Clinical Trials List
Protocol Number1438-0011
NCT Number(ClinicalTrials.gov Identfier)NCT07544654
Not yet recruiting
2026-05-01 - 2030-12-31
Phase III
Recruiting2
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
-
Trial Applicant
Boehringer Ingelheim
-
Sponsor
-
Trial scale
Multi-Regional Multi-Center
-
Update
2026/09/10
Investigators and Locations
Co-Principal Investigator
- San-Chi Chen 無
- Yi-Ping Hung 無
- 姜乃榕 無
- 唐振育 無
- 邱乃祈 無
Co-Principal Investigator
- Wen-Chi Chou 無
- Ming-Mo Hou 無
- Yung-Chia Kao 無
- Jen-Shi Chen 無
- 賴盈傑 無
- Chia-Hsun Hsieh 無
- Po-Jung Su 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
Yan-Shen Shan
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Extrapulmonary Neuroendocrine Cancer (epNEC)
Objectives
主要目的
本試驗將針對先前未接受治療且 DLL3 表現狀態檢測為陽性、無法切除之局部晚期或轉移性 epNEC 患者，比較 obrixtamig 併用 carboplatin 和 etoposide，相較於 carboplatin 併用 etoposide。
主要目的是為了證明在整體存活期 (OS) 方面具有優越性。將採用分層對數等級檢定和風險比來確定優越性。
Test Drug
注射用凍晶粉末
注射用懸液劑
注射用懸液劑
注射用懸液劑
注射用懸液劑
Active Ingredient
BI 764532 (Obrixtamig)
CARBOPLATIN
ETOPOSIDE
CARBOPLATIN
ETOPOSIDE
Dosage Form
048
27I
27I
27I
27I
Dosage
30 mg/vial
10 mg/ml
20 mg/mL
10 mg/ml
20 mg/mL
Endpoints
主要指標為 OS，定義為自隨機分配起至因任何原因死亡為止所經過的時間。
Inclution Criteria
Inclusion Criteria:
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
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 area under the curve (AUC) 5 and etoposide 80 mg/m2) prior to randomisation
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)
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
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.
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
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 area under the curve (AUC) 5 and etoposide 80 mg/m2) prior to randomisation
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)
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
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.
Exclusion Criteria
Exclusion Criteria:
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)
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.
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)
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.
The Estimated Number of Participants
-
Taiwan
14 participants
-
Global
390 participants
