancer‑directed medicines such as chemotherapy, immunotherapy, biologic therapy or hormonal therapy at the same time as the study drugs.
  • You have previously been treated with drugs that block the immune checkpoints PD‑1 or PD‑L1 (known as anti‑PD‑1/PD‑L1 antibodies) or with medicines that stop new blood vessels from forming (anti‑angiogenic therapy) for cancer.
  • You have a past history of pneumonia that was not caused by an infection and needed strong medicines called systemic corticosteroids, or you currently have a lung condition called interstitial lung disease or ongoing lung inflammation (pneumonitis) of grade 2 or higher that resulted from previous combined chemoradiation.
  • You have had a serious infection within the four weeks before the study start, such as an infection that required a hospital stay, blood‑stream infection (sepsis), or severe pneumonia; or you have an active infection that needs treatment with medicines that fight infections (systemic anti‑infective therapy) within two weeks before the study start (except for antiviral medicines used for hepatitis B or C).
  • Testing of your tumor or blood shows you have an activating epidermal growth factor receptor (EGFR) mutation, which is a specific genetic change that can affect how the cancer grows.
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Investigated drugs

  • Durvalumab

    is a medication given through an IV (intravenous) infusion. In this study it is used as the standard treatment (comparator) after patients have completed chemoradiation therapy for locally advanced, unresectable non‑small cell lung cancer. The drug is intended to help keep the cancer from growing back by helping the immune system recognize and attack any remaining cancer cells. Researchers compare how long patients stay free of disease progression while receiving durvalumab.

  • Ivonescimab

    is an experimental medication also given by IV infusion. In the trial it is the new treatment being tested (test) as a follow‑up (consolidation) therapy after the same chemoradiation regimen. The goal of ivonescimab is to boost the body’s immune response against any leftover cancer cells, and the study measures whether patients stay progression‑free longer with this drug compared to durvalumab.

What is already known about the treatment

  • Durvalumab

    It is given as an intravenous infusion of a sterile solution that is administered through a vein over a set period of time. Durvalumab is an approved drug that is widely used and described in many medical studies. It is used to help prevent cancer from returning in patients with locally advanced, unresectable non‑small cell lung cancer after chemoradiation. The medicine works by attaching to the PD‑L1 protein on tumor cells, blocking its signal and allowing the immune system to attack the cancer; it belongs to the class of immune‑checkpoint inhibitor monoclonal antibodies.

  • Ivonescimab

    It is given as an intravenous infusion, injected directly into a vein in a single‑dose injection form. Ivonescimab is still investigational and is being studied in clinical trials, so it is not yet approved for general use. It is being tested as a consolidation treatment for locally advanced, unresectable non‑small cell lung cancer after chemoradiation. The drug is a monoclonal antibody that blocks a key immune‑checkpoint pathway to boost the body’s own immune response against cancer, placing it in the immune‑checkpoint inhibitor class.

Investigated diseases

Locally advanced unresectable non‑small cell lung cancer (stage III) – It is a cancer that starts in the lining of the airways and forms a tumor in the lung. The tumor is large enough or positioned such that surgery cannot remove it, making it unresectable. In stage III the disease has spread to nearby lymph nodes or structures but not to distant organs. Over time the cancer can grow further locally and may eventually spread to other parts of the body.
Trial detailsLast updated 8 Nov 2026
Age18+ yearsPhasePhase IIITrial ID2026-526300-67-00Protocol codeSMT112-3010Estimated enrolment709 patientsSponsorSummit Therapeutics Inc.

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