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Patients With High-grade Pancreatic Neuroendocrine Tumors

Patients With High-grade Pancreatic Neuroendocrine Tumors

Enrolling By Invitation
19 years and older
All
Phase 2

Overview

  • 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.

Description

  • 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.

Eligibility

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study details
    Neuroendocrine Tumor of Pancreas
    Pancreatic Neuroendocrine Tumors

NCT07121478

National Cancer Center, Korea

20 July 2026

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