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2025-07-15
2027-03-01
2029-12-31
46
NCT07121478
National Cancer Center, Korea
National Cancer Center, Korea
INTERVENTIONAL
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.
* 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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2025-06-15 | N/A | 2025-08-06 |
2025-08-06 | N/A | 2025-08-13 |
2025-08-13 | N/A | 2025-07 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Na
Interventional Model:
Single Group
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| 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. | DRUG: Lurbinectedin 4 MG Injection [Zepzelca]
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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 Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Disease control rate | 1. 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. | 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 response to the date of disease progression, relapse, or death | 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 | time from the date of first infusion to disease progression or death from any cause | 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 to death or loss to follow-up | 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 | Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 | From the date of first infusion until disease progression or death from any cause, whichever occurs first, assessed up to 24 months. |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
19 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
