Informations générales (source: ClinicalTrials.gov)
A Phase III, Multi-center, Open-label, Randomised, Controlled Trial of Intravenous Obrixtamig in Combination With Carboplatin and Etoposide vs. Carboplatin and Etoposide as First-line Therapy in DLL3-positive Patients With Unresectable Locally Advanced or Metastatic Extrapulmonary Neuroendocrine Carcinomas
Interventional
Phase 3
Boehringer Ingelheim (Voir sur ClinicalTrials)
juillet 2026
mars 2031
07 août 2026
This study is open to adults with advanced extrapulmonary neuroendocrine cancer. The
purpose of this study is to find out if a study medicine called obrixtamig plus standard
chemotherapy (carboplatin and etoposide) improves survival when compared to standard
chemotherapy (carboplatin and etoposide) alone. Obrixtamig is an antibody-like molecule
that may help the immune system fight cancer. Another purpose of the study is to test a
medical device being developed to measure levels of the tumour marker delta-like ligand 3
(DLL3).
Participants are put into 2 groups randomly, which means by chance. One group (treatment
arm) receives obrixtamig and standard chemotherapy followed by obrixtamig alone for up to
3 years. The other group (control arm) receives standard chemotherapy without obrixtamig
for about 4 months. All treatments are given as infusions into a vein.
During the study, participants in both groups visit the study site regularly.
Participants in the treatment arm stay overnight at the study site following the first 2
obrixtamig treatments. The doctors regularly check participants' health and take note of
any unwanted effects. At some of the visits, doctors check the size of the tumour(s). The
results are compared between the 2 groups to see whether the treatment works.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Julien HADOUX | 10/08/2026 15:05:31 | Contacter | ||
Critères
Tous
1. Patients with poorly differentiated unresectable locally advanced or metastatic
extrapulmonary neuroendocrine carcinoma (epNEC) with Ki-67 >20% or mitotic rate
mitotic rate with number of mitoses >20 per 2 mm2, regardless of primary site
(including site of unknown origin)
2. Patients with tumours with mixed histologies are eligible only if neuroendocrine
carcinoma component is predominant and represents more than 70% of the overall
tumour tissue
3. No prior systemic treatment for unresectable locally advanced or metastatic epNEC
(except for the completed one cycle of standard platinum + etoposide). Prior
peri-operative chemotherapy or -radiation for curative intention is allowed if at
least 6 months have elapsed between completion of this therapy and diagnosis of
unresectable locally advanced or metastatic disease
4. Patients who have finished one cycle of standard platinum + etoposide regimen as
first-line treatment (Cycle 0: etoposide with carboplatin or cisplatin, administered
at a minimum dose of cisplatin 75 mg/m2 or carboplatin area under the curve (AUC) 5
and etoposide 80 mg/m2) prior to randomisation
5. Patients must comply with criteria for receiving further chemotherapy treatment as
first-line standard of care (SoC) treatment within 28 days after the start of the
initial chemotherapy (Cycle 0)
6. Adequate archival Formalin-Fixed Paraffin-Embedded (FFPE) tumour tissue, as
specified in the Laboratory Manual, must be available for central laboratory
analysis of Delta-like ligand 3 (DLL3) expression status. Tumours must be positive
(as defined in the diagnostic study protocol) for DLL3 expression status assessed by
investigational VENTANA DLL3 (SP347) RxDx Assay
7. Eastern Cooperative Oncology Group (ECOG) score of 0 or 1
8. Male or female participants ≥18 years old and at least at the legal age of consent
in countries where it is greater than 18 years at the time of signature of the
informed consent form (ICF) Further inclusion criteria apply.
Exclusion Criteria:
1. Presence of leptomeningeal disease and/or carcinomatous meningitis
2. Patients with diagnosis of Merkel cell carcinoma or medullary thyroid carcinoma
3. Patients with neuroendocrine prostate cancer
4. Patients with well-differentiated neuroendocrine tumours of any grade according to
the world health organization (WHO) classification, 5th edition
5. Patients with a history of well differentiated Neuroendocrine tumour (NET) tumour
that transformed into poorly differentiated Neuroendocrine carcinoma (NEC)
6. Previous treatment with obrixtamig or other DLL3-targeting therapies (e.g. T-cell
engager (TcEs), cell therapies, antibody-drug conjugates, or radiopharmaceuticals)
7. Previous treatment with anti-PD-1 or programmed death ligand 1 (PD-L1) therapies
during the one cycle of standard platinum + etoposide first-line chemotherapy (Cycle
0)
8. Toxicity from previous treatments that has not resolved to ≤ Common Terminology
Criteria for Adverse Events (CTCAE) Grade 1 or grade prior to Cycle 0. Participants
with alopecia any grade, CTCAE ≤Grade 2 asthenia/fatigue, amenorrhea/menstrual
disorders any grade, CTCAE ≤Grade 2 peripheral neuropathy, and/or CTCAE ≤Grade 2
endocrinopathies controlled by replacement therapy, and toxicities, which are
considered irreversible but stable for at least 4 weeks, per Investigator judgement
may be eligible Further exclusion criteria apply.