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Neuroendocrine Tumor of PancreasPhase 2NCT07121478

Patients With High-grade Pancreatic Neuroendocrine Tumors

A Phase 2 study testing Lurbinectedin 4 MG Injection [Zepzelca] in people with Neuroendocrine Tumor of Pancreas and Pancreatic Neuroendocrine Tumors, run by National Cancer Center, Korea at 1 site in South Korea.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 19 years and older
What is being tested?
Lurbinectedin 4 MG Injection [Zepzelca]
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
46 participants
Where
1 siteSouth Korea
Study dates
23 Sep 2025to 31 Dec 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

South Korea1 site

  • National Cancer Center

    Goyang-si, Gyeonggi-do, 10408

Other trials in South Korea

About this study

Official title: Lurbinectedin as a Second-line Treatment for 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.
Read the detailed description
  • 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.
Being tested
Lurbinectedin 4 MG Injection [Zepzelca]
Keywords
Lurbinectedin, Neuroendocrine Tumors
Medical subject headings
Adenoma, Islet Cell, Neuroendocrine Tumors

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT07121478
Study groupRoleWhat they receive
single armExperimentalLurbinectedin 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.
Receives: Drug: Lurbinectedin 4 MG Injection [Zepzelca]

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 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)

  1. 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.

    Measured: 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

  2. Duration of response

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

    Measured: 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.

  3. Progression-free survival

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

    Measured: 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.

  4. Overall survival

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

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

  5. Evaluate the safety and tolerability of Lurbinectedin

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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Aug 2025
  2. Study start23 Sep 2025
  3. Primary completion1 Mar 2027 (estimated)
  4. Study completion31 Dec 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
46 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07121478
Sponsor's protocol ID
NCC2024-0187
Status last verified
Sep 2025
First submitted
15 Jun 2025
Last updated
1 Oct 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Plans for sharing individual participant data have not yet been finalized.

Publications

  • 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.

    PubMed 32864039

  • 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.

    PubMed 32224306

  • 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.

    PubMed 35830841

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Lurbinectedin 4 MG Injection [Zepzelca] in people with Neuroendocrine Tumor of Pancreas and Pancreatic Neuroendocrine Tumors, run by National Cancer Center, Korea at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 1 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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"). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07121478, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2025.

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