NCT07121478Enrolling By Invitation2 期
Lurbinectedin as a Second-line Treatment for High-grade Pancreatic Neuroendocrine Tumors
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- Enrolling By Invitation
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- The overall response rate
研究概览
简要总结
- Pancreatic neuroendocrine tumor (pNET) is a rare form of cancer. Treatment options such as hormonal therapy (octreotide) and targeted therapy (everolimus and sunitinib) may be considered for grade 1 or 2 pNETs; however, cytotoxic chemotherapy is essential in cases with grade 3 pNETs or pNECs.
- Cisplatin/etoposide remains the treatment of choice for high-grade pNET/pNEC. Other irinotecan-based therapies, such as FOLFIRI (cisplatin/irinotecan), FOLFOX, and temozolomide ± capecitabine, have been employed; however, a standard of care remains to be established.
详细描述
- Lurbinectedin, a selective inhibitor of oncogenic transcription, recently received accelerated FDA approval for lung cancer (small cell type) after demonstrating efficacy in an open-label, phase II basket study (ORR 35%, mOS 9.3 months, mPFS 3.5 months).
- A previous study that involved patients with grade 2 or higher NET/NEC who had undergone treatment with lurbinectedin revealed that the ORR, mOS, and mPFS of the six patients with pNET was 6.5%, 7.4 months, and 1.4 months, respectively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of Pancreatic neuroendocrine tumor or neuroendocrine carcinoma
- •Documented failure of prior standard anti-cancer treatment
- •Absolute neutrophil count (ANC) ≥ 1,500 cells/mm³
- •Platelet count ≥ 100,000 cells/mm³
- •Ability to understand study content, willingness to comply with study procedures, and commitment to complete the study
排除标准
- •Currently receiving treatment for other cancers (except those who completed treatment and have been disease-free for at least 2 years prior to enrollment)
- •Pregnant or breastfeeding women
- •Deemed unsuitable for participation by the investigator due to clinical or medical reasons
研究组 & 干预措施
single arm
Experimental
Lurbinectedin shall be administered intravenously at a dose of 3.2 mg/m2 over 60 minutes every 21 days. The administration of the study drug shall be continued until disease progression or the occurrence of unacceptable toxicity.
干预措施: Lurbinectedin 4 MG Injection [Zepzelca] (Drug)
结局指标
主要结局
The overall response rate
时间窗: From date of first administration of drug until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24months"
The proportion of participants who achieve a complete response (CR) or partial response (PR) as determined by the investigators according to the Response Evaluation Criteria in Solid Tumors
次要结局
- Disease control rate(From date of the first administration of drug until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months)
- Duration of response(From date of first documented response until the date of disease progression, relapse, or death from any cause, whichever occurs first, assessed up to 24 months.)
- Progression-free survival(From the date of first infusion until the date of first documented disease progression or death from any cause, whichever occurs first, assessed up to 24 months.)
- Overall survival(from the date of first infusion until death from any cause or loss to follow-up, whichever occurs first, assessed up to 24 months.)
- Evaluate the safety and tolerability of Lurbinectedin(From the date of first infusion until disease progression or death from any cause, whichever occurs first, assessed up to 24 months.)
研究者
Sang Myung Woo
Principal investigator
National Cancer Center, Korea
研究点 (1)
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