Obrixtamig, Carboplatin, and Etoposide for First-Line Treatment of Advanced Extrapulmonary Neuroendocrine Carcinoma in DLL3-Positive Patients

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What is this study about?

This clinical trial is being done in people with advanced extrapulmonary neuroendocrine carcinoma, a rare cancer that starts outside the lungs and has spread or cannot be removed with surgery. The study will compare obrixtamig given into a vein together with carboplatin and etoposide with carboplatin and etoposide alone, which is standard chemotherapy. The purpose of the study is to see whether adding obrixtamig helps people live longer.

People in the study are placed into one of the treatment groups by chance. Treatment is given as intravenous infusion, which means medicine is delivered slowly through a vein. The study is planned to follow people over time while they receive treatment and after treatment ends to see how they do. The trial also watches for side effects, including cytokine release syndrome, a strong immune reaction, and ICANS, which is a group of brain and nerve symptoms that can happen with some immune treatments.

Obrixtamig is also known by the code name BI 764532. It is a type of treatment called a T cell engager, which is designed to help the immune system find and attack cancer cells that have DLL3 on their surface. The study is for previously untreated cancer that is DLL3-positive, meaning the cancer cells have this marker.

Who Can Join the Study?

Have a poorly differentiated unresectable locally advanced or metastatic extrapulmonary neuroendocrine carcinoma. Poorly differentiated means the cancer cells look very abnormal under a microscope. Unresectable means it cannot be removed with surgery. Locally advanced means it has grown into nearby areas. Metastatic means it has spread to other parts of the body. Extrapulmonary means it started outside the lungs.
Have a tumor with a Ki-67 level above 20% or a mitotic rate above 20 mitoses per 2 mm². Ki-67 is a test that shows how fast the cancer cells are growing. Mitotic rate means how many cells are dividing in a small area of the tumor.
Be eligible no matter where the cancer started, including if the original site is unknown.
If the tumor has more than one type of cancer tissue, the neuroendocrine carcinoma part must be the main part and make up more than 70% of the whole tumor. Neuroendocrine carcinoma is a cancer made from hormone-related cells.
Have had no previous systemic treatment for the unresectable locally advanced or metastatic cancer, except for having completed one cycle of standard platinum plus etoposide treatment. Systemic treatment means treatment that works throughout the body, such as chemotherapy.
May have had chemotherapy or radiation before surgery, if it was given with the goal of cure and at least 6 months have passed between finishing that treatment and being diagnosed with the unresectable locally advanced or metastatic disease.
Have already completed one cycle of standard first-line treatment with platinum plus etoposide before randomization. First-line treatment means the first treatment given for the cancer. Platinum can be carboplatin or cisplatin, and etoposide is a chemotherapy medicine.
Meet the requirements to continue receiving chemotherapy as first-line standard care within 28 days after the start of the first chemotherapy cycle.
Have enough stored tumor tissue from a previous biopsy or surgery, kept in a special preserved form called FFPE tissue. FFPE means the tissue was fixed in formalin and embedded in paraffin so it can be tested later.
Have tumor tissue that tests positive for DLL3 expression using the study test. DLL3 is a protein found on some cancer cells; expression means the protein is present.
Have an ECOG performance status of 0 or 1. ECOG is a scale that shows how well a person can do daily activities. A score of 0 means fully active, and 1 means only slight limitation in activity.
Be a male or female participant who is at least 18 years old, or older if the legal age of consent in the country is above 18 years, at the time of signing the consent form.

Who Cannot Join the Study?

