Patients With High-grade Pancreatic Neuroendocrine Tumors

National Cancer Center (NCC)

Status and phase: Invitation-only; Phase 2

Conditions: Pancreatic Neuroendocrine Tumors; Neuroendocrine Tumor of Pancreas

Treatments: Drug: Lurbinectedin 4 MG Injection [Zepzelca]

Study type: Interventional

Funder types: Other

Identifiers

NCT07121478

NCC2024-0187

Details and patient eligibility

About

• 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.

Full 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.

Enrollment: 46 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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46 participants in 1 patient group

single arm

Experimental group

Description:

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.

Treatment:

Drug: Lurbinectedin 4 MG Injection [Zepzelca]