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Pumitamig Versus Durvalumab in Patients With Unresectable Stage III Non-Small Cell Lung Cancer Without Progression After Chemoradiation

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What is this trial about?

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

This study is being done in unresectable Stage III non-small cell lung cancer, which means a type of lung cancer that cannot be removed with surgery and has not gotten worse after earlier treatment with platinum-based concurrent chemoradiation therapy (chemotherapy and radiation given at the same time). The study compares pumitamig with durvalumab to see which medicine is better at slowing the cancer from getting worse. Pumitamig is given into a vein as an infusion, and durvalumab is also given into a vein.

After the earlier treatment has finished, participants are assigned to receive either pumitamig or durvalumab. The study is randomized, which means the treatment is chosen by chance, and open-label, which means the treatment is known. The study team then follows the cancer over time and watches for changes, such as whether it stays stable, shrinks, or grows, and also checks how safe each medicine is and how well it is tolerated.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study and starting treatment

    After joining the study, you enter a randomized trial. this means the study assigns you to receive either pumitamig or durvalumab. the study is also open-label, which means you and the study team know which medicine you receive.

    Both medicines are given by intravenous infusion, meaning they are administered into a vein.

    pumitamig is given as bnt327 50 mg/ml or bnt327 20 mg/ml, depending on the assigned study treatment.

    The study does not provide a dose amount, dosing schedule, or treatment duration in the source data beyond the fact that the medicines are given during the trial.

  2. Step 2

    Receiving the assigned medicine during the trial

    If you are assigned to pumitamig, you receive it by intravenous infusion. the source data identifies the product as bnt327 50 mg/ml or bnt327 20 mg/ml, with the active substance pumitamig.

    If you are assigned to durvalumab, you receive it by intravenous infusion. the active substance is durvalumab.

    The source data does not state the exact dose, frequency, or length of treatment for either medicine.

  3. Step 3

    Monitoring the effect of treatment

    During the trial, your cancer is checked to see whether it stays the same, shrinks, or grows.

    The main measure is progression-free survival (pfs), which means the length of time before the cancer gets worse. bicr means an independent review of scans or test results used to judge this outcome.

    The study also looks at overall survival (os), which means how long you live after starting treatment.

    Your doctor also checks progression-free survival, called pfs by investigator, which means the time before the cancer gets worse as judged by your doctor.

    The study measures whether tumors shrink, disappear, stay the same size, or remain controlled. these are called objective response (or) and disease control rate (dcr).

    The study measures duration of response (dor), which means how long the tumor stays smaller or stable after it improves.

    The study measures time to response (ttr), which means how quickly the tumor starts to shrink after treatment begins.

    The study also checks safety and how well you can tolerate each medicine.

  4. Step 4

    Continuing follow-up during the study period

    You remain in the study while treatment and follow-up continue for the trial period.

    The source data gives the overall study timeframe as starting on 2026-05-11 and ending on 2034-01-12.

    No further step-by-step schedule is provided in the source data.

Who can join the trial?

5 criteria

  • Have unresectable Stage III non-small cell lung cancer, which means the cancer cannot be removed with surgery and is at stage 3.
  • Have had chemoradiation before joining the study, meaning treatment with both chemotherapy and radiation therapy.
  • Have no worsening of the cancer after chemoradiation.
  • May have any level of PD-L1 expression, meaning the cancer cells can have low, medium, or high amounts of the PD-L1 protein.
  • Be in good overall health, meaning the person is well enough to take part in the study treatment.

Who cannot join the trial?

10 criteria

  • Any significant heart or blood vessel disease, meaning a serious problem affecting the heart or circulation.
  • Any significant lung disease within the 6 months before randomization, meaning before being assigned to a study group.
  • A history of interstitial lung disease, which is scarring or inflammation in the tissue around the air sacs of the lungs.
  • A history of pneumonitis that needed treatment with systemic steroids, meaning steroid medicine taken by mouth or given through a vein to treat inflammation in the lungs.
  • A high risk of pulmonary hemorrhage, meaning a serious risk of bleeding from the lungs.
  • A history of abdominal fistula within the 6 months before randomization, meaning an abnormal tunnel between the abdomen and another organ or the skin.
  • A history of gastrointestinal perforation within the 6 months before randomization, meaning a hole in the stomach or intestines.
  • Having certain gene changes called EGFR mutations, which are changes in a gene that can affect how cancer grows.
  • Having certain gene changes called ALK rearrangements, which are changes in a gene that can affect how cancer grows.
  • Any major coagulation disorder, meaning a serious problem with blood clotting.
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Investigated drugs

  • Pumitamig

    is the study treatment being tested in this trial. It is given through a vein as an infusion. The goal is to see whether it can help slow down the cancer from getting worse after prior chemoradiation treatment in people with unresectable stage III non-small cell lung cancer.

  • Durvalumab

    is the comparison treatment in this trial. It is also given through a vein as an infusion. The study is checking whether pumitamig works better than durvalumab at keeping the cancer from progressing after earlier platinum-based chemoradiation therapy.

What is already known about the treatment

  • Pumitamig

    Pumitamig is given by intravenous infusion as a liquid concentrate, meaning it is delivered directly into a vein by a healthcare professional. It is an investigational medicine in current clinical research, so its full place in routine medical practice is still being studied, but it is being tested for cancer treatment. In this trial, it is being studied for unresectable stage III non-small cell lung cancer that has not worsened after chemoradiation. It is a type of cancer immunotherapy designed to help the immune system better attack tumor cells by blocking signals that tumors use to hide from immune defense.

  • Durvalumab

    Durvalumab is given by intravenous infusion, so it is administered directly into a vein by a healthcare professional. It is an approved medicine and is well described in medical literature, where it is used as a cancer immunotherapy. Its main use is in certain cancers, including non-small cell lung cancer, where it helps slow disease growth and lower the chance of the cancer returning or worsening. Durvalumab is a monoclonal antibody, a type of targeted medicine that blocks the PD-L1 protein on cancer cells, helping immune cells recognize and attack the tumor more effectively.

Investigated diseases

Unresectable stage III non-small cell lung cancer - A form of lung cancer that starts in the cells lining the airways or lung tissue and cannot be removed completely by surgery. It is at stage III, meaning it has grown beyond the original lung area and may involve nearby lymph nodes or nearby structures. When it is without progression, the cancer has not shown signs of getting worse at the time described. Over time, it may remain stable for a period or begin to grow, spread locally, or cause new tumor areas to appear.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-523576-23-00Protocol codeCA2660001Estimated enrolment850 patientsSponsorBristol-Myers Squibb Services Unlimited Company

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).