Having leptomeningeal disease or carcinomatous meningitis, which means cancer has spread to the thin layers around the brain and spinal cord.
Having Merkel cell carcinoma, a rare type of skin cancer.
Having medullary thyroid carcinoma, a cancer that starts in the thyroid gland.
Having neuroendocrine prostate cancer, a cancer of the prostate with neuroendocrine features.
Having a well-differentiated neuroendocrine tumor of any grade, meaning a slower-growing type of neuroendocrine tumor under the WHO 5th edition classification.
Having a past well-differentiated neuroendocrine tumor that changed into a poorly differentiated neuroendocrine carcinoma, meaning the cancer became a more aggressive type.
Having had previous treatment with obrixtamig or other DLL3-targeting therapies, which are treatments designed to attack a protein called DLL3, including T-cell engagers, cell therapies, antibody-drug conjugates, or radiopharmaceuticals.
Having received anti-PD-1 or anti-PD-L1 treatment during the first cycle of standard platinum + etoposide chemotherapy, which is the usual first cancer treatment used in this study.
Having side effects from previous treatments that have not improved to Grade 1 or lower, meaning only mild or no side effects, or back to the level before the first chemotherapy cycle started.
Not being allowed to join if the remaining side effects are more than mild, except for certain cases that may still be allowed: hair loss, tiredness up to moderate level, absence of periods or menstrual changes, nerve damage up to moderate level, hormone problems controlled with replacement medicine, or stable side effects that cannot improve but have stayed the same for at least 4 weeks.
Other exclusion criteria also apply, so there may be additional reasons a person cannot take part.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Uniwersyteckie Centrum Kliniczne Im. Prof. K. Gibinskiego Slaskiego Uniwersytetu Medycznego W Katowicach	Katowice	Poland
Unidade Local De Saúde De Santa Maria, E.P.E.	Lisbon	Portugal
Medical University Of Vienna	Vienna	Austria
DRK Kliniken Berlin	Berlin	Germany
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz	Mainz	Germany
Universitaetsklinikum Heidelberg AöR	Heidelberg	Germany
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
Medical University Of Graz	Graz	Austria
University Hospital Maastricht	Maastricht	The Netherlands
Institut Gustave Roussy	Villejuif	France
Azienda Ospedaliero Universitaria Careggi	Florence	Italy
Oncopole Claudius Regaud	Toulouse	France
Technische Universitaet Dresden	Dresden	Germany
Katholieke Universiteit te Leuven	Leuven	Belgium
Oslo Universitetssykehus HF	Oslo	Norway
Hospital Universitario De Navarra	Pamplona	Spain

Other Sites

Site Name	City	Country
Centre De Lutte Contre Le Cancer Eugene Marquis	Rennes	France
Virgen del Rocío University Hospital	Sevilla	Spain
Odense University Hospital	Odense	Denmark
Universitaetsklinikum Erlangen AöR	Erlangen	Germany
Universitaetsklinikum Tuebingen AöR	Tuebingen	Germany
Region Skane Skanes Universitetssjukhus	Lund	Sweden
Universita’ Campus Bio-medico Di Roma	Rome	Italy
Fakultni Nemocnice Hradec Kralove	Novy Hradec Kralove	Czechia
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
Instituto Portugues De Oncologia De Lisboa Francisco Gentil E.P.E.	Lisbon	Portugal
Turku University Hospital	Turku	Finland
Medical Center – University Of Freiburg	Freiburg Im Breisgau	Germany
Region Midtjylland	Aarhus	Denmark
Instituto de Investigacion Sanitaria Fundacion para la Investigacion del Hospital Clinico de Valencia-INCLIVA	Valencia	Spain
Rigshospitalet	Copenhagen	Denmark
Pohjois-Savon hyvinvointialue	Kuopio	Finland
Pirkanmaan hyvinvointialue	Tampere	Finland
Netherlands Cancer Institute	Amsterdam	The Netherlands
Istituto Europeo Di Oncologia S.r.l.	Milan	Italy
IRCCS Istituto Nazionale Tumori Fondazione Pascale	Naples	Italy
Centro Ricerche Cliniche Di Verona S.r.l.	Verona	Italy
Centre hospitalier universitaire de Liege	Liege	Belgium
Centre Hospitalier Lyon Sud	Pierre Benite	France
Hopital Beaujon	Clichy	France
Hospital Universitario 12 De Octubre	Madrid	Spain
Asklepios Klinik St George	Hamburg	Germany
Masarykuv Onkologicky Ustav	Brno-Stred	Czechia
St. Olavs Hospital HF	Trondheim	Norway
Helse Stavanger HF	Stavanger	Norway
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone	Palermo	Italy
Queen Silvia Childrens Hospital – Sahlgrenska University Hospital – Vaestra Goetalandsregionen	Gothenburg	Sweden
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.	Porto	Portugal
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
Hospital CUF Porto S.A.	Porto	Portugal
Azienda Universitaria Ospedaliera Consorziale Policlinico Bari	Bari	Italy
Cnsdjitlh Unsuzhaiomvbfd Syiusqupp	Woluwe-Saint-Lambert	Belgium
Ieyrwire Pgwdzgjuxizoapi Cztywg Cbplme	Marseille	France
Hnlexnjo Vwbh doqzbvwd	Barcelona	Spain
Uplklqjieo Hrbxeltl Cxchjsm	Cologne	Germany
Clhyyw Hiwzannwusj Uahkaaqhzhela Dl Dmiey	Dijon	France
Uqcjumw Uojupgmnij Hefojkco	Uppsala	Sweden
Hmqfw Bntliu Hu	Bergen	Norway
Hrgwqhjh Utsjaaatwo Ccaubqq Hrkoumni	Helsinki	Finland
Ehpdhkl Uqhtucszmfac Mnjcanm Chaogob Rpcxgtiae (iajiazm Mkf	Rotterdam	The Netherlands
Umlvkpnlkmhmgdjclintk Muiyhbeh Acm	Munster	Germany
Ulclfdsftrxpbujvhpnkl Wjecfbnyj Aso	Wuerzburg	Germany
Uzwbttiqftiwkw Cetfebx Kuljujzjd	Gdansk	Poland
Uqbnzzxcfk Oa Amchelz	Edegem	Belgium
Uhdwglbbzowk Mvxzkoa Czoyeeb Gnjrevhkx	Groningen	The Netherlands
Hrynxiqe Ucapbkaalbhkd Mvqckrw Dv Vpmyqzxqex	Santander	Spain
Dbklthezbjrr Cofjbrv Omxuxuwaf Pzvwzysbfgfz I Hrdhhgfrabm	Wroclaw	Poland
Lfvpgyng Sgdd	Lisbon	Portugal
Hnozkdbd Ulqkzohqcvmne Hpphlkhs Ttchx y Plupxb Iwmivvji Cczcfh dyeurkembxykxsmiy (rehs	Badalona	Spain

