Patients With High-grade Pancreatic Neuroendocrine Tumors

Conditions

• Neuroendocrine Tumor of Pancreas
• Pancreatic Neuroendocrine Tumors

Eligibility Criteria

Sex

ALL

Age

19 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Lurbinectedin 4 MG Injection [Zepzelca] — DRUG
  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.

Study Details

* 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.

Key Dates

Start date

Sep 23, 2025

Status verified

Sep 2025

Primary completion

Mar 1, 2027

Completion

Dec 31, 2029

Study Design

Enrollment

46 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: single arm
  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.

Primary Outcome Measure

The overall response rate [ Time Frame: 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" ]