2025-520565-51-00招募中3 期
DAREON®-Lung-1: A Phase III multi-center, open-label, randomised trial of intravenous obrixtamig in combination with atezolizumab, carboplatin, and etoposide vs. atezolizumab, carboplatin, and etoposide as first-line treatment in patients with extensive-stage small cell lung cancer.
Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A.160 个研究点 分布在 12 个国家目标入组 295 人开始时间: 2026年3月5日最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 295
- 试验地点
- 160
研究概览
简要总结
The primary objective is to demonstrate the superiority in overall survival (OS) in at least 1 of 2 populations: 1) the overall population and 2) the DLL3 high (≥50% TC) population.
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 histologically confirmed ES-SCLC who have completed 1 cycle of first-line treatment (platinum, etoposide, with or without anti-PD-1/anti-PD-L1 therapy, administered at a minimum dose of cisplatin 75 mg/m2 or carboplatin AUC 5 and etoposide 80 mg/m2).
- •Patients without any previous systematic anti-cancer treatment for ES-SCLC (except for the completed 1 cycle of first-line treatment). Patients who received previous systematic anti-cancer treatment during limited stage are eligible if the treatment has been completed more than 6 months before the diagnosis of ES-SCLC.
- •Adequate archival formalin-fixed paraffin-embedded (FFPE) tumour tissue, as specified in the Laboratory Manual, must be available for central laboratory analysis of DLL3 expression status and other biomarkers. The central laboratory investigational VENTANA DLL3 (SP347) RxDx test result must be available prior to randomisation.
- •Patients with asymptomatic brain metastasis are eligible if they meet one of the following criteria: o Treatment for brain metastases (e.g. whole brain radiation therapy, stereotactic radiotherapy, or radiosurgery) completed at least 14 days prior to randomisation and neurologically stable without the use of glucocorticoids or therapeutic anti-convulsant for at least 7 days prior to randomisation o Untreated brain metastases that do not require treatment and are neurologically stable without the use of glucocorticoids or therapeutic anti-convulsant for at least 28 days prior to randomisation.
- •Eastern Cooperative Oncology Group (ECOG) score of 0 or
- •Eligible for continuing carboplatin + etoposide + atezolizumab regimen as first-line SoC treatment within 28 days after the start of the initial cycle of standard therapy.
- •Eligible to receive treatment with full dose of atezolizumab (1200 mg fixed dose), carboplatin (AUC 5), and etoposide (80-100 mg/m2) as first-line SoC treatment, in accordance with the approved Summary of Product Characteristics if provided centrally or approved local product label if provided by the trial site.
- •Further inclusion criteria apply.
排除标准
- •Presence of leptomeningeal disease and/or carcinomatous meningitis.
- •Previous treatment targeting DLL3 (e.g. TcEs, cell therapies, antibody-drug conjugates, or radiopharmaceuticals).
- •Radiotherapy of any anatomical sites within 14 days prior to randomisation.
- •Persistent toxicity from previous treatments that has not resolved to ≤CTCAE Grade 1 (except for alopecia, asthenia/fatigue, amenorrhea/menstrual disorders, CTCAE Grade 2 peripheral neuropathy, and CTCAE Grade 2 endocrinopathies controlled by replacement therapy, and toxicities, which are considered irreversible but stable for at least 4 weeks prior to randomisation, per investigator judgment).
- •Patient with active autoimmune disease or a documented history of autoimmune disease that requires systemic treatment (e.g. glucocorticoids or immunosuppressive drugs). Patients with vitiligo, resolved childhood asthma/atopy, alopecia, or any chronic skin condition that does not require systemic therapy, patients with autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone and/or controlled Type 1 diabetes mellitus on a stable insulin regimen may be included if in the opinion of the investigator it is appropriate and safe to do so.
- •Further exclusion criteria apply.
研究组 & 干预措施
BI 764532
Test
干预措施: BI 764532 (Drug)
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)
RoActemra 20 mg/mL concentrate for solution for infusion
Auxiliary
干预措施: RoActemra 20 mg/mL concentrate for solution for infusion (Drug)
Tecentriq 1 200 mg concentrate for solution for infusion
Test
干预措施: Tecentriq 1 200 mg concentrate for solution for infusion (Drug)
研究者
CT Disclosure & Data Transparency
Scientific
Boehringer Ingelheim International GmbH
研究点 (160)
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