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Enrolling by Invitation

NCT Number: NCT07121478

Patients With High-grade Pancreatic Neuroendocrine Tumors

* 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.

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Key information

Conditions

Neuroendocrine Tumor of Pancreas Adenoma Adenoma, Islet Cell Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Pancreatic Diseases Pancreatic Neoplasms Pancreatic Neuroendocrine Tumors

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

National Cancer Center

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

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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"

    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

Secondary outcomes

  1. Disease control rate

    Time frame: 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

    • Disease control is defined as the proportion of participants achieving complete response (CR), partial response (PR), or stable disease (SD) as assessed by investigators per RECIST v1.1 criteria.

  2. Duration of response

    Time frame: 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.

    from date of first response to the date of disease progression, relapse, or death

  3. Progression-free survival

    Time frame: 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.

    time from the date of first infusion to disease progression or death from any cause

  4. Overall survival

    Time frame: from the date of first infusion until death from any cause or loss to follow-up, whichever occurs first, assessed up to 24 months.

    from the date of first infusion to death or loss to follow-up

  5. Evaluate the safety and tolerability of Lurbinectedin

    Time frame: From the date of first infusion until disease progression or death from any cause, whichever occurs first, assessed up to 24 months.

    Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

Other outcomes

  1. Tissue and blood sampling for discovering biomarkers

    Time frame: 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.

    Biomarker should be identified by statistical methods for correlation between disease control rates, response duration, progression-free survival, and overall survival.

Sponsors and collaborators

Lead sponsor

National Cancer Center, Korea

Other Gov

Collaborators

  • Gangnam Severance Hospital
  • Samsung Medical Center
  • Seoul National Hospital
  • Seoul National University Bundang Hospital

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2029
First posted
Aug 13, 2025
Registry last updated
Oct 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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