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
Unidade Local De Saúde De Santa Maria, E.P.E.	Lisbon	Portugal
Medical University Of Vienna	Vienna	Austria
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz	Mainz	Germany
Institut Gustave Roussy	Villejuif	France
Azienda Ospedaliero Universitaria Careggi	Florence	Italy
Technische Universitaet Dresden	Dresden	Germany
Katholieke Universiteit te Leuven	Leuven	Belgium
Oslo Universitetssykehus HF	Oslo	Norway
Hospital Universitario De Navarra	Pamplona	Spain
DRK Kliniken Berlin	Berlin	Germany

Other Sites

Site Name	City	Country
Fakultni Nemocnice Hradec Kralove	Novy Hradec Kralove	Czechia
Turku University Hospital	Turku	Finland
Istituto Europeo Di Oncologia S.r.l.	Milan	Italy
IRCCS Istituto Nazionale Tumori Fondazione Pascale	Naples	Italy
Hopital Beaujon	Clichy	France
Masarykuv Onkologicky Ustav	Brno-Stred	Czechia
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.	Porto	Portugal
Instituto Portugues De Oncologia De Lisboa Francisco Gentil E.P.E.	Lisbon	Portugal
Azienda Universitaria Ospedaliera Consorziale Policlinico Bari	Bari	Italy
Ciqaacccv Udwapnllvklkhx Scscuclqo	Woluwe-Saint-Lambert	Belgium
Ivqylubf Pltvgncwjxeisvw Cssslc Ctlclg	Marseille	France
Htgkhgup Vqqk dthkjwuh	Barcelona	Spain
Vhphuq dlu Rednv Uozplgqkau Hxudcrlp	Sevilla	Spain
Upofjisiyq Hqjkqkbp Cpelqvh	Cologne	Germany
Obnxau Uprnzgdsvt Hsgvraor	Odense	Denmark
Uwyebtoxhwrwtdyqdnjfj Eoxbcisq Aqr	Erlangen	Germany
Uqomwacxyzehpsaadsbao Tznexdbuw Adg	Tuebingen	Germany
Ricyrl Ssdui Svqier Ulmvhpnhlrcqiizbjww	Lund	Sweden
Hpqqb Bqaaal Hj	Bergen	Norway
Hmeegzso Uvlfpdgtdg Cglyezh Heiumpin	Helsinki	Finland
Eonlhee Uuikrqlddckf Mgcntue Cqiivvh Rjycjvlbs (xualplr Mlg	Rotterdam	The Netherlands
Hkzlvxoi Uhzvlkqqsvgix Fcdvukccv Jgzlrat Dhua	Madrid	Spain
Uursghgzuhwjgerpqbbeg Mevrnnuj Awk	Munster	Germany
Ucklucbybfopzdknrvhps Hawdwvvltx Abt	Heidelberg	Germany
Mfjggvn Cejwsh &adsvsl Ueretwknjm Os Ftmtfljy	Freiburg Im Breisgau	Germany
Rmpzomcwnscyfi	Copenhagen	Denmark
Uugsgpcluvjzmo Cppxttu Kxayhbqzl	Gdansk	Poland
Uravhsbwjj Ol Agalqji	Edegem	Belgium
Cifckn hyogyzgdrtp uxemkmiqcqwyd dd Lsgbh	Liege	Belgium
Unjnpzyshvah Mijkcuz Cjvfrgj Gdiegeauy	Groningen	The Netherlands
Hxtmwmiw Uwumsumhfrsjf 1s Dn Oynqkqd	Madrid	Spain
Hdsnhyod Uzkavrvfsxhdi Meaxdzu Do Vdrnatnkta	Santander	Spain
Hpemr Sqcrarjdi Hl	Stavanger	Norway
Fmjnxupjah Iifhkhunfe Ixqqvkrk Npeqpfitwfo Bwgob	Milan	Italy
Hkpkfpnv Cgj Propz Srbg	Porto	Portugal
Uqcgfnshpovmmg Cudugug Kucnbtszb Ixh Prcnh Kp Gyczelzyybu Seqdvcvvp Ujgdrsxhxngl Mtqxvassnp W Kxtnpulszt	Katowice	Poland
Cfzuwb Dw Ldkuy Cergut Lz Csuxlu Esetdc Mwoxogf	Rennes	France
Claglx Hnmludxrnmc Ukxijhxpcuwzt Di Defrz	Dijon	France
Uirgmkkrayisfljll Cukftw Bitpihuvyr Dy Rnun	Rome	Italy
Iaaxhmnnh dq Itsfbpqriaxku Sewdopfvh Fcqnohzdq piwx lg Iurbwrfgrbkrv dwy Hzotxhdm Ccqjzjs dx Vtswaatyanjzuhhq	Valencia	Spain
Pstgalhagbvbz hvpmibcptmcgjtd	Kuopio	Finland
Phquaiydcx htldignvlqtuzoy	Tampere	Finland
Noghrmfgjxg Cfdwtv Ipxhkqxek	Amsterdam	The Netherlands
Crksaq Rsibozel Cuuygqhe Dq Vxsdgg Sbvrmu	Verona	Italy
Aalxbjatq Kddeno So Gdclss	Hamburg	Germany
Sah Ofnoq Hwxexaoq Hm	Trondheim	Norway
Actfpxw Osiyylpmhea Uyipxdryrncaz Pojvcrecmgd Pxnrq Ggzawwpa	Palermo	Italy
Dscuhitndexc Ccjmggc Odmbebotz Pfjwnwxpmudb I Hrglgswmsgh	Wroclaw	Poland
Lbbwshgd Sqdx	Lisbon	Portugal
Hsrvwdrn Ugncqsyyeyvsy Hmgodmxd Tmzwu y Pbvdzk Iiearlov Cpscad deciulatvnwhyyxuh (gwno	Badalona	Spain
Afsdcbtwiw Zdgxzkyvjw Muclxadqhq	Maastricht	The Netherlands
Hecdfcru Cwwylz Dm Lreb	Lyon	France
Udaogfl Ucucithuro Hvnywbwo	Uppsala	Sweden
Cokrsq Hkpacgkqjss Unyspmqqkeuhw Dx Tajuymcj	Toulouse	France
Sxculuujhhk Utchfefyza Hbbeszic	Gothenburg	Sweden
Mkunqrt Unqvphtnku Ol Glqi	Graz	Austria
Aoukmm Uwiiufdxff Hvrjuwes	Aarhus	Denmark
Uohtpidbllivpzxjzwphu Wblovsnxg Alj	Wuerzburg	Germany

Trial status

Country	Status	Recruitment Start
Austria	Not yet recruiting	26.06.2026
Belgium	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	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	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?