Trial status

Country	Status	Recruitment Start
Austria	Not yet recruiting	26.06.2026
Belgium	Not yet recruiting	26.06.2026
Czechia	Not yet recruiting	26.06.2026
Denmark	Not yet recruiting	26.06.2026
Finland	Not yet recruiting	26.06.2026
France	Not yet recruiting	26.06.2026
Germany	Not yet recruiting	26.06.2026
Italy	Not yet recruiting	26.06.2026
Norway	Not yet recruiting	26.06.2026
Poland	Not yet recruiting	26.06.2026
Portugal	Not yet recruiting	26.06.2026
Spain	Not yet recruiting	26.06.2026
Sweden	Not yet recruiting	26.06.2026
The Netherlands	Not yet recruiting	26.06.2026

Trial locations

Investigated drugs:

BI 764532 is an experimental medicine given by infusion into a vein. It is being tested in this trial to see if adding it to standard treatment can help people with DLL3-positive advanced neuroendocrine cancer live longer. It is designed to attach to cancer cells and immune cells, helping the immune system find and attack the cancer.

Carboplatin is a chemotherapy medicine given by infusion into a vein. It is part of the standard treatment in this study and is used to help kill cancer cells or stop them from growing.

Etoposide is a chemotherapy medicine given by infusion into a vein. It is also part of the standard treatment and works together with carboplatin to treat the cancer by slowing or stopping cancer cell growth.

Avtozma is a medicine given by infusion into a vein that is used as background treatment in the trial. It is a form of tocilizumab and is commonly used to help control strong immune reactions, especially if the study treatment causes inflammation or an immune-related side effect.

Investigated diseases:

Neuroendocrine carcinoma

Advanced or metastatic extrapulmonary neuroendocrine carcinoma – A rare cancer that begins in hormone-producing cells outside the lungs and has spread to other parts of the body or cannot be removed by surgery. It usually grows quickly and may spread early to nearby tissues, lymph nodes, or distant organs. Symptoms can vary depending on where the cancer starts and where it spreads.

Trial ID:

2025-523869-22-00

Protocol code:

1438-0011

Trial Phase:

Therapeutic confirmatory (Phase III)

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Obrixtamig, Carboplatin, and Etoposide for First-Line Treatment of Advanced Extrapulmonary Neuroendocrine Carcinoma in DLL3-Positive Patients

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?