Patients With High-grade Pancreatic Neuroendocrine Tumors

NCT07121478 | Enrolling By Invitation Phase 2

• 1 other identifier: NCC2024-0187
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

• 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.

Conditions

Neuroendocrine Tumor of Pancreas; Pancreatic Neuroendocrine Tumors

Keywords

Lurbinectedin; Neuroendocrine Tumors

Outcome Measures

Primary Outcomes (1)

• The overall response rate

  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

  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"

Secondary Outcomes (5)

• 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.

Other Outcomes (1)

• Tissue and blood sampling for discovering biomarkers

  Every 6 weeks (two 28-day cycles) until the end of Cycle 6, and then every 9 weeks (three 28-day cycles) until documented disease progression or death from any cause, whichever occurs first, assessed up to 24 months.

Study Arms (1)

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.

Drug: Lurbinectedin 4 MG Injection [Zepzelca]

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.

single arm

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cancer Center, Korea: lead
• Seoul National University Bundang Hospital: collaborator
• Samsung Medical Center: collaborator
• Seoul National Hospital: collaborator
• Gangnam Severance Hospital: collaborator

Study Sites (1)

National Cancer Center

Goyang-si, Gyeonggi-do, 10408, South Korea

Location

Related Publications (3)

• 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 BACKGROUND

• 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 treatment for patients with small-cell lung cancer: a single-arm, open-label, phase 2 basket trial. Lancet Oncol. 2020 May;21(5):645-654. doi: 10.1016/S1470-2045(20)30068-1. Epub 2020 Mar 27.

  PMID: 32224306 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Adenoma, Islet Cell; Neuroendocrine Tumors

Interventions

PM 01183; Injections

Condition Hierarchy (Ancestors)

Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Pancreatic Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Sang Myung Woo(Principal), MD

  National Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: June 15, 2025
• First Posted: August 13, 2025
• Study Start: September 23, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): December 31, 2029
• Last Updated: October 1, 2025

Record last verified: 2025-09

Locations

KR (1)