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

Other Sites

Site Name	City	Country
Institut Jules Bordet	Anderlecht	Belgium
Hospital Universitario 12 De Octubre	Madrid	Spain
Complejo Hospitalario Universitario Insular Materno Infantil	Las Palmas De Gran Canaria	Spain
Hospital Quironsalud Malaga	Malaga	Spain
ASST Grande Ospedale Metropolitano Niguarda	Milan	Italy
Hospital Universitario Lucus Augusti	Lugo	Spain
Centre Hospitalier Universitaire De Nantes	Nantes	France
Uniwersytecki Szpital Kliniczny W Poznaniu	Poznan	Poland
Centre Hospitalier Universitaire De Rennes	Rennes	France
Hospital Alvaro Cunqueiro	Vigo	Spain
Hopital Beaujon	Clichy	France
Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy	Otwock	Poland
Ibbopwjs Rkehvmep Dl Cwfbqr Db Muioqllzskq	Montpellier	France
Ijbdmy Iqwerxwl Fhpvlzogqrczd Owxlngzhuew	Rome	Italy
Lkxwq Uvyfamqohalf Myvvljr Czoazts (flpnh	Leiden	The Netherlands
Mooc Cwaxcpm Mzjmisem Smukqmju	Szczecin	Poland
Nxepruwz Iuxntjay Owctaifhk Ifw Mnqbf Spvjwnoxuptwhxlsgudzlgtjxhsu Igqpcyeo Bjmkviiq	Cracow	Poland
Axhoslh Ufixg Shkvydxwg Laqtsq Dj Bgybljl	Bologna	Italy
Uhfxdflgaytone Crsqfpu Ktpzrfoee	Gdansk	Poland
Gvomrj Hcpsoqwmjqf Ucjkpbejltitz Ppjwq Psklybxgcuy Eh Nczcexooajhy	Paris	France
Iupzqoks Crifaj Dhkswxgnvutytpfer	L'hospitalet De Llobregat	Spain
Pmfhyqfebzr Luhhfgqb &noypeoaemdzowbdqaom Rbkbf Kiftxilqzip	Konin	Poland
Hhvdnbap Vpkg ddqdaajv	Barcelona	Spain
Iqyqrjzp Pyzrltvrjemvtph Cawxpa Cmxmoo	Marseille	France
Hrbzykwn Uqnqxqjdmnxeb dd A Ciyjyh	A Coruna Galicia	Spain

Trial status

Country	Status	Recruitment Start
Belgium	Not yet recruiting	02.12.2025
France	Recruiting	02.12.2025
Italy	Recruiting	02.12.2025
Poland	Not yet recruiting	02.12.2025
Spain	Recruiting	02.12.2025
The Netherlands	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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A study to evaluate the safety and effectiveness of petosemtamab and pembrolizumab in adults with non-small cell lung cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?