Lurbinectedin as second-line treatment for patients with high-grade pancreatic neuroendocrine tumors: a single-arm, open-label, phase 2 trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CRIS

Registry ID

KCT0009931

Enrollment

Registered

2024-11-18

Start date

2025-01-01

Completion date

Unknown

Last updated

2024-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

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 th

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: ? Voluntary written consent to participate in this study ? Aged =19 years ? Histologically confirmed diagnosis of grade 3 or higher neuroendocrine tumor/cancer (pNET/NEC) ? Failure of prior standard anti-cancer treatment ? Absolute neutrophil count (ANC) of =1,500 cells/mm3 and platelet count of =100,000/mm3 ? Ability to understand the study content, willingness to cooperate with the study protocols, and commitment to participate until the end of the study

Exclusion criteria

Exclusion criteria: ? History of receiving lurbinectedin ? Patients who are receiving treatment for other cancers (except for those who had received treatment and have been cancer-free for 2 years prior to enrollment) ? Pregnant or nursing women ? Deemed ineligible for inclusion in the study by the investigator

Design outcomes

Primary

Measure	Time frame
1) Primary efficacy endpoint The ORR assessed by the investigators (complete or partial response according to RECIST v1.1)	—

Secondary

Measure	Time frame
2) Secondary efficacy endpoints ? Disease control rate (ORR plus stable disease according to RECIST v1.1) ? Duration of response (duration between the date of the first response and the date of disease progression, relapse, or death) ? Progression-free survival (duration between the date of the first infusion and disease progression or death from any cause) ? Overall survival (duration between the date of the first infusion and death or loss to follow-up) ?Safety and tolerability of lurbinectedin (frequency, severity, significance, and relevance of adverse events that occurred after administration are evaluated using NCI-CTC AE v5.0) ? Biomarker should be identified by statistical methods for the correlation between disease control rates, response duration, progression-free survival, and overall survival.	—

Measure

Time frame

2) Secondary efficacy endpoints ? Disease control rate (ORR plus stable disease according to RECIST v1.1) ? Duration of response (duration between the date of the first response and the date of disease progression, relapse, or death) ? Progression-free survival (duration between the date of the first infusion and disease progression or death from any cause) ? Overall survival (duration between the date of the first infusion and death or loss to follow-up) ?Safety and tolerability of lurbinectedin (frequency, severity, significance, and relevance of adverse events that occurred after administration are evaluated using NCI-CTC AE v5.0) ? Biomarker should be identified by statistical methods for the correlation between disease control rates, response duration, progression-free survival, and overall survival.

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Countries

Korea, Republic of

Contacts

Public ContactMEE YOUNG LEE

National Cancer Center

leemyyoung@ncc.re.kr@ncc.re.kr+82-31-920-0740

Outcome results