Clinical trial • Phase II • Oncology

PETOSEMTAMAB for Non-small cell lung cancer

Phase II trial of PETOSEMTAMAB for Non-small cell lung cancer. None/Not specified-controlled. 90 participants.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Non-small cell lung cancer
Trial Stage
Phase II
Drug Modality
Other antibody | Monoclonal antibody

Key dates

Initial CTIS Submission Date
27-11-2025
First CTIS Authorization Date
09-04-2026

Trial design

None/Not specified-controlled Phase II trial in Belgium, France, Italy and others.

Comparator
None/Not specified
Target Sample Size
90

Eligibility

Recruits 90 No vulnerable populations selected. Participants must be adults (Age ≥ 18) and able to provide written informed consent; assent/parental consent is not applicable..

Vulnerable Population
No vulnerable populations selected. Participants must be adults (Age ≥ 18) and able to provide written informed consent; assent/parental consent is not applicable.

Inclusion criteria

  • {"criterion_text":"- 1. Able to provide written informed consent and is willing and able to comply with all study procedures and contraception requirements (see Appendix 4)\n- 6. Adequate hematologic function as defined below: a. Platelet count ≥ 100 × 109/L (without transfusion within the past 7 days) b. ANC ≥ 1.5 × 109/L c. Hemoglobin ≥ 9 g/dL (without transfusion within the past 7 days)\n- 7. Creatinine clearance ≥ 60 mL/min calculated according to the Cockroft and Gault formula\n- 2. Age ≥ 18 years at the signing of ICF\n- 3. At least 1 measurable lesion as defined by RECIST 1.1 by radiologic methods and confirmed by the Investigator to meet both of the following criteria: a. Non-nodal lesion that measures ≥ 10 mm in the longest diameter or lymph node lesion that measures ≥ 15 mm in the short axis b. The lesion is suitable for repeat measurement using CT/MRI. Lesions that have had external beam radiotherapy or locoregional therapy must show radiographic evidence of subsequent growth.\n- 4. ECOG performance status of 0 or 1\n- 5. Life expectancy ≥ 12 weeks, in the opinion of the Investigator\n- 8. Please refer to the protocol for further criteria"}

Exclusion criteria

  • {"criterion_text":"- 1. Has untreated CNS metastases and/or carcinomatous meningitis a. Participants whose brain metastases have been treated may participate provided they show radiographic stability (defined as 2 brain images, both obtained after treatment to the brain metastases at least 4 weeks apart, that show no evidence of intracranial progression) b. In addition, any neurologic symptoms that developed either as a result of the brain metastases or their treatment must have returned to baseline or resolved. Any steroids administered as part of this therapy must be completed at least 3 days prior to study medication.\n- 2. Participation in an interventional clinical study with any investigational drug within 4 weeks prior to the first dose of study treatment OR participation in any clinical study with petosemtamab at any time prior to the first dose of study treatment, regardless of whether petosemtamab was received\n- 3. Please refer to the protocol for further criteria"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- ORR per Investigator assessment using RECIST 1.1","definition_or_measurement_approach":"Investigator assessment using RECIST 1.1"}

Secondary endpoints

  • {"endpoint_text":"- DoR per Investigator assessment using RECIST 1.1\n- DCR per Investigator assessment using RECIST 1.1\n- CBR per Investigator assessment using RECIST 1.1\n- PFS per Investigator assessment using RECIST 1.1\n- OS\n- AEs\n- Clinical laboratory data\n- Integrated analysis using population PK model approach\n- Please refer to Protocol for further secondary end points","definition_or_measurement_approach":"DoR/DCR/CBR/PFS: per Investigator assessment using RECIST 1.1; OS: overall survival (time-to-event); AEs: adverse event reporting per safety procedures; Clinical laboratory data: clinical laboratory assessments; Integrated analysis: using population PK model approach; 'Please refer to Protocol' - no definition provided here."}

Recruitment

Planned Sample Size
90
Recruitment Window Months
60
Consent Approach
Written informed consent required from each participant (must be able to provide written informed consent). Subject information and informed consent form documents are provided (multiple language versions available as listed, including French, Dutch, Italian, Spanish, Polish and English).

