Patients With High-grade Pancreatic Neuroendocrine Tumors

Phase 2Enrolling By InvitationNCT07121478

National Cancer Center, Korea46 enrolled

Overview

* 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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Neuroendocrine Tumor of Pancreas Pancreatic Neuroendocrine Tumors

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

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"

Secondary Outcomes

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.

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

Duration of response

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

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.

Progression-free survival

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

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.

Overall survival

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

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.

Evaluate the safety and tolerability of Lurbinectedin

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

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