Patients With High-grade Pancreatic Neuroendocrine Tumors

Официальное название

Lurbinectedin as a Second-line Treatment for High-grade Pancreatic Neuroendocrine Tumors

Обзор

* 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.

Подробное описание

* 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.

Вмешательства

• Препарат Lurbinectedin 4 MG Injection [Zepzelca]
  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.

Первичные конечные точки

• The overall response rate [Срок оценки: 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"]

Вторичные конечные точки (5)

• Disease control rate [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: From the date of first infusion until disease progression or death from any cause, whichever occurs first, assessed up to 24 months.]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

South Korea · 1 центр

• National Cancer Center — Goyang-si

Публикации

• Zhang MY, He D, Zhang S. Pancreatic neuroendocrine tumors G3 and pancreatic neuroendocrine carcinomas: Differences in basic biology and treatment. World J Gastrointest Oncol. 2020 Jul 15;12(7):705-718. doi: 10.4251/wjgo.v12.i7.705. PMID 32864039
• Trigo J, Subbiah V, Besse B, Moreno V, Lopez R, Sala MA, Peters S, Ponce S, Fernandez C, Alfaro V, Gomez J, Kahatt C, Zeaiter A, Zaman K, Boni V, Arrondeau J, Martinez M, Delord JP, Awada A, Kristeleit R, Olmedo ME, Wannesson L, Valdivia J, Rubio MJ, Anton A, Sarantopoulos J, Chawla SP, Mosquera-Martinez J, D'Arcangelo M, Santoro A, Villalobos VM, Sands J, Paz-Ares L. Lurbinectedin as second-line PMID 32224306
• Longo-Munoz F, Castellano D, Alexandre J, Chawla SP, Fernandez C, Kahatt C, Alfaro V, Siguero M, Zeaiter A, Moreno V, Sanz-Garcia E, Awada A, Santaballa A, Subbiah V. Lurbinectedin in patients with pretreated neuroendocrine tumours: Results from a phase II basket study. Eur J Cancer. 2022 Sep;172:340-348. doi: 10.1016/j.ejca.2022.06.024. Epub 2022 Jul 10. PMID 35830841

Идентификаторы

NCT: NCT07121478 · NCC2024-0187

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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