Geography

Total Number Of Sites
38
Total Number Of Participants
90

Belgium

Earliest CTIS Part Ii Submission Date
23-03-2026
Latest Decision Or Authorization Date
09-04-2026
Processing Time Days
17
Number Of Sites
2
Number Of Participants
15

Sites

Site Name
Institut Jules Bordet
Department Name
Lung Oncology
Contact Person Name
Mariana Brandão
Contact Person Email
mariana.brandao@hubruxelles.be
Site Name
UZ Leuven
Department Name
Respiratory Oncology
Contact Person Name
Els Wauters
Contact Person Email
els.wauters@uzleuven.be

France

Earliest CTIS Part Ii Submission Date
24-02-2026
Latest Decision Or Authorization Date
13-04-2026
Processing Time Days
48
Number Of Sites
12
Number Of Participants
15

Sites

Site Name
Assistance Publique Hopitaux De Paris
Department Name
Oncology Thoracic Unit
Contact Person Name
Marie Wislez
Contact Person Email
marie.wislez@aphp.fr
Site Name
Institut Paoli Calmettes
Department Name
Medical Oncology
Contact Person Name
Anne Madroszyk-Flandin
Contact Person Email
madroszyka@ipc.unicancer.fr
Site Name
Fondation Hopital Saint Joseph
Department Name
Oncology
Contact Person Name
Carole Helissey
Contact Person Email
chelissey@ghpsj.fr
Site Name
Centre Hospitalier Universitaire De Nantes
Department Name
Oncology
Contact Person Name
Elvire Pons-Tostivint
Contact Person Email
elvire.pons@chu-nantes.fr
Site Name
Centre Hospitalier Intercommunal Creteil
Department Name
Pneumology
Contact Person Name
Jean Bernard Auliac
Site Name
Institut Regional Du Cancer De Montpellier
Department Name
Medical Oncology
Contact Person Name
Quentin Thomas
Site Name
Centre Hospitalier Regional Et Universitaire De Brest
Department Name
Oncology
Contact Person Name
Gilles Quere
Contact Person Email
gilles.quere@chu-brest.fr
Site Name
Centre Hospitalier Universitaire De Rennes
Department Name
Pneumology
Contact Person Name
Hervé Lena
Contact Person Email
herve.lena@chu-rennes.fr
Site Name
Institut De Cancerologie De L Ouest
Department Name
Medical Oncology
Contact Person Name
Sandrine Hiret
Site Name
Centre Hospitalier Universitaire Grenoble Alpes
Department Name
Oncology
Contact Person Name
Denis Moro-Sibilot
Contact Person Email
DMoro-Sibilot@chu-grenoble.fr
Site Name
Institut Curie
Department Name
Pneumology
Contact Person Name
Nicolas Girard
Contact Person Email
nicolas.girard2@curie.fr
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
Oncology
Contact Person Name
Charlotte Domblides

Italy

Earliest CTIS Part Ii Submission Date
23-02-2026
Latest Decision Or Authorization Date
09-04-2026
Processing Time Days
45
Number Of Sites
5
Number Of Participants
15

Sites

Site Name
ASST Grande Ospedale Metropolitano Niguarda
Department Name
Falck Oncology Complex Structure
Contact Person Name
Diego Signorelli
Site Name
Azienda Ospedaliero Universitaria Careggi
Department Name
D.O.S. Oncological Radiotherapy
Contact Person Name
Lorenzo Livi
Contact Person Email
lorenzo.livi@unifi.it
Site Name
I.F.O. Istituti Fisioterapici Ospitalieri
Department Name
Oncology Medicine 2
Contact Person Name
Federico Cappuzzo
Contact Person Email
federico.cappuzzo@ifo.it
Site Name
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Department Name
Oncology-Hematology
Contact Person Name
Francesco Gelsomino
Contact Person Email
francesco_gelsomino@aosp.bo.it
Site Name
Humanitas Mirasole S.p.A.
Department Name
Medical Oncology and Hematology
Contact Person Name
Luca Toschi

Spain

Earliest CTIS Part Ii Submission Date
05-03-2026
Latest Decision Or Authorization Date
09-04-2026
Processing Time Days
35
Number Of Sites
12
Number Of Participants
15

