Obrixtamig Phase 3 Trial for Advanced Extrapulmonary Neuroendocrine Cancer
Summary
NCT07544654 is a Phase 3 clinical trial registering adults with advanced extrapulmonary neuroendocrine cancer. The treatment arm receives obrixtamig plus standard chemotherapy (carboplatin and etoposide) followed by obrixtamig alone for up to 3 years, while the control arm receives standard chemotherapy alone for approximately 4 months. The trial also evaluates the Ventana DLL3 RxDx assay as a companion diagnostic device. The study is designated to begin on April 22, 2026.
“One group (treatment arm) receives obrixtamig and standard chemotherapy followed by obrixtamig alone for up to 3 years.”
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What changed
This ClinicalTrials.gov record registers a new Phase 3 clinical trial (NCT07544654) evaluating obrixtamig, an antibody-like molecule, in combination with carboplatin and etoposide chemotherapy for adults with unresectable locally advanced or metastatic extrapulmonary neuroendocrine carcinomas. The randomized study compares obrixtamig plus chemotherapy against chemotherapy alone as the control arm.
Pharmaceutical companies developing oncology therapeutics and clinical investigators conducting neuroendocrine cancer research should be aware of this trial's design, which includes a companion diagnostic device (Ventana DLL3 RxDx assay) and extended treatment duration of up to 3 years in the treatment arm. The study's primary endpoint focuses on survival improvement.
Archived snapshot
Apr 23, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
A Study in People With Advanced Extrapulmonary Neuroendocrine Cancer to Compare Obrixtamig Plus Carboplatin and Etoposide Treatment With Standard Chemotherapy
Phase 3 NCT07544654 Kind: PHASE3 Apr 22, 2026
Abstract
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.
Conditions: Unresectable Locally Advanced or Metastatic Extrapulmonary Neuroendocrine Carcinomas
Interventions: Obrixtamig, Carboplatin, Etoposide, Ventana DLL3 RxDx assay
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