2025-523869-22-00招募中3 期
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.
Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A.85 个研究点 分布在 10 个国家目标入组 144 人开始时间: 2026年6月26日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 144
- 试验地点
- 85
- 主要终点
- Overall survival (OS), defined as the time from randomisation until death from any cause
研究概览
简要总结
The trial will compare obrixtamig in combination with carboplatin and etoposide vs. carboplatin and etoposide in patients with unresectable locally advanced or metastatic epNEC, previously untreated and tested positive. The primary objective is to demonstrate the superiority in overall survival (OS).
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Patients with poorly differentiated unresectable locally advanced or metastatic 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
- •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
- •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 AUC 5 and etoposide 80 mg/m2) prior to randomisation
- •Patients must comply with criteria for receiving further chemotherapy treatment as first-line SoC treatment within 28 days after the start of the initial chemotherapy (Cycle 0)
- •Adequate archival FFPE tumour tissue, as specified in the Laboratory Manual, must be available for central laboratory analysis of 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
- •Eastern Cooperative Oncology Group (ECOG) score of 0 or 1
- •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.
排除标准
- •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 WHO classification, 5th edition
- •Patients with a history of well differentiated NET tumour that transformed into poorly differentiated NEC
- •Previous treatment with obrixtamig or other DLL3-targeting therapies (e.g. TcEs, cell therapies, antibody-drug conjugates, or radiopharmaceuticals)
- •Previous treatment with anti-PD-1 or PD-L1 therapies during the one cycle of standard platinum + etoposide first-line chemotherapy (Cycle 0)
- •Toxicity from previous treatments that has not resolved to ≤ CTCAE Grade 1 or grade prior to Cycle
- •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.
研究组 & 干预措施
Etoposid Hikma 20 mg/ml Konzentrat zur Herstellung einer Infusionslösung
Test
干预措施: Etoposid Hikma 20 mg/ml Konzentrat zur Herstellung einer Infusionslösung (Drug)
Carboplatin Hikma 10 mg/ml Konzentrat zur Herstellung einer Infusionslösung
Test
干预措施: Carboplatin Hikma 10 mg/ml Konzentrat zur Herstellung einer Infusionslösung (Drug)
Avtozma 20 mg/mL concentrate for solution for infusion.
Auxiliary
干预措施: Avtozma 20 mg/mL concentrate for solution for infusion. (Drug)
BI 764532
Test
干预措施: BI 764532 (Drug)
结局指标
主要结局
Overall survival (OS), defined as the time from randomisation until death from any cause
Overall survival (OS), defined as the time from randomisation until death from any cause
次要结局
- PFS is defined as the time from randomisation until the earliest date of disease progression according to RECIST 1.1 based on investigator assessments or death from any cause, whichever occurs first
- Change from baseline to Week 19 in the physical functioning domain of the EORTC QLQ-C30
- Objective response (OR) is defined as a best overall response of complete response (CR) or partial response (PR) according to RECIST 1.1 (based on investigator assessments) from randomisation until the earliest date of disease progression, death, last evaluable tumour assessment before the start of next line of anti-cancer treatment, loss to follow-up, or withdrawal of consent
- DoR, defined as the time from the first documented OR according to RECIST 1.1 until the earliest date of disease progression or death among patients with objective response based on investigator assessments
- Disease control (DC), defined as best overall response of complete response (CR) or partial response (PR) or stable disease (SD) where best overall response is defined according to RECIST 1.1 based on investigator assessments from randomisation until the earliest of disease progression, death or last evaluable tumour assessment before start of next line of anti-cancer treatment, loss to follow-up or withdrawal of consent
- Occurrence of treatment-emergent Grade 3 or greater CRS
- Occurrence of treatment-emergent Grade 3 or greater ICANS
- Occurrence of treatment-emergent AEs leading to permanent discontinuation of trial medication during the on-treatment period
- Occurrence of treatment-emergent AEs leading to dose modification of trial medication (i.e. dose interruption, dose delay, dose reduction)
研究者
CT Disclosure & Data Transparency
Scientific
Boehringer Ingelheim International GmbH
研究点 (85)
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