Sites

Site Name
H.C. Hospitales S.L.
Department Name
Oncology
Contact Person Name
José Manuel Trigo
Contact Person Email
jmtrigo@seom.org
Site Name
Complejo Hospitalario Universitario Insular Materno Infantil
Contact Person Name
Delvys Rodriguez Abreu
Contact Person Email
delvysra@yahoo.com
Site Name
Hospital Universitario 12 De Octubre
Department Name
Oncology
Contact Person Name
Luis Gonzaga Paz-Ares
Contact Person Email
lpazaresr@seom.org
Site Name
Area Sanitaria Da Coruna E Cee
Department Name
Oncology
Contact Person Name
Maria Rosario Garcia Campelo
Site Name
Fundacion Rioja Salud
Department Name
CIBIR
Contact Person Name
Maria De Miguel
Contact Person Email
maria.demiguel@startrioja.com
Site Name
Hospital Universitari Vall D Hebron
Department Name
Oncology
Contact Person Name
Laura Masfarre
Contact Person Email
lauramasfarre@vhio.net
Site Name
Institut Catala D'oncologia
Department Name
oncology
Contact Person Name
Enric Carcereny
Contact Person Email
ecarcereny@iconcologia.net
Site Name
Hospital Alvaro Cunqueiro
Department Name
oncology
Contact Person Name
Martin Emilio Lazaro Quintela
Site Name
Clinica Universidad De Navarra
Department Name
oncology
Contact Person Name
Miguel Fernandez de Sanmamed
Contact Person Email
msanmamed@unav.es
Site Name
Hospital Quironsalud Malaga
Department Name
oncology
Contact Person Name
Manuel Cobo
Contact Person Email
manuel.cobo.co@quironsalud.es
Site Name
Fundacion Instituto De Investigacion Sanitaria De Navarra
Department Name
Oncology
Contact Person Name
Hugo Arasanz
Contact Person Email
info.idisna@navarra.es
Site Name
Hospital Universitario Lucus Augusti
Department Name
Oncology
Contact Person Name
Sergio Vazquez

Netherlands

Earliest CTIS Part Ii Submission Date
10-03-2026
Latest Decision Or Authorization Date
13-04-2026
Processing Time Days
34
Number Of Sites
1
Number Of Participants
15

Sites

Site Name
Leids Universitair Medisch Centrum (LUMC)
Department Name
Pulmonary Diseases
Contact Person Name
Egbert Frederik Smit
Contact Person Email
e.f.smit@lumc.nl

Poland

Earliest CTIS Part Ii Submission Date
27-03-2026
Latest Decision Or Authorization Date
13-04-2026
Processing Time Days
17
Number Of Sites
6
Number Of Participants
15

Sites

Site Name
Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy
Department Name
Oddział III Chorób Płuc
Contact Person Name
Aleksandra Szczęsna
Contact Person Email
aszczesna@otwock-szpital.pl
Site Name
Uniwersyteckie Centrum Kliniczne
Department Name
Ośrodek Badań Klinicznych Wczesnych Faz
Contact Person Name
Hanna Liberek
Contact Person Email
hliberek@uck.gda.pl
Site Name
Centrum Medyczne Damiana Holding Sp. z o.o.
Department Name
Dom Lekarski - Ambulatorium Struga
Contact Person Name
Bartosz Dąbek
Contact Person Email
bdabek@gmail.com
Site Name
I Przychodnia Lekarska Komed Roman Karaszewski
Department Name
Przychodnia lekarska „Komed”
Contact Person Name
Bogusława Karaszewska
Contact Person Email
komed.badania@gmail.com
Site Name
Uniwersytecki Szpital Kliniczny W Poznaniu
Department Name
Oddział Chemioterapii
Contact Person Name
Rodryg Ramlau
Contact Person Email
rramlau@gmail.com
Site Name
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Department Name
Oddział Zachowawczy Kliniki Nowotworów Płuca i Klatki Piersiowej
Contact Person Name
Dariusz Kowalski
Contact Person Email
dariusz.kowalski@pib-nio.pl

Sponsor

Primary sponsor

Full Name
Merus B.V.
Organisation Type
Pharmaceutical company
Country Of Registered Address
Netherlands

Investigational products

Investigational Product Name
petosemtamab (MCLA-158 / PB10651)
Active Substance
PETOSEMTAMAB
Modality
Other antibody
Routes Of Administration
IV INFUSION
Route
IV INFUSION
Authorisation Status
Not authorised / Investigational
Maximum Dose
max daily 1500 mg; max total 90000 mg
Investigational Product Name
KEYTRUDA 25 mg/mL concentrate for solution for infusion (pembrolizumab)
Active Substance
PEMBROLIZUMAB
Modality
Monoclonal antibody
Routes Of Administration
IV INFUSION
Route
IV INFUSION
Authorisation Status
Marketing authorisation (authorized product) - EU marketing authorisation present
Maximum Dose
max daily 400 mg; max total 9000 mg
Combination Treatment
Yes

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