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A study to evaluate the safety and effectiveness of petosemtamab and pembrolizumab in adults with non-small cell lung cancer

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What is this study about?

This study focuses on individuals with Non-Small Cell Lung Cancer, which is a common type of lung cancer. The research aims to evaluate how well the combination of petosemtamab and pembrolizumab works to treat this disease and to ensure its safety. Both medications are administered through an IV infusion, which means the medicine is delivered directly into a vein through a small tube.

Who Can Join the Study?

  • You must be at least 18 years old when you sign the consent form to participate.
  • You must be willing and able to follow all study rules, including using contraception (methods to prevent pregnancy) and signing a written agreement to join the study.
  • You must have healthy blood cell levels, which includes:
    • A platelet count (cells that help your blood clot) of 100 or more.
    • An absolute neutrophil count (a type of white blood cell that fights infection) of 1.5 or more.
    • A hemoglobin level (a protein in red blood cells that carries oxygen) of at least 9 g/dL.
    • You must not have received a blood transfusion in the 7 days before testing these levels.
  • Your kidney function must be good, measured by a creatinine clearance (a test that shows how well your kidneys filter waste) of at least 60 mL/min.
  • You must have at least one measurable tumor that can be seen on a scan like a CT scan or MRI. This tumor must be large enough to be measured accurately by the doctor.
  • Your performance status, which is a scale used to measure how well you can perform daily activities, must be 0 or 1 (meaning you are fully active or able to do light work).
  • The doctor must believe you have a life expectancy (how long you are expected to live) of at least 12 weeks.

Who Cannot Join the Study?

  • You cannot participate if you have untreated CNS metastases, which means cancer that has spread to your central nervous system (your brain or spinal cord).
  • You cannot participate if you have carcinomatous meningitis, which is a condition where cancer cells spread to the protective layers covering your brain and spinal cord.
  • If you have had cancer in your brain that was treated, you may still join if your radiographic stability is confirmed. This means that two brain scans taken at least 4 weeks apart show that the cancer has not grown or spread in the brain.
  • You cannot participate if you have neurologic symptoms (such as numbness, weakness, or balance issues) caused by the brain cancer or its treatment, unless these symptoms have completely gone away or returned to your normal state.
  • You must have finished taking any steroids (medications used to reduce swelling or inflammation) at least 3 days before receiving the study medicine.
  • You cannot participate if you have taken any experimental drugs in a clinical trial within 4 weeks before the first dose of this study treatment.
  • You are not allowed to participate if you have ever taken petosemtamab (the specific drug being studied) in any other clinical trial at any time in the past.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
IRCCS Humanitas Research Hospital Rozzano Italy
Centre Hospitalier Intercommunal Creteil Creteil France
Centre Hospitalier Regional Et Universitaire De Brest Brest France
Azienda Ospedaliero Universitaria Careggi Florence Italy
Katholieke Universiteit te Leuven Leuven Belgium
Hospital Universitario De Navarra Pamplona Spain
Institut Curie – Site Paris Paris France
CHU Grenoble Alpes La Tronche France
Comite Entreprise Paul Papin Angers France
Centre Hospitalier Universitaire De Bordeaux Bordeaux France

Other Sites

Site Name City Country Status
Institut Jules Bordet Anderlecht Belgium
ASST Grande Ospedale Metropolitano Niguarda Milan Italy
Centre Hospitalier Universitaire De Nantes Nantes France
Centre Hospitalier Universitaire De Rennes Rennes France
Hopital Beaujon Clichy France
Hospital Universitario 12 De Octubre Madrid Spain
Hospital Universitario Lucus Augusti Lugo Spain
Uniwersytecki Szpital Kliniczny W Poznaniu Poznan Poland
Hospital Alvaro Cunqueiro Vigo Spain
Hospital Quironsalud Malaga Malaga Spain
Complejo Hospitalario Universitario Insular Materno Infantil Las Palmas De Gran Canaria Spain
Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy Otwock Poland
Igvsxaju Pirnzcbmptnvjzy Cyfpra Crnunk Marseille France
Hkplqwdu Vdwz dqnqqvbs Barcelona Spain
Htqtqvcd Ucbjbcgmldzug dg A Cdsnco A Coruna Galicia Spain
Amavjiw Uacbb Sxyotcbvj Lgrfwx Dj Bnjsaxw Bologna Italy
Uswymdqyntejpp Ckmizjd Kjdqklkjh Gdansk Poland
Iozoek Iydaqjzg Fakwkmqczztrt Ozdogjwalal Rome Italy
Iftdvvbj Cvtgti Dxbseukiuacsuyhyl L'hospitalet De Llobregat Spain
Ijpbpsss Ratfbypq Dh Cvouzq Dl Muyxvmwpbgq Montpellier France
Plekmryxfyq Lgipwawr &bluebroitryztcwrdzx Rmrdi Ktvtmenlkme Konin Poland
Mplw Ctfcgbg Mafbyvvd Sumtntmh Szczecin Poland
Nvuzlpak Ikjbtxco Osuaexfmn Idy Mmgwx Svjpfltxulhfqdrkfupxbmddzsfa Ilyommsm Bxkblqxh Cracow Poland
Glpahh Hwasajoalht Ugblzvqgvzcxg Psifn Pphefolhyvu Ez Nhlmgycukubv Paris France
Lxgut Uiqrduamfmry Mbqqamg Cpauirg (psepd Leiden The Netherlands

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
02.12.2025
France France
Not recruiting
02.12.2025
Italy Italy
Not recruiting
02.12.2025
Poland Poland
Not yet recruiting
02.12.2025
Spain Spain
Not recruiting
02.12.2025
The Netherlands The Netherlands
Not recruiting
02.12.2025

Trial locations

Investigated Drugs:

Petosemtamab is a medication given through a vein as an infusion to help fight cancer cells in adults with non-small cell lung cancer.

Pembrolizumab is a type of therapy given through a vein as an infusion that helps the body’s immune system recognize and attack cancer cells.

Non-small cell lung cancer – This is a type of cancer that starts in the cells of the lung. It is the most common form of lung cancer and involves cells that are not small and round. The disease typically begins in the lining of the airways or in the lung tissue itself. As it progresses, abnormal cells grow and multiply uncontrollably within the lungs. These cells can eventually spread to nearby tissues or other parts of the body.

Trial ID:
2025-522867-13-00
Protocol code:
MCLA-158-CL04
Trial Phase:
Therapeutic exploratory (Phase II)

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