Phase 3: testing Obrixtamig for Extrapulmonary Neuroendocrine Cancer (epNEC)
This study is open to adults with advanced extrapulmonary neuroendocrine cancer. this study wants 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.
Official registry: https://clinicaltrials.gov/study/NCT07544654 · Boehringer Ingelheim · enrollment listed as 390
What this phase means
Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Obrixtamig, Carboplatin, or Etoposide. The registry lists allocation as randomized. This study is open to adults with advanced extrapulmonary neuroendocrine cancer.
They plan to enroll about 390 people at 170 sites. Taking part typically means taking a study drug (or dummy pill), using or being fitted with a device plus check-ins.
Official title (unrewritten)
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
Interventions: Obrixtamig, Carboplatin, Etoposide, Ventana DLL3 RxDx assay
Primary outcome (registry wording): Overall survival (OS)
Who it is for (from inclusion criteria)
- Ages 18 Years to any
- 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)
- 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
- 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)
- Eastern Cooperative Oncology Group (ECOG) score of 0 or 1
Who the registry excludes
- Presence of leptomeningeal disease and/or carcinomatous meningitis
- Patients with diagnosis of Merkel cell carcinoma or medullary thyroid carcinoma
- Patients with neuroendocrine prostate cancer
- Patients with well-differentiated neuroendocrine tumours of any grade according to the world health organization (WHO) classification, 5th edition
- Patients with a history of well differentiated Neuroendocrine tumour (NET) tumour that transformed into poorly differentiated Neuroendocrine carcinoma (NEC)
- Previous treatment with obrixtamig or other DLL3-targeting therapies (e.g. T-cell engager (TcEs), cell therapies, antibody-drug conjugates, or radiopharmaceuticals)
- 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)
Public study contact (from the registry)
Boehringer Ingelheim
clintriage.rdg@boehringer-ingelheim.com
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
170 listed- Mayo Clinic — Scottsdale, Arizona (not_yet_recruiting)
- City of Hope-Duarte-56419 — Duarte, California (recruiting)
- University of California San Francisco — San Francisco, California (not_yet_recruiting)
- University of California Los Angeles — Santa Monica, California (not_yet_recruiting)
- Mayo Clinic - Florida — Jacksonville, Florida (not_yet_recruiting)
- Emory University — Atlanta, Georgia (recruiting)
- The University of Chicago Medical Center — Chicago, Illinois (not_yet_recruiting)
- The Skip Viragh Outpatient Cancer Research Building — Baltimore, Maryland (not_yet_recruiting)
- Dana-Farber Cancer Institute — Boston, Massachusetts (not_yet_recruiting)
- Mayo Clinic, Rochester — Rochester, Minnesota (not_yet_recruiting)
- Washington University School of Medicine — St Louis, Missouri (recruiting)
- Memorial Sloan-Kettering Cancer Center — New York, New York (not_yet_recruiting)
+ 149 sites outside the US on the same record
FAQ about this NCT record
Is NCT07544654 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT07544654?
Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT07544654?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
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