Clinical trialPhase 2Enrolling by invitation
Patients With High-grade Pancreatic Neuroendocrine Tumors
Lurbinectedin as a Second-line Treatment for High-grade Pancreatic Neuroendocrine Tumors
- Outcome
- Ongoing
- Phase
- Phase 2
- Status
- Enrolling by invitation
- Study type
- Interventional
- Start
- 23 September 2025
- Expected end
- 31 December 2029
- Enrollment
- 46 participants
- Sites
- 1
- Primary outcomes
- The overall response rate
- Sponsor type
- Other government
- Results posted
- No
- Last update
- 1 October 2025
These fields come from the trial’s registry entry. A summary of its population, design, endpoints and results, each tied to a quote, has not been written for this trial yet.
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Brief summary public domain (ClinicalTrials.gov)
* 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.
Detailed description public domain (ClinicalTrials.gov)
* 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.