Clinical trial · Interventional
Patients With High-grade Pancreatic Neuroendocrine Tumors
Lurbinectedin as a Second-line Treatment for High-grade Pancreatic Neuroendocrine Tumors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
* 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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neuroendocrine Tumor of Pancreas | — | UNRESOLVED | — |
| Pancreatic Neuroendocrine Tumors | Pancreatic Neuroendocrine Tumor | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lurbinectedin 4 MG Injection [Zepzelca] | Drug | Lurbinectedin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- single arm
- 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.
- interventionNames
- Drug: Lurbinectedin 4 MG Injection [Zepzelca]
Primary outcomes (1)
- measure
- The overall response rate
- timeFrame
- 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"
- description
- 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 (5)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
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
References
Publications (3)
- BACKGROUNDZhang 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
- BACKGROUNDTrigo 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
- BACKGROUNDLongo-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